+++ CV Therapeutics Inc (CVTX) - Kurssturz +++ - 500 Beiträge pro Seite
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Reuters
CV shares fall on FDA concerns over angina drug
Monday December 8, 10:00 am ET
NEW YORK, Dec 8 (Reuters) - U.S. regulators on Monday expressed concern that an angina drug being developed by CV Therapeutics Inc. (NasdaqNM:CVTX - News) causes an electrical impulse problem that could result in abnormal heart rhythms, sending shares of the company down 16 percent.
Concerns voiced by reviewers for the U.S. Food and Drug Administration (News - Websites) were posted on the agency`s Web site on Monday in advance of Tuesday`s meeting of a FDA advisory panel to evaluate whether the medicine, Ranexa, should be approved.
____________________________________________________________
Hat jemand weitere Infos - es geht bei mir nichts über die Ticker! Morgen soll die FDA-Entscheidung über Ranexa kommen.
Thanx!
Kosto
CV shares fall on FDA concerns over angina drug
Monday December 8, 10:00 am ET
NEW YORK, Dec 8 (Reuters) - U.S. regulators on Monday expressed concern that an angina drug being developed by CV Therapeutics Inc. (NasdaqNM:CVTX - News) causes an electrical impulse problem that could result in abnormal heart rhythms, sending shares of the company down 16 percent.
Concerns voiced by reviewers for the U.S. Food and Drug Administration (News - Websites) were posted on the agency`s Web site on Monday in advance of Tuesday`s meeting of a FDA advisory panel to evaluate whether the medicine, Ranexa, should be approved.
____________________________________________________________
Hat jemand weitere Infos - es geht bei mir nichts über die Ticker! Morgen soll die FDA-Entscheidung über Ranexa kommen.
Thanx!
Kosto
Der Kursverfall heute läßt nix Gutes erahnen...
mfg
Money
mfg
Money
BIOTECH STOCKS
CV Therapeutics falls; biotechs mixed
By Ted Griffith, CBS.MarketWatch.com
Last Update: 9:45 AM ET Dec. 8, 2003
BOSTON (CBS.MW) -- Biotechnology stocks were mixed in early trading Monday, with shares of CV Therapeutics tumbling ahead of a crucial regulatory review.
The Amex Biotechnology Index (BTK: news, chart, profile) dipped 0.3 percent, while the Nasdaq Biotechnology Index (NBI: news, chart, profile) edged up 0.3 percent.
CV Therapeutics (CVTX: news, chart, profile) plunged $2.80, or 16.7 percent, to $13.96. A Food and Drug Administration advisory panel on Tuesday is expected to make a recommendation on whether CV Therapeutics` experimental angina treatment, Ranexa, should be approved. The FDA typically follows the recommendations of its advisory panels.
Among the leading gainers, shares of American Pharmaceutical Partners (APPX: news, chart, profile) jumped $1.65 to $37.15. The drugmaker late Friday said its breast cancer therapy produced encouraging results in late-stage patient testing.
Ted Griffith is a reporter for CBS.MarketWatch.com
CV Therapeutics falls; biotechs mixed
By Ted Griffith, CBS.MarketWatch.com
Last Update: 9:45 AM ET Dec. 8, 2003
BOSTON (CBS.MW) -- Biotechnology stocks were mixed in early trading Monday, with shares of CV Therapeutics tumbling ahead of a crucial regulatory review.
The Amex Biotechnology Index (BTK: news, chart, profile) dipped 0.3 percent, while the Nasdaq Biotechnology Index (NBI: news, chart, profile) edged up 0.3 percent.
CV Therapeutics (CVTX: news, chart, profile) plunged $2.80, or 16.7 percent, to $13.96. A Food and Drug Administration advisory panel on Tuesday is expected to make a recommendation on whether CV Therapeutics` experimental angina treatment, Ranexa, should be approved. The FDA typically follows the recommendations of its advisory panels.
Among the leading gainers, shares of American Pharmaceutical Partners (APPX: news, chart, profile) jumped $1.65 to $37.15. The drugmaker late Friday said its breast cancer therapy produced encouraging results in late-stage patient testing.
Ted Griffith is a reporter for CBS.MarketWatch.com
alle Biotechaktien sind überbewerteter Schrott.
Dazu nur folgene Meldung:
Bittere Pille
Viele Medikamente unwirksam
Der Vizepräsident eines der führenden Pharmaunternehmen Europas hat ein vernichtendes Urteil über seine Branche gefällt. Die meisten rezeptpflichtigen Medikamente seien bei vielen Menschen unwirksam, stellte Allen Roses, Vizepräsident des Unternehmens für Genetik, in einem Interview mit der britischen Zeitung "The Independent" fest:
"Die große Mehrheit der Medikamente - mehr als 90 Prozent - sind nur bei 30 bis 50 Prozent der Leute wirksam." Ob das auch für die Medikamente von Glaxo zutrifft, ließ Roses offen.
Roses befasst sich in seinem Spezialgebiet damit herauszufinden, warum bestimmte Stoffe bei einigen Menschen wirken und bei anderen nicht. Bislang versuchen Pharmafirmen, Medikamente zu entwickeln, die bei möglichst vielen Menschen wirken.
GlaxoSmithKline gehe zunehmend von diesem Prinzip "Ein Medikament, passend für alle" ab, sagte Roses. Ziel sei die Herstellung von Medikamenten, die speziell auf die Wirksamkeit bei bestimmten Menschen zugeschnitten seien.
Wusst ich doch. die Patienten fressen alle Placebos und geben dafür Milliarden aus.
Dazu nur folgene Meldung:
Bittere Pille
Viele Medikamente unwirksam
Der Vizepräsident eines der führenden Pharmaunternehmen Europas hat ein vernichtendes Urteil über seine Branche gefällt. Die meisten rezeptpflichtigen Medikamente seien bei vielen Menschen unwirksam, stellte Allen Roses, Vizepräsident des Unternehmens für Genetik, in einem Interview mit der britischen Zeitung "The Independent" fest:
"Die große Mehrheit der Medikamente - mehr als 90 Prozent - sind nur bei 30 bis 50 Prozent der Leute wirksam." Ob das auch für die Medikamente von Glaxo zutrifft, ließ Roses offen.
Roses befasst sich in seinem Spezialgebiet damit herauszufinden, warum bestimmte Stoffe bei einigen Menschen wirken und bei anderen nicht. Bislang versuchen Pharmafirmen, Medikamente zu entwickeln, die bei möglichst vielen Menschen wirken.
GlaxoSmithKline gehe zunehmend von diesem Prinzip "Ein Medikament, passend für alle" ab, sagte Roses. Ziel sei die Herstellung von Medikamenten, die speziell auf die Wirksamkeit bei bestimmten Menschen zugeschnitten seien.
Wusst ich doch. die Patienten fressen alle Placebos und geben dafür Milliarden aus.
10:53AM CV Therapeutics cut to Neutral at First Albany (CVTX) 13.05 -3.71: -- Update -- First Albany downgrades to Neutral from Buy and cuts their target to $13 from $43 following the FDA briefing documents that implied that it is unlikely that Ranexa can be approved without a substantial new clinical trial. In the documents, the FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits. Firm believes that the stock could trade as low as the $10-$13 level, but not to the $5.81 net cash value since the drug has been deemed "approvable".
Reuters
UPDATE - CV shares fall on FDA concerns over angina drug
Monday December 8, 11:14 am ET
(Recasts first sentence, adds details)
NEW YORK, Dec 8 (Reuters) - An angina drug being developed by CV Therapeutics Inc. (NasdaqNM:CVTX - News) could cause greater heart risks than the company has suggested, U.S. regulators said on Monday, sending CV shares down about 23 percent.
The concerns were raised by staff members of the U.S. Food and Drug Administration (News - Websites) in memos posted on the agency`s Web site in advance of Tuesday`s meeting of an FDA advisory panel to evaluate whether the drug, Ranexa, should be approved.
Ranexa is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The memos emphasized a potential health risk called QT prolongation, in which there is a delay in the time it takes the heart to electrically recharge itself. The problem can lead to fatal heart arrhythmias, and has caused the FDA to reject medicines in the past or delay their approvals.
A staff memo on the FDA Web site from John Koerner, of the agency`s cardio-renal drug products division, said the company had failed in its attempt to prove that QT prolongation is not a concern.
CV Therapeutics, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make it profitable.
In a memo dated Oct. 23, Koerner said the drug caused worrisome electrical irregularities in some animals but not in others and that the studies therefore could not rule out the possibility of causing heart rhythm problems in people.
"These study results do not alter the previous conclusion that the nonclinical electrophysiology findings do not preclude human risk," he wrote.
The FDA in October had granted conditional approval for Ranexa, making final approval conditional on the company providing additional clinical information.
Ranexa works by directing the heart to burn sugar for energy instead of fat.
FDA advisory panels often meet in the weeks before a final decision is made on a drug so that leading independent physicians can weigh its merits on both safety and effectiveness.
Shares of CV Therapeutics, based in Palo Alto, California, were down $3.78 at $12.98 in morning trading on the Nasdaq, where it was the top percentage loser.
UPDATE - CV shares fall on FDA concerns over angina drug
Monday December 8, 11:14 am ET
(Recasts first sentence, adds details)
NEW YORK, Dec 8 (Reuters) - An angina drug being developed by CV Therapeutics Inc. (NasdaqNM:CVTX - News) could cause greater heart risks than the company has suggested, U.S. regulators said on Monday, sending CV shares down about 23 percent.
The concerns were raised by staff members of the U.S. Food and Drug Administration (News - Websites) in memos posted on the agency`s Web site in advance of Tuesday`s meeting of an FDA advisory panel to evaluate whether the drug, Ranexa, should be approved.
Ranexa is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The memos emphasized a potential health risk called QT prolongation, in which there is a delay in the time it takes the heart to electrically recharge itself. The problem can lead to fatal heart arrhythmias, and has caused the FDA to reject medicines in the past or delay their approvals.
A staff memo on the FDA Web site from John Koerner, of the agency`s cardio-renal drug products division, said the company had failed in its attempt to prove that QT prolongation is not a concern.
CV Therapeutics, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make it profitable.
In a memo dated Oct. 23, Koerner said the drug caused worrisome electrical irregularities in some animals but not in others and that the studies therefore could not rule out the possibility of causing heart rhythm problems in people.
"These study results do not alter the previous conclusion that the nonclinical electrophysiology findings do not preclude human risk," he wrote.
The FDA in October had granted conditional approval for Ranexa, making final approval conditional on the company providing additional clinical information.
Ranexa works by directing the heart to burn sugar for energy instead of fat.
FDA advisory panels often meet in the weeks before a final decision is made on a drug so that leading independent physicians can weigh its merits on both safety and effectiveness.
Shares of CV Therapeutics, based in Palo Alto, California, were down $3.78 at $12.98 in morning trading on the Nasdaq, where it was the top percentage loser.
Dow Jones Business News
FDA May Require More Trials of CV Therapeutics` Ranexa
Monday December 8, 11:16 am ET
By Hollister H. Hovey
NEW YORK -- Shares of CV Therapeutics slumped after documents from Food and Drug Administration (News - Websites) staff said the company may need to run more clinical trials of its angina drug Ranexa before it can be approved.
ADVERTISEMENT
The FDA`s Cardiac and Renal Drugs Advisory Committee will discuss CV Therapeutics` marketing application for Ranexa on Tuesday, but the agency posted its analyses of the data on its Web site Monday.
"Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said.
The advisory committee will discuss the company`s data and the agency`s take on it and give the FDA a recommendation, which it usually will accept.
At about 11 a.m. EST on the Nasdaq Stock Market (News - Websites) , shares of CV Therapeutics were down $3.69, or 22%, at $13.07 on volume of 8.5 million. The daily average is 1.4 million. The stock earlier fell to a 52-week low of $12.51.
According to the FDA documents, the agency is asking the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing the drug to placebo. The FDA said CV Therapeutics could run that study on patients who have failed other angina drugs.
The company also needs to clarify appropriate dosing, the agency said, and will ask CV Therapeutics to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said.
In addition, the FDA has concerns about side effects, most notably the increase the so-called QTc interval, or the time between heart beats that occurred during the clinical trial. There were incidences of a three- to nine- millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death.
The FDA is also concerned about drug interactions.
First Albany analyst David Webber said in a research note Monday he expects the stock to trade in the $10 to $13 range if the FDA voiced strong concerns about the QTc interval, which it has. He doesn`t own shares of CV Therapeutics, but First Albany did act as co-manager of the company`s most-recent convertible- debt offering.
In late October, CV Therapeutics received an approvable letter from the FDA, indicating that the agency thinks the drug works.
In August, the company and the advisory panel canceled a review planned for September, citing a need for ongoing talks and more time to put together documents. CV Therapeutics` shares lost more than 25% of their value on the news, which also prompted a shareholder lawsuit.
The cancellation of that meeting, which the FDA had scheduled for Sept. 15-16, had no bearing on the fact that the agency had to decide by Thursday whether to approve Ranexa. But most analysts thought the chances of receiving approval were slim without an advisory-board meeting.
However, investors sent the company`s stock soaring Oct. 23, when the company said the FDA panel would review Ranexa on Dec. 9 despite the fact there was no new scientific data about the QTc levels made public.
If approved, Ranexa would represent the first new class of antiangina therapy in more than 20 years. Ranexa is meant to change the heart`s metabolism so that it uses up sugars more than lipids.
Company officials weren`t immediately available to comment.
-By Hollister H. Hovey; Dow Jones Newswires; 201-938-5287; hollister.hovey@dowjones.com
FDA May Require More Trials of CV Therapeutics` Ranexa
Monday December 8, 11:16 am ET
By Hollister H. Hovey
NEW YORK -- Shares of CV Therapeutics slumped after documents from Food and Drug Administration (News - Websites) staff said the company may need to run more clinical trials of its angina drug Ranexa before it can be approved.
ADVERTISEMENT
The FDA`s Cardiac and Renal Drugs Advisory Committee will discuss CV Therapeutics` marketing application for Ranexa on Tuesday, but the agency posted its analyses of the data on its Web site Monday.
"Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said.
The advisory committee will discuss the company`s data and the agency`s take on it and give the FDA a recommendation, which it usually will accept.
At about 11 a.m. EST on the Nasdaq Stock Market (News - Websites) , shares of CV Therapeutics were down $3.69, or 22%, at $13.07 on volume of 8.5 million. The daily average is 1.4 million. The stock earlier fell to a 52-week low of $12.51.
According to the FDA documents, the agency is asking the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing the drug to placebo. The FDA said CV Therapeutics could run that study on patients who have failed other angina drugs.
The company also needs to clarify appropriate dosing, the agency said, and will ask CV Therapeutics to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said.
In addition, the FDA has concerns about side effects, most notably the increase the so-called QTc interval, or the time between heart beats that occurred during the clinical trial. There were incidences of a three- to nine- millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death.
The FDA is also concerned about drug interactions.
First Albany analyst David Webber said in a research note Monday he expects the stock to trade in the $10 to $13 range if the FDA voiced strong concerns about the QTc interval, which it has. He doesn`t own shares of CV Therapeutics, but First Albany did act as co-manager of the company`s most-recent convertible- debt offering.
In late October, CV Therapeutics received an approvable letter from the FDA, indicating that the agency thinks the drug works.
In August, the company and the advisory panel canceled a review planned for September, citing a need for ongoing talks and more time to put together documents. CV Therapeutics` shares lost more than 25% of their value on the news, which also prompted a shareholder lawsuit.
The cancellation of that meeting, which the FDA had scheduled for Sept. 15-16, had no bearing on the fact that the agency had to decide by Thursday whether to approve Ranexa. But most analysts thought the chances of receiving approval were slim without an advisory-board meeting.
However, investors sent the company`s stock soaring Oct. 23, when the company said the FDA panel would review Ranexa on Dec. 9 despite the fact there was no new scientific data about the QTc levels made public.
If approved, Ranexa would represent the first new class of antiangina therapy in more than 20 years. Ranexa is meant to change the heart`s metabolism so that it uses up sugars more than lipids.
Company officials weren`t immediately available to comment.
-By Hollister H. Hovey; Dow Jones Newswires; 201-938-5287; hollister.hovey@dowjones.com
The FDA typically follows the recommendations of its advisory panels.
Da steht´s ja auch! Normalerweise wird den Empfehlungen gefolgt. Die scheinen nicht positiv auslegbar zu sein. Wenn morgen die Entscheidung raus ist, kann man sicher irgendwann wieder einsteigen. es gibt noch mehr Produkte in der Pipeline. Aber kurz- und mittelfristig sieht´s düster aus, wenn morgen die FDA gegen CVTX spricht.
Da steht´s ja auch! Normalerweise wird den Empfehlungen gefolgt. Die scheinen nicht positiv auslegbar zu sein. Wenn morgen die Entscheidung raus ist, kann man sicher irgendwann wieder einsteigen. es gibt noch mehr Produkte in der Pipeline. Aber kurz- und mittelfristig sieht´s düster aus, wenn morgen die FDA gegen CVTX spricht.
BIOTECH REPORT
CV Therapeutics hit by FDA concerns
Agency`s report highlights risk of cardiac side effects
By Ted Griffith, CBS.MarketWatch.com
Last Update: 11:49 AM ET Dec. 8, 2003
BOSTON (CBS.MW) -- Shares of CV Therapeutics sank to their lowest level in four years on Monday amid concerns about the regulatory outlook for the biotech firm`s lead product candidate, an angina drug.
Shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) plunged $3.86, or 23 percent, to $12.91 after earlier touching $12.51, a level not seen since late 1999.
Shares were under pressure amid renewed concerns about a cardiac side effect associated with Ranexa, the company`s experimental treatment for angina, a painful heart condition.
A Food and Drug Administration advisory panel is expected to vote Tuesday on whether to recommend Ranexa for approval. The final decision will be up to the FDA, but the federal agency typically follows the recommendations of its advisory panels, which are made up of outside medical experts.
Ahead of the panel meeting, the FDA on its web site published its own assessment of Ranexa. The commentary, prepared by internal FDA experts, raised questions about the potential for Ranexa to cause a heart rhythm, side effect. The side effect, known as QT prolongation, can be an indication of a developing heart arrhythmia, a potentially life-threatening condition.
The FDA report said Ranexa appears to have effectiveness but called for further study. CV Therapeutics has no drugs on the market and Ranexa is its lead product candidate.
Following the release of the FDA`s commentary, analyst David Webber at First Albany cut his rating on CV Therapeutics` shares to "neutral" from "buy."
"The FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber wrote in a note to clients.
The FDA in October had said it would grant CV Therapeutics conditional approval for Ranexa, but also indicated that further clinical trials would be necessary before the drug would be allowed on the market. Such trials are often time-consuming and expensive for a company to perform.
A spokesman for CV Therapeutics wasn`t immediately available for comment.
Ted Griffith is a reporter for CBS.MarketWatch.com
CV Therapeutics hit by FDA concerns
Agency`s report highlights risk of cardiac side effects
By Ted Griffith, CBS.MarketWatch.com
Last Update: 11:49 AM ET Dec. 8, 2003
BOSTON (CBS.MW) -- Shares of CV Therapeutics sank to their lowest level in four years on Monday amid concerns about the regulatory outlook for the biotech firm`s lead product candidate, an angina drug.
Shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) plunged $3.86, or 23 percent, to $12.91 after earlier touching $12.51, a level not seen since late 1999.
Shares were under pressure amid renewed concerns about a cardiac side effect associated with Ranexa, the company`s experimental treatment for angina, a painful heart condition.
A Food and Drug Administration advisory panel is expected to vote Tuesday on whether to recommend Ranexa for approval. The final decision will be up to the FDA, but the federal agency typically follows the recommendations of its advisory panels, which are made up of outside medical experts.
Ahead of the panel meeting, the FDA on its web site published its own assessment of Ranexa. The commentary, prepared by internal FDA experts, raised questions about the potential for Ranexa to cause a heart rhythm, side effect. The side effect, known as QT prolongation, can be an indication of a developing heart arrhythmia, a potentially life-threatening condition.
The FDA report said Ranexa appears to have effectiveness but called for further study. CV Therapeutics has no drugs on the market and Ranexa is its lead product candidate.
Following the release of the FDA`s commentary, analyst David Webber at First Albany cut his rating on CV Therapeutics` shares to "neutral" from "buy."
"The FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber wrote in a note to clients.
The FDA in October had said it would grant CV Therapeutics conditional approval for Ranexa, but also indicated that further clinical trials would be necessary before the drug would be allowed on the market. Such trials are often time-consuming and expensive for a company to perform.
A spokesman for CV Therapeutics wasn`t immediately available for comment.
Ted Griffith is a reporter for CBS.MarketWatch.com
Reuters
UPDATE - CV shares plunge on FDA concerns over angina drug
Monday December 8, 12:08 pm ET
By Ransdell Pierson and Jed Seltzer
(Adds details, analyst quotes, updates share price)
NEW YORK, Dec 8 (Reuters) - An experimental angina drug could cause greater heart risks than developer CV Therapeutics Inc. (NasdaqNM:CVTX - News) has suggested, U.S. regulators said on Monday, sending the company`s shares down about 23 percent.
ADVERTISEMENT
Staff members of the U.S. Food and Drug Administration (News - Websites) raised the concerns in memos posted on the agency`s Web site in advance of Tuesday`s meeting of an advisory panel that will decide whether the drug, Ranexa, should be approved.
Ranexa, which works by directing the heart to burn sugar instead of fat for energy, is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The memos emphasized a potential health risk called QT prolongation, or a delay in the time it takes the heart to electrically recharge itself. The problem can lead to fatal heart arrhythmias and in the past has caused the FDA to reject medicines or delay their approvals.
A staff memo on the FDA Web site from John Koerner, of the agency`s cardio-renal drug products division, said CV failed to prove QT prolongation is not a concern.
CV Therapeutics, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make it profitable. Its shares on Monday fell to a four-year low.
In a memo dated Oct. 23, Koerner said the drug caused worrisome electrical irregularities in some animals, though not in others, so the studies could not rule out the possibility of causing heart rhythm problems in people.
First Albany Capital analyst David Webber on Monday cut his rating on the company to "neutral" from "buy," saying FDA staff members cited problems not previously revealed, including the drug`s lack of effectiveness in women and inadequate safety data.
Webber said the negative comments by FDA staff imply the agency will now require CV Therapeutics to conduct a "substantial new clinical trial" that could seriously delay or derail Ranexa`s launch.
"In the documents, the FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber said in a research note.
The FDA in October had granted conditional approval for Ranexa, with additional information from the company required for final approval.
FDA advisory panels often meet in the weeks before a final decision is made on a drug so that leading independent physicians can weigh its merits on both safety and effectiveness.
Shares of CV Therapeutics, based in Palo Alto, California, were down $3.88 at $12.88 in late morning trading on the Nasdaq, where it was the second-biggest percentage loser. The shares earlier fell to a four-year low of $12.51.
UPDATE - CV shares plunge on FDA concerns over angina drug
Monday December 8, 12:08 pm ET
By Ransdell Pierson and Jed Seltzer
(Adds details, analyst quotes, updates share price)
NEW YORK, Dec 8 (Reuters) - An experimental angina drug could cause greater heart risks than developer CV Therapeutics Inc. (NasdaqNM:CVTX - News) has suggested, U.S. regulators said on Monday, sending the company`s shares down about 23 percent.
ADVERTISEMENT
Staff members of the U.S. Food and Drug Administration (News - Websites) raised the concerns in memos posted on the agency`s Web site in advance of Tuesday`s meeting of an advisory panel that will decide whether the drug, Ranexa, should be approved.
Ranexa, which works by directing the heart to burn sugar instead of fat for energy, is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The memos emphasized a potential health risk called QT prolongation, or a delay in the time it takes the heart to electrically recharge itself. The problem can lead to fatal heart arrhythmias and in the past has caused the FDA to reject medicines or delay their approvals.
A staff memo on the FDA Web site from John Koerner, of the agency`s cardio-renal drug products division, said CV failed to prove QT prolongation is not a concern.
CV Therapeutics, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make it profitable. Its shares on Monday fell to a four-year low.
In a memo dated Oct. 23, Koerner said the drug caused worrisome electrical irregularities in some animals, though not in others, so the studies could not rule out the possibility of causing heart rhythm problems in people.
First Albany Capital analyst David Webber on Monday cut his rating on the company to "neutral" from "buy," saying FDA staff members cited problems not previously revealed, including the drug`s lack of effectiveness in women and inadequate safety data.
Webber said the negative comments by FDA staff imply the agency will now require CV Therapeutics to conduct a "substantial new clinical trial" that could seriously delay or derail Ranexa`s launch.
"In the documents, the FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber said in a research note.
The FDA in October had granted conditional approval for Ranexa, with additional information from the company required for final approval.
FDA advisory panels often meet in the weeks before a final decision is made on a drug so that leading independent physicians can weigh its merits on both safety and effectiveness.
Shares of CV Therapeutics, based in Palo Alto, California, were down $3.88 at $12.88 in late morning trading on the Nasdaq, where it was the second-biggest percentage loser. The shares earlier fell to a four-year low of $12.51.
Für die Watchlist, mal sehen wo das Close ist
Greetinxx Heinerle2
Greetinxx Heinerle2
Haben nochmal das Tief unterschritten und das bei sich erholende Märkten.
Ich bin auf der Lauer.
Gruss Kosto
Ich bin auf der Lauer.
Gruss Kosto
CV8: AUSSETZUNG/SUSPENSION
DIE FOLGENDE AKTIE IST AUSGESETZT.
THE FOLLOWING SHARE IS SUSPENDED.
INSTRUMENT NAME KURZ/SHORT ISIN BIS/UNTIL GRUND/REASON
CV THERAPEUTICS DL-,001 CV8 US1266671049 BAW / TBA HOME EXCHANGE
DIE FOLGENDE AKTIE IST AUSGESETZT.
THE FOLLOWING SHARE IS SUSPENDED.
INSTRUMENT NAME KURZ/SHORT ISIN BIS/UNTIL GRUND/REASON
CV THERAPEUTICS DL-,001 CV8 US1266671049 BAW / TBA HOME EXCHANGE
Bis auf weiteres ausgesetzt? Hat jemand vorher gekauft?
Ich nicht.
Ich auch nicht. Ich checke grad mal fda.gov, ob die irgendwelche Infos haben, wann genau die Meldung rauskommt. Aber eigentlich wissen wir ja, wie´s ausgeht. Aber WENN es doch positiv wird, dann EXPLODIERT der Kurs!!! Da will man dabeisein!!
#15
100 Stk. als Ersatz für Mittwochlotto
100 Stk. als Ersatz für Mittwochlotto
Das ist wohl eher eine Tombola.
Finde nichts. Muß man warten und gucken. Ne Tombola ist es wirklich. Wie würde man denn werten, wenn die einen neuen FDA-Termin bekämen? Wäre ja auch ne Möglichkeit...
#20
Kaufst Du nochmal nach? Auch gg. den Gesamtmarkt?
Gruss Kosto
Kaufst Du nochmal nach? Auch gg. den Gesamtmarkt?
Gruss Kosto
War das Prozedere bei Imclones Erbitux nicht ähnlich? Zulassung verweigert, zusätzliche Daten angefordert? Der Kurs sackte auf 8€ um später bis auf 40€ hochzulaufen.
Huhu Isa...sagte ja: Ganz schön heiße Speku..seitdem ist der kurs auch schon ganz schön zurückgekommen..
Naja, Imclone ist ein pos. Bsp...
Es gibt aber auch Negative!
Ich war mal bei Sepracor drin - Herzflimmern = -30% (gut das ich sofort ausgestiegen bin - war zum Glück nur ein 10% Minus).
Aber der Wert war auch heißgelaufen.
Es gibt aber auch Negative!
Ich war mal bei Sepracor drin - Herzflimmern = -30% (gut das ich sofort ausgestiegen bin - war zum Glück nur ein 10% Minus).
Aber der Wert war auch heißgelaufen.
Motley Fool
CV Therapeutics Misses a Beat
Tuesday December 9, 7:40 am ET
By Alyce Lomax
Shares of biotechnology company CV Therapeutics (Nasdaq: CVTX - News) plummeted Monday as investors reacted to a letter from the Food and Drug Administration that outlined hurdles to approval of the company`s angina drug, Renexa. The letter, posted on the FDA`s website, prompted the stock`s 27% drop, as well as a rash of analyst downgrades.
Although the FDA letter acknowledges signs that the drug is effective, it says CV Therapeutics needs to address a serious side effect, QT prolongation, as well as questions regarding gender differences in effectiveness. The letter also seems to imply that more clinical trials will be required.
The stock has lost about half of its value since October, when hopeful investors were buoyed by word that the FDA had set the review date. There were many reasons for the excitement. If approved, Renexa could have the distinction of being the first angina drug introduced in two decades, as well as the first drug in a new class.
Angina (chest pain associated with decreased blood flow to the heart) is a growing problem as America`s population ages. CV Therapeutics has cited U.S. Census Bureau statistics in its regulatory filings, which estimate that the number of people over the age of 55 will increase by 80% during the next 30 years. Some analysts estimate the market for Renexa somewhere between $300 million and $500 million.
However, CV Therapeutics has a long way to go before turning that potential into profit. The company is still operating at a loss, with no drugs on the market. And Renexa is its star candidate. While it has others in various stages of research and clinical trials, this was the one closest to regulatory approval.
Despite Renexa`s promise when and if the FDA gives the green light, potential rewards still seem more than a heartbeat away.
Sick of the biotech roller-coaster ride? If you`re looking for great ideas for growth, consider checking out The Motley Fool Hidden Gems. Talk about drugs and drug development with other Fools on the Biotech discussion board. Alyce Lomax welcomes your feedback at alomax@fool.com.
CV Therapeutics Misses a Beat
Tuesday December 9, 7:40 am ET
By Alyce Lomax
Shares of biotechnology company CV Therapeutics (Nasdaq: CVTX - News) plummeted Monday as investors reacted to a letter from the Food and Drug Administration that outlined hurdles to approval of the company`s angina drug, Renexa. The letter, posted on the FDA`s website, prompted the stock`s 27% drop, as well as a rash of analyst downgrades.
Although the FDA letter acknowledges signs that the drug is effective, it says CV Therapeutics needs to address a serious side effect, QT prolongation, as well as questions regarding gender differences in effectiveness. The letter also seems to imply that more clinical trials will be required.
The stock has lost about half of its value since October, when hopeful investors were buoyed by word that the FDA had set the review date. There were many reasons for the excitement. If approved, Renexa could have the distinction of being the first angina drug introduced in two decades, as well as the first drug in a new class.
Angina (chest pain associated with decreased blood flow to the heart) is a growing problem as America`s population ages. CV Therapeutics has cited U.S. Census Bureau statistics in its regulatory filings, which estimate that the number of people over the age of 55 will increase by 80% during the next 30 years. Some analysts estimate the market for Renexa somewhere between $300 million and $500 million.
However, CV Therapeutics has a long way to go before turning that potential into profit. The company is still operating at a loss, with no drugs on the market. And Renexa is its star candidate. While it has others in various stages of research and clinical trials, this was the one closest to regulatory approval.
Despite Renexa`s promise when and if the FDA gives the green light, potential rewards still seem more than a heartbeat away.
Sick of the biotech roller-coaster ride? If you`re looking for great ideas for growth, consider checking out The Motley Fool Hidden Gems. Talk about drugs and drug development with other Fools on the Biotech discussion board. Alyce Lomax welcomes your feedback at alomax@fool.com.
Sehr heiss Zicke. Etwas für gaaaanz Mutige(wie ich)oder
Wahnsinnige(wie ich auch)
Wahnsinnige(wie ich auch)
..na dann, Glück und belohnung für die Mutigen..
Viel Erfolg! Wo bist Du eingestiegen?
Hab gestern und letzte Woche auch noch gekauft. Denke in US haben dies auch sehr viele ebenso gemacht und warten nun auf News, wenns negativ ausfällt gehts wieder gegen Süden. Gut gestern über 15 Mio gehandelt, dies haben sicher viele zum Kauf genutzt die heute und morgen aussteigen werden, da sich kurzfristig kein großer Gewinn erziehlen lässt und schließlich noch einiges im Biotechsektor zu holen ist. Vielleicht sind mir die Verluste auf den Magen geschlagen, immer diese Zockerei!!!
Steht noch ein guter Wert kurz vor der Zulassung???
Steht noch ein guter Wert kurz vor der Zulassung???
#27 Danke!!!
#28 leider zu früh bei 13,48€. Dachte ja auch nicht, dass da gestern schon die Post abgeht. Wollte eigentlich nur gewisse Schwankungen traden. Und jetzt hänge ich drin. Zur Not halte ich die aber ein paar Jahre!
#28 leider zu früh bei 13,48€. Dachte ja auch nicht, dass da gestern schon die Post abgeht. Wollte eigentlich nur gewisse Schwankungen traden. Und jetzt hänge ich drin. Zur Not halte ich die aber ein paar Jahre!
#29
Bei den Umsätzen waren sicherlich auch viele Trader am Werk. Ich werde langfr. einsteigen, wenn der Bio-Index mitspielt.
Bei den Umsätzen waren sicherlich auch viele Trader am Werk. Ich werde langfr. einsteigen, wenn der Bio-Index mitspielt.
#30
Hatte gestern auch 3 Limits drin - wollte mit min. Risiko (Kursunterschied US-D traden). Kam aber nicht dazu.
Hatte gestern auch 3 Limits drin - wollte mit min. Risiko (Kursunterschied US-D traden). Kam aber nicht dazu.
Ich denke auch, wenn die FDA Rexena ablehnt, dauert es Monate, bis CVTX das nächste Medikament zur Zulassung schicken kann. Bis dahin geht der Kurs bis auf Buchwert runter (ca. 6 USD). DANN kann man einsammeln.
Das wäre aber schlecht für Dich.
Bei mir sind 3.500 St. Handel an Nasi - ist das ein Datenfehler?
#33
Es gibt 28,5 Millionen Aktien. Ende 3. Quartal verfügte die Firma über cash und cashähnliches im Wert von 460 Mio.$(nachzulesen im Quartalsbericht).
Wieso dann ein Buchwert von 6$??????
Es gibt 28,5 Millionen Aktien. Ende 3. Quartal verfügte die Firma über cash und cashähnliches im Wert von 460 Mio.$(nachzulesen im Quartalsbericht).
Wieso dann ein Buchwert von 6$??????
@ Isa...das ist wohl die neue RSB(Rechen-schmuh-Reform..*fg
Balance Sheet
Total Cash (mrq): 461.95M
Total Cash Per Share (mrq): 15.9
Total Debt (mrq)²: 296.74M
Total Debt/Equity (mrq): 1.616
Current Ratio (mrq): 28.344
Book Value Per Share (mrq): 6.32
Total Cash (mrq): 461.95M
Total Cash Per Share (mrq): 15.9
Total Debt (mrq)²: 296.74M
Total Debt/Equity (mrq): 1.616
Current Ratio (mrq): 28.344
Book Value Per Share (mrq): 6.32
Nun gut. Durch den hohen Cashbestand dürfte die Aktie nach unten hin doch gut abgesichert sein oder? Die können schon noch ein paar jahre forschen uns sind vielleicht sogar ein Übernahmekandidat? Und die Pipeline umfasst ja noch mehr als Renexa.
Kosto
Für so einen alten Zausel(1929 ist doch sicher Dein Geburtsjahr ) bist Du aber ganz schön fix!!
Für so einen alten Zausel(1929 ist doch sicher Dein Geburtsjahr ) bist Du aber ganz schön fix!!
Laut CV Homepage wurden tatsächlich 3100 Aktien gehandelt.
Wie geht denn das??
Security: CVTX (Common Stock)
12.25 Minimum 20 minutes delayed
+0.04 (up 0.33%)
Current Day`s High: 12.25
Current Day`s Low: 12.22
Current Day`s Volume: 3,100 shares
Last Trade: December 9, 2003 11:15 AM
Stock Exchange: NASDAQ
NOTE: The stock price performance shown on the quote above is not necessarily indicative of future price performance.
Copyright © 1998-2003 MarketWatch.com Inc. User agreement applies.
Historical and current end-of-day data provided by Interactive Data Corp.
Intraday data is at least 20-minutes delayed. All times are EDT.
Intraday data provided by S&P Comstock and subject to terms of use.
Copyright 1999-2003, CV Therapeutics, Inc.
Wie geht denn das??
Security: CVTX (Common Stock)
12.25 Minimum 20 minutes delayed
+0.04 (up 0.33%)
Current Day`s High: 12.25
Current Day`s Low: 12.22
Current Day`s Volume: 3,100 shares
Last Trade: December 9, 2003 11:15 AM
Stock Exchange: NASDAQ
NOTE: The stock price performance shown on the quote above is not necessarily indicative of future price performance.
Copyright © 1998-2003 MarketWatch.com Inc. User agreement applies.
Historical and current end-of-day data provided by Interactive Data Corp.
Intraday data is at least 20-minutes delayed. All times are EDT.
Intraday data provided by S&P Comstock and subject to terms of use.
Copyright 1999-2003, CV Therapeutics, Inc.
Die Trades gestern hatten sicherlich auch einen steuerlichen Background.
Ich denke, ich liege morgen mal auf der Lauer.....
Greetinxx Heinerle2
Greetinxx Heinerle2
Die News waren das, was ich befürchtet hatte, eine Verschiedung des ganzen Prozesses.
Panel asks for more data on heart drug
CV Therapeutics hits snag in effort to win OK for Ranexa
BOSTON (CBS.MW) -- In a setback for CV Therapeutics, a Food and Drug Administration advisory panel on Tuesday asked for more studies of the biotechnology firm`s experimental treatment for a heart condition.
Panel asks for more data on heart drug
CV Therapeutics hits snag in effort to win OK for Ranexa
BOSTON (CBS.MW) -- In a setback for CV Therapeutics, a Food and Drug Administration advisory panel on Tuesday asked for more studies of the biotechnology firm`s experimental treatment for a heart condition.
Und noch zu Eurer Idee, es wären nur 3.500 Aktien gehandelt worden:
Trading in shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) were halted Tuesday morning. They last traded at $12.22.
Trading in shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) were halted Tuesday morning. They last traded at $12.22.
@ Isabartels #36
CV Therapeutics downgraded on `negative` FDA documents (CVTX) By Tomi Kilgore
NEW YORK (CBS.MW) -- Analyst David Webber at First Albany downgraded CV Therapeutics (CVTX) to "neutral" from "buy," citing negative Food and Drug Administration briefing documents that suggest that its angina treatment Ranexa is unlikely to be approved without a "substantial" new clinical trial. The stock took a $3.68, or 22 percent dive to $13.08, and was the leading percentage loser listed on the Nasdaq National Market. "In the documents, the FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber said in a note to clients. He feels the stock could trade down as low as the $10 to $13 level, but not as low as the USD 5.81, which is the company`s net cash value.
CV Therapeutics downgraded on `negative` FDA documents (CVTX) By Tomi Kilgore
NEW YORK (CBS.MW) -- Analyst David Webber at First Albany downgraded CV Therapeutics (CVTX) to "neutral" from "buy," citing negative Food and Drug Administration briefing documents that suggest that its angina treatment Ranexa is unlikely to be approved without a "substantial" new clinical trial. The stock took a $3.68, or 22 percent dive to $13.08, and was the leading percentage loser listed on the Nasdaq National Market. "In the documents, the FDA appears to view Ranexa as modestly effective, but notes significant safety risks that are not offset by the product`s demonstrated benefits," Webber said in a note to clients. He feels the stock could trade down as low as the $10 to $13 level, but not as low as the USD 5.81, which is the company`s net cash value.
Champions League Spiele waren super!! Wer hätte gedacht, daß Celta de Vigo in Mailand gewinnt!?
Gut´s Nächtle!!
Gut´s Nächtle!!
#48
Die Meldung ist alt.
Die Meldung ist alt.
BIOTECH REPORT
Panel asks for more data on heart drug
CV Therapeutics hits snag in effort to win OK for Ranexa
By Ted Griffith, CBS.MarketWatch.com
Last Update: 5:20 PM ET Dec. 9, 2003
BOSTON (CBS.MW) -- In a setback for CV Therapeutics, a Food and Drug Administration advisory panel on Tuesday asked for more studies of the biotechnology firm`s experimental treatment for a heart condition.
The advisory panel found that the FDA should ask for more research before deciding whether to approve the company`s Ranexa drug, Reuters reported. Additional studies of Ranexa, which treats the painful heart condition angina, could significantly delay approval of the drug.
The final decision is up to the FDA, but the agency typically follows the recommendations of its advisory panels, which are made up of outside medical experts.
Trading in shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) were halted Tuesday morning. They last traded at $12.22.
A company spokeswoman didn`t immediately return a call seeking comment.
Ranexa is CV Therapeutics` lead product candidate. The company has no products on the market.
CV Therapeutics shares had been under pressure ahead of the FDA review. On Monday, shares plunged 27 percent after documents posted by the FDA on the agency`s Web site renewed concerns about a cardiac side effect associated with Ranexa.
The FDA in the documents released Monday said studies appeared to show that the drug was linked with a heart rhythm side effect. The side effect, known as QT prolongation, can be an indication of a developing heart arrhythmia, a potentially life-threatening condition.
Ahead of the panel meeting, analyst Thomas Wei at US Bancorp Piper Jaffray predicted Ranexa wouldn`t reach the U.S. market until the second half of 2006. The analyst, in a note to clients, projected peak sales of the drug would eventually exceed $300 million.
CV Therapeutics` shares had also plunged in late October after the company first said the FDA had indicated further studies may be needed before the drug wins final approval. At the same time, the FDA granted Ranexa conditional approval status and said the drug appeared to be effective.
Ted Griffith is a reporter for CBS.MarketWatch.com
Panel asks for more data on heart drug
CV Therapeutics hits snag in effort to win OK for Ranexa
By Ted Griffith, CBS.MarketWatch.com
Last Update: 5:20 PM ET Dec. 9, 2003
BOSTON (CBS.MW) -- In a setback for CV Therapeutics, a Food and Drug Administration advisory panel on Tuesday asked for more studies of the biotechnology firm`s experimental treatment for a heart condition.
The advisory panel found that the FDA should ask for more research before deciding whether to approve the company`s Ranexa drug, Reuters reported. Additional studies of Ranexa, which treats the painful heart condition angina, could significantly delay approval of the drug.
The final decision is up to the FDA, but the agency typically follows the recommendations of its advisory panels, which are made up of outside medical experts.
Trading in shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) were halted Tuesday morning. They last traded at $12.22.
A company spokeswoman didn`t immediately return a call seeking comment.
Ranexa is CV Therapeutics` lead product candidate. The company has no products on the market.
CV Therapeutics shares had been under pressure ahead of the FDA review. On Monday, shares plunged 27 percent after documents posted by the FDA on the agency`s Web site renewed concerns about a cardiac side effect associated with Ranexa.
The FDA in the documents released Monday said studies appeared to show that the drug was linked with a heart rhythm side effect. The side effect, known as QT prolongation, can be an indication of a developing heart arrhythmia, a potentially life-threatening condition.
Ahead of the panel meeting, analyst Thomas Wei at US Bancorp Piper Jaffray predicted Ranexa wouldn`t reach the U.S. market until the second half of 2006. The analyst, in a note to clients, projected peak sales of the drug would eventually exceed $300 million.
CV Therapeutics` shares had also plunged in late October after the company first said the FDA had indicated further studies may be needed before the drug wins final approval. At the same time, the FDA granted Ranexa conditional approval status and said the drug appeared to be effective.
Ted Griffith is a reporter for CBS.MarketWatch.com
Reuters
UPDATE - US panel wants more data on CV Therapeutics drug
Tuesday December 9, 6:11 pm ET
By Lisa Richwine
(New throughout with panel, company comments background)
GAITHERSBURG, Md., Dec 9 (Reuters) - U.S. regulators should require more research before deciding whether to approve a CV Therapeutics Inc. (NasdaqNM:CVTX - News) experimental drug for treating chronic chest pain, a U.S. advisory panel said on Tuesday.
ADVERTISEMENT
The Food and Drug Administration will make the final decision on whether to clear the drug, called Ranexa. The agency usually follows the advice of its panels.
Ranexa is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The panel debated whether the FDA should approve Ranexa for any angina patient or should restrict use to certain people, such as those who cannot tolerate current therapies.
"If unrestricted (labeling) is desired, more data is needed, and if it`s a restricted label, more data is needed," panel chairman Jeffery Borer said in summarizing the panel`s opinion.
Members were particularly concerned Ranexa might react with other medicines and cause fainting, Borer said. Many also were worried that the company`s studies included mostly white males and suggested more research in a broader population.
Panelists were less concerned the drug might cause potentially dangerous heart rhythms, Borer said.
The FDA highlighted that issue in October when it said Ranexa was "approvable" if additional information answered lingering safety questions.
Dr. Steven Nissen, a panel member and medical director of the Cleveland Clinic`s Cardiovascular Coordinating Center, said he was less worried about the drug`s safety after hearing the company`s presentation.
"I have to give the sponsor credit for putting forth a very convincing case, both for efficacy and for safety. I got reassurance on both sides," he said.
Angina results from an insufficient supply of oxygen to the heart. Researchers believe Ranexa can prevent the problem by enabling the heart to use oxygen more efficiently, the maker said.
The Palo Alto, California-based company, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make the company profitable.
Louis Lange, the company`s chairman and chief executive, said it was too early to say if the company would need to conduct another clinical trial or to try to predict when the drug might reach the market.
"I think this (panel discussion) opens the door to have a very productive discussion with the FDA," Lange told reporters. "We are very encouraged by the general tenor of the discussion on safety and efficacy."
Trading in the company`s shares was halted during the panel meeting.
UPDATE - US panel wants more data on CV Therapeutics drug
Tuesday December 9, 6:11 pm ET
By Lisa Richwine
(New throughout with panel, company comments background)
GAITHERSBURG, Md., Dec 9 (Reuters) - U.S. regulators should require more research before deciding whether to approve a CV Therapeutics Inc. (NasdaqNM:CVTX - News) experimental drug for treating chronic chest pain, a U.S. advisory panel said on Tuesday.
ADVERTISEMENT
The Food and Drug Administration will make the final decision on whether to clear the drug, called Ranexa. The agency usually follows the advice of its panels.
Ranexa is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The panel debated whether the FDA should approve Ranexa for any angina patient or should restrict use to certain people, such as those who cannot tolerate current therapies.
"If unrestricted (labeling) is desired, more data is needed, and if it`s a restricted label, more data is needed," panel chairman Jeffery Borer said in summarizing the panel`s opinion.
Members were particularly concerned Ranexa might react with other medicines and cause fainting, Borer said. Many also were worried that the company`s studies included mostly white males and suggested more research in a broader population.
Panelists were less concerned the drug might cause potentially dangerous heart rhythms, Borer said.
The FDA highlighted that issue in October when it said Ranexa was "approvable" if additional information answered lingering safety questions.
Dr. Steven Nissen, a panel member and medical director of the Cleveland Clinic`s Cardiovascular Coordinating Center, said he was less worried about the drug`s safety after hearing the company`s presentation.
"I have to give the sponsor credit for putting forth a very convincing case, both for efficacy and for safety. I got reassurance on both sides," he said.
Angina results from an insufficient supply of oxygen to the heart. Researchers believe Ranexa can prevent the problem by enabling the heart to use oxygen more efficiently, the maker said.
The Palo Alto, California-based company, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make the company profitable.
Louis Lange, the company`s chairman and chief executive, said it was too early to say if the company would need to conduct another clinical trial or to try to predict when the drug might reach the market.
"I think this (panel discussion) opens the door to have a very productive discussion with the FDA," Lange told reporters. "We are very encouraged by the general tenor of the discussion on safety and efficacy."
Trading in the company`s shares was halted during the panel meeting.
Press Release Source: CV Therapeutics, Inc.,
FDA Advisory Committee Evaluates Ranexa(TM)
Tuesday December 9, 6:09 pm ET
PALO ALTO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) today discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
ADVERTISEMENT
" We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics (Nasdaq: CVTX - News).
None of CV Therapeutics` products, including Ranexa, have been approved for marketing by the FDA or other foreign regulatory agencies. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Company management will webcast a conference call on Tuesday, December 9 at 6:30 p.m. EST, 3:30 p.m. PST on the Company`s website to discuss this announcement. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, December 16, 2003. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 4420762.
If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. It affects 6.6 million people in the U.S., according to the American Heart Association, and results in more than 700 million angina attacks per year in the U.S.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical trials. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 20 years. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. For more information, please visit CV Therapeutics` website at http://www.cvt.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the " safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2002, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
--------------------------------------------------------------------------------
Source: CV Therapeutics, Inc.,
FDA Advisory Committee Evaluates Ranexa(TM)
Tuesday December 9, 6:09 pm ET
PALO ALTO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) today discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
ADVERTISEMENT
" We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics (Nasdaq: CVTX - News).
None of CV Therapeutics` products, including Ranexa, have been approved for marketing by the FDA or other foreign regulatory agencies. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Company management will webcast a conference call on Tuesday, December 9 at 6:30 p.m. EST, 3:30 p.m. PST on the Company`s website to discuss this announcement. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, December 16, 2003. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 4420762.
If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. It affects 6.6 million people in the U.S., according to the American Heart Association, and results in more than 700 million angina attacks per year in the U.S.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical trials. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 20 years. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. For more information, please visit CV Therapeutics` website at http://www.cvt.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the " safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2002, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
--------------------------------------------------------------------------------
Source: CV Therapeutics, Inc.,
Call Details
CV Therapeutics Advisory Committee Meeting
Scheduled to start Tue, Dec 9, 2003, 6:30 pm Eastern
CV Therapeutics Advisory Committee Meeting
Scheduled to start Tue, Dec 9, 2003, 6:30 pm Eastern
Ich sehr enttäuscht von CVTX. Ich habe nicht das Gefühl, dass sie alles für eine Zulassung getan haben.
Stimmt ... dieses Gefühl läßt sich schwerlich unterdrücken ... wenn man lesen muß, daß kritisiert wird, daß unter den Probanten fast nur weiße Männer, aber kaum Farbige und noch nicht einmal Frauen waren ... klingt wirklich nicht nach einer umfassenden Studie ... könnte jetzt wahrlich ein langer, sehr langer und steiniger Weg bis zu einer eventuellen Zulassung werden und so schnell dürften wir wohl unsere erhofften Kursziele nicht sehen ... dessen muß man sich jetzt bewußt sein!!
Gruß Seinfeld
Gruß Seinfeld
@kosto
Der Unterschied zwischen Aktienanlage und Tombola ist nur, dass man bei der Tombola gleich nach Ziehung weiß, wie man liegt. Bei Aktien (speziell jetzt CVTX) weiß man im Moment wirklich nicht, ob man eine Niete oder Gewinn gezogen hat. Wie ich die Amis kenne, ist heute von -30% bis +30% alles drin.
Neues ist ja gestern nichts gekommen, hängt ab wieviel bzgl. dieser Verzögerung beim Zulassungsprozess Ranexa schon im Kurs eingepreist ist.
Na ja, hab gestern ja nur 100Stk. gekauft und auch bei einem satten Minus heute ist dies kein Beinbruch; aber ein Satz aus #51 gibt mir doch noch etwas Hoffnung: "...the FDA granted Ranexa conditional approval status and said the drug appeared to be effective"
Wie auch immer, mal schaun was die Amis draus machen.
Good trades
TB
Der Unterschied zwischen Aktienanlage und Tombola ist nur, dass man bei der Tombola gleich nach Ziehung weiß, wie man liegt. Bei Aktien (speziell jetzt CVTX) weiß man im Moment wirklich nicht, ob man eine Niete oder Gewinn gezogen hat. Wie ich die Amis kenne, ist heute von -30% bis +30% alles drin.
Neues ist ja gestern nichts gekommen, hängt ab wieviel bzgl. dieser Verzögerung beim Zulassungsprozess Ranexa schon im Kurs eingepreist ist.
Na ja, hab gestern ja nur 100Stk. gekauft und auch bei einem satten Minus heute ist dies kein Beinbruch; aber ein Satz aus #51 gibt mir doch noch etwas Hoffnung: "...the FDA granted Ranexa conditional approval status and said the drug appeared to be effective"
Wie auch immer, mal schaun was die Amis draus machen.
Good trades
TB
Das sind keine Probanden sondern Herzinsuffiziens-Patienten gewesen, und die sind vmtl. so getestet worden, wie sie in der Aufnahme der Medizinzentren aufgeschlagen sind und auch bereit waren, dem Test beizutreten. Probates Studiendesign ist etwas diffiziles, und nur große Pharmafirmen können sich bei echten Blockbuster-Anwendungen ala Statine 10000 Patienten Studien leisten, verlusttragende Biotechs oft nicht.
Von QT-Intervallen ist eigentlich keine Rede mehr.
Von QT-Intervallen ist eigentlich keine Rede mehr.
#50 Kosto:
Die Meldung ist vom 8.12., ist das alt? Außerdem wollte ich zeigen, wo ich meine Buchwert-Geschichte her habe.
Die Meldung ist vom 8.12., ist das alt? Außerdem wollte ich zeigen, wo ich meine Buchwert-Geschichte her habe.
Diese Einschätzung von Anfang November traf die Sache ja genau; also alles schon bekannt und genauso erwartet worden:
SUNDAY-BIOTECH
CV Therapeutics kaufen Datum: 03.11.2003
Dem langfristig ausgerichteten Anleger empfehlen derzeit die Analysten von "sunday-biotech" die Aktien von CV Therapeutics (ISIN US1266671049/ WKN 912268) zum Kauf. Das Unternehmen habe sich spezialisiert auf Wirkstoffe zur Behandlung von Herz-Kreislauf-Erkrankungen. Für das Angina pectoris-Mittel Ranexa sei bereits ein Zulassungsantrag bei der FDA eingereicht worden und am 9. Dezember werde sich eine von der FDA einberufene Kommission mit dem Zulassungsantrag für Ranexa beschäftigen. Eine eher verwirrende Situation habe die FDA jedoch in der letzten Woche geschaffen. Statt wie bislang üblich auf das Votum der Kommission zu warten, habe die FDA bereits vorher einen sogenannten "approvable letter" an CV Therapeutics versendet. Der Kurs der Aktie sei daraufhin um mehr als 25 Prozent abgesackt. "Approvable letter" würden in der Regel bedeuten, dass die FDA weitere klinische Tests vor einer Zulassungsentscheidung benötige. Der genaue Inhalt des Schreibens sei zwar bisher nicht bekannt. Ungewöhnlich sei jedoch, dass dieser nicht als Ergebnis der Kommissionssitzung, sondern vorher versendet worden sei. Die Intentionen der FDA seien somit nicht eindeutig klar. CV Therapeutics habe eine relativ gut aufgestellte Pipeline. Neben Ranexa würden sich zwei weitere Kandidaten in der letzten Phase der klinischen Erprobung befinden. Auch stehe das Unternehmen ohne finanzielle Schwierigkeiten da. In der Kasse würden sich rund 460 Millionen US-Dollar befinden. Die Marktbewertung habe am vergangenen Freitag zu Redaktionsschluss ebenfalls bei 460 Millionen US-Dollar gelegen. Damit seien die Pipeline inkl. Ranexa praktisch umsonst zu haben. Vor dem 9. Dezember dürfte zwar weiter Unsicherheit am Markt dominieren. Langfristig seien Unternehmen, die in der Nähe ihres Kassenbestandes notieren würden, allerdings ein Kauf, auch wenn - wie zu vermuten sei - der FDA-Letter weitere teure klinische Tests bedeute. Vor diesem Hintergrund lautet das Rating der Analysten von "sunday-biotech" für die Aktien von CV Therapeutics auf "langfristig kaufen". Der Stoppkurs sollte bei 12 Dollar platziert werden.
Quelle: AKTIENCHECK.DE
SUNDAY-BIOTECH
CV Therapeutics kaufen Datum: 03.11.2003
Dem langfristig ausgerichteten Anleger empfehlen derzeit die Analysten von "sunday-biotech" die Aktien von CV Therapeutics (ISIN US1266671049/ WKN 912268) zum Kauf. Das Unternehmen habe sich spezialisiert auf Wirkstoffe zur Behandlung von Herz-Kreislauf-Erkrankungen. Für das Angina pectoris-Mittel Ranexa sei bereits ein Zulassungsantrag bei der FDA eingereicht worden und am 9. Dezember werde sich eine von der FDA einberufene Kommission mit dem Zulassungsantrag für Ranexa beschäftigen. Eine eher verwirrende Situation habe die FDA jedoch in der letzten Woche geschaffen. Statt wie bislang üblich auf das Votum der Kommission zu warten, habe die FDA bereits vorher einen sogenannten "approvable letter" an CV Therapeutics versendet. Der Kurs der Aktie sei daraufhin um mehr als 25 Prozent abgesackt. "Approvable letter" würden in der Regel bedeuten, dass die FDA weitere klinische Tests vor einer Zulassungsentscheidung benötige. Der genaue Inhalt des Schreibens sei zwar bisher nicht bekannt. Ungewöhnlich sei jedoch, dass dieser nicht als Ergebnis der Kommissionssitzung, sondern vorher versendet worden sei. Die Intentionen der FDA seien somit nicht eindeutig klar. CV Therapeutics habe eine relativ gut aufgestellte Pipeline. Neben Ranexa würden sich zwei weitere Kandidaten in der letzten Phase der klinischen Erprobung befinden. Auch stehe das Unternehmen ohne finanzielle Schwierigkeiten da. In der Kasse würden sich rund 460 Millionen US-Dollar befinden. Die Marktbewertung habe am vergangenen Freitag zu Redaktionsschluss ebenfalls bei 460 Millionen US-Dollar gelegen. Damit seien die Pipeline inkl. Ranexa praktisch umsonst zu haben. Vor dem 9. Dezember dürfte zwar weiter Unsicherheit am Markt dominieren. Langfristig seien Unternehmen, die in der Nähe ihres Kassenbestandes notieren würden, allerdings ein Kauf, auch wenn - wie zu vermuten sei - der FDA-Letter weitere teure klinische Tests bedeute. Vor diesem Hintergrund lautet das Rating der Analysten von "sunday-biotech" für die Aktien von CV Therapeutics auf "langfristig kaufen". Der Stoppkurs sollte bei 12 Dollar platziert werden.
Quelle: AKTIENCHECK.DE
Hat mal jemand auf der Homepage von CV in die Konferenz reingehört(dauert 2 Stunden!). Ich habe leider keine Lautsprecher an meinem PC(Weiss auch nicht ob mein Englisch für eventuelles Fachchinesisch ausreicht!). Die Stellungnahme und event. Ausblick von CV wären schon interessant!!
Stimmt ... diese Analyse könnte auch von heute stammen ...
wäre mal interessant zu wissen, wie die aktuelle
Analyse des Sunday-Biotech ausschaut ...
vielleicht kommt ja bald ein Update.
Gruß Seinfeld
wäre mal interessant zu wissen, wie die aktuelle
Analyse des Sunday-Biotech ausschaut ...
vielleicht kommt ja bald ein Update.
Gruß Seinfeld
seinfeld
Ich glaube nicht dass die heute anders wäre. Genauso ist von Sunday ja alles erwartet worden und genau unter den Bedingungen zum Kauf empfohlen. Also war eigentlich alles eingepreisst. Aber wie so oft spielt die Börse komplett verrückt. Das Gute and er Entscheidung der Kommission ist, dass es kein komplettes aus für den Wirkstoff gab. Und genug Geld für weitere Studien hat CV allemal. Also ich könnte mir vorstellen, dass nach der ganzen Aufregung der Kurs wieder anzieht, da viele diese Kurse jetzt zum Einstieg nutzen!
Ich glaube nicht dass die heute anders wäre. Genauso ist von Sunday ja alles erwartet worden und genau unter den Bedingungen zum Kauf empfohlen. Also war eigentlich alles eingepreisst. Aber wie so oft spielt die Börse komplett verrückt. Das Gute and er Entscheidung der Kommission ist, dass es kein komplettes aus für den Wirkstoff gab. Und genug Geld für weitere Studien hat CV allemal. Also ich könnte mir vorstellen, dass nach der ganzen Aufregung der Kurs wieder anzieht, da viele diese Kurse jetzt zum Einstieg nutzen!
Zicke
Wieso kackt Morphy heute eigentlich so ab? ist da auch eine Zulassung gefloppt?
Gruss
Isa
Wieso kackt Morphy heute eigentlich so ab? ist da auch eine Zulassung gefloppt?
Gruss
Isa
10.12.03 09:25:56
9,81 EUR
+1,03% [+0,10]
Isa, was siehst Du??
Oder ist das der CV Frust??
9,81 EUR
+1,03% [+0,10]
Isa, was siehst Du??
Oder ist das der CV Frust??
Aber war die nicht schon über 10€ in den letzten Tagen?
Zicke:
Realtime-Kurse
Datum Zeit Bid Ask
10.12. 10:00:21 9,62 EUR 9,80 EUR
Letzte Kursänderung: 09:21:41
Realtime-Kurse
Datum Zeit Bid Ask
10.12. 10:00:21 9,62 EUR 9,80 EUR
Letzte Kursänderung: 09:21:41
stimmt Isa, sieht im Vergleich zu Cv echt übel aus..
@Isa: Was den Kurs aber hemmen wird sind die ganzen offenstehenden Call-Optionen auf CVTX.
Ich werde mir mal den Conference Call anhören, aber erwartet nichts Erhellendes! Die werden sich schön brav bedeckt halten, bevor sie sich wieder mit der FDA-Bürokraten treffen werden. Alles andere wäre Selbstmord.
Und wie so oft gibt Dow Jones den spätesten aber auch den qualitativ besten Bericht.
_______________________________
Dow Jones Business News
Panel Suggests Additional TestsPanel Suggests Additional Tests for CV Therapeutics Heart Drug
Tuesday December 9, 6:46 pm ET
By Roger Cheng
NEW YORK -- A Food and Drug Administration advisory committee adjourned Tuesday without making any recommendations on CV Therapeutics Inc. (NasdaqNM:CVTX - News)`s angina drug Ranexa, but has indicated more tests are needed.
The FDA`s cardiovascular and renal drug advisory committee asked CV Therapeutics to clarify and expand its trials.
After the meeting, panel Chairman Jeffrey Borer said in a Bloomberg report "a population resistant to available drugs wasn`t studied. So it is hard to know if the drug would add benefit relative to risk."
The meeting came a day after the fate of Ranexa was thrown into question when the FDA outlined its concerns on its Web site Monday. The news sent the stock down 27% Monday. The stock was up one cent to $12.22 Tuesday.
"Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said.
According to the documents, the agency is asking for the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing to a placebo. The agency said the company could run that study on patients who have failed other angina drugs.
CV Therapeutics also needs to clarify appropriate dosing, the agency said.
The FDA is also asking the company to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said.
A spokesman for the FDA wasn`t immediately available for comment.
A CV Therapeutics spokeswoman confirmed the panel adjourned without making a decision, but didn`t elaborate on the what was said.
In his downgrade of CV Therapeutics` stock Monday, CIBC World Markets Corp. analyst Matt Geller wrote that "when and if the drug will be approved is now uncertain."
The FDA has concerns about side effects, most notably the increase the so- called QTc interval, or the time between heart beats that occurred during the clinical trial.
There were incidences of a three- to nine-millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death. The agency is also concerned about drug interactions.
"The FDA is not convinced that the company has demonstrated that the QTc prolongation will not lead to arrhythmias," Mr. Geller wrote in his note.
The analyst doesn`t own shares in CV Therapeutics, but CIBC has an investment- banking relationship, and has managed or co-managed a public offering the last 12 months.
Ich werde mir mal den Conference Call anhören, aber erwartet nichts Erhellendes! Die werden sich schön brav bedeckt halten, bevor sie sich wieder mit der FDA-Bürokraten treffen werden. Alles andere wäre Selbstmord.
Und wie so oft gibt Dow Jones den spätesten aber auch den qualitativ besten Bericht.
_______________________________
Dow Jones Business News
Panel Suggests Additional TestsPanel Suggests Additional Tests for CV Therapeutics Heart Drug
Tuesday December 9, 6:46 pm ET
By Roger Cheng
NEW YORK -- A Food and Drug Administration advisory committee adjourned Tuesday without making any recommendations on CV Therapeutics Inc. (NasdaqNM:CVTX - News)`s angina drug Ranexa, but has indicated more tests are needed.
The FDA`s cardiovascular and renal drug advisory committee asked CV Therapeutics to clarify and expand its trials.
After the meeting, panel Chairman Jeffrey Borer said in a Bloomberg report "a population resistant to available drugs wasn`t studied. So it is hard to know if the drug would add benefit relative to risk."
The meeting came a day after the fate of Ranexa was thrown into question when the FDA outlined its concerns on its Web site Monday. The news sent the stock down 27% Monday. The stock was up one cent to $12.22 Tuesday.
"Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said.
According to the documents, the agency is asking for the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing to a placebo. The agency said the company could run that study on patients who have failed other angina drugs.
CV Therapeutics also needs to clarify appropriate dosing, the agency said.
The FDA is also asking the company to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said.
A spokesman for the FDA wasn`t immediately available for comment.
A CV Therapeutics spokeswoman confirmed the panel adjourned without making a decision, but didn`t elaborate on the what was said.
In his downgrade of CV Therapeutics` stock Monday, CIBC World Markets Corp. analyst Matt Geller wrote that "when and if the drug will be approved is now uncertain."
The FDA has concerns about side effects, most notably the increase the so- called QTc interval, or the time between heart beats that occurred during the clinical trial.
There were incidences of a three- to nine-millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death. The agency is also concerned about drug interactions.
"The FDA is not convinced that the company has demonstrated that the QTc prolongation will not lead to arrhythmias," Mr. Geller wrote in his note.
The analyst doesn`t own shares in CV Therapeutics, but CIBC has an investment- banking relationship, and has managed or co-managed a public offering the last 12 months.
Ich sollte Pressesprecher werden, denn die haben alle Fragen wie erwartet abgewimmelt.
Die Pressekonferenz dauerte 10 Minuten, aber außer das heute Nachmittag die Aktie wieder zum Handel zugelassen wird, wurde nix Konkretes erwähnt.
Die Pressekonferenz dauerte 10 Minuten, aber außer das heute Nachmittag die Aktie wieder zum Handel zugelassen wird, wurde nix Konkretes erwähnt.
Ich war leider nicht dabei - scheine ja nichts verpaßt zu haben.
Danke für die Info!
Gruss
Danke für die Info!
Gruss
Das war natürlich zu erwarten, daß sich die Damen und Herren von CVTX bedeckt halten würden,
wäre ja auch sehr töricht gewesen, wenn sie aus dem Nähkästchen geplaudert hätten ...
... aber danke, daß Du Dir das angetan hast
Gruß Seinfeld
wäre ja auch sehr töricht gewesen, wenn sie aus dem Nähkästchen geplaudert hätten ...
... aber danke, daß Du Dir das angetan hast
Gruß Seinfeld
@kosto:
Das kannst du dir immer noch antun. Am Anfang 3 Minute Forward looking statement. Dann bedanken die sich fein artig beim Panel und der FDA . Und dann wird jede Frage abgeblockt mit dem Hinweis, das sie sich erst mit der FDA treffen müssen, bevor sie überhaupt etwas sagen können. Alles andere wäre auch ein schwerer dummer Fehler, den Imclone zB gemacht hat.
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CVTX&…
Das kannst du dir immer noch antun. Am Anfang 3 Minute Forward looking statement. Dann bedanken die sich fein artig beim Panel und der FDA . Und dann wird jede Frage abgeblockt mit dem Hinweis, das sie sich erst mit der FDA treffen müssen, bevor sie überhaupt etwas sagen können. Alles andere wäre auch ein schwerer dummer Fehler, den Imclone zB gemacht hat.
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CVTX&…
Leute haltet euch fest es geht mit hoher geschwindigkeit nach unten,und das ungebremst. lol.
Kursziel für heute 6 $ lol
Kursziel für heute 6 $ lol
Gegen den Gesamtmarkt einsammeln... Ich überlege noch.
Ich liebe diese versierten Aussagen ... wenn Du nichts Fundamentales zum Thema beizutragen hast, dann geh bitte ins amerikanische Yahoo-Board, dort sind deine 6$ sogar noch hoch angesetzt ... dort reden die Basher schon von einem Dollar ... VÖLLIGER BLÖDSINN!!!!!!!!
#74
Manche schwätzen einen Scheiss daher!!!
Manche schwätzen einen Scheiss daher!!!
US Bancorp Piper Jaffray INVESTMENT RECOMMENDATION:
" We would be buyers of CVTX shares at these levels and believe that the shares are
undervalued, given the positive tone of the FDA panel. We believe it is highly
likely Ranexa will be approved by the FDA and that there is upside potential to our 2H06 approval timeline
" We would be buyers of CVTX shares at these levels and believe that the shares are
undervalued, given the positive tone of the FDA panel. We believe it is highly
likely Ranexa will be approved by the FDA and that there is upside potential to our 2H06 approval timeline
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - December 9, 2003
--------------------------------------------------------------------------------
FDA Advisory Committee Evaluates Ranexa(TM)
PALO ALTO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) today discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
"We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics (Nasdaq: CVTX).
None of CV Therapeutics` products, including Ranexa, have been approved for marketing by the FDA or other foreign regulatory agencies. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Company management will webcast a conference call on Tuesday, December 9 at 6:30 p.m. EST, 3:30 p.m. PST on the Company`s website to discuss this announcement. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, December 16, 2003. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 4420762.
If approved, Ranexa would represent the first new class
--------------------------------------------------------------------------------
FDA Advisory Committee Evaluates Ranexa(TM)
PALO ALTO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) today discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
"We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics (Nasdaq: CVTX).
None of CV Therapeutics` products, including Ranexa, have been approved for marketing by the FDA or other foreign regulatory agencies. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Company management will webcast a conference call on Tuesday, December 9 at 6:30 p.m. EST, 3:30 p.m. PST on the Company`s website to discuss this announcement. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, December 16, 2003. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 4420762.
If approved, Ranexa would represent the first new class
Brauchgeld
Erzähl noch mehr über die 6$
Erzähl noch mehr über die 6$
isa das war eigentlich nicht ernst gemeint, war halt nur neugierig auf die reaktionen.
Ach so.
Techn. Bewegung, doch mit leicht fallender Tendenz...
Wahsinn, da wurde in 2 Handelstagen der gesamte Aktienbestand gehandelt.
...leider bisher ohne tech. gegenreaktion..
Die Marktkapitalisierung liegt jetzt deutlich unter cash. Dabei ist die Pipeline noch nicht einmal berücksichtigt. Diese Erkenntnis wird sich mittelfristig durchsetzen!
FDA fordert zusätzliche Daten zu Ranexa von CV Therapeutics Alle Nachrichten
10.12. / 16:42
Das Biotechnologie-Unternehmen CV Therapeutics Inc. erlitt einen Rückschlag mit seinem Medikament Ranexa. Ein Beratergremium der US-Gesundheitsbehörde FDA empfahl das Präparat nicht zur Behandlung von chronischer Angina sondern forderte ergänzende Daten für den Zulassungsantrag
CV Therapeutics wurde aufgefordert seine Tests besser zu erläutern und auszuweiten. Das Unternehmen soll nachweisen, dass Ranexa die Überlebensrate gegenüber Placebo steigert. Zudem müsse noch die richtige Dosierung ermittelt werden. Die FDA Berater zweifelten auch am Nutzen-Risiko-Verhältnis des Mittels.
Angina ist oft ein Hauptsymptom einer koronaren Herzerkrankung. Diese Erkrankung der Herzkranzgefäße beeinträchtigt die Sauerstoffversorgung des Körpers und tritt oft im Vorfeld einer Herzattacke auf.
Bisher kletterten die Aktien an der NASDAQ um 10,31 Prozent und stehen aktuell bei 13,48 Dollar.
© finanzen.net
10.12. / 16:42
Das Biotechnologie-Unternehmen CV Therapeutics Inc. erlitt einen Rückschlag mit seinem Medikament Ranexa. Ein Beratergremium der US-Gesundheitsbehörde FDA empfahl das Präparat nicht zur Behandlung von chronischer Angina sondern forderte ergänzende Daten für den Zulassungsantrag
CV Therapeutics wurde aufgefordert seine Tests besser zu erläutern und auszuweiten. Das Unternehmen soll nachweisen, dass Ranexa die Überlebensrate gegenüber Placebo steigert. Zudem müsse noch die richtige Dosierung ermittelt werden. Die FDA Berater zweifelten auch am Nutzen-Risiko-Verhältnis des Mittels.
Angina ist oft ein Hauptsymptom einer koronaren Herzerkrankung. Diese Erkrankung der Herzkranzgefäße beeinträchtigt die Sauerstoffversorgung des Körpers und tritt oft im Vorfeld einer Herzattacke auf.
Bisher kletterten die Aktien an der NASDAQ um 10,31 Prozent und stehen aktuell bei 13,48 Dollar.
© finanzen.net
16:38 10.12.2003 Uhr
ANALYSE: Deutsche Bank North America stuft CV Therapeutics auf `Hold` ab
NEW YORK (dpa-AFX) - Die Analysten der Deutschen Bank North America haben die Aktien des Biotechnologieunternehmens CV Therapeuticsvon"Buy"auf"Hold"herabgestuft und das Kursziel von 43 auf 14 US-Dollar reduziert. Die amerikanische Gesundheitsbehörde FDA habe dem Anginamittel Ranexa die Freigabe versagt, hießes einer am Mittwoch in New York veröffentlichten Studie zur Begründung.
Infolge dessen seien zusätzliche Studien erforderlich, was die Markteinführung des Anginamedikaments voraussichtlich um etwa zwei Jahre verzögere.
Gemäß der Einstufung "Hold" gehen die Analysten der Deutschen Bank davon aus, dass die Gesamtrendite des Papiers in den kommenden zwölf Monaten zwischen minus und plus zehn Prozent liegen wird./sf/she
Das sich die Markteinführung um ca. 2 Jahre verzögern könnte, lese ich hier zum ersten Mal ... hab schon bessere News gelesen ... naja, vielleicht ist der ganze Pessimismus auch übertrieben, den CVTX besteht ja nicht nur aus Ranexa
Gruß Seinfeld
ANALYSE: Deutsche Bank North America stuft CV Therapeutics auf `Hold` ab
NEW YORK (dpa-AFX) - Die Analysten der Deutschen Bank North America haben die Aktien des Biotechnologieunternehmens CV Therapeuticsvon"Buy"auf"Hold"herabgestuft und das Kursziel von 43 auf 14 US-Dollar reduziert. Die amerikanische Gesundheitsbehörde FDA habe dem Anginamittel Ranexa die Freigabe versagt, hießes einer am Mittwoch in New York veröffentlichten Studie zur Begründung.
Infolge dessen seien zusätzliche Studien erforderlich, was die Markteinführung des Anginamedikaments voraussichtlich um etwa zwei Jahre verzögere.
Gemäß der Einstufung "Hold" gehen die Analysten der Deutschen Bank davon aus, dass die Gesamtrendite des Papiers in den kommenden zwölf Monaten zwischen minus und plus zehn Prozent liegen wird./sf/she
Das sich die Markteinführung um ca. 2 Jahre verzögern könnte, lese ich hier zum ersten Mal ... hab schon bessere News gelesen ... naja, vielleicht ist der ganze Pessimismus auch übertrieben, den CVTX besteht ja nicht nur aus Ranexa
Gruß Seinfeld
... und noch ein Downgrade ...
11.12.2003
CV Therapeutics Downgrade
Bear Stearns
Rating-Update:
Die Analysten vom Investmenthaus Bear Stearns stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "peer perform" auf "underperform" zurück.
11.12.2003
CV Therapeutics Downgrade
Bear Stearns
Rating-Update:
Die Analysten vom Investmenthaus Bear Stearns stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "peer perform" auf "underperform" zurück.
Ist wohl die gleiche Analyse wie bei #88, aber doppelt gemoppelt hält besser
Bei so vielen Abstufungen dürfte ja kaum noch viel nach unten gehen,
vielleicht erleben wir ja sogar eine positive Überraschung mit einer kleinen Gegenbewegung
11.12.2003
CV Therapeutics Downgrade
Deutsche Securities
Die Analysten vom Investmenthaus Deutsche Securities stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "buy" auf "hold" zurück.
Das Kursziel sei gleichzeitig von 43 auf 14 US-Dollar reduziert worden. Die amerikanische Gesundheitsbehörde FDA habe dem Angina-Mittel Ranexa die Freigabe versagt.
Infolge dessen seien zusätzliche Studien erforderlich, was die Markteinführung des Angina-Medikaments voraussichtlich um etwa zwei Jahre verzögere.
Vor diesem Hintergrund empfehlen die Analysten von Deutsche Securities die Aktie von CV Therapeutics nunmehr zu halten.
Bei so vielen Abstufungen dürfte ja kaum noch viel nach unten gehen,
vielleicht erleben wir ja sogar eine positive Überraschung mit einer kleinen Gegenbewegung
11.12.2003
CV Therapeutics Downgrade
Deutsche Securities
Die Analysten vom Investmenthaus Deutsche Securities stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "buy" auf "hold" zurück.
Das Kursziel sei gleichzeitig von 43 auf 14 US-Dollar reduziert worden. Die amerikanische Gesundheitsbehörde FDA habe dem Angina-Mittel Ranexa die Freigabe versagt.
Infolge dessen seien zusätzliche Studien erforderlich, was die Markteinführung des Angina-Medikaments voraussichtlich um etwa zwei Jahre verzögere.
Vor diesem Hintergrund empfehlen die Analysten von Deutsche Securities die Aktie von CV Therapeutics nunmehr zu halten.
Na dann halten wir sie eben. Kaufen muss ich sie ja auch nicht mehr!
Ist noch nicht lange her, da wurde bei Millenium z.B. Kursziel 9$ genannt, Imclone bei 10$ zum Verkauf empfohlen usw.usw. Soviel zu dem selbstgefälligen Geschwätz von Analysten!!
Ist noch nicht lange her, da wurde bei Millenium z.B. Kursziel 9$ genannt, Imclone bei 10$ zum Verkauf empfohlen usw.usw. Soviel zu dem selbstgefälligen Geschwätz von Analysten!!
Klar Isa, auf das Geschwätz von Analysten muß man wirklich nicht viel geben ...
manchmal kann man sie sogar sehr gut als Kontra-Indikator benutzen ...
und das würde uns ja sehr gefallen
Gruß Seinfeld ... and go long, CVTX
manchmal kann man sie sogar sehr gut als Kontra-Indikator benutzen ...
und das würde uns ja sehr gefallen
Gruß Seinfeld ... and go long, CVTX
..und so wird scheinbar aus einer Tradingposition eine Haltepostion..
Hier ein interessanter Auszug aus der Stellungnahme der SG Cowen ...
Analyst Eric Schmidt at SG Cowen said the additional studies will likely delay the commercial launch of Ranexa by two years, from the second quarter of 2004 to the second quarter of 2006.
Still, the analyst said he expects the drug will eventually win the FDA`s OK. There had been some concerns that a potential cardiac side effect might jeopardize Ranexa`s final approval.
"We heard nothing at the advisory panel meeting that changes our opinion that Ranexa is an approvable drug," Schmidt wrote in a note to clients.
"WILL EVENTUALLY WIN THE FDA´s OK" and "RANEXA IS AN APPROVABLE DRUG"
Gruß Seinfeld
Analyst Eric Schmidt at SG Cowen said the additional studies will likely delay the commercial launch of Ranexa by two years, from the second quarter of 2004 to the second quarter of 2006.
Still, the analyst said he expects the drug will eventually win the FDA`s OK. There had been some concerns that a potential cardiac side effect might jeopardize Ranexa`s final approval.
"We heard nothing at the advisory panel meeting that changes our opinion that Ranexa is an approvable drug," Schmidt wrote in a note to clients.
"WILL EVENTUALLY WIN THE FDA´s OK" and "RANEXA IS AN APPROVABLE DRUG"
Gruß Seinfeld
Klingt doch gut. Müssen wir uns halt in Geduld üben. Und die Pipeline hat ja noch einiges zu bieten. In einem halben Jahr gibt es garantiert wieder andere Analysten Ratings.
Gruss
Isa
Gruss
Isa
Die Kommission scheint sich übrigens sehr uneins
gewesen zu sein, was die Zulasung von Ranexa betrifft ...
5 von 11 Mitgliedern waren für die Markteinführung,
6 dagegen ... also eine ganz schön enge Geschichte!!
The analyst noted that five of the 11 members of the
FDA panel had voted to approve the drug outright,
5 of 11= 45.45%, while the other six asked for additional data.
Of those wanting more information on the drug, some
said the Ranexa was "close to approval," Mr. Wei said.
"We appreciate the thorough review by the advisory
committee of Ranexa and we look forward to meeting
with the FDA as soon as possible to discuss next steps,"
said Louis G. Lange, M.D., Ph.D., chairman and chief
executive officer of CV Therapeutics.
gewesen zu sein, was die Zulasung von Ranexa betrifft ...
5 von 11 Mitgliedern waren für die Markteinführung,
6 dagegen ... also eine ganz schön enge Geschichte!!
The analyst noted that five of the 11 members of the
FDA panel had voted to approve the drug outright,
5 of 11= 45.45%, while the other six asked for additional data.
Of those wanting more information on the drug, some
said the Ranexa was "close to approval," Mr. Wei said.
"We appreciate the thorough review by the advisory
committee of Ranexa and we look forward to meeting
with the FDA as soon as possible to discuss next steps,"
said Louis G. Lange, M.D., Ph.D., chairman and chief
executive officer of CV Therapeutics.
FDA panel said that the company`s preclinical and
clinical data on QT prolongation were acceptable.
"The general tenor of the panel was much more positive
than the tone of the FDA briefing documents," said
Thomas Wei, an analyst at U.S. Bancorp Piper Jaffray.
Five of the 11 panel members at Tuesday`s meeting
recommended approving Ranexa based on the current
available data. The other six members recommended
more data be submitted prior to approval.
JUST MISSED BY ONE VOTE
THE DRUG IS EFFECTIVE
THE DRUG IS SAFE
THE PANEL WOULD LIKE MORE DATA --- GOT IT MORE DATA ---
WAIT FOR FDA FINAL DECISION. YOU MIGHT BE VERY SUPRISED.
FDA CAN`T DISMISS 5 VOTES AS NOTHING.
Puuuh, stellt euch mal vor, daß einer der elf Mitglieder
seine Meinung noch ändern würde
clinical data on QT prolongation were acceptable.
"The general tenor of the panel was much more positive
than the tone of the FDA briefing documents," said
Thomas Wei, an analyst at U.S. Bancorp Piper Jaffray.
Five of the 11 panel members at Tuesday`s meeting
recommended approving Ranexa based on the current
available data. The other six members recommended
more data be submitted prior to approval.
JUST MISSED BY ONE VOTE
THE DRUG IS EFFECTIVE
THE DRUG IS SAFE
THE PANEL WOULD LIKE MORE DATA --- GOT IT MORE DATA ---
WAIT FOR FDA FINAL DECISION. YOU MIGHT BE VERY SUPRISED.
FDA CAN`T DISMISS 5 VOTES AS NOTHING.
Puuuh, stellt euch mal vor, daß einer der elf Mitglieder
seine Meinung noch ändern würde
11.12.2003
CV Therapeutics "outperform"
SG Cowen
Rating-Update:
Die Analysten vom Investmenthaus SG Cowen stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) unverändert mit "outperform" ein. Man rechne mit einer zusätzlichen Effizienz-Studie für Ranexa, was eine Verzögerung von ca. zwei Jahren mit sich bringe. 2006 dürfte die Markteinführung stattfinden.
CV Therapeutics "outperform"
SG Cowen
Rating-Update:
Die Analysten vom Investmenthaus SG Cowen stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) unverändert mit "outperform" ein. Man rechne mit einer zusätzlichen Effizienz-Studie für Ranexa, was eine Verzögerung von ca. zwei Jahren mit sich bringe. 2006 dürfte die Markteinführung stattfinden.
11.12.2003
CV Therapeutics neues Kursziel
Lehman Brothers
Rating-Update:
Die Analysten vom Investmenthaus Lehman Brothers stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) unverändert mit "equal weight" ein. Das Kursziel sei von 23 auf 12 USD reduziert worden.
CV Therapeutics neues Kursziel
Lehman Brothers
Rating-Update:
Die Analysten vom Investmenthaus Lehman Brothers stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) unverändert mit "equal weight" ein. Das Kursziel sei von 23 auf 12 USD reduziert worden.
Die FDA kann das Präparat durchaus zulassen. Sie fogt zwar meistens der Empfehlung des Kommites, ist aber nicht daran gebunden!!!
@Isa : Ich kenne nur einen Fall, dessen Namen ich zu allem Überfluss ich auch noch vergessen habe, wo die FDA tasächlich das Expertengremium zugunsten des Herstellers überstimmt hat. Eher bekommen unsere Politiker eine Sozialreform zustande, die auch mal über ein Jahr hält.
@puhvogel
Volle Zustimmung - ist eher etwas auf lange Sicht.
Gruss Kosto
Volle Zustimmung - ist eher etwas auf lange Sicht.
Gruss Kosto
#101
zicke
Morphosys schwächelt heute aber!
Morphosys schwächelt heute aber!
Nochmals etwas zu Analysten. Vor 2 Wochen hat ein Schwachkopf bei Schwarz Pharma das Kursziel von 10€ genannt. Steigt jetzt gerade vorbörslich auf 23€!!!!!!!!!!!!!
Vielleicht haben ja viele ihre Aktien aufgrund dieser Aussage verkauft!
Vielleicht haben ja viele ihre Aktien aufgrund dieser Aussage verkauft!
CV Therapeutics (Nasdaq: CVTX) Upgraded to BUY by Independent ... 12.12. / 14:46
NANUET, N.Y., Dec. 12 /PRNewswire-FirstCall/ -- White Mountain Capital, a provider of independent research on select biotechnology companies, today upgraded its rating of CV Therapeutics to BUY from its initial HOLD rating issued in October.
"The recent decline in stock price resulting from the FDA``s review of ranolazine makes this a significantly undervalued company at these levels," said Oren Levy, M.D., Ph.D., the Director of Biotechnology Research at White Mountain Capital. "We believe that ranolazine will still reach the market, gaining regulatory approval in 2006. We think the current stock price reflects the needed additional trials."
Dr. Levy said that despite the company``s missteps in communicating with the investment community, CV Therapeutics is an excellent company with three promising drug candidates, ample financial resources and a capable management team.
For a copy of the report, call toll-free 866-833-5300 during market hours. For more White Mountain Capital research titles, visit http://www.whitemountaincapital.com/.
Gruß Seinfeld
NANUET, N.Y., Dec. 12 /PRNewswire-FirstCall/ -- White Mountain Capital, a provider of independent research on select biotechnology companies, today upgraded its rating of CV Therapeutics to BUY from its initial HOLD rating issued in October.
"The recent decline in stock price resulting from the FDA``s review of ranolazine makes this a significantly undervalued company at these levels," said Oren Levy, M.D., Ph.D., the Director of Biotechnology Research at White Mountain Capital. "We believe that ranolazine will still reach the market, gaining regulatory approval in 2006. We think the current stock price reflects the needed additional trials."
Dr. Levy said that despite the company``s missteps in communicating with the investment community, CV Therapeutics is an excellent company with three promising drug candidates, ample financial resources and a capable management team.
For a copy of the report, call toll-free 866-833-5300 during market hours. For more White Mountain Capital research titles, visit http://www.whitemountaincapital.com/.
Gruß Seinfeld
Endlich mal positive News
Immerhin schon das zweite Analystenhaus, das positiv in die Zukunft blickt ...
Auch SG Cowen hat sein Rating "Outperform" erneuert, aber natürlich überwiegen noch die Downgrades ...
Auch SG Cowen hat sein Rating "Outperform" erneuert, aber natürlich überwiegen noch die Downgrades ...
Die wollen sich sowieso meisten nur günstig eindecken bzw. schöne Kurse für die Kundschaft generieren.
Ich hasse Werte die hoch gestiegen sind und dann auf Buy gestuft werden. Ist für mich ein klares Warnsignal.
Gruss Kosto
Ich hasse Werte die hoch gestiegen sind und dann auf Buy gestuft werden. Ist für mich ein klares Warnsignal.
Gruss Kosto
Seit 2 tagen schöner Anstieg!
13:33 ET VCLK +0.02 and CVTX +0.45 highlighted on CNBC as stocks experiencing recent insider buying :
Über die Insider-Käufe wird auch in Amerikanischen Boards viel spekuliert ... naja, dem Kurs tut´s jedenfalls gut ... fest steht wohl, daß mindestens zwei Vorstandsmitglieder die niedrigen Kurse zum größeren Nachkauf genutzt haben ... bahnt sich da was an???
Viele Grüße und Frohe Weihnachten wünscht euch allen ...
Seinfeld
Viele Grüße und Frohe Weihnachten wünscht euch allen ...
Seinfeld
Das hört sich doch positiv an - ich werde gleich mal die Insiderscores anschaun...
Gruss + Guten Rutsch!
Kosto
Gruss + Guten Rutsch!
Kosto
hi,
ziemlich ruhig hier geworden..denke über einen
Einstieg bei CV nach..gibt es auch Os oder Zertifikate
in Deutschland ?
Gruß,
KingsX
ziemlich ruhig hier geworden..denke über einen
Einstieg bei CV nach..gibt es auch Os oder Zertifikate
in Deutschland ?
Gruß,
KingsX
Das Teil steigt heute endlich mal wieder mit einigen %ten- (6,5%), was mich natürlich sehr freut, weil ich heute noch etwas nachgelegt habe...
Anlass (anscheinend) ist die Ankündigung, dass CVTX am 13ten Januar einen Vortrag auf den JPMorgan Healthcare Conference machen wird...
was der Markt nicht alles bewegen kann..
Anlass (anscheinend) ist die Ankündigung, dass CVTX am 13ten Januar einen Vortrag auf den JPMorgan Healthcare Conference machen wird...
was der Markt nicht alles bewegen kann..
Unser CV Therapeutics!
Warum plötzlich diese Wandel nach oben, + 3,5% ? Weiß jemand
etwas näheres??
mfg
kurttilly
Warum plötzlich diese Wandel nach oben, + 3,5% ? Weiß jemand
etwas näheres??
mfg
kurttilly
Vielleicht, weil ich heute nochmals kräftig zu 11,48€ nachgekauft habe!
JAMA Publishes Data on Effect of Ranexa(TM) on Key Markers of Angina Severity in Patients on Background Angina Therapy
PALO ALTO, Calif., Jan. 20 /PRNewswire-FirstCall/ -- The Journal of the American Medical Association tomorrow publishes data from the Combination Assessment of Ranolazine In Stable Angina (CARISA) trial showing that Ranexa(TM) (ranolazine) produced statistically significant reductions in angina frequency (p<=0.006) and nitroglycerin use (p<0.02), two important measures of angina severity. In this study, Ranexa produced statistically significant (p=0.012) increases in symptom-limited exercise duration at trough drug concentrations, the primary endpoint of the study.
CARISA was a Phase III multi-national, double-blind, placebo-controlled, parallel group trial of the safety and efficacy of ranolazine in persistently symptomatic angina patients. In this trial, 823 patients were randomized to assess the anti-anginal effects of 12 weeks of treatment with Ranexa in chronic angina patients also receiving a background anti-anginal medication.
The most common adverse effects with Ranexa were constipation, nausea, asthenia and dizziness, all of which occurred with a frequency <6.2 percent more than with placebo.
CV Therapeutics (Nasdaq: CVTX) is developing Ranexa for the treatment of chronic angina and a New Drug Application is under review by the U.S. Food and Drug Administration. If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than a quarter century. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
"What is especially exciting about the CARISA data is that patients who were on standard anti-anginal drug therapy had substantial improvement in their angina after taking Ranexa, without suffering clinically meaningful decreases in heart rate or blood pressure. This is particularly important for the significant number of angina patients who cannot tolerate further reductions in heart rate or blood pressure caused by existing anti-anginal drugs. In addition, angina patients with other illnesses like diabetes, congestive heart failure and COPD often cannot tolerate the side effects from these drugs," said lead author Bernard R. Chaitman, M.D., Professor of Medicine, Director of Cardiovascular Research, Saint Louis University School of Medicine, St. Louis, MO.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. It affects 6.8 million people in the U.S., according to the American Heart Association, and results in more than 700 million angina attacks per year in the U.S.
Study Detail
Patients received one of three background therapies at once-daily standard doses (atenolol 50 mg, diltiazem CD 180 mg, or amlodipine 5 mg) and were randomized to receive twice daily doses of Ranexa 750 mg, Ranexa 1000 mg or placebo. Exercise testing was performed at trough plasma concentrations (12 hours after dosing) after two, six, and 12 weeks and at peak plasma concentrations (four hours after dosing) after two and 12 weeks.
Study Results
In both Ranexa dose groups combined, symptom-limited exercise duration at trough plasma concentrations, the primary endpoint of the trial, increased on Ranexa by an average of 116 seconds, compared to an average increase of 92 seconds on placebo (p=0.012). The average increases in symptom-limited exercise duration at trough plasma concentrations on each ranolazine dose, considered independently, were 115 seconds on 750 mg and 116 seconds on 1000 mg, compared to 92 seconds on placebo (p<=0.03). The increases in exercise times on Ranexa were not significantly different among the three background therapies.
Statistically significant effects of Ranexa also were observed on other secondary efficacy endpoints. Compared to placebo, Ranexa at both doses statistically significantly increased the average time to onset of angina at both peak (38 seconds on each dose; p<=0.003) and trough (30 and 26 seconds, respectively; p<=0.033). Ranexa doses of 750 mg and 1000 mg increased the average time to electrocardiographic evidence of ischemia compared to placebo. These increases approached statistical significance at trough (20 and 21 seconds, respectively; p<=0.1) and achieved statistical significance at peak (41 and 35 seconds, respectively; p<=0.004). Ranexa at doses of 750 mg and 1000 mg reduced the frequency of angina by an average of 0.8 (p=0.006) and 1.2 (p<0.001) attacks per week, compared to placebo. Ranexa also significantly reduced nitroglycerin consumption by an average of 1.0 (p=0.016) and 1.4 (p<0.001) tablets per week at Ranexa doses of 750 mg and 1000 mg, respectively, compared to placebo.
Ranexa had no clinically meaningful impact on heart rate or blood pressure, either at rest or following exercise.
The adverse event rate was 26 percent for placebo, 31 percent for Ranexa 750 mg, and 33 percent for Ranexa 1000 mg. Small (<10 milliseconds) but statistically significant (p<0.001) mean increases in QTc were observed compared to placebo. Five patients receiving the 1000 mg dose of Ranexa experienced syncope. None of the syncopal episodes appeared to be due to ventricular arrhythmia or torsades de pointes and no cases of torsade de pointes have ever been observed in patients taking Ranexa. Serious adverse events were observed in six percent, seven percent, and seven percent of patients on placebo, Ranexa 750 mg, and Ranexa 1000 mg, respectively. In CARISA, three patients died on placebo, two on Ranexa 750 mg and one on Ranexa 1000 mg.
About CV Therapeutics
CV Therapeutics, Inc.(NASDAQ-NMS:CVTX) is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory agencies. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
CV Therapeutics, headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical trials. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 25 years. On October 30, 2003, the U.S. Food and Drug Administration (FDA) sent CV Therapeutics an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. On December 9, 2003, the Cardiovascular and Renal Drugs Advisory Committee of the FDA discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc.(NASDAQ-NMS:BIIB) For more information, please visit CV Therapeutics` website at www.cvt.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2002, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.(
Gruß Seinfeld
PALO ALTO, Calif., Jan. 20 /PRNewswire-FirstCall/ -- The Journal of the American Medical Association tomorrow publishes data from the Combination Assessment of Ranolazine In Stable Angina (CARISA) trial showing that Ranexa(TM) (ranolazine) produced statistically significant reductions in angina frequency (p<=0.006) and nitroglycerin use (p<0.02), two important measures of angina severity. In this study, Ranexa produced statistically significant (p=0.012) increases in symptom-limited exercise duration at trough drug concentrations, the primary endpoint of the study.
CARISA was a Phase III multi-national, double-blind, placebo-controlled, parallel group trial of the safety and efficacy of ranolazine in persistently symptomatic angina patients. In this trial, 823 patients were randomized to assess the anti-anginal effects of 12 weeks of treatment with Ranexa in chronic angina patients also receiving a background anti-anginal medication.
The most common adverse effects with Ranexa were constipation, nausea, asthenia and dizziness, all of which occurred with a frequency <6.2 percent more than with placebo.
CV Therapeutics (Nasdaq: CVTX) is developing Ranexa for the treatment of chronic angina and a New Drug Application is under review by the U.S. Food and Drug Administration. If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than a quarter century. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
"What is especially exciting about the CARISA data is that patients who were on standard anti-anginal drug therapy had substantial improvement in their angina after taking Ranexa, without suffering clinically meaningful decreases in heart rate or blood pressure. This is particularly important for the significant number of angina patients who cannot tolerate further reductions in heart rate or blood pressure caused by existing anti-anginal drugs. In addition, angina patients with other illnesses like diabetes, congestive heart failure and COPD often cannot tolerate the side effects from these drugs," said lead author Bernard R. Chaitman, M.D., Professor of Medicine, Director of Cardiovascular Research, Saint Louis University School of Medicine, St. Louis, MO.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. It affects 6.8 million people in the U.S., according to the American Heart Association, and results in more than 700 million angina attacks per year in the U.S.
Study Detail
Patients received one of three background therapies at once-daily standard doses (atenolol 50 mg, diltiazem CD 180 mg, or amlodipine 5 mg) and were randomized to receive twice daily doses of Ranexa 750 mg, Ranexa 1000 mg or placebo. Exercise testing was performed at trough plasma concentrations (12 hours after dosing) after two, six, and 12 weeks and at peak plasma concentrations (four hours after dosing) after two and 12 weeks.
Study Results
In both Ranexa dose groups combined, symptom-limited exercise duration at trough plasma concentrations, the primary endpoint of the trial, increased on Ranexa by an average of 116 seconds, compared to an average increase of 92 seconds on placebo (p=0.012). The average increases in symptom-limited exercise duration at trough plasma concentrations on each ranolazine dose, considered independently, were 115 seconds on 750 mg and 116 seconds on 1000 mg, compared to 92 seconds on placebo (p<=0.03). The increases in exercise times on Ranexa were not significantly different among the three background therapies.
Statistically significant effects of Ranexa also were observed on other secondary efficacy endpoints. Compared to placebo, Ranexa at both doses statistically significantly increased the average time to onset of angina at both peak (38 seconds on each dose; p<=0.003) and trough (30 and 26 seconds, respectively; p<=0.033). Ranexa doses of 750 mg and 1000 mg increased the average time to electrocardiographic evidence of ischemia compared to placebo. These increases approached statistical significance at trough (20 and 21 seconds, respectively; p<=0.1) and achieved statistical significance at peak (41 and 35 seconds, respectively; p<=0.004). Ranexa at doses of 750 mg and 1000 mg reduced the frequency of angina by an average of 0.8 (p=0.006) and 1.2 (p<0.001) attacks per week, compared to placebo. Ranexa also significantly reduced nitroglycerin consumption by an average of 1.0 (p=0.016) and 1.4 (p<0.001) tablets per week at Ranexa doses of 750 mg and 1000 mg, respectively, compared to placebo.
Ranexa had no clinically meaningful impact on heart rate or blood pressure, either at rest or following exercise.
The adverse event rate was 26 percent for placebo, 31 percent for Ranexa 750 mg, and 33 percent for Ranexa 1000 mg. Small (<10 milliseconds) but statistically significant (p<0.001) mean increases in QTc were observed compared to placebo. Five patients receiving the 1000 mg dose of Ranexa experienced syncope. None of the syncopal episodes appeared to be due to ventricular arrhythmia or torsades de pointes and no cases of torsade de pointes have ever been observed in patients taking Ranexa. Serious adverse events were observed in six percent, seven percent, and seven percent of patients on placebo, Ranexa 750 mg, and Ranexa 1000 mg, respectively. In CARISA, three patients died on placebo, two on Ranexa 750 mg and one on Ranexa 1000 mg.
About CV Therapeutics
CV Therapeutics, Inc.(NASDAQ-NMS:CVTX) is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory agencies. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
CV Therapeutics, headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical trials. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 25 years. On October 30, 2003, the U.S. Food and Drug Administration (FDA) sent CV Therapeutics an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. On December 9, 2003, the Cardiovascular and Renal Drugs Advisory Committee of the FDA discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it.
Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc.(NASDAQ-NMS:BIIB) For more information, please visit CV Therapeutics` website at www.cvt.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2002, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.(
Gruß Seinfeld
Es wird immer besser ... nachbörslich aktuell bei 16,25$ ...
Hier noch eine Meldung von gerade eben ...
Dow Jones Business News
CV Therapeutics` Ranolazine Cuts Angina Attacks -Study
Tuesday January 20, 4:16 pm ET
WASHINGTON (Dow Jones)--A study in The Journal of the American Medical Association (News - Websites) shows CV Therapeutics Inc. (NasdaqNM:CVTX - News)`s drug ranolazine helps reduce the frequency of angina attacks.
ADVERTISEMENT
A news release by the medical journal also says the medication increases exercise capacity for patients with severe chronic angina.
The study, conducted by Dr. Bernard R. Chaitman and colleagues at the St. Louis University School of Medicine, is in the Jan. 21 issue of the journal. It included 823 adult patients with chronic angina randomly assigned to receive placebo or ranolazine.
The patients received twice daily placebo or 750 mg or 1000 mg of ranolazine. Treadmill exercise following dosage was assessed after two, six and 12 weeks of treatment.
"We report the first evidence that ranolazine can reduce both angina frequency and nitroglycerin consumption when added to a standard dose of 1 of 3 frequently prescribed antianginal drugs: atenolol, amlodipine or diltiazem," the study`s authors said. "The decrease in angina attacks vs. placebo were slightly less than 1 per week for those in the 750-mg and somewhat more than 1 per week for those in the 1000-mg ranolazine groups."
"Exercise duration after 12 weeks of ranolazine therapy increased by 115.6 seconds at trough for those taking ranolazine compared with 91.7 seconds for taking placebo," according to the study. Trough is the lowest level of the drug in the bloodstream.
Angina is characterized by a buildup of plaque in the arteries that leads to unpredictable attacks of debilitating cardiac pain. It affects 7 million people in the U.S.
-By Jeff Bater, Dow Jones Newswires; 202-862-6616; Jeff.Bater@dowjones.com
Gruß Seinfeld
Hier noch eine Meldung von gerade eben ...
Dow Jones Business News
CV Therapeutics` Ranolazine Cuts Angina Attacks -Study
Tuesday January 20, 4:16 pm ET
WASHINGTON (Dow Jones)--A study in The Journal of the American Medical Association (News - Websites) shows CV Therapeutics Inc. (NasdaqNM:CVTX - News)`s drug ranolazine helps reduce the frequency of angina attacks.
ADVERTISEMENT
A news release by the medical journal also says the medication increases exercise capacity for patients with severe chronic angina.
The study, conducted by Dr. Bernard R. Chaitman and colleagues at the St. Louis University School of Medicine, is in the Jan. 21 issue of the journal. It included 823 adult patients with chronic angina randomly assigned to receive placebo or ranolazine.
The patients received twice daily placebo or 750 mg or 1000 mg of ranolazine. Treadmill exercise following dosage was assessed after two, six and 12 weeks of treatment.
"We report the first evidence that ranolazine can reduce both angina frequency and nitroglycerin consumption when added to a standard dose of 1 of 3 frequently prescribed antianginal drugs: atenolol, amlodipine or diltiazem," the study`s authors said. "The decrease in angina attacks vs. placebo were slightly less than 1 per week for those in the 750-mg and somewhat more than 1 per week for those in the 1000-mg ranolazine groups."
"Exercise duration after 12 weeks of ranolazine therapy increased by 115.6 seconds at trough for those taking ranolazine compared with 91.7 seconds for taking placebo," according to the study. Trough is the lowest level of the drug in the bloodstream.
Angina is characterized by a buildup of plaque in the arteries that leads to unpredictable attacks of debilitating cardiac pain. It affects 7 million people in the U.S.
-By Jeff Bater, Dow Jones Newswires; 202-862-6616; Jeff.Bater@dowjones.com
Gruß Seinfeld
Ungewöhnlich große Aktivität nachbörslich bei unserer
CVTX ... inzwischen 16,40 Dollar und viele Umsätze ...
CVTX ... inzwischen 16,40 Dollar und viele Umsätze ...
die Aktie wird morgen durch die Decke gehen und noch mal weiter explodieren wenn gegen die allgemeine Erwartung doch mitte Februar FDA-approval für Ranexa erhalten wird...
yuchuuuuu...gratuliere alle Investierten!
Greetz
Sheepshead
yuchuuuuu...gratuliere alle Investierten!
Greetz
Sheepshead
Das ist nur die alte Phase 3 Studie veröffentlicht in einem medizinischen Journal.
Hmm ... stimmt ... handelt sich wohl wirklich um einen älteren Artikel ... jedenfalls wird das auch in amerikanischen Boards gesagt ... vielleicht kommt aber trotzdem Bewegung in die Aktie, denn es ist zumindest interessant, daß der Kurs gestern sofort ansprang ...
Hoffen wir mal das Beste ...
Gruß Seinfeld
Hoffen wir mal das Beste ...
Gruß Seinfeld
hum ja, das Yahoo-Board meldet das Gleiche- Pre-market Quote liegt bei 15$.
Wenigstens ist fest zustellen, dass die Aktie unter Hochspannung steht und schnellstens hoch schiessen kann bei der dafür geeigneten Meldung.. also, erst mal Tee trinken gehen...
Wenigstens ist fest zustellen, dass die Aktie unter Hochspannung steht und schnellstens hoch schiessen kann bei der dafür geeigneten Meldung.. also, erst mal Tee trinken gehen...
Kann aber auch sein, dass heute die Gewinne eingesackt werden. Glaube ich eher dran! Habe ich auch getan und in Medimmune umgeschichtet; die sollte auch endlich mal laufen!
Aufgrund einer alten Meldung glaube ich nicht, dass der Anstieg nachhaltig ist!
Aufgrund einer alten Meldung glaube ich nicht, dass der Anstieg nachhaltig ist!
da könntest du wohl recht haben- aber die endgültige Entscheidung des FDA´s steht noch immer aus und könnte eine Überraschung geben...
Pre-market bisher war doch von 16-bis 16,40$, also doch ziemlich positiv. (+4% oder sowas)
Pre-market bisher war doch von 16-bis 16,40$, also doch ziemlich positiv. (+4% oder sowas)
Siehst Du, geht schon deutlich runter. Würde mich nicht wundern, wenn die bald wieder unter 12 € notiert!
Isa
Isa
Gibts was neues, oder warum steigt die heute so? Kann nichts finden!
Hier ein sehr interessanter und positiv stimmenden Bericht
BusinessWeek Online
CV Investors: Take Heart
Friday January 23, 4:19 pm ET
Lately, CV Therapeutics (NasdaqNM:CVTX - News) is bouncing around on rumors of what the Food & Drug Administration might do about Ranexa, CV`s angina treatment. The stock has dropped from 18 in November to 12 on Dec. 8, when an FDA panel sought more data on the drug. Quickly, most analysts cooled on CV. But lately, the stock has perked up -- to 15.17 on Jan. 21. That may be due to the Jan. 21 issue of the Journal of the American Medical Assn., which said Ranexa significantly reduced angina frequency. Some investors now say it may get early FDA approval. (Five of the 11 FDA panel members urged an outright O.K.) With the stock`s low price and better prospects, CV is buyout bait, say some pros. In late 2000, as takeover talk swirled, CV soared to 80. One New York fund manager, who asked not to be identified, is buying shares because he expects a bid. Big drugmakers are snapping up biotechs to fill their pipelines (in December, Pfizer (NYSE:PFE - News) bought Esperion (NasdaqNM:ESPR - News)). CV has yet to make money, but if Ranexa is approved, it could be a home run. He notes that CV`S stock price is equal to its cash stash of $15 a share. Thomas Wei of Piper Jaffray (NYSE:USB - News) rates the stock outperform. He foresees approval in 2006 -- or earlier. Piper has done banking for CV. Oren Levy, head of biotech research at White Mountain Capital, has upped CV from hold to buy. He says it has promising drugs and ample finances.
Gruß Seinfeld
BusinessWeek Online
CV Investors: Take Heart
Friday January 23, 4:19 pm ET
Lately, CV Therapeutics (NasdaqNM:CVTX - News) is bouncing around on rumors of what the Food & Drug Administration might do about Ranexa, CV`s angina treatment. The stock has dropped from 18 in November to 12 on Dec. 8, when an FDA panel sought more data on the drug. Quickly, most analysts cooled on CV. But lately, the stock has perked up -- to 15.17 on Jan. 21. That may be due to the Jan. 21 issue of the Journal of the American Medical Assn., which said Ranexa significantly reduced angina frequency. Some investors now say it may get early FDA approval. (Five of the 11 FDA panel members urged an outright O.K.) With the stock`s low price and better prospects, CV is buyout bait, say some pros. In late 2000, as takeover talk swirled, CV soared to 80. One New York fund manager, who asked not to be identified, is buying shares because he expects a bid. Big drugmakers are snapping up biotechs to fill their pipelines (in December, Pfizer (NYSE:PFE - News) bought Esperion (NasdaqNM:ESPR - News)). CV has yet to make money, but if Ranexa is approved, it could be a home run. He notes that CV`S stock price is equal to its cash stash of $15 a share. Thomas Wei of Piper Jaffray (NYSE:USB - News) rates the stock outperform. He foresees approval in 2006 -- or earlier. Piper has done banking for CV. Oren Levy, head of biotech research at White Mountain Capital, has upped CV from hold to buy. He says it has promising drugs and ample finances.
Gruß Seinfeld
Kann mir jemand von Euch den Bericht kurz übersetzen
(kurze Zusammenfassung). Wäre nett von Euch!
(kurze Zusammenfassung). Wäre nett von Euch!
Übernahmespekulationen und die Annahme, das die Publikation alter Daten die FDA überzeugen könnte, ihre Meinung zum Positiven zu ändern:
Eine aberwitzige Vorstellung.
Eine aberwitzige Vorstellung.
Naja, immerhin hat das Gremium eine Zulassung des Medikaments nur mit 5:6 Stimmen abgelehnt. Es war also eine sehr, sehr knappe Entscheidung zu Ungunsten von CV ... so völlig ausgeschlossen halte ich eine Revidierung durch die FDA nicht ... gefährlich ist jetzt allerdings, daß der Kurs natürlich nur deshalb relativ positiv läuft, weil es diese (leichten) Hoffnungen gibt ...sollte die FDA das Urteil des Panels übernehmen (was in der Regel so ist!!!), dann kann der Kurs natürlich wieder zusammenbrechen ... ... andererseits besteht CV ja nicht nur aus Ranexa und der faire Wert der Firma anhand der Cash-Position beläuft sich ja schon auf ca. 15 Dollar pro Aktie ... daher sollte es eigentlich kaum viel tiefer gehen. Ich denke man muß bei CV einen recht langen Atem haben und eine Zulassung nicht vor 2006 einkalkulieren, trotzdem dürfte uns der Aktienkurs auf lange Sicht wieder Freude bereiten
Schönes Wochenende, Seinfeld
Schönes Wochenende, Seinfeld
Diese 5:6 Entscheidung ist in der Hinsicht zu sehen, dass einige Ärzte gerne eine Alternativpräparat für Problempatienten hätten, die auf konventionelle Therapien nicht ansprechen. Das ist häufig der Unterschied zwischen Praktikern, die mit der lückenhaften Therapie jetzt konfrontiert sind, und den Sesselpupsern der FDA, die a priori von einem guten Versorgungsstandard ausgehen.
Das wurde mir noch nie so klar wie bei UTHRs Remodulin, wo die FDA-Kullefutzkis doch tatsächlich verlangt hatten, dass es besser wirken solle als Flolan, das ja nur mit einem permanenten Katheter appliziert werden muß.
Das Hauptproblem bei Ranexa ist u.a., dass es für ein potenzielles Blockbustermedikament zu stark bei weißen Männern ausgetestet wurde, die anderen Subgruppen leider aber zu stark ausgespart wurden. Solche Daten werden ja nur beim FDA-Review bekanntgegeben. In der Tat gibt es bei einigen Herzmedikamenten wie den Betablockern deutliche Differenzen der Nebenwirkungen unter verschiedenen ethnischen Gruppen, den Einwand kann man nicht so einfach wegwischen. Umgekehrt sind aber 10000 Patienten Sicherheitsstudien von kleinen Biotechs nicht mehr finanzierbar. Irgendwo muß auch eine Grenze gezogen werden und auch die verschreibenen Ärzte mehr in die Pflicht genommen werden, eventuelle Nebenwirkungen anzuzeigen, ohne das ein Schar von Anwälten sich daran gesundstößt.
Es ist nun die Entscheidung von CVT, ob sie Ranexa für alle Patienten zulassen wollen oder nur für die Subgruppe der Problempatienten. Letzteres ist erheblich leichter, aber natürlich nicht so lukrativ.
Das Ranexa nicht das einzige Medikament ist, und das sie eine gute Pipeline haben, ist für mich auch der Hauptgrund für den Kauf. Es kann auch daher sein, das Insider jetzt ob der baldigen Phase 3 Daten von CVT-510 kaufen.
Die Parallelen zu Amylin sind übrigens frappierend. Schade das man die Charts nicht übereinanderlegen kann.
Das wurde mir noch nie so klar wie bei UTHRs Remodulin, wo die FDA-Kullefutzkis doch tatsächlich verlangt hatten, dass es besser wirken solle als Flolan, das ja nur mit einem permanenten Katheter appliziert werden muß.
Das Hauptproblem bei Ranexa ist u.a., dass es für ein potenzielles Blockbustermedikament zu stark bei weißen Männern ausgetestet wurde, die anderen Subgruppen leider aber zu stark ausgespart wurden. Solche Daten werden ja nur beim FDA-Review bekanntgegeben. In der Tat gibt es bei einigen Herzmedikamenten wie den Betablockern deutliche Differenzen der Nebenwirkungen unter verschiedenen ethnischen Gruppen, den Einwand kann man nicht so einfach wegwischen. Umgekehrt sind aber 10000 Patienten Sicherheitsstudien von kleinen Biotechs nicht mehr finanzierbar. Irgendwo muß auch eine Grenze gezogen werden und auch die verschreibenen Ärzte mehr in die Pflicht genommen werden, eventuelle Nebenwirkungen anzuzeigen, ohne das ein Schar von Anwälten sich daran gesundstößt.
Es ist nun die Entscheidung von CVT, ob sie Ranexa für alle Patienten zulassen wollen oder nur für die Subgruppe der Problempatienten. Letzteres ist erheblich leichter, aber natürlich nicht so lukrativ.
Das Ranexa nicht das einzige Medikament ist, und das sie eine gute Pipeline haben, ist für mich auch der Hauptgrund für den Kauf. Es kann auch daher sein, das Insider jetzt ob der baldigen Phase 3 Daten von CVT-510 kaufen.
Die Parallelen zu Amylin sind übrigens frappierend. Schade das man die Charts nicht übereinanderlegen kann.
Na, da huscht aber ein Lächeln über mein Gesicht
Aktuell ... 17.30$ (+7,8%)
Gruß Seinfeld
Aktuell ... 17.30$ (+7,8%)
Gruß Seinfeld
Wann ist denn eigentlich die endgültige Entscheidung der FDA?
Gruß
BFW
Gruß
BFW
Einen "Approval letter" respektive "conditional approval" hat Ranexa ja schon bekommen, danach gibt es meinesachtens keine festen Zeitrahmen mehr, bis wann etwas entschieden werden muß.
Die Diskussionen die ich verfolge, habe ich anders verstanden. Mein Verständniss ist "approvable Letter" erhalten irgendwann mal in Sept (weil "efficacy" nachgewiesen war) - danach Hearing vom Expertenpanel am 9e Dez. mit den knappen negativen Ergebniss und jetzt wird noch gewartet auf die endgültige Entscheidung von der FDA, wobei die Spekulation noch ist:
-Abweichung vom Experten, also vll doch (unconditional) Approval.
-Limited Approval, für Einsatz bei bestimmten Gruppen von patienten.
-oder doch noch 1-2 Jahre erweiterten klinischen Testen durchführen zu müssen usw
glaube, so wars.
-Abweichung vom Experten, also vll doch (unconditional) Approval.
-Limited Approval, für Einsatz bei bestimmten Gruppen von patienten.
-oder doch noch 1-2 Jahre erweiterten klinischen Testen durchführen zu müssen usw
glaube, so wars.
und.. die offizielle FDA-Entscheidung wird normalerweise innerhalb von 60 Tage nach Panel-review bekannt gegeben.
Also, spätestens am 9e Februar- könnte diese Woche doch noch einiges an Spannung aufkommen
Also, spätestens am 9e Februar- könnte diese Woche doch noch einiges an Spannung aufkommen
Also das mit der 60 Tage Regelung ist mir völlig neu. Als einzige feste Bezugsgröße ist für mich der Termin der NDA-Beantragung, nach einem Jahr muß irgendetwas entschieden sein. Im Fall Ranexa war das eben der conditional approval.
Das Advisitory Board ist ja auch kein Entscheidungsgremium sondern wie der Name schon sagt ein Beratungsgremium, dem die FDA aber glücklicherweise recht häufig folgt.
Beispiel Amylin/Symlin:
http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol-ne…
7.12.2000: NDA-Filing für Symlin für Diabetes Typ 1 und 2
25.1.2001: FDA akzeptiert das NDA (dafür gibt es IMHO auch eine zeitliche Frist, offenbar nicht wie von mir gedacht schon nach einem Monat)
26.7.2001: Advisitory Board trifft zusammen und befürwortet Zulassung sofern Sicherheitsfragen beantwortet werden.
12.10.2001: FDA gibt Symlin ein approval letter
2002: Werden neue Studien angeleiert
16.6.2003: Amylin stellt NDA Ergänzungsantrag bei der FDA
17.12.2003: Die FDA meldet sich erstmals seit über 2 Jahren wieder offiziell zurück und gibt den 2. approvable letter für Symlin.
Wir werden es ja sehen, ob diese beiden Wochen etwas kommt.
Das Advisitory Board ist ja auch kein Entscheidungsgremium sondern wie der Name schon sagt ein Beratungsgremium, dem die FDA aber glücklicherweise recht häufig folgt.
Beispiel Amylin/Symlin:
http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol-ne…
7.12.2000: NDA-Filing für Symlin für Diabetes Typ 1 und 2
25.1.2001: FDA akzeptiert das NDA (dafür gibt es IMHO auch eine zeitliche Frist, offenbar nicht wie von mir gedacht schon nach einem Monat)
26.7.2001: Advisitory Board trifft zusammen und befürwortet Zulassung sofern Sicherheitsfragen beantwortet werden.
12.10.2001: FDA gibt Symlin ein approval letter
2002: Werden neue Studien angeleiert
16.6.2003: Amylin stellt NDA Ergänzungsantrag bei der FDA
17.12.2003: Die FDA meldet sich erstmals seit über 2 Jahren wieder offiziell zurück und gibt den 2. approvable letter für Symlin.
Wir werden es ja sehen, ob diese beiden Wochen etwas kommt.
Man ersetze in meinem TExt "approval letter" durch "approvable letter"!
Ich kenne die Regelung persönlich auch nicht, aber hatte diese Bemerkung gelesen im Yahoo-Board. Leider ist es öfters sehr schwierig, das Unterschied zwischen Wahrheit und Humbug zu erkennen, weil seriöse Leute UND Schreihälse da posten
sicherlich etwas seriöser UND interessant war folgenden Beitrag:
I can answer a few of your questions from a cardiologist`s view. The FDA was alarmed when in the CARISA trial there were 4 cases of syncope and a possibility that that was due to an arrythmia secondary to QT prolongation. However, this issue has more or less been settled, the patients were on several other drugs known to cause orthostatic hypotension ie. Ace-inhibitors, Ca++ channel blockers. The AC has been convinced by CVT that there was no risk of QT-prolongation. However, since the FDA had placed an alarming letter on its website, most analysts with no medical knowledge downgraded the stock. The AC did not take a formal decision on approval to avoid embarrasing the FDA and gave a conditional approval. We, however, in the cardiology community realize that the drug had no adversed effecrt in Placebo-controlled triple blind studies and expect the drug Ranolazine to be approved soon. It will help in a significant portion on the population with angina post-PCI, CABG or on current approved medical therapy. I do not work for CVT, however,I own the stock
Greetz
Sheepshead
sicherlich etwas seriöser UND interessant war folgenden Beitrag:
I can answer a few of your questions from a cardiologist`s view. The FDA was alarmed when in the CARISA trial there were 4 cases of syncope and a possibility that that was due to an arrythmia secondary to QT prolongation. However, this issue has more or less been settled, the patients were on several other drugs known to cause orthostatic hypotension ie. Ace-inhibitors, Ca++ channel blockers. The AC has been convinced by CVT that there was no risk of QT-prolongation. However, since the FDA had placed an alarming letter on its website, most analysts with no medical knowledge downgraded the stock. The AC did not take a formal decision on approval to avoid embarrasing the FDA and gave a conditional approval. We, however, in the cardiology community realize that the drug had no adversed effecrt in Placebo-controlled triple blind studies and expect the drug Ranolazine to be approved soon. It will help in a significant portion on the population with angina post-PCI, CABG or on current approved medical therapy. I do not work for CVT, however,I own the stock
Greetz
Sheepshead
Datum CV Therapeutics to Announce 2003 Fourth Quarter and Year End ... 02.02.2004 22:10
PALO ALTO, Calif., Feb. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. today announced that it will release fourth quarter and year end financial results for 2003 after the market closes on Tuesday, February 10, 2004. Company management will webcast a conference call at 5:30 p.m. EST, 2:30 p.m. PST, on the company``s website.
To access the live webcast, please log on to the company``s website at http://www.cvt.com/ and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, February 17, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 5336322.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. If approved by the FDA, Ranexa(TM) would represent the first new class of anti-anginal therapy in more than 25 years. Regadenoson (CVT-3146), a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec). For more information, please visit CV Therapeutics`` website at http://www.cvt.com/.
CV Therapeutics, Inc.
© PR Newswire
Gruß Seinfeld
PALO ALTO, Calif., Feb. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. today announced that it will release fourth quarter and year end financial results for 2003 after the market closes on Tuesday, February 10, 2004. Company management will webcast a conference call at 5:30 p.m. EST, 2:30 p.m. PST, on the company``s website.
To access the live webcast, please log on to the company``s website at http://www.cvt.com/ and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, February 17, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 5336322.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. If approved by the FDA, Ranexa(TM) would represent the first new class of anti-anginal therapy in more than 25 years. Regadenoson (CVT-3146), a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec). For more information, please visit CV Therapeutics`` website at http://www.cvt.com/.
CV Therapeutics, Inc.
© PR Newswire
Gruß Seinfeld
kann mir das jemand von Euch kurz (Zusammenfassung) übersetzen.Mein Schulenglisch ist leider schon ein paar
Jährchen her. Danke im voraus!
Gruß BFW
Jährchen her. Danke im voraus!
Gruß BFW
Naja, heißt nicht mehr, als das CV seine Zahlen für´s 4.Quartal sowie auch die für´s gesamte Jahr 2003 am 10. Februar nach Börsenschluß bekanntgeben wird ...
@Schapekop:
Leider ist es öfters sehr schwierig, das Unterschied zwischen Wahrheit und Humbug zu erkennen, weil seriöse Leute UND Schreihälse da posten
Das ist wohl wahr. Falls du jemals einen sicheren Hinweis finden solltest, ernsthafte Kritiker und "educated basher" zu unterscheiden, dann gib mir bitte Bescheid. Die Großbuchstabenschreiber oder die CVTX-im-Namen-haber sind ja ganz schnell aussortierbar. Auch Leuten, die nur im CVTX-Board zu finden sind, traue ich recht wenig.
Ich hatte mir ja damals die Mitschrift des Advisitory Boards durchgelesen, und da war meiner Erinnerung folgendes der Hauptkritikpunkt.
Für eine breite Massen- bzw. Erstanwendung bei Angina pectoris sind die beiden Phase III Studien
a) zu klein und damit
b) leider nur für weiße ältere Männer aussagekräftig. Ich schimpfe ja gerne mal auf die Erbsenzählerei der FDA- Statistiker, aber diese Einwände haben durchaus ihre Berechtigung!
Das hinzukriegen wird IMHO aber so richtig teuer (0,5-1 Milliarde $ Gesamtkosten schätze ich).
Sind die Patienten dagegen gegen die anderen Medikamente resistent und damit echte Problemfälle, so existieren aber leider auch keine Daten für diese spezielle Subgruppe, inwiefern Ranexa bei denen anschlägt. Hier bräuchte die Studie nicht so umfangreich zu sein.
Es ist nun die Entscheidung von CVT, welchen Weg sie gehen wollen. Ich hoffe ja den letzteren, solange die keinen Pharmapartner haben.
Die QTC-Problematik ist bei weitem nicht sooo entscheidend gewesen , wie immer auf dem Yahoo-Board diskutiert worden ist.
Im Dow Jones-Bericht #69 ist das einzig relativ korrekt wiedergegeben worden. Reuters hat sich wohl mehr am Yahoo-Board orientiert.
Leider ist es öfters sehr schwierig, das Unterschied zwischen Wahrheit und Humbug zu erkennen, weil seriöse Leute UND Schreihälse da posten
Das ist wohl wahr. Falls du jemals einen sicheren Hinweis finden solltest, ernsthafte Kritiker und "educated basher" zu unterscheiden, dann gib mir bitte Bescheid. Die Großbuchstabenschreiber oder die CVTX-im-Namen-haber sind ja ganz schnell aussortierbar. Auch Leuten, die nur im CVTX-Board zu finden sind, traue ich recht wenig.
Ich hatte mir ja damals die Mitschrift des Advisitory Boards durchgelesen, und da war meiner Erinnerung folgendes der Hauptkritikpunkt.
Für eine breite Massen- bzw. Erstanwendung bei Angina pectoris sind die beiden Phase III Studien
a) zu klein und damit
b) leider nur für weiße ältere Männer aussagekräftig. Ich schimpfe ja gerne mal auf die Erbsenzählerei der FDA- Statistiker, aber diese Einwände haben durchaus ihre Berechtigung!
Das hinzukriegen wird IMHO aber so richtig teuer (0,5-1 Milliarde $ Gesamtkosten schätze ich).
Sind die Patienten dagegen gegen die anderen Medikamente resistent und damit echte Problemfälle, so existieren aber leider auch keine Daten für diese spezielle Subgruppe, inwiefern Ranexa bei denen anschlägt. Hier bräuchte die Studie nicht so umfangreich zu sein.
Es ist nun die Entscheidung von CVT, welchen Weg sie gehen wollen. Ich hoffe ja den letzteren, solange die keinen Pharmapartner haben.
Die QTC-Problematik ist bei weitem nicht sooo entscheidend gewesen , wie immer auf dem Yahoo-Board diskutiert worden ist.
Im Dow Jones-Bericht #69 ist das einzig relativ korrekt wiedergegeben worden. Reuters hat sich wohl mehr am Yahoo-Board orientiert.
@Puhvogel,
das Populationsproblem war mir auch bekannt und wird meines Achtens bei der Entscheidung eine grosse Rolle spielen. Aber die Kernfrage bleibt, wie der "Scope" dieser erweiterten Tests für Frauen/Minoritäten aussehen wird in die Entscheidung..diese könnte durchaus eine positive Überraschung sein.
Wegen das Pusher/Basher Thema- tja das kriegt man schlecht raus, aber wenn man nur auf die Suche nach Fakten und Tatsachen ist wird man sogar manchmal fundig..
Within 90 days after a scientific advisory panel makes recommendations on any matter under its review, the Food and Drug Administration official responsible for the matter shall review the conclusions and recommendations of the panel, and notify the affected persons of the final decision on the matter, or of the reasons that no such decision has been reached. Each such final decision shall be documented including the rationale for the decision.``.
(aus dem FDA Regelwerk ) -also doch 90 Tage i.e am 7ten März spätestens wissen wir bescheid
Greetz
Sheepshead
das Populationsproblem war mir auch bekannt und wird meines Achtens bei der Entscheidung eine grosse Rolle spielen. Aber die Kernfrage bleibt, wie der "Scope" dieser erweiterten Tests für Frauen/Minoritäten aussehen wird in die Entscheidung..diese könnte durchaus eine positive Überraschung sein.
Wegen das Pusher/Basher Thema- tja das kriegt man schlecht raus, aber wenn man nur auf die Suche nach Fakten und Tatsachen ist wird man sogar manchmal fundig..
Within 90 days after a scientific advisory panel makes recommendations on any matter under its review, the Food and Drug Administration official responsible for the matter shall review the conclusions and recommendations of the panel, and notify the affected persons of the final decision on the matter, or of the reasons that no such decision has been reached. Each such final decision shall be documented including the rationale for the decision.``.
(aus dem FDA Regelwerk ) -also doch 90 Tage i.e am 7ten März spätestens wissen wir bescheid
Greetz
Sheepshead
Tnx für den interessanten Link!
90 Tage, das kommt dann ja auch bei Amylin hin!
Na wenn es dann doch tatsächlich Pflicht der FDA ist sich zu äußern, dann gibt es wohl einen zweiten approvable letter ("that CVTX should provide additional analyses
and information prior to marketing approval") , wie bei Amylin, deren Aktionäre sich ja ein klein wenig verscheissert vorkommen müssen.
Ich erwarte nichts Konkretes, da muß man schon auf die Quartalsberichte warten, was für Studien konkret demnächst angeleiert werden.
An für sich war der approvable letter vor dem Zusammentreffen des Beratungsgremiums ja schon sehr ungewöhlich. Ich kenne jedenfalls adhoc keinen Präzedenzfall!
Im ganzen obigen Regelwerk steht nicht ein einziges mal das Wort "approvable letter" or "conditional" drin. Es ist aber eindeutig ein feststehender Begriff.
90 Tage, das kommt dann ja auch bei Amylin hin!
Na wenn es dann doch tatsächlich Pflicht der FDA ist sich zu äußern, dann gibt es wohl einen zweiten approvable letter ("that CVTX should provide additional analyses
and information prior to marketing approval") , wie bei Amylin, deren Aktionäre sich ja ein klein wenig verscheissert vorkommen müssen.
Ich erwarte nichts Konkretes, da muß man schon auf die Quartalsberichte warten, was für Studien konkret demnächst angeleiert werden.
An für sich war der approvable letter vor dem Zusammentreffen des Beratungsgremiums ja schon sehr ungewöhlich. Ich kenne jedenfalls adhoc keinen Präzedenzfall!
Im ganzen obigen Regelwerk steht nicht ein einziges mal das Wort "approvable letter" or "conditional" drin. Es ist aber eindeutig ein feststehender Begriff.
Für mich langfr. sehr interessant.
Heute kommen die Zahlen.
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - February 10, 2004
--------------------------------------------------------------------------------
CV Therapeutics Reports Fourth Quarter and Year End Financial Results for 2003
PALO ALTO, Calif., Feb. 10 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the fourth quarter and the year ended December 31, 2003. For the quarter ended December 31, 2003, the Company reported a net loss of $35.1 million, or $1.21 per share, compared to a net loss of $29.4 million, or $1.09 per share, for the same quarter in 2002. For the year ended December 31, 2003, the Company reported a net loss of $111.0 million, or $3.91 per share, compared to a net loss of $107.8 million, or $4.13 per share, for the year ended December 31, 2002.
For the quarter ended December 31, 2003, total operating expenses increased to approximately $39.4 million, from $32.3 million for the same quarter in 2002. Total operating expenses increased to $121.3 million for the year ended December 31, 2003, from $118.2 million for the year ended December 31, 2002. The increase in operating expenses for the quarter ended December 31, 2003, compared to the same quarter in 2002, was primarily due to increased pre-commercialization efforts for the Ranexa(TM) program. The increase in operating expenses for the year ended December 31, 2003, compared to the year ended December 31, 2002, was primarily due to increased pre-commercialization efforts for the Ranexa program, partially offset by decreased research and development expenses compared to the prior year, when we incurred greater expenses related to manufacturing and NDA filing for the Ranexa program.
The Company recognized collaborative research revenue of $5.6 million for the quarter ended December 31, 2003, compared to $1.8 million for the same quarter in 2002. For the year ended December 31, 2003, the Company recognized revenues of $11.3 million, compared to $5.3 million for the year ended December 31, 2002. The revenue recognized for all periods relates to the reimbursement of certain development costs from collaborative partners. For the quarter and year ended December 31, 2003, collaborative research revenue also includes a $3.0 million milestone payment for the initiation of a Phase III clinical trial for regadenoson (CVT-3146).
At December 31, 2003, the Company had cash, cash equivalents and marketable securities of approximately $430.1 million, compared to $410.9 million at December 31, 2002. The increase was primarily due to the issuance of 2.0% senior subordinated convertible debentures in June 2003, which resulted in gross proceeds of $100.0 million.
Company management will webcast a conference call to review the quarterly and year end financial results on Tuesday, February 10, 2004 at 5:30 p.m. EST, 2:30 p.m. PST, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, February 17, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 5336322.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 25 years. Regadenoson (CVT-3146), a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to our financial performance and the development and commercialization of our products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended Year ended
December 31, December 31,
2002 2003 2002 2003
(A) (A)
Revenues:
Collaborative research $1,774 $5,567 $5,287 $11,305
Operating expenses:
Research and development 23,773 27,242 90,973 80,792
Sales and marketing 4,105 7,949 11,271 23,476
General and administrative 4,387 4,257 15,955 17,015
Total operating expenses 32,265 39,448 118,199 121,283
Loss from operations (30,491) (33,881) (112,912) (109,978)
Interest and other income
(expense), net 1,130 (1,176) 5,139 (973)
Net loss $(29,361) $(35,057) $(107,773) $(110,951)
Basic and diluted net loss per
share $(1.09) $(1.21) $(4.13) $(3.91)
Shares used in computing basic
and diluted net loss per share 26,881 29,068 26,093 28,360
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, December 31,
2002 2003
(B)
Assets:
Cash, cash equivalents and
marketable securities $410,913 $430,107
Other current assets 8,952 13,009
Total current assets 419,865 443,116
Property and equipment, net 15,934 16,358
Other assets 5,203 11,301
Total assets $441,002 $470,775
Liabilities and stockholders` equity:
Current liabilities $20,907 $21,016
Convertible subordinated notes 196,250 296,250
Other long-term obligations 4,880 5,182
Stockholders` equity 218,965 148,327
Total liabilities and
stockholders` equity $441,002 $470,775
(A) Certain reclassifications of prior year amounts have been made to
conform with the current year presentation.
(B) Derived from the audited financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2002.
SOURCE CV Therapeutics, Inc.
-0- 02/10/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc. /
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
ST: California
IN: HEA BIO MTC
SU: ERN CCA
JP-GF
-- SFTU122 --
1324 02/10/2004 15:59 EST http://www.prnewswire.com
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding CV Therapeutics` business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company`s Annual Report or Form 10-K for the most recently ended fiscal year.
Copyright 1999-2004, CV Therapeutics, Inc.
--------------------------------------------------------------------------------
CV Therapeutics Reports Fourth Quarter and Year End Financial Results for 2003
PALO ALTO, Calif., Feb. 10 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the fourth quarter and the year ended December 31, 2003. For the quarter ended December 31, 2003, the Company reported a net loss of $35.1 million, or $1.21 per share, compared to a net loss of $29.4 million, or $1.09 per share, for the same quarter in 2002. For the year ended December 31, 2003, the Company reported a net loss of $111.0 million, or $3.91 per share, compared to a net loss of $107.8 million, or $4.13 per share, for the year ended December 31, 2002.
For the quarter ended December 31, 2003, total operating expenses increased to approximately $39.4 million, from $32.3 million for the same quarter in 2002. Total operating expenses increased to $121.3 million for the year ended December 31, 2003, from $118.2 million for the year ended December 31, 2002. The increase in operating expenses for the quarter ended December 31, 2003, compared to the same quarter in 2002, was primarily due to increased pre-commercialization efforts for the Ranexa(TM) program. The increase in operating expenses for the year ended December 31, 2003, compared to the year ended December 31, 2002, was primarily due to increased pre-commercialization efforts for the Ranexa program, partially offset by decreased research and development expenses compared to the prior year, when we incurred greater expenses related to manufacturing and NDA filing for the Ranexa program.
The Company recognized collaborative research revenue of $5.6 million for the quarter ended December 31, 2003, compared to $1.8 million for the same quarter in 2002. For the year ended December 31, 2003, the Company recognized revenues of $11.3 million, compared to $5.3 million for the year ended December 31, 2002. The revenue recognized for all periods relates to the reimbursement of certain development costs from collaborative partners. For the quarter and year ended December 31, 2003, collaborative research revenue also includes a $3.0 million milestone payment for the initiation of a Phase III clinical trial for regadenoson (CVT-3146).
At December 31, 2003, the Company had cash, cash equivalents and marketable securities of approximately $430.1 million, compared to $410.9 million at December 31, 2002. The increase was primarily due to the issuance of 2.0% senior subordinated convertible debentures in June 2003, which resulted in gross proceeds of $100.0 million.
Company management will webcast a conference call to review the quarterly and year end financial results on Tuesday, February 10, 2004 at 5:30 p.m. EST, 2:30 p.m. PST, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, February 17, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 5336322.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 25 years. Regadenoson (CVT-3146), a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to our financial performance and the development and commercialization of our products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended Year ended
December 31, December 31,
2002 2003 2002 2003
(A) (A)
Revenues:
Collaborative research $1,774 $5,567 $5,287 $11,305
Operating expenses:
Research and development 23,773 27,242 90,973 80,792
Sales and marketing 4,105 7,949 11,271 23,476
General and administrative 4,387 4,257 15,955 17,015
Total operating expenses 32,265 39,448 118,199 121,283
Loss from operations (30,491) (33,881) (112,912) (109,978)
Interest and other income
(expense), net 1,130 (1,176) 5,139 (973)
Net loss $(29,361) $(35,057) $(107,773) $(110,951)
Basic and diluted net loss per
share $(1.09) $(1.21) $(4.13) $(3.91)
Shares used in computing basic
and diluted net loss per share 26,881 29,068 26,093 28,360
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, December 31,
2002 2003
(B)
Assets:
Cash, cash equivalents and
marketable securities $410,913 $430,107
Other current assets 8,952 13,009
Total current assets 419,865 443,116
Property and equipment, net 15,934 16,358
Other assets 5,203 11,301
Total assets $441,002 $470,775
Liabilities and stockholders` equity:
Current liabilities $20,907 $21,016
Convertible subordinated notes 196,250 296,250
Other long-term obligations 4,880 5,182
Stockholders` equity 218,965 148,327
Total liabilities and
stockholders` equity $441,002 $470,775
(A) Certain reclassifications of prior year amounts have been made to
conform with the current year presentation.
(B) Derived from the audited financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2002.
SOURCE CV Therapeutics, Inc.
-0- 02/10/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc. /
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
ST: California
IN: HEA BIO MTC
SU: ERN CCA
JP-GF
-- SFTU122 --
1324 02/10/2004 15:59 EST http://www.prnewswire.com
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding CV Therapeutics` business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company`s Annual Report or Form 10-K for the most recently ended fiscal year.
Copyright 1999-2004, CV Therapeutics, Inc.
CV Therapeutics: Verlust ausgeweitet 10.02.2004 22:31
Der Biotechnologiekonzern CV Therapeutics hat seinen Verlust im abgelaufenen Quartal auf 35,1 Millionen Dollar oder 1,21 Dollar pro Aktie ausgeweitet. Im Vorjahreszeitraum war ein Minus von 29,4 Millionen Dollar angefallen. Der Verlust lag laut Reuters Research allerdings im Rahmen der Erwartungen.
CV Therapeutics, die sich im regulären Handel noch um 0,75 Prozent auf 16,20 Dollar verbessern konnten, geben nachbörslich aktuell 0,3 Prozent auf 16,15 Dollar ab.
© BörseGo
Der Biotechnologiekonzern CV Therapeutics hat seinen Verlust im abgelaufenen Quartal auf 35,1 Millionen Dollar oder 1,21 Dollar pro Aktie ausgeweitet. Im Vorjahreszeitraum war ein Minus von 29,4 Millionen Dollar angefallen. Der Verlust lag laut Reuters Research allerdings im Rahmen der Erwartungen.
CV Therapeutics, die sich im regulären Handel noch um 0,75 Prozent auf 16,20 Dollar verbessern konnten, geben nachbörslich aktuell 0,3 Prozent auf 16,15 Dollar ab.
© BörseGo
Die haben ihre Promotiontätigkeit für Ranexa heruntergefahren und ihr Forschungsetat musste erhöht werden. Nix überraschendes.
Aktienkurs ist komplett durch Cash abgedeckt. Pipeline ist quasi umsonst. Habe heute erste position aufgebaut.
Dürfte wohl nich mehr lange dauern, bis der Wert entdeckt wird. Ist meiner meinung nach im Verhältnis zu anderen Bios völlig unterbewertet!!
Dürfte wohl nich mehr lange dauern, bis der Wert entdeckt wird. Ist meiner meinung nach im Verhältnis zu anderen Bios völlig unterbewertet!!
Im Vergleich - Richtig. Cashposition ist gut (aber vergesse die Schulden nicht).
Sehr interessanter Wert.
Sehr interessanter Wert.
Sofern die ihre Produkte nicht in den Markt durchkriegen, dann werden die ihre Schulden genau der Mühlstein sein, der den Kurs gewaltig drückt. Unterschätzt die Probleme bei der Refinanzierung nicht, diese Cash-Positionen blenden!
Dies Spielchen habe ich des öfteren beobachtet.
Jüngst habe ich das nochmal bei Elan auf die ganz harte Tour gelernt, für dessen Kurssturz auch retrospektiv eigentlich keinen konkreten Grund gab außer Angst der grundbescheuerten Anleger, wie die Schulden im worst case Szenario zurückgezahlt werden können.
Als Warren Buffett hätte ich die aufgekauft und ich würde die jetzt für 10 Millionen $ an Novartis oder so weiterverscherbeln.
Dies Spielchen habe ich des öfteren beobachtet.
Jüngst habe ich das nochmal bei Elan auf die ganz harte Tour gelernt, für dessen Kurssturz auch retrospektiv eigentlich keinen konkreten Grund gab außer Angst der grundbescheuerten Anleger, wie die Schulden im worst case Szenario zurückgezahlt werden können.
Als Warren Buffett hätte ich die aufgekauft und ich würde die jetzt für 10 Millionen $ an Novartis oder so weiterverscherbeln.
Kein Ein-Produkt-Unternehmen.
CVTX hat kein Schuldenproblem, nur ein Kauf wg. der Cashposition ist auch nicht anzuraten.
Nur wegen cash kaufen sicher nicht. Aber cash plus diese Pipeline finde ich schon sehr beeindruckend!!!!
Ich denke langfristig gesehen kann man jetzt bei einem kauf nicht viel falsch machen!
Ich denke langfristig gesehen kann man jetzt bei einem kauf nicht viel falsch machen!
Auf das Timing kommt es an - aber im Prinzip hast du Recht.
Weisst Du, wenn ich jetzt höre wie begeistert die Leute über GPC sind. Cash deckt den halben Aktienkurs+ 1 fortgeschrittenes Produkt.
Da kaufe ich mir dann lieber CV!! Und wenn Ranexa irgendwann doch noch die Zulassung erhält(davon denke ich kann man ausgehen) werden wir ganz schnell andere Kurse sehen. Und dann sind immer noch 4 Produkte in einem fortgeschrittenen Stadium!!
Da kaufe ich mir dann lieber CV!! Und wenn Ranexa irgendwann doch noch die Zulassung erhält(davon denke ich kann man ausgehen) werden wir ganz schnell andere Kurse sehen. Und dann sind immer noch 4 Produkte in einem fortgeschrittenen Stadium!!
Aus dem letzten 10K:
In March 2000, we sold $196.3 million aggregate principal amount of 4.75% convertible subordinated notes due in March 2007.
Also entweder man mag die Pipeline oder nicht, entsprechend kauft man die Aktie oder nicht. Cashriesen gab es schon ganz andere: Die verrückteste Version war mal KDE mit einem free-Cash-Kurs-Verhältnis von 3:2 und einem durchaus reellen KGV von 4. Bis CVTs Produkte Marktreife erreichen, wird aber sehr viel vom Cashbestand aufgeschmolzen sein. Scheitern die Produkte, dann haben die sehr wohl ein Schuldenproblem. Auch ist zu bendenken, das bis zwei Jahre nach Markteinführung generieren die vermutlich keinen Gewinn.
Mir schmeckt nicht richtig, wie wenig der Markt diese Pipeline wertschätzt.
Da könnte aber wieder eine Parallele zwischen Amylin und CVTX existieren. Bei Amylin schauten die Investoren zu sehr auf die Probleme mit Symlin und ignorierten dabei grandios die Chancen von Exendin, eine echte Blockbusteranwendung.
Hier könnten die Probleme mit Ranexa die Pipeline verdecken.
In March 2000, we sold $196.3 million aggregate principal amount of 4.75% convertible subordinated notes due in March 2007.
Also entweder man mag die Pipeline oder nicht, entsprechend kauft man die Aktie oder nicht. Cashriesen gab es schon ganz andere: Die verrückteste Version war mal KDE mit einem free-Cash-Kurs-Verhältnis von 3:2 und einem durchaus reellen KGV von 4. Bis CVTs Produkte Marktreife erreichen, wird aber sehr viel vom Cashbestand aufgeschmolzen sein. Scheitern die Produkte, dann haben die sehr wohl ein Schuldenproblem. Auch ist zu bendenken, das bis zwei Jahre nach Markteinführung generieren die vermutlich keinen Gewinn.
Mir schmeckt nicht richtig, wie wenig der Markt diese Pipeline wertschätzt.
Da könnte aber wieder eine Parallele zwischen Amylin und CVTX existieren. Bei Amylin schauten die Investoren zu sehr auf die Probleme mit Symlin und ignorierten dabei grandios die Chancen von Exendin, eine echte Blockbusteranwendung.
Hier könnten die Probleme mit Ranexa die Pipeline verdecken.
seit dezember anstieg linear von ca. 10 euro auf jetzt 13,10 euro ist ja wohl auch nicht schlecht.
sukashi
sukashi
gibt es etwas neues, oder warum fällt CVTX in den letzten
Tagen (heute über 5 %) so?
Tagen (heute über 5 %) so?
Hängt mit dem Gesamtmarkt zusammen.
CV Th. fällt aber schon deutlich durch eine negative Outperformance auf. Die sind schliesslich kein Semiconductor.
Entweder Zufall, Nachwirkungen auf den neuerlichen Aktienverkäufe (*Kotz*) oder jemand weiß was, was wir nicht wissen. Gefällt mir gar nicht.-
27-Feb-2004
Other Events and Financial Statements & Exhibits
ITEM 5. OTHER EVENTS
On October 2, 2003, we filed a registration statement on Form S-3, which registration statement was amended pursuant to pre-effective amendment no. 1 filed on February 5, 2004, registering up to an aggregate of $300,000,000 of our securities, $47,500,000 of which was carried over from a registration statement on Form S-3 that we filed on January 4, 2001, which was amended pursuant to pre-effective amendment no. 1 filed on January 12, 2001.
On February 26, 2004, we entered into a Common Stock Purchase Agreement with Mainfield Enterprises, Inc., pursuant to which we agreed to issue and sell 1,609,186 shares of our common stock at a purchase price of $15.5358 per share, for aggregate gross proceeds of approximately $25,000,000. The shares will be issued pursuant to the registration statements referenced above. We intend to deliver the shares on or about March 2, 2004.
The foregoing description is qualified in its entirety by reference to the Common Stock Purchase Agreement, dated as of February 26, 2004, by and between Mainfield Enterprises and us, which is incorporated by reference into this report.
Entweder Zufall, Nachwirkungen auf den neuerlichen Aktienverkäufe (*Kotz*) oder jemand weiß was, was wir nicht wissen. Gefällt mir gar nicht.-
27-Feb-2004
Other Events and Financial Statements & Exhibits
ITEM 5. OTHER EVENTS
On October 2, 2003, we filed a registration statement on Form S-3, which registration statement was amended pursuant to pre-effective amendment no. 1 filed on February 5, 2004, registering up to an aggregate of $300,000,000 of our securities, $47,500,000 of which was carried over from a registration statement on Form S-3 that we filed on January 4, 2001, which was amended pursuant to pre-effective amendment no. 1 filed on January 12, 2001.
On February 26, 2004, we entered into a Common Stock Purchase Agreement with Mainfield Enterprises, Inc., pursuant to which we agreed to issue and sell 1,609,186 shares of our common stock at a purchase price of $15.5358 per share, for aggregate gross proceeds of approximately $25,000,000. The shares will be issued pursuant to the registration statements referenced above. We intend to deliver the shares on or about March 2, 2004.
The foregoing description is qualified in its entirety by reference to the Common Stock Purchase Agreement, dated as of February 26, 2004, by and between Mainfield Enterprises and us, which is incorporated by reference into this report.
@puhvogel,
damals, am 27-02 hatte diese Meldung nur bedingt negative Auswirkungen (so 0,40c oder was) und es wurde intensiv über den Zweck spekuliert..
aber wirklich, solange man die Cashplanung der Firma mit Begründungen nicht mitgeliefert kriegt, bringt diese Spekulation herzlichst wenig..
CVTX bleibt eine hoch volatile Aktie (shortinterest >20%), aber auch Eine mit hohen Chancen. Ich finde den Pipeline (neben Ranexa) auch sehr beeindruckend - also, würde sagen, abwarten und Tee trinken.
Greetz
Sheepshead
damals, am 27-02 hatte diese Meldung nur bedingt negative Auswirkungen (so 0,40c oder was) und es wurde intensiv über den Zweck spekuliert..
aber wirklich, solange man die Cashplanung der Firma mit Begründungen nicht mitgeliefert kriegt, bringt diese Spekulation herzlichst wenig..
CVTX bleibt eine hoch volatile Aktie (shortinterest >20%), aber auch Eine mit hohen Chancen. Ich finde den Pipeline (neben Ranexa) auch sehr beeindruckend - also, würde sagen, abwarten und Tee trinken.
Greetz
Sheepshead
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - March 30, 2004
--------------------------------------------------------------------------------
CV Therapeutics Files Application for European Marketing Approval of Ranolazine for Treatment of Chronic Angina
Company Announces Appointment of President for CVT Europe and Establishment of European Office in United Kingdom
PALO ALTO, Calif., Mar 30, 2004 /PRNewswire-FirstCall via COMTEX/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that a Marketing Authorization Application (MAA) seeking approval of ranolazine for the treatment of chronic angina has been filed with the European Agency for the Evaluation of Medicinal Products (EMEA).
The MAA for ranolazine, a new chemical entity, has been filed for review under the EMEA centralized procedure by the company`s new European subsidiary, CV Therapeutics Europe, Ltd.
"Angina is a tremendous problem around the world, and our submission of an MAA for ranolazine marks an important milestone for CVT as we examine potential commercialization activities in Europe," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.9 million people in the five largest markets in Europe.
To support current and potential activities in Europe, CV Therapeutics has established a European subsidiary based in the United Kingdom and appointed Huw Jones, Ph.D., as president of CV Therapeutics Europe, Ltd. Dr. Jones is responsible for managing European operations and evaluating commercialization opportunities for ranolazine, and other CV Therapeutics products, in Europe.
"Cardiovascular disease is the leading cause of death in Europe and CVT`s broad pipeline of unique potential cardiovascular therapies offers the opportunity to improve patient care and realize significant European commercial potential," Jones said.
Dr. Jones held various positions at Elan Pharmaceuticals from 1997 to 2001, including senior vice president, northern Europe. In this role, Dr. Jones was responsible for managing operations in the United Kingdom, Germany, France and other European countries. From 1986 to 1997, Dr. Jones held various positions at SmithKline Beecham Pharmaceuticals, including marketing director, UK. During his career to date, Dr. Jones has supervised product launches in several European countries and co-founded Daffodil Consulting LLP, a consulting company focusing on providing strategic advice and senior management to companies wishing to enter the European healthcare market. Dr. Jones received a Ph.D. in pharmacology from the University of Birmingham, UK in 1986.
CV Therapeutics Europe, Ltd. has also appointed David Rowley-Jones, MA, MB BChir, MRCP as non-executive director. Dr. Rowley-Jones spent 17 years at SmithKline Beecham Pharmaceuticals, including roles as vice president, UK medical and regulatory and senior vice president, worldwide strategic marketing. Dr. Rowley-Jones established Athena Neurosciences Europe in 1994 and subsequently Elan Pharmaceuticals` commercial organization in Europe. He co-founded Daffodil Consulting LLP in 2001.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the FDA and EMEA. Regadenoson, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc.; or media,
Alisha Parr/Gayle Sawyer of Packer Forbes Communications,
--------------------------------------------------------------------------------
CV Therapeutics Files Application for European Marketing Approval of Ranolazine for Treatment of Chronic Angina
Company Announces Appointment of President for CVT Europe and Establishment of European Office in United Kingdom
PALO ALTO, Calif., Mar 30, 2004 /PRNewswire-FirstCall via COMTEX/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that a Marketing Authorization Application (MAA) seeking approval of ranolazine for the treatment of chronic angina has been filed with the European Agency for the Evaluation of Medicinal Products (EMEA).
The MAA for ranolazine, a new chemical entity, has been filed for review under the EMEA centralized procedure by the company`s new European subsidiary, CV Therapeutics Europe, Ltd.
"Angina is a tremendous problem around the world, and our submission of an MAA for ranolazine marks an important milestone for CVT as we examine potential commercialization activities in Europe," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.9 million people in the five largest markets in Europe.
To support current and potential activities in Europe, CV Therapeutics has established a European subsidiary based in the United Kingdom and appointed Huw Jones, Ph.D., as president of CV Therapeutics Europe, Ltd. Dr. Jones is responsible for managing European operations and evaluating commercialization opportunities for ranolazine, and other CV Therapeutics products, in Europe.
"Cardiovascular disease is the leading cause of death in Europe and CVT`s broad pipeline of unique potential cardiovascular therapies offers the opportunity to improve patient care and realize significant European commercial potential," Jones said.
Dr. Jones held various positions at Elan Pharmaceuticals from 1997 to 2001, including senior vice president, northern Europe. In this role, Dr. Jones was responsible for managing operations in the United Kingdom, Germany, France and other European countries. From 1986 to 1997, Dr. Jones held various positions at SmithKline Beecham Pharmaceuticals, including marketing director, UK. During his career to date, Dr. Jones has supervised product launches in several European countries and co-founded Daffodil Consulting LLP, a consulting company focusing on providing strategic advice and senior management to companies wishing to enter the European healthcare market. Dr. Jones received a Ph.D. in pharmacology from the University of Birmingham, UK in 1986.
CV Therapeutics Europe, Ltd. has also appointed David Rowley-Jones, MA, MB BChir, MRCP as non-executive director. Dr. Rowley-Jones spent 17 years at SmithKline Beecham Pharmaceuticals, including roles as vice president, UK medical and regulatory and senior vice president, worldwide strategic marketing. Dr. Rowley-Jones established Athena Neurosciences Europe in 1994 and subsequently Elan Pharmaceuticals` commercial organization in Europe. He co-founded Daffodil Consulting LLP in 2001.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the FDA and EMEA. Regadenoson, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA or any foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc.; or media,
Alisha Parr/Gayle Sawyer of Packer Forbes Communications,
Das macht doch wieder Hoffnung
Gruß Seinfeld
Gruß Seinfeld
Ich bin zuversichtlich, dass Ranexa bei der nächsten Sitzung durchkommt.
So dämlich kann man sich nicht 2x anstellen...
So dämlich kann man sich nicht 2x anstellen...
Was meinst du konkret mit dämlich?
Es war IMHO mehr eine Schwäche der Daten denn ein Demonstrationsfehler. Der Kurs fiel ja im Vorfeld der Tagung so stark.
Es war IMHO mehr eine Schwäche der Daten denn ein Demonstrationsfehler. Der Kurs fiel ja im Vorfeld der Tagung so stark.
Hallo,
kann mir einer von Euch kurz sagen, was in der Mitteilung
von 30.03.2004 genau steht und was das für CVTX bedeutet.
Gruß
BFW
kann mir einer von Euch kurz sagen, was in der Mitteilung
von 30.03.2004 genau steht und was das für CVTX bedeutet.
Gruß
BFW
Besser spät als gar nicht.
CVTX hat bei der europäischen Zulassungbehörde die Zulassung von Ranozaline für chronische Angina Pectoris beantragt.
Dies wurde von der FDA letztes Jahr abgelehnt. Es ist ungewöhlich, dass daraufhin der Antrag in Europa gestellt wird. Ich denke/hoffe einmal, das die das nicht nur aus Langeweile machen sondern Anhaltspunkte für einen positiven Ausgang haben. Ob sie die Zulassung für spezielle Pateintengruppen beantragt haben, habe ich aus dem Artikel nicht rauslesen können.
CVTX hat bei der europäischen Zulassungbehörde die Zulassung von Ranozaline für chronische Angina Pectoris beantragt.
Dies wurde von der FDA letztes Jahr abgelehnt. Es ist ungewöhlich, dass daraufhin der Antrag in Europa gestellt wird. Ich denke/hoffe einmal, das die das nicht nur aus Langeweile machen sondern Anhaltspunkte für einen positiven Ausgang haben. Ob sie die Zulassung für spezielle Pateintengruppen beantragt haben, habe ich aus dem Artikel nicht rauslesen können.
Hallo puhvogel,
danke für Deine Antwort. Wäre nett von Dir wenn Du mich
über Neuigkeiten bei CVTX auf den laufenden halten köntest.
Gruß
kleiner-bfw
danke für Deine Antwort. Wäre nett von Dir wenn Du mich
über Neuigkeiten bei CVTX auf den laufenden halten köntest.
Gruß
kleiner-bfw
Immerhin auf Tageshoch geschlossen ... es steckt noch Phantasie in CVTX
Hoffnungsvoller Gruß, Seinfeld
Hoffnungsvoller Gruß, Seinfeld
Und das bei dem relativ schwachen Markt gestern!
Also wenn in diesem Wert mit dieser supervollen Pipeline und bei den Major-Indikationen bei einer Marktkapitalisierung von 480 Millionen $ keine Phantasie drin stecken sollte, dann weiß ich auch nicht.
Momentan glotzt eben alles auf Ranexa.
Das heißt aber leider lange noch nicht, dass jede Phantasie realisiert wird!
Momentan glotzt eben alles auf Ranexa.
Das heißt aber leider lange noch nicht, dass jede Phantasie realisiert wird!
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - April 20, 2004
--------------------------------------------------------------------------------
JACC Publishes MARISA Trial Results, Including Anti-Ischemic and Long-Term Survival Data
PALO ALTO, Calif., April 20 /PRNewswire-FirstCall/ -- Data from the Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial showing that Ranexa(TM) (ranolazine) produced statistically significant (p<0.005) increases in symptom-limited exercise duration at trough drug concentrations, the primary endpoint of the study, will be published tomorrow in the Journal of the American College of Cardiology. CV Therapeutics (Nasdaq: CVTX) is developing Ranexa for the potential treatment of chronic angina.
"It is very exciting that clinical trials of Ranexa, whether used alone or in combination with other therapies, continue to demonstrate anti-anginal activity without compromises in heart rate or blood pressure. The long-term survival data with Ranexa suggests an area worthy of further investigation," said lead author Bernard R. Chaitman, M.D., Professor of Medicine, Director of Cardiovascular Research, Saint Louis University School of Medicine, St. Louis, MO.
In MARISA, a Phase III, multi-national, double-blind, placebo-controlled trial, 191 angina patients not receiving any other anti-anginal medication were randomized to receive placebo or Ranexa twice a day at doses of 500 mg, 1000 mg and 1500 mg. In addition to observing significant increases in exercise duration, the researchers found that secondary endpoints evaluating time to onset of angina pain during exercise testing and exercise time to electrocardiographic evidence of ischemia were statistically significantly (p<0.005) increased in patients receiving Ranexa.
Specific dose-related adverse events included dizziness, nausea, asthenia and constipation. The overall adverse event rate for the 500 mg dose of Ranexa was similar to that of placebo (16.0 percent vs. 15.6 percent). The adverse event rate for the 1000 mg dose was greater than that of placebo (21.7 percent vs. 15.6 percent). At the 1500 mg dose, adverse events occurred substantially more frequently than with lower Ranexa doses or placebo (34.2 percent vs. 15.6 percent with placebo). Because of decreased tolerability at the 1500 mg dose, CV Therapeutics is not seeking approval for this dose of Ranexa. Minor dose-related electrocardiogram changes were observed with Ranexa treatment. Mean differences in QTc interval versus placebo were less than 10 msec at the proposed commercial doses of 500 mg and 1000 mg.
After the double-blind treatment period in the MARISA study, most patients elected to continue taking Ranexa in an open-label study collecting further safety information. Based on this open-label data, the one-year mortality rate observed for patients taking Ranexa was 3.7 percent, compared to an estimated nine percent for a historical cohort of patients at similar risk who were not in the study. The authors emphasize that comparative treatment differences on survival would need to be addressed by randomized clinical trials.
CV Therapeutics is developing Ranexa for the treatment of chronic angina. If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than a quarter century. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. According to the American Heart Association, angina affects 6.8 million people and results in more than 700 million angina attacks per year in the United States.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). Regadenoson, a selective A2A- adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1- adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com. CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA, the EMEA or any other foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; operating at a loss; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward- looking statements.
SOURCE CV Therapeutics, Inc.
/CONTACT: Investors, Dan Spiegelman, SVP & Chief
--------------------------------------------------------------------------------
JACC Publishes MARISA Trial Results, Including Anti-Ischemic and Long-Term Survival Data
PALO ALTO, Calif., April 20 /PRNewswire-FirstCall/ -- Data from the Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial showing that Ranexa(TM) (ranolazine) produced statistically significant (p<0.005) increases in symptom-limited exercise duration at trough drug concentrations, the primary endpoint of the study, will be published tomorrow in the Journal of the American College of Cardiology. CV Therapeutics (Nasdaq: CVTX) is developing Ranexa for the potential treatment of chronic angina.
"It is very exciting that clinical trials of Ranexa, whether used alone or in combination with other therapies, continue to demonstrate anti-anginal activity without compromises in heart rate or blood pressure. The long-term survival data with Ranexa suggests an area worthy of further investigation," said lead author Bernard R. Chaitman, M.D., Professor of Medicine, Director of Cardiovascular Research, Saint Louis University School of Medicine, St. Louis, MO.
In MARISA, a Phase III, multi-national, double-blind, placebo-controlled trial, 191 angina patients not receiving any other anti-anginal medication were randomized to receive placebo or Ranexa twice a day at doses of 500 mg, 1000 mg and 1500 mg. In addition to observing significant increases in exercise duration, the researchers found that secondary endpoints evaluating time to onset of angina pain during exercise testing and exercise time to electrocardiographic evidence of ischemia were statistically significantly (p<0.005) increased in patients receiving Ranexa.
Specific dose-related adverse events included dizziness, nausea, asthenia and constipation. The overall adverse event rate for the 500 mg dose of Ranexa was similar to that of placebo (16.0 percent vs. 15.6 percent). The adverse event rate for the 1000 mg dose was greater than that of placebo (21.7 percent vs. 15.6 percent). At the 1500 mg dose, adverse events occurred substantially more frequently than with lower Ranexa doses or placebo (34.2 percent vs. 15.6 percent with placebo). Because of decreased tolerability at the 1500 mg dose, CV Therapeutics is not seeking approval for this dose of Ranexa. Minor dose-related electrocardiogram changes were observed with Ranexa treatment. Mean differences in QTc interval versus placebo were less than 10 msec at the proposed commercial doses of 500 mg and 1000 mg.
After the double-blind treatment period in the MARISA study, most patients elected to continue taking Ranexa in an open-label study collecting further safety information. Based on this open-label data, the one-year mortality rate observed for patients taking Ranexa was 3.7 percent, compared to an estimated nine percent for a historical cohort of patients at similar risk who were not in the study. The authors emphasize that comparative treatment differences on survival would need to be addressed by randomized clinical trials.
CV Therapeutics is developing Ranexa for the treatment of chronic angina. If approved, Ranexa would represent the first new class of therapy for angina introduced in the United States in more than a quarter century. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease (CAD) and marked by repeated and sometimes unpredictable attacks of chest pain. According to the American Heart Association, angina affects 6.8 million people and results in more than 700 million angina attacks per year in the United States.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). Regadenoson, a selective A2A- adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1- adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com. CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA, the EMEA or any other foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; operating at a loss; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward- looking statements.
SOURCE CV Therapeutics, Inc.
/CONTACT: Investors, Dan Spiegelman, SVP & Chief
PALO ALTO, Calif., April 22 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. today announced that it will release first quarter financial results for 2004 before the market opens on Friday, April 30, 2004. Company management will webcast a conference call at 8:30 a.m. EDT, 5:30 a.m. PDT, on the company``s website.
To access the live webcast, please log on to the company``s website at http://www.cvt.com/ and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Friday, May 7, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 6681883.
To access the live webcast, please log on to the company``s website at http://www.cvt.com/ and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Friday, May 7, 2004. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 6681883.
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - April 30, 2004
--------------------------------------------------------------------------------
CV Therapeutics Reports 2004 First Quarter Financial Results
PALO ALTO, Calif., April 30 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the first quarter ended March 31, 2004. For the quarter ended March 31, 2004, the Company reported a net loss of $31.3 million, or $1.04 per share. This compares to a net loss of $20.7 million, or $0.75 per share, for the same quarter in 2003 and to a net loss of $35.1 million, or $1.21 per share, for the prior quarter ended December 31, 2003.
Operating expenses for the quarter ended March 31, 2004 were approximately $32.7 million. This compares to operating expenses of $23.3 million for the same quarter in 2003, and to operating expenses of $39.4 million for the quarter ended December 31, 2003. The increase in operating expenses compared to the same quarter in 2003 was primarily due to additional Phase III clinical trial expenses, pre-commercialization marketing, general and administrative and manufacturing expenses. The decrease in operating expenses compared to the quarter ended December 31, 2003 was primarily due to decreased pre-commercialization, marketing and manufacturing costs and costs relating to the Company`s new drug application for Ranexa(TM), partially offset by increased general and administrative costs.
The Company recognized collaborative research revenue of $2.9 million for the quarter ended March 31, 2004. This compares to collaborative research revenue of $1.8 million for the same quarter in 2003, and to collaborative research revenue of $5.6 million for the quarter ended December 31, 2003. The revenue recognized for each of the periods relates to the reimbursement of certain development costs from collaborative partners and amortization of up-front milestone payments earned. For the quarter and year ended December 31, 2003, collaborative research revenue also includes a $3.0 million milestone payment for the initiation of a Phase III clinical trial for regadenoson (CVT-3146).
At March 31, 2004, the Company had cash, cash equivalents and marketable securities of approximately $432.1 million, compared to $430.1 million at December 31, 2003.
Company management will webcast a conference call on Friday, April 30, 2004 at 8:30 a.m. EDT, 5:30 a.m. PDT, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 6681883.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). Regadenoson, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA, the EMEA or any other foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to our financial performance and the development and commercialization of our products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; operating at a loss; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV Therapeutics, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended
March 31,
2003 2004
Revenues:
Collaborative research $1,797 $2,939
Operating expenses:
Research and development 16,878 22,330
Sales and marketing 2,859 4,993
General and administrative 3,516 5,404
Total operating expenses 23,253 32,727
Loss from operations (21,456) (29,788)
Interest and other income (expense), net 730 (1,536)
Net loss $(20,726) $(31,324)
Basic and diluted net loss per share $(0.75) $(1.04)
Shares used in computing basic & diluted
net loss per share 27,476 30,145
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, March 31,
2003 2004
(A)
Assets:
Cash, cash equivalents, and
marketable securities $430,107 $432,074
Other current assets 13,009 14,325
Total current assets 443,116 446,399
Property and equipment, net 16,358 15,807
Other assets 11,921 11,350
Total assets $471,395 $473,556
Liabilities and stockholders` equity:
Current liabilities $21,017 $17,763
Convertible subordinated notes 296,250 296,250
Other long-term obligations 5,182 5,342
Stockholders` equity 148,946 154,201
Total liabilities and stockholders` equity $471,395 $473,556
(A) Derived from the audited financial statements included in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2003.
SOURCE CV Therapeutics, Inc.
-0- 04/30/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, or Christopher Chai, Treasurer & Executive
Director, Investor Relations, +1-650-384-8560, all of CV Therapeutics, Inc./
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
ST: California
IN: HEA MTC BIO
SU: ERN ERP CCA
GK-MW
-- SFF009 --
0699 04/30/2004 05:30 EDT http://www.prnewswire.com
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding CV Therapeutics` business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company`s Annual Report or Form 10-K for the most recently ended fiscal year.
Copyright 1999-2004, CV Therapeutics, Inc.
--------------------------------------------------------------------------------
CV Therapeutics Reports 2004 First Quarter Financial Results
PALO ALTO, Calif., April 30 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the first quarter ended March 31, 2004. For the quarter ended March 31, 2004, the Company reported a net loss of $31.3 million, or $1.04 per share. This compares to a net loss of $20.7 million, or $0.75 per share, for the same quarter in 2003 and to a net loss of $35.1 million, or $1.21 per share, for the prior quarter ended December 31, 2003.
Operating expenses for the quarter ended March 31, 2004 were approximately $32.7 million. This compares to operating expenses of $23.3 million for the same quarter in 2003, and to operating expenses of $39.4 million for the quarter ended December 31, 2003. The increase in operating expenses compared to the same quarter in 2003 was primarily due to additional Phase III clinical trial expenses, pre-commercialization marketing, general and administrative and manufacturing expenses. The decrease in operating expenses compared to the quarter ended December 31, 2003 was primarily due to decreased pre-commercialization, marketing and manufacturing costs and costs relating to the Company`s new drug application for Ranexa(TM), partially offset by increased general and administrative costs.
The Company recognized collaborative research revenue of $2.9 million for the quarter ended March 31, 2004. This compares to collaborative research revenue of $1.8 million for the same quarter in 2003, and to collaborative research revenue of $5.6 million for the quarter ended December 31, 2003. The revenue recognized for each of the periods relates to the reimbursement of certain development costs from collaborative partners and amortization of up-front milestone payments earned. For the quarter and year ended December 31, 2003, collaborative research revenue also includes a $3.0 million milestone payment for the initiation of a Phase III clinical trial for regadenoson (CVT-3146).
At March 31, 2004, the Company had cash, cash equivalents and marketable securities of approximately $432.1 million, compared to $430.1 million at December 31, 2003.
Company management will webcast a conference call on Friday, April 30, 2004 at 8:30 a.m. EDT, 5:30 a.m. PDT, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing 888-370-6121, and international callers may participate in the conference call by dialing 706-679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Domestic callers can access the replay by dialing 800-642-1687, and international callers can access the replay by dialing 706-645-9291; the PIN access number is 6681883.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical development. Applications for the approval of ranolazine for the treatment of chronic angina have been submitted to the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). Regadenoson, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of congestive heart failure, is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more information, please visit CV Therapeutics` website at www.cvt.com.
CV Therapeutics is a development-stage company. None of the company`s products have been approved for marketing by the FDA, the EMEA or any other foreign regulatory authorities. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to our financial performance and the development and commercialization of our products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; operating at a loss; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV Therapeutics, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended
March 31,
2003 2004
Revenues:
Collaborative research $1,797 $2,939
Operating expenses:
Research and development 16,878 22,330
Sales and marketing 2,859 4,993
General and administrative 3,516 5,404
Total operating expenses 23,253 32,727
Loss from operations (21,456) (29,788)
Interest and other income (expense), net 730 (1,536)
Net loss $(20,726) $(31,324)
Basic and diluted net loss per share $(0.75) $(1.04)
Shares used in computing basic & diluted
net loss per share 27,476 30,145
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, March 31,
2003 2004
(A)
Assets:
Cash, cash equivalents, and
marketable securities $430,107 $432,074
Other current assets 13,009 14,325
Total current assets 443,116 446,399
Property and equipment, net 16,358 15,807
Other assets 11,921 11,350
Total assets $471,395 $473,556
Liabilities and stockholders` equity:
Current liabilities $21,017 $17,763
Convertible subordinated notes 296,250 296,250
Other long-term obligations 5,182 5,342
Stockholders` equity 148,946 154,201
Total liabilities and stockholders` equity $471,395 $473,556
(A) Derived from the audited financial statements included in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2003.
SOURCE CV Therapeutics, Inc.
-0- 04/30/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, or Christopher Chai, Treasurer & Executive
Director, Investor Relations, +1-650-384-8560, all of CV Therapeutics, Inc./
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
ST: California
IN: HEA MTC BIO
SU: ERN ERP CCA
GK-MW
-- SFF009 --
0699 04/30/2004 05:30 EDT http://www.prnewswire.com
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding CV Therapeutics` business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company`s Annual Report or Form 10-K for the most recently ended fiscal year.
Copyright 1999-2004, CV Therapeutics, Inc.
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - May 11, 2004
--------------------------------------------------------------------------------
CV Therapeutics Announces Proposed Private Offering of Senior Subordinated Convertible Notes
PALO ALTO, Calif., May 11 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it intends to offer, subject to market and other conditions, $100 million aggregate principal amount of senior subordinated convertible notes. The Company also expects to grant to the initial purchasers of the notes a 30-day option to purchase up to an additional $25 million of the notes.
The Company intends to use a portion of the net proceeds from the offering to repurchase a portion of its outstanding convertible debt, including subordinated debt. The Company will use a portion of the net proceeds of the offering to fund an escrow account to provide security for the first six scheduled interest payments on the notes. The Company intends to use the remaining net proceeds of the offering for general corporate purposes, which may include funding research, development and product manufacturing, preclinical and clinical trials, preparation and filing of new drug applications, product commercialization, increasing its working capital and capital expenditures.
The notes have not been registered under the Securities Act of 1933, as amended, or any applicable state securities laws, and will be offered only to qualified institutional buyers in reliance on Rule 144A. Unless so registered, the notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; operating at a loss; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
-0- 05/11/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc./
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
--------------------------------------------------------------------------------
CV Therapeutics Announces Proposed Private Offering of Senior Subordinated Convertible Notes
PALO ALTO, Calif., May 11 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it intends to offer, subject to market and other conditions, $100 million aggregate principal amount of senior subordinated convertible notes. The Company also expects to grant to the initial purchasers of the notes a 30-day option to purchase up to an additional $25 million of the notes.
The Company intends to use a portion of the net proceeds from the offering to repurchase a portion of its outstanding convertible debt, including subordinated debt. The Company will use a portion of the net proceeds of the offering to fund an escrow account to provide security for the first six scheduled interest payments on the notes. The Company intends to use the remaining net proceeds of the offering for general corporate purposes, which may include funding research, development and product manufacturing, preclinical and clinical trials, preparation and filing of new drug applications, product commercialization, increasing its working capital and capital expenditures.
The notes have not been registered under the Securities Act of 1933, as amended, or any applicable state securities laws, and will be offered only to qualified institutional buyers in reliance on Rule 144A. Unless so registered, the notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company`s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; operating at a loss; commercialization of our products; and other risks detailed from time to time in CVT`s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
-0- 05/11/2004
/CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer,
+1-650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc./
/Web site: http://www.cvt.com /
(CVTX)
CO: CV Therapeutics, Inc.
... und wie ist Deine Meinung dazu??? ...
Gruß Seinfeld
Gruß Seinfeld
Also das gleiche war bei Medarex. Der Kurs gab kurzfristig deutlich nach, erholte sich aber sehr rasch. Überlege ob ich morgen zukaufe.
Gruss
isa
Gruss
isa
Tja, erstmal geht´s hier auch deutlich zurück ... nachbörslich unter 14 Dollar!!
CV Therapeutics Inc. (NasdaqNM:CVTX - News) shares also fell, after the biotechnology company said it plans to offer $100 million in senior subordinated convertible notes. CV Therapeutics shares fell to $13.93 on INET from their Nasdaq close of $14.87.
(Quelle Yahoo)
Gruß Seinfeld
CV Therapeutics Inc. (NasdaqNM:CVTX - News) shares also fell, after the biotechnology company said it plans to offer $100 million in senior subordinated convertible notes. CV Therapeutics shares fell to $13.93 on INET from their Nasdaq close of $14.87.
(Quelle Yahoo)
Gruß Seinfeld
Ich glaube ich warte noch die Amieröffnung ab. mal schauen wie es heute dort weitergeht.
kann mir aber vorstellen, dass der nachbörsliche Einbruch dort heute nicht nachvollzogen wird!
kann mir aber vorstellen, dass der nachbörsliche Einbruch dort heute nicht nachvollzogen wird!
CV Therapeutics Announces Private Offering of Senior Subordinated Convertible Notes
13.05.2004
13:11
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PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that it has agreed to sell $125.0 million aggregate principal amount of its 2.75% senior subordinated convertible notes due 2012 through a private placement to qualified institutional buyers pursuant to Rule 144A. The Company expects to close the transaction on or about May 18, 2004. The Company has also granted to the initial purchasers of the notes a 30-day option to purchase up to an additional $25.0 million of the notes.
The Company may redeem all or a portion of the notes at any time after May 20, 2009. The notes will be convertible by holders at any time on or prior to maturity into shares of the Company``s common stock at an initial conversion rate of 56.5475 shares of common stock per $1,000 principal amount of notes (subject to adjustment in certain circumstances), which represents an initial conversion price of approximately $17.68 per share of common stock based on the issue price of the notes.
The Company has reached agreements in principle with a limited number of holders of its outstanding 4.75% convertible subordinated notes due 2007 in privately negotiated transactions to repurchase approximately $71.6 million aggregate principal amount of the notes.
In addition, the Company may also use an additional portion of the net proceeds from the offering to repurchase an additional portion of its outstanding convertible debt, including subordinated debt. The Company will use approximately $10.3 million of the net proceeds of the offering to fund an escrow account to provide security for the first six scheduled interest payments on the notes. The Company intends to use the remaining net proceeds of the offering for general corporate purposes, which may include funding research, development and product manufacturing, preclinical and clinical trials, preparation and filing of new drug applications, product commercialization, increasing its working capital and capital expenditures.
The notes have not been registered under the Securities Act of 1933, as amended, or any applicable state securities laws. Unless so registered, the notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the Company``s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; operating at a loss; commercialization of our products; and other risks detailed from time to time in CVT``s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV Therapeutics, Inc.
© PR Newswire
Klicken Sie hier, um weitere aktuelle Nachrichten zum Unternehmen zu finden:
CV THERAPEUTICS
13.05.2004
13:11
< zurück <
Archiv
Aktuelle
Nachrichten
Druckversion
PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that it has agreed to sell $125.0 million aggregate principal amount of its 2.75% senior subordinated convertible notes due 2012 through a private placement to qualified institutional buyers pursuant to Rule 144A. The Company expects to close the transaction on or about May 18, 2004. The Company has also granted to the initial purchasers of the notes a 30-day option to purchase up to an additional $25.0 million of the notes.
The Company may redeem all or a portion of the notes at any time after May 20, 2009. The notes will be convertible by holders at any time on or prior to maturity into shares of the Company``s common stock at an initial conversion rate of 56.5475 shares of common stock per $1,000 principal amount of notes (subject to adjustment in certain circumstances), which represents an initial conversion price of approximately $17.68 per share of common stock based on the issue price of the notes.
The Company has reached agreements in principle with a limited number of holders of its outstanding 4.75% convertible subordinated notes due 2007 in privately negotiated transactions to repurchase approximately $71.6 million aggregate principal amount of the notes.
In addition, the Company may also use an additional portion of the net proceeds from the offering to repurchase an additional portion of its outstanding convertible debt, including subordinated debt. The Company will use approximately $10.3 million of the net proceeds of the offering to fund an escrow account to provide security for the first six scheduled interest payments on the notes. The Company intends to use the remaining net proceeds of the offering for general corporate purposes, which may include funding research, development and product manufacturing, preclinical and clinical trials, preparation and filing of new drug applications, product commercialization, increasing its working capital and capital expenditures.
The notes have not been registered under the Securities Act of 1933, as amended, or any applicable state securities laws. Unless so registered, the notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the Company``s products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; the timing of clinical trials; the dependence on collaborative and licensing agreements; operating at a loss; commercialization of our products; and other risks detailed from time to time in CVT``s SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT disclaims any intent or obligation to update these forward-looking statements.
CV Therapeutics, Inc.
© PR Newswire
Klicken Sie hier, um weitere aktuelle Nachrichten zum Unternehmen zu finden:
CV THERAPEUTICS
Ob das die Sache besser macht
Werde heute mal nachlegen!
Könnte eine gute Idee sein
"Eigentlich" kann es nicht mehr viel tiefer gehen
"Eigentlich" kann es nicht mehr viel tiefer gehen
Ich denke, dass es kurzfr. noch weiter runtergeht.
Leider.
Leider.
Hallo,
warum geht der Kurs von CVTX so runter? Wo seht Ihr den Boden der Aktie?
Gruß
BFW
warum geht der Kurs von CVTX so runter? Wo seht Ihr den Boden der Aktie?
Gruß
BFW
Habe zu 10,80 nachgekauft. Hoffe, dass es nicht mehr viel tiefer gehen kann. Immerhin kann jederzeit etwas positives zu Ranexa vermeldet werden. Dann könnte man auf dem falschen Fuss erwischt werden!?
Hatte ich noch nicht gesehen, ist auch noch relativ neu:
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - April 26, 2004
CV Therapeutics Initiates Second Phase III Trial of Regadenoson
PALO ALTO, Calif., April 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has initiated a second Phase III clinical trial of regadenoson (CVT-3146). Regadenoson is a selective A2A-adenosine receptor agonist being jointly developed with Fujisawa Healthcare, Inc. (Fujisawa) for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies.
This is the second double-blind international Phase III trial of regadenoson in patients undergoing a cardiac stress test. The first Phase III trial was initiated in October 2003.
"We are very pleased to initiate this second Phase III trial. Our objective is to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) as quickly as possible. If approved, our partner Fujisawa, a leader in the cardiac stress imaging marketplace, will be responsible for the commercialization of regadenoson in the United States," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
Cardiac perfusion imaging studies
Cardiac perfusion imaging studies help detect and characterize coronary artery disease by identifying areas of poor blood flow in the heart. In 2002, approximately 7.8 million patients underwent cardiac perfusion imaging studies in the United States.
Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform a cardiac perfusion imaging test. However, more than 40 percent of the patients undergoing a cardiac perfusion imaging test are unable to exercise adequately because of medical conditions such as peripheral vascular disease, arthritis or other limiting medical conditions which prevent them from exercising on the treadmill. For these patients, a pharmacologic agent that temporarily increases coronary blood flow is used to mimic the increase in coronary blood flow caused by exercise. Regadenoson is being studied for potential use as a pharmacologic agent under these circumstances.
Regadenoson has been designed to be delivered rapidly as a bolus and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation. Current pharmacologic stress agents, which are not selective for the A2A-adenosine receptor, may cause unwanted physiological side effects.
Under a collaboration agreement providing Fujisawa with exclusive North American rights to regadenoson, CV Therapeutics manages the clinical development program and Fujisawa will be responsible for manufacturing, selling and marketing regadenoson in North America, if the product is approved for marketing. Under the arrangement, Fujisawa reimburses CV Therapeutics for 75 percent of development costs and CV Therapeutics will receive a royalty on product sales of regadenoson, if approved, and may receive a royalty on another product.
In an open label Phase II trial, regadenoson produced a dose-dependent increase in coronary blood flow velocity in patients undergoing cardiac catheterization. Regadenoson was generally well-tolerated, and drug-related adverse events, including chest discomfort, increased heart rate, hypotension, flushing and shortness of breath, were mild and self-limited.
Regadenoson has not been approved for marketing by the FDA or foreign regulatory authorities. Regadenoson presently is being investigated in clinical trials subject to a United States investigational new drug application and applicable foreign regulatory submissions. CV Therapeutics has not yet submitted a new drug application to the FDA or equivalent application to any foreign regulatory authority for regadenoson. Neither the FDA or any foreign regulatory authority have determined regadenoson to be safe or effective in humans for any use.
CV Therapeutics, Inc.
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular
CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - April 26, 2004
CV Therapeutics Initiates Second Phase III Trial of Regadenoson
PALO ALTO, Calif., April 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has initiated a second Phase III clinical trial of regadenoson (CVT-3146). Regadenoson is a selective A2A-adenosine receptor agonist being jointly developed with Fujisawa Healthcare, Inc. (Fujisawa) for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies.
This is the second double-blind international Phase III trial of regadenoson in patients undergoing a cardiac stress test. The first Phase III trial was initiated in October 2003.
"We are very pleased to initiate this second Phase III trial. Our objective is to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) as quickly as possible. If approved, our partner Fujisawa, a leader in the cardiac stress imaging marketplace, will be responsible for the commercialization of regadenoson in the United States," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
Cardiac perfusion imaging studies
Cardiac perfusion imaging studies help detect and characterize coronary artery disease by identifying areas of poor blood flow in the heart. In 2002, approximately 7.8 million patients underwent cardiac perfusion imaging studies in the United States.
Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform a cardiac perfusion imaging test. However, more than 40 percent of the patients undergoing a cardiac perfusion imaging test are unable to exercise adequately because of medical conditions such as peripheral vascular disease, arthritis or other limiting medical conditions which prevent them from exercising on the treadmill. For these patients, a pharmacologic agent that temporarily increases coronary blood flow is used to mimic the increase in coronary blood flow caused by exercise. Regadenoson is being studied for potential use as a pharmacologic agent under these circumstances.
Regadenoson has been designed to be delivered rapidly as a bolus and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation. Current pharmacologic stress agents, which are not selective for the A2A-adenosine receptor, may cause unwanted physiological side effects.
Under a collaboration agreement providing Fujisawa with exclusive North American rights to regadenoson, CV Therapeutics manages the clinical development program and Fujisawa will be responsible for manufacturing, selling and marketing regadenoson in North America, if the product is approved for marketing. Under the arrangement, Fujisawa reimburses CV Therapeutics for 75 percent of development costs and CV Therapeutics will receive a royalty on product sales of regadenoson, if approved, and may receive a royalty on another product.
In an open label Phase II trial, regadenoson produced a dose-dependent increase in coronary blood flow velocity in patients undergoing cardiac catheterization. Regadenoson was generally well-tolerated, and drug-related adverse events, including chest discomfort, increased heart rate, hypotension, flushing and shortness of breath, were mild and self-limited.
Regadenoson has not been approved for marketing by the FDA or foreign regulatory authorities. Regadenoson presently is being investigated in clinical trials subject to a United States investigational new drug application and applicable foreign regulatory submissions. CV Therapeutics has not yet submitted a new drug application to the FDA or equivalent application to any foreign regulatory authority for regadenoson. Neither the FDA or any foreign regulatory authority have determined regadenoson to be safe or effective in humans for any use.
CV Therapeutics, Inc.
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular
Hallo,
kann mir jemand von Euch die Meldung (Kurzfassung) übersetzten. Danke im voraus.
Gruß
BFW
kann mir jemand von Euch die Meldung (Kurzfassung) übersetzten. Danke im voraus.
Gruß
BFW
Die zweite Phase 3 Studie von CVTX zweiten Produkt Regadenoson wurde gestartet.
..bin ja froh über 13 in D verkauft zu haben..
#196
Könnte sich bald ändern.
Könnte sich bald ändern.
jetzt wollen wir auch wissen warum natürlich...
CV Therapeutics rose 6 percent in after-hours trading after it announced an accord with the Food and Drug Administration on special standards for its Ranexa chronic angina drug.
The FDA gave Ranexa special protocol assessment status, or SPA, which sets up the design of a clinical trial as well as goals that must be met to gain regulatory approval. Although this isn`t fast track status, the SPA process can speed up how quickly a drug is approved.
"We anticipate being able to begin enrollment in this study in the third quarter. We also plan to initiate at least one additional clinical trial later this year to support approval of Ranexa in a broader patient population," said Chairman Louis Lange.
If approved, Ranexa would be the first new class of preventive angina therapy in the U.S. in more than 25 years, CV Therapeutics said.
The heart condition affects about 6.8 million people in the U.S., the Palo Alto, Calif.-based drug developer added.
In after-market action, shares (CVTX: news, chart, profile) rose 74 cents to $13.95. Ahead of the news, shares closed up 21 cents at $13.21.
Kommt voran..
Greetz
Sheepshead
CV Therapeutics rose 6 percent in after-hours trading after it announced an accord with the Food and Drug Administration on special standards for its Ranexa chronic angina drug.
The FDA gave Ranexa special protocol assessment status, or SPA, which sets up the design of a clinical trial as well as goals that must be met to gain regulatory approval. Although this isn`t fast track status, the SPA process can speed up how quickly a drug is approved.
"We anticipate being able to begin enrollment in this study in the third quarter. We also plan to initiate at least one additional clinical trial later this year to support approval of Ranexa in a broader patient population," said Chairman Louis Lange.
If approved, Ranexa would be the first new class of preventive angina therapy in the U.S. in more than 25 years, CV Therapeutics said.
The heart condition affects about 6.8 million people in the U.S., the Palo Alto, Calif.-based drug developer added.
In after-market action, shares (CVTX: news, chart, profile) rose 74 cents to $13.95. Ahead of the news, shares closed up 21 cents at $13.21.
Kommt voran..
Greetz
Sheepshead
Pssst, nicht so laut!
Andererseits kommt die Ranexa-Zulassung in den USA damit (wenn überhaupt) erst in 1,5 bis 2 Jahren (vielleicht klappt es ja in Europa früher). Bis dahin sind fette Quartalsverluste und weitere Kapitalerhöhungen vorprogrammiert.
Gruß,
BN
(der auch mal Wasser in den Wein gießen möchte )
Andererseits kommt die Ranexa-Zulassung in den USA damit (wenn überhaupt) erst in 1,5 bis 2 Jahren (vielleicht klappt es ja in Europa früher). Bis dahin sind fette Quartalsverluste und weitere Kapitalerhöhungen vorprogrammiert.
Gruß,
BN
(der auch mal Wasser in den Wein gießen möchte )
1ste Upgrade von First Albany to buy- KZ 20 ist raus.
Es muss nicht sein natürlich, aber mit einem Short-Interest von 21% könnte dieses Teil wohl ziemlich stark laufen heute..
Es muss nicht sein natürlich, aber mit einem Short-Interest von 21% könnte dieses Teil wohl ziemlich stark laufen heute..
War wohl richtig- 27% Tageshoch (16,75) und bei 16 wird es für heute wohl enden- immerhin 20%.
Habe die CC reingezogen- für mich hört sich das an als ob es ein "easy" SPA ist. Frühestens fertig medio 05 spätestens Ende 05, was weiterhin der "guidance" bleibt.
Ob CVTX groß abheben wird bezweifele ich, 20$ sind denke ich KF schon drin. Für die Geduldigen (dazu zähle ich mir selbst) wird es bestimmt lohnen dabei zu bleiben. Die Rendite auf einem CVTX -Investment wird das Postsparbuch bestimmt wohl schlagen bis Anfang 2006.
Habe die CC reingezogen- für mich hört sich das an als ob es ein "easy" SPA ist. Frühestens fertig medio 05 spätestens Ende 05, was weiterhin der "guidance" bleibt.
Ob CVTX groß abheben wird bezweifele ich, 20$ sind denke ich KF schon drin. Für die Geduldigen (dazu zähle ich mir selbst) wird es bestimmt lohnen dabei zu bleiben. Die Rendite auf einem CVTX -Investment wird das Postsparbuch bestimmt wohl schlagen bis Anfang 2006.
Auch ein schneller Hype macht Laune - berechtigt?!
CVTX hebt auf.Ziel 20$.Geduld wird sich auszahlen.
Kannst du mir deine Meinunug schreiben für Aphton und Arquele.
Gruß
Tsgeron
Kannst du mir deine Meinunug schreiben für Aphton und Arquele.
Gruß
Tsgeron
FDA Proposes Changes To Drug Review Process
The Food and Drug Administration proposed to change its review processes and timelines for both new and generic drug applications to “ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.” Under the proposed rule, the regulatory agency would issue “complete response letters” to drug firms instead of the “approvable” and “not approvable” letters currently sent. The FDA would send the complete response letter if the agency determines that it will not approve a New Drug Application or Abbreviated New Drug Application in its present form. The letter would describe all of the specific deficiencies and, where appropriate, explain the conditions necessary for the application to be approved. This new process, which is already being utilized by the agency for biological drugs, would be formalized for all drugs under the proposal. Additionally, the proposed rule would amend current provisions regarding review cycles after application resubmissions, supplements or amendments. The review period following resubmissions of efficacy supplements to NDAs would depend on the class of the resubmission. A Class 1 resubmission, which would begin a new two-month review cycle, would be defined as a resubmission after receipt of a complete response letter that includes items like draft or final printed labeling, safety or stability updates or other minor clarifying information. A Class 2 resubmission would require additional information beyond that necessary for a Class 1 resubmission and would initiate a new six-month review cycle.
The Food and Drug Administration proposed to change its review processes and timelines for both new and generic drug applications to “ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.” Under the proposed rule, the regulatory agency would issue “complete response letters” to drug firms instead of the “approvable” and “not approvable” letters currently sent. The FDA would send the complete response letter if the agency determines that it will not approve a New Drug Application or Abbreviated New Drug Application in its present form. The letter would describe all of the specific deficiencies and, where appropriate, explain the conditions necessary for the application to be approved. This new process, which is already being utilized by the agency for biological drugs, would be formalized for all drugs under the proposal. Additionally, the proposed rule would amend current provisions regarding review cycles after application resubmissions, supplements or amendments. The review period following resubmissions of efficacy supplements to NDAs would depend on the class of the resubmission. A Class 1 resubmission, which would begin a new two-month review cycle, would be defined as a resubmission after receipt of a complete response letter that includes items like draft or final printed labeling, safety or stability updates or other minor clarifying information. A Class 2 resubmission would require additional information beyond that necessary for a Class 1 resubmission and would initiate a new six-month review cycle.
Neben der "SPA", der dann mitte/ende 2005 zur FDA- Genehmigung von Ranexa führen soll, hat man jetzt noch einen superdeal mit dem FDA gemacht..das Merlin-projekt soll dazu führen, dass Ranexa erster Wahl wird für Angina-pectoris Patienten..aber erst in 06/07 und dann das Marktpotential entsprechend erweitert wird.
http://biz.yahoo.com/prnews/040729/sfth064_1.html
Link ist zum ausführlichen Yahoo-Artikel.
Das gibt den Wert schon einiges an neuen Phantasie, albeit sind die "Früchte" erst nach einiger Zeit pflückreif
Greetz
Sheepshead
http://biz.yahoo.com/prnews/040729/sfth064_1.html
Link ist zum ausführlichen Yahoo-Artikel.
Das gibt den Wert schon einiges an neuen Phantasie, albeit sind die "Früchte" erst nach einiger Zeit pflückreif
Greetz
Sheepshead
Bei CVTX geht es nur runter, weiter und weiter....shortinterest so bei 25%, ob dies der Grund wäre?
Na ja, vll einfach doch ein Imclone mit langem Anlauf? Jedenfalls ist der Roadmap jetzt mehr als klar und ich meine, auf Basis der CARISA und MARISA Ergebnisse, dass sie eine gute Chance haben durchzukommen, aber das dauert noch. Deswegen auch der Kurs- reichlich Zeit um noch einzusteigen, vll sogar noch bis in 2006....
also hier die Lage und deutlichkeit- 2 SPA´s, 500 Patienten für FDA Genehmigung und MERLIN für den Knalleffekt. (5500)
CV Therapeutics Initiates Approval-Enabling Trial of Ranexa(TM)
Monday August 2, 4:02 pm ET
PALO ALTO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population. The study is being conducted under the U.S. Food and Drug Administration`s (FDA) special protocol assessment (SPA) process, as announced on June 2, 2004.
ADVERTISEMENT
"We are very excited to have initiated this approval-enabling study. In addition to the SPA agreement we have in place for this study, we also have a second SPA in place for the MERLIN trial, which could support potential approval of Ranexa as first-line therapy in chronic angina, and could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Design
This approval-enabling study is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period.
The primary efficacy endpoint of the study is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, this approval-enabling study is calculated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p<0.001).
Other objectives of this approval-enabling study are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and quality of life.
Prior to entering the study, patients are required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina.
In two previous Phase III studies of Ranexa (CARISA and MARISA), the most common adverse effects seen with Ranexa included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). In these studies, adverse event frequency increased as dose increased, and small but statistically significant mean increases in QTc, an electrocardiographic measurement, were observed compared to placebo. Clinical trials with Ranexa have demonstrated evidence that Ranexa exerts its anti-anginal activity without depending on reductions in heart rate and blood pressure.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
Quelle: http://biz.yahoo.com/prnews/040802/sfm073a_1.html
greetz
Sheepshead
Na ja, vll einfach doch ein Imclone mit langem Anlauf? Jedenfalls ist der Roadmap jetzt mehr als klar und ich meine, auf Basis der CARISA und MARISA Ergebnisse, dass sie eine gute Chance haben durchzukommen, aber das dauert noch. Deswegen auch der Kurs- reichlich Zeit um noch einzusteigen, vll sogar noch bis in 2006....
also hier die Lage und deutlichkeit- 2 SPA´s, 500 Patienten für FDA Genehmigung und MERLIN für den Knalleffekt. (5500)
CV Therapeutics Initiates Approval-Enabling Trial of Ranexa(TM)
Monday August 2, 4:02 pm ET
PALO ALTO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population. The study is being conducted under the U.S. Food and Drug Administration`s (FDA) special protocol assessment (SPA) process, as announced on June 2, 2004.
ADVERTISEMENT
"We are very excited to have initiated this approval-enabling study. In addition to the SPA agreement we have in place for this study, we also have a second SPA in place for the MERLIN trial, which could support potential approval of Ranexa as first-line therapy in chronic angina, and could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Design
This approval-enabling study is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period.
The primary efficacy endpoint of the study is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, this approval-enabling study is calculated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p<0.001).
Other objectives of this approval-enabling study are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and quality of life.
Prior to entering the study, patients are required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina.
In two previous Phase III studies of Ranexa (CARISA and MARISA), the most common adverse effects seen with Ranexa included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). In these studies, adverse event frequency increased as dose increased, and small but statistically significant mean increases in QTc, an electrocardiographic measurement, were observed compared to placebo. Clinical trials with Ranexa have demonstrated evidence that Ranexa exerts its anti-anginal activity without depending on reductions in heart rate and blood pressure.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
Quelle: http://biz.yahoo.com/prnews/040802/sfm073a_1.html
greetz
Sheepshead
Kauf zu 9,75€!
@Isa-
jetzt schnell verkaufen und in UI umtauschen
jetzt schnell verkaufen und in UI umtauschen
Schapekopp
In U.I. bin ich tatsächlich seit heute drin. Aber die sind auch nicht so dolle!
In U.I. bin ich tatsächlich seit heute drin. Aber die sind auch nicht so dolle!
V Therapeutics Initiates MERLIN TIMI-36 Study of Ranexa(TM)
PALO ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has initiated enrollment in the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa. MERLIN TIMI-36 is being conducted under the U.S. Food and Drug Administration`s (FDA) special protocol assessment (SPA) process, and if successful, could support approval of Ranexa as first-line therapy for patients suffering from chronic angina. This study could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS.
The MERLIN TIMI-36 study is being conducted by the Harvard-based Thrombolysis In Myocardial Infarction (TIMI) Study Group, under the direction of Eugene Braunwald, M.D. and David Morrow, M.D.
"We are very pleased to begin enrollment in this important study, which could bring us closer to our goal of commercializing Ranexa for a broad population of patients with ischemic conditions such as angina," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Summary
MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN-TIMI 36 have been studied in previous Phase 3 clinical trials.
Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based treatment of ACS and for long-term prevention of ACS in patients that present at the hospital with ACS and are treated and discharged.
Importantly, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the large safety database could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. As part of this SPA agreement, CV Therapeutics also has committed to perform a separate clinical evaluation of higher doses of Ranexa to support potential use as first-line therapy for chronic angina.
The study`s duration will be event driven. It is expected to continue until a pre-specified number of cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and a pre-determined number of deaths from any cause have occurred. Approximately 600 study sites worldwide are expected to enroll patients. Based on historical clinical trial information from the TIMI Study Group, preliminary data could be available by the end of 2006.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
PALO ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has initiated enrollment in the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa. MERLIN TIMI-36 is being conducted under the U.S. Food and Drug Administration`s (FDA) special protocol assessment (SPA) process, and if successful, could support approval of Ranexa as first-line therapy for patients suffering from chronic angina. This study could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS.
The MERLIN TIMI-36 study is being conducted by the Harvard-based Thrombolysis In Myocardial Infarction (TIMI) Study Group, under the direction of Eugene Braunwald, M.D. and David Morrow, M.D.
"We are very pleased to begin enrollment in this important study, which could bring us closer to our goal of commercializing Ranexa for a broad population of patients with ischemic conditions such as angina," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Summary
MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa used in MERLIN-TIMI 36 have been studied in previous Phase 3 clinical trials.
Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based treatment of ACS and for long-term prevention of ACS in patients that present at the hospital with ACS and are treated and discharged.
Importantly, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the large safety database could support potential approval of Ranexa as first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. As part of this SPA agreement, CV Therapeutics also has committed to perform a separate clinical evaluation of higher doses of Ranexa to support potential use as first-line therapy for chronic angina.
The study`s duration will be event driven. It is expected to continue until a pre-specified number of cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and a pre-determined number of deaths from any cause have occurred. Approximately 600 study sites worldwide are expected to enroll patients. Based on historical clinical trial information from the TIMI Study Group, preliminary data could be available by the end of 2006.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
CV Therapeutics to Announce 2004 Third Quarter Financial Results on Tuesday, October 26, 2004
PALO ALTO, Calif., Oct. 18 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that it will release third quarter financial results for 2004 after the market closes on Tuesday, October 26, 2004. Company management will webcast a conference call at 5:30 p.m. EDT, 2:30 p.m. PDT, on the company`s website.
PALO ALTO, Calif., Oct. 18 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that it will release third quarter financial results for 2004 after the market closes on Tuesday, October 26, 2004. Company management will webcast a conference call at 5:30 p.m. EDT, 2:30 p.m. PDT, on the company`s website.
Approval-Enabling Study of Ranexa(TM) Enrolling Ahead of Schedule
PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that investigators have, to date, been enrolling angina patients into the potentially approval-enabling study of Ranexa (ERICA -- Evaluation of Ranolazine In Chronic Angina) ahead of schedule. Should the current rate of enrollment continue, the company now expects that patient enrollment should be completed by the end of the first quarter of 2005 and data could then be available late in the second quarter or early in the third quarter of 2005.
Since it began in August 2004, the study has enrolled 372 of the approximately 500 patients expected to be enrolled.
"We are very pleased with the rapid rate of enrollment we have seen in this study to date. Should this rate of enrollment continue, we would expect to complete enrollment sooner than we had originally anticipated," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Prior to the initiation of the study, the company had expected to complete enrollment by the end of 2005.
As previously announced, CV Therapeutics and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for this clinical trial which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA`s special protocol assessment (SPA) process.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Details
PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that investigators have, to date, been enrolling angina patients into the potentially approval-enabling study of Ranexa (ERICA -- Evaluation of Ranolazine In Chronic Angina) ahead of schedule. Should the current rate of enrollment continue, the company now expects that patient enrollment should be completed by the end of the first quarter of 2005 and data could then be available late in the second quarter or early in the third quarter of 2005.
Since it began in August 2004, the study has enrolled 372 of the approximately 500 patients expected to be enrolled.
"We are very pleased with the rapid rate of enrollment we have seen in this study to date. Should this rate of enrollment continue, we would expect to complete enrollment sooner than we had originally anticipated," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Prior to the initiation of the study, the company had expected to complete enrollment by the end of 2005.
As previously announced, CV Therapeutics and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for this clinical trial which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA`s special protocol assessment (SPA) process.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
Study Details
CV Therapeutics Reports 2004 Third Quarter Financial Results
PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the third quarter ended September 30, 2004. For the quarter ended September 30, 2004, the Company reported a net loss of $32.8 million, or $1.03 per share, compared to a net loss of $32.3 million, or $1.13 per share, for the same period in 2003. For the nine months ended September 30, 2004, the Company reported a net loss of $101.3 million, or $3.25 per share, compared to a net loss of $75.9 million, or $2.70 per share, for the same period in 2003.
Operating expenses for the quarter ended September 30, 2004 increased to $37.4 million from $33.7 million for the same quarter in 2003. Operating expenses increased to $107.1 million for the nine months ended September 30, 2004, from $81.8 million for the same period in 2003. The increase in operating expenses in the third quarter of 2004 compared to the same quarter in 2003 was primarily due to increased contract service expenses for the Company`s initiation of additional Phase III Ranexa(TM) (ranolazine) studies and its two ongoing Phase III regadenoson studies, offset in part by a decline in pre-commercialization sales and marketing expenses. The increase in operating expenses for the nine months ended September 30, 2004 compared to the comparable period in 2003 was primarily due to increases in contract service expenses for the studies mentioned above, a small increase in associated research and development headcount, and an increase in general and administrative expenses primarily due to increased headcount.
Net interest and other expense for the nine months ended September 30, 2004 increased to a net expense of $7.1 million, compared to net interest and other income of $0.2 million in the same period in 2003, primarily due to a reduction of $3.4 million in interest earned on our investments and to a loss of $3.3 million during the second quarter ended June 30, 2004 on the early retirement of $116.6 million of the Company`s outstanding 4.75% convertible subordinated notes due in 2007.
The Company recognized collaborative research revenue of $5.6 million for the quarter ended September 30, 2004, compared to $2.2 million for the same period in 2003. For the nine months ended September 30, 2004, the Company recognized collaborative research revenue of $12.8 million, compared to $5.7 million for the same period in 2003. The revenue recognized for each of the periods relates to the reimbursement of certain development costs from a collaborative partner and amortization of up-front milestone payments earned.
At September 30, 2004, the Company had cash, cash equivalents and marketable securities of approximately $400.9 million, compared to $430.1 million at December 31, 2003.
Company management will webcast a conference call on Tuesday, October 26, 2004 at 5:30 p.m. EDT, 2:30 p.m. PDT, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 1609419.
PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the third quarter ended September 30, 2004. For the quarter ended September 30, 2004, the Company reported a net loss of $32.8 million, or $1.03 per share, compared to a net loss of $32.3 million, or $1.13 per share, for the same period in 2003. For the nine months ended September 30, 2004, the Company reported a net loss of $101.3 million, or $3.25 per share, compared to a net loss of $75.9 million, or $2.70 per share, for the same period in 2003.
Operating expenses for the quarter ended September 30, 2004 increased to $37.4 million from $33.7 million for the same quarter in 2003. Operating expenses increased to $107.1 million for the nine months ended September 30, 2004, from $81.8 million for the same period in 2003. The increase in operating expenses in the third quarter of 2004 compared to the same quarter in 2003 was primarily due to increased contract service expenses for the Company`s initiation of additional Phase III Ranexa(TM) (ranolazine) studies and its two ongoing Phase III regadenoson studies, offset in part by a decline in pre-commercialization sales and marketing expenses. The increase in operating expenses for the nine months ended September 30, 2004 compared to the comparable period in 2003 was primarily due to increases in contract service expenses for the studies mentioned above, a small increase in associated research and development headcount, and an increase in general and administrative expenses primarily due to increased headcount.
Net interest and other expense for the nine months ended September 30, 2004 increased to a net expense of $7.1 million, compared to net interest and other income of $0.2 million in the same period in 2003, primarily due to a reduction of $3.4 million in interest earned on our investments and to a loss of $3.3 million during the second quarter ended June 30, 2004 on the early retirement of $116.6 million of the Company`s outstanding 4.75% convertible subordinated notes due in 2007.
The Company recognized collaborative research revenue of $5.6 million for the quarter ended September 30, 2004, compared to $2.2 million for the same period in 2003. For the nine months ended September 30, 2004, the Company recognized collaborative research revenue of $12.8 million, compared to $5.7 million for the same period in 2003. The revenue recognized for each of the periods relates to the reimbursement of certain development costs from a collaborative partner and amortization of up-front milestone payments earned.
At September 30, 2004, the Company had cash, cash equivalents and marketable securities of approximately $400.9 million, compared to $430.1 million at December 31, 2003.
Company management will webcast a conference call on Tuesday, October 26, 2004 at 5:30 p.m. EDT, 2:30 p.m. PDT, on the Company`s website. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 1609419.
Sorry, hatte den Rest vergessen:
Study Details
The study, known as ERICA (Evaluation of Ranolazine In Chronic Angina), is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients are being randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period.
The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, ERICA is calculated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p<0.001).
Other objectives of ERICA are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and quality of life.
Prior to entering the study, patients are required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina. Physicians are able to add long acting nitrates as background therapy at the start of the study.
Many factors can affect the rates of enrollment and randomization for this study, including, but not limited to, slower than anticipated enrollment and/or randomization, a higher number of discontinuations, and/or adverse events occurring during the trial. As a result, the rates of enrollment and randomization for this study may change in the future.
In the two Phase III studies of Ranexa (CARISA and MARISA), the most common adverse effects seen with Ranexa included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). In these studies, adverse event frequency increased as dose increased, and small but statistically significant mean increases in QTc, an electrocardiographic measurement, were observed compared to placebo. Clinical trials with Ranexa have demonstrated evidence that Ranexa exerts its anti-anginal activity without depending on reductions in heart rate and blood pressure.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
Study Details
The study, known as ERICA (Evaluation of Ranolazine In Chronic Angina), is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients are being randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period.
The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, ERICA is calculated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p<0.001).
Other objectives of ERICA are to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and quality of life.
Prior to entering the study, patients are required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina. Physicians are able to add long acting nitrates as background therapy at the start of the study.
Many factors can affect the rates of enrollment and randomization for this study, including, but not limited to, slower than anticipated enrollment and/or randomization, a higher number of discontinuations, and/or adverse events occurring during the trial. As a result, the rates of enrollment and randomization for this study may change in the future.
In the two Phase III studies of Ranexa (CARISA and MARISA), the most common adverse effects seen with Ranexa included dizziness, constipation, nausea, asthenia (weakness), headaches and dyspepsia (indigestion). In these studies, adverse event frequency increased as dose increased, and small but statistically significant mean increases in QTc, an electrocardiographic measurement, were observed compared to placebo. Clinical trials with Ranexa have demonstrated evidence that Ranexa exerts its anti-anginal activity without depending on reductions in heart rate and blood pressure.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
Und schon gehts nach Norden! Hatte mich unter 10€ nochmals eingedeckt.
Das hier scheint aber mein privater Alleinunterhalter Thread zu sein.
Das hier scheint aber mein privater Alleinunterhalter Thread zu sein.
eine schöne geschichte... dies macht ranexa/cvtx wieder zu einer 05er story... hatte bei meinen käufen befürchtet, daß ich etwas mehr geduld aufbringen muß.
zudem ist der titel massiv geshortet...
zudem ist der titel massiv geshortet...
kleiner wermutstropfen das sofortige cibc-upgrade... und möglicherweise weitere.
also doch bald wieder raus?!
also doch bald wieder raus?!
Bin wieder raus. Glaube schon, dass der Kurs wieder etwas zurückkommt.
ja, 20% in so kurzer zeit reicht mir auch erst mal...
Gut so. Kurs wieder deutlich runter. Man soll hakt nicht zu gierig sein. Ausserdem ist die Ranexa Geschichte ja schon alt. Zieht den Kurs aber immer wieder hoch!
Habe die Kohle in Epcos gesteckt!
28.10. 17:33
CV Therapeutics - strong buy
(©BörseGo - http://www.boerse-go.de)
First Albany haben heute die Aktie des Biotech-Unternehmens CV Therapeutics von "buy" auf "strong buy" aufgestuft. Das Kursziel wurde von 20 auf 24 Dollar angehoben.
Wie der mit der Gesellschaft befasste Analyst darlegte, komme das Unternehmen bei der Fortentwicklung seines Angina-Medikaments Ranexa gut voran. Auf die endgültige Zulassung könne im Erfolgsfall nun schon 2006, und damit ein Jahr früher als erwartet, gehofft werden.
CV Therapeutics - strong buy
(©BörseGo - http://www.boerse-go.de)
First Albany haben heute die Aktie des Biotech-Unternehmens CV Therapeutics von "buy" auf "strong buy" aufgestuft. Das Kursziel wurde von 20 auf 24 Dollar angehoben.
Wie der mit der Gesellschaft befasste Analyst darlegte, komme das Unternehmen bei der Fortentwicklung seines Angina-Medikaments Ranexa gut voran. Auf die endgültige Zulassung könne im Erfolgsfall nun schon 2006, und damit ein Jahr früher als erwartet, gehofft werden.
bisschel früh gewechselt oder
2006? Meines Achtens wird ERICA dank SPA schon im zweiten Hälfte 2005 erledigt sein. Das große Geld jedoch erst kommen wenn Ranexa "standard prescription" für Angina ist (Anfang 2007?? ).
Irgendwie ist das alles schon in Blickweite und kann ich mir weitere Shortattacken kaum noch vorstellen. Die 24% vom Float, die wir jetzt haben müssen auch bald "gedeckt" werden. Leider habe ich den Zug bei 9,5 verpasst, aber bin trotzdem zufrieden und freu mich schon auf die kommende Imclone-ähnliche Reise in die Zukunft
Greetz
Sheepshead
2006? Meines Achtens wird ERICA dank SPA schon im zweiten Hälfte 2005 erledigt sein. Das große Geld jedoch erst kommen wenn Ranexa "standard prescription" für Angina ist (Anfang 2007?? ).
Irgendwie ist das alles schon in Blickweite und kann ich mir weitere Shortattacken kaum noch vorstellen. Die 24% vom Float, die wir jetzt haben müssen auch bald "gedeckt" werden. Leider habe ich den Zug bei 9,5 verpasst, aber bin trotzdem zufrieden und freu mich schon auf die kommende Imclone-ähnliche Reise in die Zukunft
Greetz
Sheepshead
Fliegt der Deckel an der NAS?
Gucke mal was da an der Nasdaq fliegt
Ranolazine mit Flügelchens anscheinend. Tja, wenn die Shorties die Nervenanspannung nicht mehr aushalten können, geht es verdammt schnell
Mir isses recht so.
Greetz
Sheepshead
Ranolazine mit Flügelchens anscheinend. Tja, wenn die Shorties die Nervenanspannung nicht mehr aushalten können, geht es verdammt schnell
Mir isses recht so.
Greetz
Sheepshead
@kosto1929,
wird doch glaube ich Zeit,dass du ein neuer Thread aufmachst
Der Titel passt überhaupt nicht mehr
wird doch glaube ich Zeit,dass du ein neuer Thread aufmachst
Der Titel passt überhaupt nicht mehr
Och ich finde solche Threads immer lustig, wenn so ein Wert anfängt zu fliegen und der Titel des zugehörigen Threads pessimistisch ist.
Die Lemming sollen ja schliesslich noch ihr Geld noch vorerst behalten.
Immer noch tief vershortet der Wert, mögen sie bluten
Die Lemming sollen ja schliesslich noch ihr Geld noch vorerst behalten.
Immer noch tief vershortet der Wert, mögen sie bluten
warum geht es heute so runter? Gibts Neuigkeiten oder
sind das nur Gewinnmitnahmen?
sind das nur Gewinnmitnahmen?
Abstufung auf Buy
Kosto
was geht ab heute ? Vorbörslich um die $ 22; News ???
Gruß in die Bankenmetropole
Clouse
was geht ab heute ? Vorbörslich um die $ 22; News ???
Gruß in die Bankenmetropole
Clouse
Meldung von gerade eben..
CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) has completed patient enrolment for a clinical trial that will be the basis for another application to U.S. regulators for an experimental heart drug, the drug developer said on Tuesday.
The Palo Alto, California, company said it expected data from the trial in the second quarter of next year.
An advisory panel to the U.S. Food and Drug Administration recommended last year that the agency demand more research from the company before approving Ranexa, the company`s experimental treatment for chronic chest pain, or angina.
Quelle: Reuters
Vorbörslich geht es 8% aufwärts auf 22 Dollaren. Die SPA sollte eigentlich jetzt innerhalb 6 Monate erledigt sein und dann fängt der Spaß erst an
Greetz
Sheepshead
CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) has completed patient enrolment for a clinical trial that will be the basis for another application to U.S. regulators for an experimental heart drug, the drug developer said on Tuesday.
The Palo Alto, California, company said it expected data from the trial in the second quarter of next year.
An advisory panel to the U.S. Food and Drug Administration recommended last year that the agency demand more research from the company before approving Ranexa, the company`s experimental treatment for chronic chest pain, or angina.
Quelle: Reuters
Vorbörslich geht es 8% aufwärts auf 22 Dollaren. Die SPA sollte eigentlich jetzt innerhalb 6 Monate erledigt sein und dann fängt der Spaß erst an
Greetz
Sheepshead
Das ist Service oder Clouse????
Da werden heute auch einige Shorties gegrillt werden Gold richtig auch Pre-market jetzt 22.40$
Uii das geht tatsächlich flott....
Uii das geht tatsächlich flott....
Etwas zu flott ging auch mein Posting:
"We are pleased that the pace of enrollment has exceeded our expectations and we now expect data solidly in the second quarter of 2005," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
"We are pleased that the pace of enrollment has exceeded our expectations and we now expect data solidly in the second quarter of 2005," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Weiss jemand eine Internetadresse, wo man die Fristen für Dividenden finden könnte ?
Die Fristen für WAS..... ?
60 Dollar sind im Jahr 2005 drin cvtx ist bei dem Product Portfolio total unterbewertet.Wenn die Zulassung kommt in Europa müssen die Leerverkäufer sich warm anziehen.Eine übertreibung wie in alten zeiten ist dann wieder drin, osi hat es vorgemacht.
Press Release
Source: CV Therapeutics, Inc.
ASCOT Study Which Included Perindopril Stopped Early Due to Significant Benefit in Treatment Arm of Study
Wednesday December 15, 4:02 pm ET
Perindopril Marketed as ACEON(R) in United States
PALO ALTO, Calif., Dec. 15 /PRNewswire/ -- The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), evaluating the effectiveness of a treatment regimen with the calcium channel blocker amlodipine and the angiotensin converting enzyme (ACE) inhibitor perindopril compared to a treatment regimen with the beta blocker atenolol and the diuretic bendroflumethiazide, has been stopped early by the ASCOT steering committee due to significant benefits observed in the amlodipine plus perindopril arm of the study, according to those conducting the study.
ADVERTISEMENT
In the United States, perindopril is marketed under the brand name ACEON®. CV Therapeutics, Inc. (Nasdaq: CVTX - News) and Solvay Pharmaceuticals, Inc. recently entered into a co-promotion agreement for ACEON®, an ACE inhibitor with tissue activity approved in the United States for the treatment of patients with essential hypertension. In Europe, perindopril is marketed under the brand name Coversyl®.
About the ASCOT Study
The antihypertensive arm of the multi- national, randomized ASCOT study compared the ability of two different treatment regimens to reduce a composite endpoint of nonfatal myocardial infarction and fatal coronary heart disease in more than 19,000 hypertensive patients.
Patients were randomized to receive a treatment regimen of the beta blocker atenolol and the diuretic bendroflumethiazide or a treatment regimen of the calcium channel blocker amlodipine and the ACE inhibitor perindopril. The study`s steering committee stopped the study early after observing significant benefit in the amlodipine plus perindopril arm, which would have made it unethical to continue the study. Results from ASCOT are expected to be presented at an upcoming medical conference.
This study was neither funded nor sponsored by CV Therapeutics, Inc. or Solvay Pharmaceuticals, Inc., holder of the ACEON® Tablets IND and NDA in the United States. Further information on the study can be found at http://www.ascotstudy.org .
About ACE Inhibitors
ACE inhibitors act to reduce hypertension by interfering with the conversion of angiotensin I to artery- constricting, angiotensin II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure.
ACE inhibitors currently are recommended as first-line therapy for hypertension in certain patient populations, because of their safety and efficacy. Most recently, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure has recommended ACE inhibitors as one of the initial therapy choices for compelling indications such as heart failure, postmyocardial infarction, high coronary disease risk, diabetes, chronic kidney disease and recurrent stroke prevention. ACEON® is only indicated for the treatment of patients with essential hypertension.
Certain ACE inhibitors, including ACEON®, which have been shown to have an enhanced affinity for the tissues, are known as tissue-ACEs.
About ACEON®
ACEON® is an ACE inhibitor indicated for the treatment of essential hypertension. It offers continuous 24-hour blood pressure control with once-daily dosing for hypertensive patients. ACEON® may be used alone or with other classes of antihypertensives.
ACEON® is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitors and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACEON® should be discontinued as soon as possible.
Morgen wird evtl. gegrillt
Kann mir einer von Euch die Meldung bitte kurz übersetzen
und was bedeutet sie für CVTX? Danke!
und was bedeutet sie für CVTX? Danke!
Wie die Jungfrau zum Kind.
Ein Medikament gegen Bluthochdruck, dass CVTX seit kurzem gemeinsam mit Solvay vermarktet, hat in einer Kombi-Vergleichsstudie offenbar so gute Ergebnisse abgeliefert, dass die Studie vorzeitig abgebrochen wurde. Das ist meines Wissens bemerkenswert bei einer Anwendung ohne direkte Bedrohung für das Leben der Probanden. Bei Krebsstuiden gab es so etwas öfters, beim Bluthochdruck.
UPDATE 1-CV Therapeutics up 8 percent after positive trial
Wed Dec 15, 2004 05:40 PM ET
CHICAGO, Dec 15 (Reuters) - Shares of CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) rose 8 percent after the bell on Wednesday after the company said European investigators had halted a large study of a blood pressure drug the company sells in the U.S., due to positive results.
The European trial compared the combination of Pfizer Inc.`s. Norvasc with Aceon, known chemically as perindopril, versus a treatment with an older class of high blood pressure drugs called beta-blockers and a diuretic, the company said.
The high blood pressure drug Aceon is sold by CV Therapeutics and Solvay Pharmaceuticals in the U.S. and by French drugmaker Servier in Europe. The study looked at the effect of both treatments on nonfatal heart attacks and coronary heart disease.
Palo Alto, California-based CV Therapeutics said the study`s oversight panel stopped the trial of 19,000 patients early because of "significant benefits" seen in the group getting the perindopril combination treatment, because it "would have made it unethical to continue the study."
Shares of CV rose nearly 8 percent on Inet to $23.96 in after hours trading, after closing at $22.27 on the Nasdaq, before the news was announced.
Ein Medikament gegen Bluthochdruck, dass CVTX seit kurzem gemeinsam mit Solvay vermarktet, hat in einer Kombi-Vergleichsstudie offenbar so gute Ergebnisse abgeliefert, dass die Studie vorzeitig abgebrochen wurde. Das ist meines Wissens bemerkenswert bei einer Anwendung ohne direkte Bedrohung für das Leben der Probanden. Bei Krebsstuiden gab es so etwas öfters, beim Bluthochdruck.
UPDATE 1-CV Therapeutics up 8 percent after positive trial
Wed Dec 15, 2004 05:40 PM ET
CHICAGO, Dec 15 (Reuters) - Shares of CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) rose 8 percent after the bell on Wednesday after the company said European investigators had halted a large study of a blood pressure drug the company sells in the U.S., due to positive results.
The European trial compared the combination of Pfizer Inc.`s. Norvasc with Aceon, known chemically as perindopril, versus a treatment with an older class of high blood pressure drugs called beta-blockers and a diuretic, the company said.
The high blood pressure drug Aceon is sold by CV Therapeutics and Solvay Pharmaceuticals in the U.S. and by French drugmaker Servier in Europe. The study looked at the effect of both treatments on nonfatal heart attacks and coronary heart disease.
Palo Alto, California-based CV Therapeutics said the study`s oversight panel stopped the trial of 19,000 patients early because of "significant benefits" seen in the group getting the perindopril combination treatment, because it "would have made it unethical to continue the study."
Shares of CV rose nearly 8 percent on Inet to $23.96 in after hours trading, after closing at $22.27 on the Nasdaq, before the news was announced.
BTW: CVTX ist in der Rangliste der 3 Monats-Performance der AMi-Biotechs tatsächlich inzwischen auf Platz 7.
osi macht es heute vor was mit cvtx noch passieren wird,ich lass sie alle schwätzen.Meine letzten käufe matk,ctic,osi,cvtx gingen alle durch die Decke.Und warum weil alle Daten 2005 anstehen.Hier im Monatsbörsenspiel hab ich sie alle nahe den Tiefpunkten gekauft.Bei cvtx liegen Kursziele bei 35 Dollar,nicht weit mehr zu meinen 60 Dollar.Bei osi hab ich gewartet bis der RSI im keller war das kann Monate dauern aber zocken wollen wir doch nicht oder ? In nächster Zeit schreibe ich mal meine Gründe warum ich bei cvtx bei ca.11,00 Euro eingestiegen bin.ich habe andere gründe beim kauf .Was passiert in ca. 2.Jahren mit den oben genannten Aktien.Inseider käufe? Wieviel in der Kasse ? Wieviel Phase 3 Studien ? Letzte Nachrichten ca 12 Monate im Internet ? Und dann denn Zeitpunkt abpassen.
Tschau Aktientrader 62
P.S Die Aktienjahre 2000 sollten uns alle schlauer machen.Blutige Nasen haben wir uns alle geholt aber gelernt habe ich draus.
Tschau Aktientrader 62
P.S Die Aktienjahre 2000 sollten uns alle schlauer machen.Blutige Nasen haben wir uns alle geholt aber gelernt habe ich draus.
CVTX haben im März 2004 in Europa den Zulassungsantrag von Ranexa abgegeben. In 2005 müßte eigentlich der Antrag durch sein !!!
Aber CVTX hat noch andere Produkte in der Pipeline. In Phase 3 befindet sich ein Medikament gegen Herzrhythmusstörungen CVT-510.
Auch sonst ist die Pipeline von CVTX voll es gibt insgesamt 11 Produktstudien in unterschiedlichen Phasen. CVTX hat zu Zeit ca. 400.Mio Dollar in der Kasse das dürfte eine weile reichen. Bewertet wird CVTX an der Börse mit ca. 700-750 Mio. Dollar. Auch der Stress-Löser Regadenoson ist schon in Phase 3. CVTX ist die einzige Bioschmiede
die so erfolgreich in der Herzkreislauf Geschichte ist. Medigene war schon in den Anfängen gescheitert. Actelion hat es auch nicht geschaft die Meldung kam vor ein paar Monaten. Bei 13-14 Dollar gabs die Firma umsonst Kasse 400.Mio Dollar an der Börse bewertet mit 370-420 Mio Dollar vor paar Monaten oder 9,50 bis 11,00 Euro. CVTX begleite ich seit einer ganzen weile, hab alle höhen und tiefen mitgemacht. Auch im Monatsbörsenspiel hab ich sie bei 10,45 Euro gekauft.Ich bleibe dabei 60,00 Dollar sind locker drin.Wenn man aber die Kasse in den Jahren von CVTX im Auge hatte, ist sie in der Zeit von 465.Mio auf 400.Mio Dollar NUR gefallen. Das sagt mir wieder die müssen nicht schlecht Arbeiten.Und die Analysten erst 12,16,24,30, und jetzt schon 35 Dollar Kursziel, da liegen 200% Plus zwischen ? Bei 30,00 Dollar haben wir eine Marktkap.von 990.Mio Dollar. Ab dieser Masse werden wieder Fonds einsteigen die Leerverkäufer ( ca. 20% ) sind auch nicht zuvergessen. Und wenn wir Glück haben kommt noch N24 oder 3 Sat Börsenspiel dazu,die ganzen Börsenzeitungen darf man auch nicht vergessen. Deshalb 2005 wird ein schönes Jahr ( Dollar hoch ) hin oder her. Im Herz / Kreislaufmarkt ist CVTX Spitze meiner Meinung. Ab März 2005 liegt der Antrag schon 1. Jahr Zulassungszeit in Europa 15 bis 24 Monate.Und 2006 entscheidet die FDA in der USA. Was will man mehr das Jahr 2004 ist vorbei wir reden hier von ein paar Monaten.Wenn die anderen CVTX groß entdecken ist der Zug abgefahren.
In diesem Sinne Frohes Fest
Aktientrader 62
Aber CVTX hat noch andere Produkte in der Pipeline. In Phase 3 befindet sich ein Medikament gegen Herzrhythmusstörungen CVT-510.
Auch sonst ist die Pipeline von CVTX voll es gibt insgesamt 11 Produktstudien in unterschiedlichen Phasen. CVTX hat zu Zeit ca. 400.Mio Dollar in der Kasse das dürfte eine weile reichen. Bewertet wird CVTX an der Börse mit ca. 700-750 Mio. Dollar. Auch der Stress-Löser Regadenoson ist schon in Phase 3. CVTX ist die einzige Bioschmiede
die so erfolgreich in der Herzkreislauf Geschichte ist. Medigene war schon in den Anfängen gescheitert. Actelion hat es auch nicht geschaft die Meldung kam vor ein paar Monaten. Bei 13-14 Dollar gabs die Firma umsonst Kasse 400.Mio Dollar an der Börse bewertet mit 370-420 Mio Dollar vor paar Monaten oder 9,50 bis 11,00 Euro. CVTX begleite ich seit einer ganzen weile, hab alle höhen und tiefen mitgemacht. Auch im Monatsbörsenspiel hab ich sie bei 10,45 Euro gekauft.Ich bleibe dabei 60,00 Dollar sind locker drin.Wenn man aber die Kasse in den Jahren von CVTX im Auge hatte, ist sie in der Zeit von 465.Mio auf 400.Mio Dollar NUR gefallen. Das sagt mir wieder die müssen nicht schlecht Arbeiten.Und die Analysten erst 12,16,24,30, und jetzt schon 35 Dollar Kursziel, da liegen 200% Plus zwischen ? Bei 30,00 Dollar haben wir eine Marktkap.von 990.Mio Dollar. Ab dieser Masse werden wieder Fonds einsteigen die Leerverkäufer ( ca. 20% ) sind auch nicht zuvergessen. Und wenn wir Glück haben kommt noch N24 oder 3 Sat Börsenspiel dazu,die ganzen Börsenzeitungen darf man auch nicht vergessen. Deshalb 2005 wird ein schönes Jahr ( Dollar hoch ) hin oder her. Im Herz / Kreislaufmarkt ist CVTX Spitze meiner Meinung. Ab März 2005 liegt der Antrag schon 1. Jahr Zulassungszeit in Europa 15 bis 24 Monate.Und 2006 entscheidet die FDA in der USA. Was will man mehr das Jahr 2004 ist vorbei wir reden hier von ein paar Monaten.Wenn die anderen CVTX groß entdecken ist der Zug abgefahren.
In diesem Sinne Frohes Fest
Aktientrader 62
Hiermit möchte ich mich als stiller Leser für die informativen Mitteilungen bedanken und wünsche allen ein gesundes und erfolgreiches Jahr 2005.
@aktientrader62,
Lese erst jetzt deine Beiträge und ich muß sagen, deine Begeisterung für CVTX ist ansteckend und freut mich. Im Herzbereich klar ist CVTX führend qua Pipeline und Ranexa natürlich, als erstes richtig neues Produkt seit 20 Jahre in diesem Bereich, wird das Kursfeuer schon entflammen.
Rechne schon in 2005 mit FDA-Genehmigung über den SPA, aber richtig klotzig wird es natürlich wenn ERICA in 2006 irgendwann durch- und erfolgreich ist.
Du täuschst dich schon über den cashflow/cashbestände. Es werden grob, 100 mio pro Annum verbraten (und wird mehr wegen den trials), aber über die Ausgabe von convertables fließt wieder Geld in die Kasse. Dilution/Verwässerung spielt da wohl mit natürlich und die LT- Bankdarlehen sollst du auch nicht vergessen, wenn du auf den cash hinweisst.
Egal. Dies spielt wirklich ein klar untergeordnete Rolle, da die Überlebensfrage kein Thema mehr ist.
Die Frage stellt sich für mich nur ob CVTX eine Art Imclone oder Genentech in 2-3 Jahre ist
Greetz
Sheepshead
Lese erst jetzt deine Beiträge und ich muß sagen, deine Begeisterung für CVTX ist ansteckend und freut mich. Im Herzbereich klar ist CVTX führend qua Pipeline und Ranexa natürlich, als erstes richtig neues Produkt seit 20 Jahre in diesem Bereich, wird das Kursfeuer schon entflammen.
Rechne schon in 2005 mit FDA-Genehmigung über den SPA, aber richtig klotzig wird es natürlich wenn ERICA in 2006 irgendwann durch- und erfolgreich ist.
Du täuschst dich schon über den cashflow/cashbestände. Es werden grob, 100 mio pro Annum verbraten (und wird mehr wegen den trials), aber über die Ausgabe von convertables fließt wieder Geld in die Kasse. Dilution/Verwässerung spielt da wohl mit natürlich und die LT- Bankdarlehen sollst du auch nicht vergessen, wenn du auf den cash hinweisst.
Egal. Dies spielt wirklich ein klar untergeordnete Rolle, da die Überlebensfrage kein Thema mehr ist.
Die Frage stellt sich für mich nur ob CVTX eine Art Imclone oder Genentech in 2-3 Jahre ist
Greetz
Sheepshead
Das stimmt schon verbraten tun sie alle viel Geld im Jahr. Aber Phase 3 wird bewertet mit 200 - 250 Mio Dollar und Phase 2 mit 100 - 200 Mio Dollar und CVTX hat eine gute Pipeline. Sollte ein Unternehmen auf die Idee kommen das Produkt zu kaufen. Ob das eine Imclone wird weiß ich nicht. Aber zu Genentech oder der US-Merk würde CVTX gut passen. CVTX dürfte alles haben was ein Käuferherz begehrt. Ich gehe mehr auf Übernahme 1,5 bis 2,0 Mdr. Dollar sind wohl drin, dann wären wir schon bei meinen Kursziel von 60,00 Dollar. Wird es ein Zock wie bei Imclone Stops nachziehen aussteigen und Tschüß ,, Steuerfrei "
Denkt dran Gier hat noch keinen geholfen ( Neuer Markt )
PS. An Verengung der Herzkranzgefäße leiden ca. 7.Mio Amerikaner. Der Markt hat ein Volumen von rund 2,00 Mrd. Dollar macht ( 60,00 Dollar mein Kursziel )
Ich hätte gerne eure Meinung zu CTIC WKN. 906780 in Meinen Thread. Würde mich freuen über Beiträge.
Tschau Aktientrader 62
Denkt dran Gier hat noch keinen geholfen ( Neuer Markt )
PS. An Verengung der Herzkranzgefäße leiden ca. 7.Mio Amerikaner. Der Markt hat ein Volumen von rund 2,00 Mrd. Dollar macht ( 60,00 Dollar mein Kursziel )
Ich hätte gerne eure Meinung zu CTIC WKN. 906780 in Meinen Thread. Würde mich freuen über Beiträge.
Tschau Aktientrader 62
Hat jemand eine Ahnung, was Aceon insgesamt und für CVTX an Umsätzen/Einnahmen bringen kann?
Preis, Patientenzahlen, Konkurrenz usw.?
Ich werd mich nachher bei Yahoo auf die Suche machen, aber was zu finden wird sicher dauern.
--------------------
FDA to consider wider approval of Solvay`s Aceon
Mon Jan 10, 2005 07:25 AM ET
NEW YORK, Jan 10 (Reuters) - CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) and Solvay Pharmaceuticals Inc. (SOLBt.BR: Quote, Profile, Research) on Monday said U.S. regulators will consider approving their hypertension drug for an additional indication on an accelerated basis.
The U.S. Food and Drug Administration will quickly consider approving, Aceon, an ACE inhibitor that is marketed in Europe under the brand name Coversyl, to help reduce heart deaths, nonfatal heart attacks and cardiac arrest in patients with stable coronary artery disease who do not have heart failure or substantial hypertension, the companies said..
CV Therapeutics and Solvay Pharmaceuticals, part of Solvay Group, recently entered into a co-promotion agreement for Aceon, which is approved in the United States to treat hypertension that is not necessarily linked to other health problems.
Preis, Patientenzahlen, Konkurrenz usw.?
Ich werd mich nachher bei Yahoo auf die Suche machen, aber was zu finden wird sicher dauern.
--------------------
FDA to consider wider approval of Solvay`s Aceon
Mon Jan 10, 2005 07:25 AM ET
NEW YORK, Jan 10 (Reuters) - CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) and Solvay Pharmaceuticals Inc. (SOLBt.BR: Quote, Profile, Research) on Monday said U.S. regulators will consider approving their hypertension drug for an additional indication on an accelerated basis.
The U.S. Food and Drug Administration will quickly consider approving, Aceon, an ACE inhibitor that is marketed in Europe under the brand name Coversyl, to help reduce heart deaths, nonfatal heart attacks and cardiac arrest in patients with stable coronary artery disease who do not have heart failure or substantial hypertension, the companies said..
CV Therapeutics and Solvay Pharmaceuticals, part of Solvay Group, recently entered into a co-promotion agreement for Aceon, which is approved in the United States to treat hypertension that is not necessarily linked to other health problems.
Aus dem 8-K:
Solvay Pharmaceuticals plans to submit in the near future a supplemental new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking an expansion of the ACEON label based on the data from the EUROPA study. According to current PDUFA guidelines, a response from the FDA could be expeced within ten months of the FDA`s receipt of the supplemental NDA. CV Therapeutics does not expect meaningful revenue from the co-promotion agreement until after the potential expansion of the ACEON label.
Am 13. Dezember wurde das NDA eingereicht:
http://biz.yahoo.com/prnews/041213/sfm107_1.html
Werbetext zur Europastudie http://www.europa-trial.org/pro/study_rationale_2.asp
Da das sicher schnell aus dem Netz verschwindet, kopiere ich es mal gleich hier rein.
Why is perindopril the ACE inhibitor of choice for EUROPe?
Coronary artery disease has been shown to be clearly associated with abnormalities of the renin-angiotensin aldosterone system (RAAS). Consequently, perindopril, a long-acting ACE inhibitor that inhibits the formation of angiotensin II and increases bradykinin levels, is an extremely promising weapon in the fight against coronary artery disease.
Perindopril is indicated for the treatment of hypertension and heart failure. Many clinical trials have demonstrated its efficacy in cardiovascular disease, including the treatment of hypertension, heart failure and post myocardial infarction (MI). Its antihypertensive efficacy with a 4 mg and 8 mg dose once daily dose has been proven over a 24-hour period and it is well tolerated even in high-risk patients, such as the elderly or in patients with heart failure or recent ischaemic stroke, in whom it causes no changes in cerebral circulation.
The beneficial effects of perindopril on cardiovascular remodelling are well documented. These benefits include improvement of arterial compliance in large arteries; restoration of the structure of small resistance arteries; restoration of flow-mediated coronary vasodilatation in hypertensive patients and the reversal of endothelial dysfunction in patients with hypertension and heart failure.
Furthermore, Perindopril has a very high tissue and plasma affinity, as proven for the first time ever with an ACEI in humans suffering from CAD in this study. As shown in the picture below, Perindopril inhibits both endothelial and advential ACE, this being further proof supporting its choice for the EUROPe trial.
Perindopril has also been shown to cause a notable reduction in myocardial ischaemia. Its anti-atherosclerotic properties have been demonstrated in an experimental model of atherosclerosis, in which perindopril significantly reduced atherosclerotic lesion size and made them more stable and less likely to rupture. In addition, perindopril decreased the number of lipid-laden macrophages and reduced lipid accumulation in developing atherosclerotic plaques, or even prevents the development of atherosclerotic lesions.
Furthermore, a recent large-scale study using perindopril illustrated the potential for perindopril in patients with stable coronary artery disease. The Perindopril pROtection aGainst REcurrent Stroke Study (PROGRESS Collaborative Group, 2001) demonstrated that a drug regimen based on perindopril significantly reduced the risk of stroke by 28%, the risk of MI by 38% and heart failure by 26%. These benefits were noticed even in patients without hypertension suggesting that perindopril may have benefits above and beyond its role as a blood-pressure lowering agent.
Eigentlich ein ganz großes Rad ist das.
http://www.infomed.org/pharma-kritik/pk06b-95.html
http://www.ims-global.com/insight/news_story/0207/news_story…
-> Konkurrenztprodukt Zestril bekam massive generische Konkurrenz:
http://www.astrazeneca.com/sites/7/imagebank/migratedpress/q… Seite 3
Bei solchen massiven Konkurrenzumfeldern traue ich mir persönlich keine Prognose zu, dazu müsste ich auch unterscheiden können, welche Aussage Werbung ist und was nicht. Da bin ich etwas überfordert.
Werte wie UTHR/Reminyl sind da wesentlich einfacher.
Solvay Pharmaceuticals plans to submit in the near future a supplemental new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking an expansion of the ACEON label based on the data from the EUROPA study. According to current PDUFA guidelines, a response from the FDA could be expeced within ten months of the FDA`s receipt of the supplemental NDA. CV Therapeutics does not expect meaningful revenue from the co-promotion agreement until after the potential expansion of the ACEON label.
Am 13. Dezember wurde das NDA eingereicht:
http://biz.yahoo.com/prnews/041213/sfm107_1.html
Werbetext zur Europastudie http://www.europa-trial.org/pro/study_rationale_2.asp
Da das sicher schnell aus dem Netz verschwindet, kopiere ich es mal gleich hier rein.
Why is perindopril the ACE inhibitor of choice for EUROPe?
Coronary artery disease has been shown to be clearly associated with abnormalities of the renin-angiotensin aldosterone system (RAAS). Consequently, perindopril, a long-acting ACE inhibitor that inhibits the formation of angiotensin II and increases bradykinin levels, is an extremely promising weapon in the fight against coronary artery disease.
Perindopril is indicated for the treatment of hypertension and heart failure. Many clinical trials have demonstrated its efficacy in cardiovascular disease, including the treatment of hypertension, heart failure and post myocardial infarction (MI). Its antihypertensive efficacy with a 4 mg and 8 mg dose once daily dose has been proven over a 24-hour period and it is well tolerated even in high-risk patients, such as the elderly or in patients with heart failure or recent ischaemic stroke, in whom it causes no changes in cerebral circulation.
The beneficial effects of perindopril on cardiovascular remodelling are well documented. These benefits include improvement of arterial compliance in large arteries; restoration of the structure of small resistance arteries; restoration of flow-mediated coronary vasodilatation in hypertensive patients and the reversal of endothelial dysfunction in patients with hypertension and heart failure.
Furthermore, Perindopril has a very high tissue and plasma affinity, as proven for the first time ever with an ACEI in humans suffering from CAD in this study. As shown in the picture below, Perindopril inhibits both endothelial and advential ACE, this being further proof supporting its choice for the EUROPe trial.
Perindopril has also been shown to cause a notable reduction in myocardial ischaemia. Its anti-atherosclerotic properties have been demonstrated in an experimental model of atherosclerosis, in which perindopril significantly reduced atherosclerotic lesion size and made them more stable and less likely to rupture. In addition, perindopril decreased the number of lipid-laden macrophages and reduced lipid accumulation in developing atherosclerotic plaques, or even prevents the development of atherosclerotic lesions.
Furthermore, a recent large-scale study using perindopril illustrated the potential for perindopril in patients with stable coronary artery disease. The Perindopril pROtection aGainst REcurrent Stroke Study (PROGRESS Collaborative Group, 2001) demonstrated that a drug regimen based on perindopril significantly reduced the risk of stroke by 28%, the risk of MI by 38% and heart failure by 26%. These benefits were noticed even in patients without hypertension suggesting that perindopril may have benefits above and beyond its role as a blood-pressure lowering agent.
Eigentlich ein ganz großes Rad ist das.
http://www.infomed.org/pharma-kritik/pk06b-95.html
http://www.ims-global.com/insight/news_story/0207/news_story…
-> Konkurrenztprodukt Zestril bekam massive generische Konkurrenz:
http://www.astrazeneca.com/sites/7/imagebank/migratedpress/q… Seite 3
Bei solchen massiven Konkurrenzumfeldern traue ich mir persönlich keine Prognose zu, dazu müsste ich auch unterscheiden können, welche Aussage Werbung ist und was nicht. Da bin ich etwas überfordert.
Werte wie UTHR/Reminyl sind da wesentlich einfacher.
Leider oder vielleicht glücklicherweise fehlt CVTX in dieser Liste:
http://www.forbes.com/sciencesandmedicine/2004/01/22/cx_mh_r…
Mit ENCY hatte Forbes ein sehr glückliches Händchen.
http://www.forbes.com/sciencesandmedicine/2004/01/22/cx_mh_r…
Mit ENCY hatte Forbes ein sehr glückliches Händchen.
@borazon wg. 252: Schon konkretere Zahlen irgendwo gefunden?
Nö, noch nix gefunden. Hab neulich nicht lang gesucht.
Aber nach den heutigen Nachrichten wird das Thema wieder wichtiger.
US FDA to consider wider approval of Solvay`s Aceon
Tue Feb 15, 2005 04:36 PM ET
NEW YORK, Feb 15 (Reuters) - Solvay Pharmaceuticals Inc. (SOLBt.BR: Quote, Profile, Research) and CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) said on Tuesday that U.S. regulators would consider wider approval for Solvay`s blood pressure medicine Aceon, and that they expect a decision by June 10.
The companies are seeking approval from the Food and Drug Administration (FDA) for Aceon to help reduce heart deaths, nonfatal heart attacks and cardiac arrest in patients with stable coronary artery disease who do not suffer from heart failure.
CV Therapeutics and Belgium-based Solvay have a co-promotion agreement for the drug, which belongs to a class of blood pressure medicines known as ACE inhibitors.
Aber nach den heutigen Nachrichten wird das Thema wieder wichtiger.
US FDA to consider wider approval of Solvay`s Aceon
Tue Feb 15, 2005 04:36 PM ET
NEW YORK, Feb 15 (Reuters) - Solvay Pharmaceuticals Inc. (SOLBt.BR: Quote, Profile, Research) and CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) said on Tuesday that U.S. regulators would consider wider approval for Solvay`s blood pressure medicine Aceon, and that they expect a decision by June 10.
The companies are seeking approval from the Food and Drug Administration (FDA) for Aceon to help reduce heart deaths, nonfatal heart attacks and cardiac arrest in patients with stable coronary artery disease who do not suffer from heart failure.
CV Therapeutics and Belgium-based Solvay have a co-promotion agreement for the drug, which belongs to a class of blood pressure medicines known as ACE inhibitors.
http://www.jagnotes.com/archive_jagnotes_body.cfm?jagdate=07…
06:31 am ET Piper Jaffray & Co.
(CVTX) Reit Outperform
CVTX In Co-Promotion Agreement With Solvay For Aceon. CV Therapeutics announced yesterday, December 6, that it signed a U.S. co- promotion agreement with Solvay for Aceon, an ACE inhibitor approved for the treatment of hypertension. Under the terms of the agreement, CV Therapeutics will be responsible for promoting Aceon to cardiologists, will not have any upfront payments to Solvay, and will receive a 50%- 60% royalty on Aceon U.S. sales over current levels (Aceon currently sells approximately $30 million a year in the U.S.). CVTX plans to establish a cardiology sales force of approximately 150 people in 2Q05, six months ahead of our original projections for the Company`s launch of its lead pipeline drug, Ranexa. Based on the current patent estate, we expect Aceon to retain marketing exclusivity through early November 2009.
http://www.jagnotes.com/archive_jagnotes_body.cfm?jagdate=09…
05:56 am ET CIBC World Markets Corp.
(CVTX) Reit Sector Performer
On 12/06, CVTX announced a co-promotion agreement with Solvay Pharmaceuticals (SVYSY, Not Rated) for the ACE-inhibitor Aceon, approved in the U.S. for hypertension and widely used in Europe. We believe CVTX can generate incremental revenues from Aceon sales and will target physicians who would potentially co-prescribe Ranexa. We continue to believe that Ranexa has a reasonable probability of approval and commercialization in a restricted angina population by year-end 2005.
06:31 am ET Piper Jaffray & Co.
(CVTX) Reit Outperform
CVTX In Co-Promotion Agreement With Solvay For Aceon. CV Therapeutics announced yesterday, December 6, that it signed a U.S. co- promotion agreement with Solvay for Aceon, an ACE inhibitor approved for the treatment of hypertension. Under the terms of the agreement, CV Therapeutics will be responsible for promoting Aceon to cardiologists, will not have any upfront payments to Solvay, and will receive a 50%- 60% royalty on Aceon U.S. sales over current levels (Aceon currently sells approximately $30 million a year in the U.S.). CVTX plans to establish a cardiology sales force of approximately 150 people in 2Q05, six months ahead of our original projections for the Company`s launch of its lead pipeline drug, Ranexa. Based on the current patent estate, we expect Aceon to retain marketing exclusivity through early November 2009.
http://www.jagnotes.com/archive_jagnotes_body.cfm?jagdate=09…
05:56 am ET CIBC World Markets Corp.
(CVTX) Reit Sector Performer
On 12/06, CVTX announced a co-promotion agreement with Solvay Pharmaceuticals (SVYSY, Not Rated) for the ACE-inhibitor Aceon, approved in the U.S. for hypertension and widely used in Europe. We believe CVTX can generate incremental revenues from Aceon sales and will target physicians who would potentially co-prescribe Ranexa. We continue to believe that Ranexa has a reasonable probability of approval and commercialization in a restricted angina population by year-end 2005.
Immer noch nix Genaues gefunden. Einer auf Yahoo hat behauptet, das Zeug brächte in Europa einen Umsatz von 500 Mio EUR, aber hier ist es offenbar schon seit zehn Jahren auf dem Markt. Ist ein bißchen schwierig zu verfolgen aufgrund der verschiedenen Namen und Vertriebspartnerschaften. In den USA läuft das Patent auch nur noch bis max. 2009. Der große Wurf ist es offensichtlich nicht. War aber auch klar, daß Solvay nichts verschenkt. Wird wohl Synergien geben, wenn Aceon und Ranexa gemeinsam vertrieben werden; um die 700+ Mio MktKap von CVTX ohne Ranexa zu rechtfertigen, reicht es sicher bei weitem nicht.
100 % agree. Das Solvay was verschenkt, kann ich auch nicht recht glauben. Das sind so Präparate, bei denen die Sales force und die "Werbeaufwendungen" wichtiger sind als die echte klinische Relevanz.
Zu den 500 Mille. Das war wohl höchstens mal.
Ich finde hier in den annuals jedenfalls nichts unter Conversyl, nur unter Aceon.
http://www.solvay-investors.com/static/wma/pdf/2/0/5/0/Pharm…
In Europa wird Perindopril als Coversum/Servier auch bei Bluthochdruck eingesetzt, da gibt es wohl jetzt aber heftige generische Konkurrenz. Generell hat Aceon selbst im eigenen Haus heftige Konkurrenz, vielleicht wollte Solvay das Aceon auch deshalb loswerden, damit sich die Vertreter einen Knoten ins Hirn winden müssen.
S. auch http://www.aerzteblatt.de/v4/archiv/artikel.asp?id=44260 in der Mitte
Zu den 500 Mille. Das war wohl höchstens mal.
Ich finde hier in den annuals jedenfalls nichts unter Conversyl, nur unter Aceon.
http://www.solvay-investors.com/static/wma/pdf/2/0/5/0/Pharm…
In Europa wird Perindopril als Coversum/Servier auch bei Bluthochdruck eingesetzt, da gibt es wohl jetzt aber heftige generische Konkurrenz. Generell hat Aceon selbst im eigenen Haus heftige Konkurrenz, vielleicht wollte Solvay das Aceon auch deshalb loswerden, damit sich die Vertreter einen Knoten ins Hirn winden müssen.
S. auch http://www.aerzteblatt.de/v4/archiv/artikel.asp?id=44260 in der Mitte
Ich verstehe die Aufregung hier nicht !!!!
CVTX hat die beste Produktpipeline.
CVT-510 könnte dieses Jahr oder nächstes die Zulassung bekommen. Aber allen schauen wie blöd auf Ranexa. Market.Cap 800,00 Mio Dollar na und 400,00 Mio. sind in der kasse. Schaut euch doch die großen Bio´s oder Pharma an.Was sie in den letzten Wochen gebracht haben , konnte man vergessen. Ihre Produktpipeline wird immer dünner. Die Übernahmewelle wird Ende 2005 losgehen im Biobereich. Viele kleine Unternehmen haben Produkte in Phase 3.
Wenn da die Zulassungen kommen ist der NBI bald bei 1000 Punkten.
Ich meine keine Zockerwerte wie APHT , AXYX und der gleichen. Mit 1000 oder 2000 Euro zum Spielen kann man mal reingehen. Aber wie gesagt im BörsenSPIEL in echt im Leben nicht.
Eine solide Pipeline mit mindestens 2 oder 3 Produkte in Phase 3 und 2-3 Produkte in Phase 2 Studien.
Die kann man kaufen alle anderen lasse ich links liegen CVTX hat alles.
Tschau Aktientrader 62
CVTX hat die beste Produktpipeline.
CVT-510 könnte dieses Jahr oder nächstes die Zulassung bekommen. Aber allen schauen wie blöd auf Ranexa. Market.Cap 800,00 Mio Dollar na und 400,00 Mio. sind in der kasse. Schaut euch doch die großen Bio´s oder Pharma an.Was sie in den letzten Wochen gebracht haben , konnte man vergessen. Ihre Produktpipeline wird immer dünner. Die Übernahmewelle wird Ende 2005 losgehen im Biobereich. Viele kleine Unternehmen haben Produkte in Phase 3.
Wenn da die Zulassungen kommen ist der NBI bald bei 1000 Punkten.
Ich meine keine Zockerwerte wie APHT , AXYX und der gleichen. Mit 1000 oder 2000 Euro zum Spielen kann man mal reingehen. Aber wie gesagt im BörsenSPIEL in echt im Leben nicht.
Eine solide Pipeline mit mindestens 2 oder 3 Produkte in Phase 3 und 2-3 Produkte in Phase 2 Studien.
Die kann man kaufen alle anderen lasse ich links liegen CVTX hat alles.
Tschau Aktientrader 62
Du hast Recht, dass das Gros der Anleger sich zu sehr auf Ranexa konzentriert , wobei ich von einer Marktzulassung ausgehe (das ist im wesentlichen Fleissarbeit) und dass der Bedarf der Pharmas entwickelte Medikamente gerade in diesem Segment riesig ist. Scios ist mit einem markkompatiblen Produkt für 2,4 Millionen $ von J&J übernommen worden. Die gab 2-3 Jahr vorher auch für 100 Mille.
Nur sind 700 Mille auch niemals ein gedankenloser Kauf mehr. Und was ich dem Management ankreide ist, dass es bisher reichlich den Kurs verwässert, umgekehrt staune ich über den hohen Prozentsatz von Produktkandidaten durch die Pipeline durchbekommen, d.h die Forschungsgelder waren bisher wirklich gut angelegt.
Aufgeregt bin ich sicher nicht.
Nur sind 700 Mille auch niemals ein gedankenloser Kauf mehr. Und was ich dem Management ankreide ist, dass es bisher reichlich den Kurs verwässert, umgekehrt staune ich über den hohen Prozentsatz von Produktkandidaten durch die Pipeline durchbekommen, d.h die Forschungsgelder waren bisher wirklich gut angelegt.
Aufgeregt bin ich sicher nicht.
Hier ein paar neuere Empfehlungen!
CV Therapeutics: Auf Strong Buy hochgestuft
01.04.2005 - Die Experten von Needham & Co haben die Aktie des Biotech-Unternehmens CV Therapeutics von „buy“ auf „strong buy“ hochgestuft.
( aa )
31.03.2005
CV Therapeutics "strong buy"
Needham & Co
Rating-Update:
Die Analysten von Needham & Co stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "buy" auf "strong buy" hoch. Das Kursziel werde bei 30 USD gesehen.
CV Therapeutics: Buy – Kursziel 30 Dollar
30.03.2005 -
Zum Auftakt ihrer Coverage haben die Analysten von IRG Research die Aktie des Biotech-Unternehmens CV Therapeutics mit „buy“ eingestuft. Als Kursziel werden 30 Dollar genannt.
( aa )
CV Therapeutics: Buy
30.03.2005 -
Zum Auftakt ihrer Coverage haben die Analysten von IRG Research die Aktie des Biotech-Unternehmens CV Therapeutics mit „buy“ eingestuft. Das Unternehmen habe eine robuste Produktpipeline, die in näherer Zukunft für signifikante Umsätze verantwortlich zeichnen solle.
( aa )
29.03.2005 18:09
Update CV Therapeutics Inc.: Buy (IRG Research)
Die Analysten von IRG Research bewerten in ihrer Analyse vom Dienstag, 29. März 2005 die Aktie von CV Therapeutics (Nachrichten) neu mit dem Rating "Buy". Das Kursziel für die Aktie liegt momentan bei 30 $.
Bin gespannt wie lange es noch dauert!
Cu
Spilandi
CV Therapeutics: Auf Strong Buy hochgestuft
01.04.2005 - Die Experten von Needham & Co haben die Aktie des Biotech-Unternehmens CV Therapeutics von „buy“ auf „strong buy“ hochgestuft.
( aa )
31.03.2005
CV Therapeutics "strong buy"
Needham & Co
Rating-Update:
Die Analysten von Needham & Co stufen die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) von "buy" auf "strong buy" hoch. Das Kursziel werde bei 30 USD gesehen.
CV Therapeutics: Buy – Kursziel 30 Dollar
30.03.2005 -
Zum Auftakt ihrer Coverage haben die Analysten von IRG Research die Aktie des Biotech-Unternehmens CV Therapeutics mit „buy“ eingestuft. Als Kursziel werden 30 Dollar genannt.
( aa )
CV Therapeutics: Buy
30.03.2005 -
Zum Auftakt ihrer Coverage haben die Analysten von IRG Research die Aktie des Biotech-Unternehmens CV Therapeutics mit „buy“ eingestuft. Das Unternehmen habe eine robuste Produktpipeline, die in näherer Zukunft für signifikante Umsätze verantwortlich zeichnen solle.
( aa )
29.03.2005 18:09
Update CV Therapeutics Inc.: Buy (IRG Research)
Die Analysten von IRG Research bewerten in ihrer Analyse vom Dienstag, 29. März 2005 die Aktie von CV Therapeutics (Nachrichten) neu mit dem Rating "Buy". Das Kursziel für die Aktie liegt momentan bei 30 $.
Bin gespannt wie lange es noch dauert!
Cu
Spilandi
Bio/Pharma ist ein böses Wort heutzutage.. aber nicht für immer..
Der Motley Fool hatte ein schönes Artikelchen über CVTX heute:
When our supposedly efficient markets get this grumpy, I like to go bargain shopping. One company that has captured my attention is CV Therapeutics (Nasdaq: CVTX). True, it`s only off about 13% for the year, but it has virtues beyond the recent discount given by sour investors.
Sizing up CV
There are a lot of things to keep in mind when sizing up a biotech company. Does it have a promising product with hope of approval in a reasonable timeframe? Has it given away all the upside to a partner with deep pockets, or kept a good chunk for itself? Does it have a pipeline to back the lead product? Does it have decent cash reserves? Talented management? I think CV Therapeutics pleases on all counts.
Ranexa, its flagship product, is a novel treatment for chronic angina with an approvable letter in hand. While the mainstay of angina treatment at present is beta blockers, calcium channel blockers, and nitroglycerin, Ranexa may become the first new class of anti-anginal in decades. The story behind this product is a lengthy one that I won`t go into here, but suffice it to say that in May, give or take a few weeks, the company will be reporting results that, if positive, should allow for approval of Ranexa in a restricted population of angina patients (presumably patients whose symptoms are not sufficiently controlled by standard drugs and who have established coronary artery disease or a prior heart attack). A larger study, with preliminary results expected in late 2006, could open up the drug for use in frontline angina treatment as well as the prevention of acute coronary syndromes, both in hospitals and out.
While Ranexa would probably not make a huge market impact with its initial label, the potential of this drug is substantial. Expected to cost around $1,000 a year ($3 a day) in pill form, Ranexa does not have to win a huge market share among nearly 7 million people in the U.S. with chronic angina to become a major success. And the company owns 100% of Ranexa in the U.S. and most of the rest of the world -- no royalties, no profit-sharing.
Backing this up is a drug called Regadenoson, designed for use in cardiac stress testing. Over 3 million myocardial perfusion imaging studies a year require the use of a pharmacological stress-testing agent, and choices now are limited to drugs that cause some unwanted side effects. There are two phase 3 trials underway, with results expected in the third quarter and around year-end 2005, respectively.
There are other pipeline compounds in development, too, but perhaps most interesting is a new addition -- Aceon, an angiotensin-converting enzyme (ACE) inhibitor that CV recently licensed from Solvay. Aceon hasn`t been a big product in the U.S. to date -- it brought in only about $30 million last year, versus the roughly $500 million it raked in across Europe. But a label expansion may change that. In June, the FDA is expected to decide on a supplemental NDA that would establish Aceon`s benefits in reducing the relative risk of heart attack and cardiovascular death by about 20% in low-risk patients with stable coronary disease. A further study on Aceon was halted in December because when given with a calcium channel blocker (Pfizer`s Norvasc), Aceon was significantly better than a beta blocker/diuretic combination in preventing heart attack or death.
The Aceon licensing deal allows CV to collect a significant royalty (in excess of 50%) on all U.S. sales above the baseline (around $30 million) and also allows the company to ramp up a sales force in anticipation of a Ranexa launch -- a good stroke of forward planning by the management team.
CV has also been good about keeping cash around, with reserves of cash and marketable securities of over $400 million at the end of 2004. It carries convertible debt totaling almost $300 million, however, so the balance sheet is not without burden. A market cap of $716 million may not look cheap for a company currently losing money hand over fist, but this is only a fraction of the sales that Ranexa alone could potentially bring in over the next several years. If you`re not feeling quite as grumpy as most investors seem to be these days, this company is worth a look.
Finde ich auch,
greetz
Sheepshead
Der Motley Fool hatte ein schönes Artikelchen über CVTX heute:
When our supposedly efficient markets get this grumpy, I like to go bargain shopping. One company that has captured my attention is CV Therapeutics (Nasdaq: CVTX). True, it`s only off about 13% for the year, but it has virtues beyond the recent discount given by sour investors.
Sizing up CV
There are a lot of things to keep in mind when sizing up a biotech company. Does it have a promising product with hope of approval in a reasonable timeframe? Has it given away all the upside to a partner with deep pockets, or kept a good chunk for itself? Does it have a pipeline to back the lead product? Does it have decent cash reserves? Talented management? I think CV Therapeutics pleases on all counts.
Ranexa, its flagship product, is a novel treatment for chronic angina with an approvable letter in hand. While the mainstay of angina treatment at present is beta blockers, calcium channel blockers, and nitroglycerin, Ranexa may become the first new class of anti-anginal in decades. The story behind this product is a lengthy one that I won`t go into here, but suffice it to say that in May, give or take a few weeks, the company will be reporting results that, if positive, should allow for approval of Ranexa in a restricted population of angina patients (presumably patients whose symptoms are not sufficiently controlled by standard drugs and who have established coronary artery disease or a prior heart attack). A larger study, with preliminary results expected in late 2006, could open up the drug for use in frontline angina treatment as well as the prevention of acute coronary syndromes, both in hospitals and out.
While Ranexa would probably not make a huge market impact with its initial label, the potential of this drug is substantial. Expected to cost around $1,000 a year ($3 a day) in pill form, Ranexa does not have to win a huge market share among nearly 7 million people in the U.S. with chronic angina to become a major success. And the company owns 100% of Ranexa in the U.S. and most of the rest of the world -- no royalties, no profit-sharing.
Backing this up is a drug called Regadenoson, designed for use in cardiac stress testing. Over 3 million myocardial perfusion imaging studies a year require the use of a pharmacological stress-testing agent, and choices now are limited to drugs that cause some unwanted side effects. There are two phase 3 trials underway, with results expected in the third quarter and around year-end 2005, respectively.
There are other pipeline compounds in development, too, but perhaps most interesting is a new addition -- Aceon, an angiotensin-converting enzyme (ACE) inhibitor that CV recently licensed from Solvay. Aceon hasn`t been a big product in the U.S. to date -- it brought in only about $30 million last year, versus the roughly $500 million it raked in across Europe. But a label expansion may change that. In June, the FDA is expected to decide on a supplemental NDA that would establish Aceon`s benefits in reducing the relative risk of heart attack and cardiovascular death by about 20% in low-risk patients with stable coronary disease. A further study on Aceon was halted in December because when given with a calcium channel blocker (Pfizer`s Norvasc), Aceon was significantly better than a beta blocker/diuretic combination in preventing heart attack or death.
The Aceon licensing deal allows CV to collect a significant royalty (in excess of 50%) on all U.S. sales above the baseline (around $30 million) and also allows the company to ramp up a sales force in anticipation of a Ranexa launch -- a good stroke of forward planning by the management team.
CV has also been good about keeping cash around, with reserves of cash and marketable securities of over $400 million at the end of 2004. It carries convertible debt totaling almost $300 million, however, so the balance sheet is not without burden. A market cap of $716 million may not look cheap for a company currently losing money hand over fist, but this is only a fraction of the sales that Ranexa alone could potentially bring in over the next several years. If you`re not feeling quite as grumpy as most investors seem to be these days, this company is worth a look.
Finde ich auch,
greetz
Sheepshead
Aus dem Artikelchen unten: Datum für die FDA-Genehmigung ist 10 Juni, also, in einer Woche wieder was "Action"
There are other pipeline compounds in development, too, but perhaps most interesting is a new addition -- Aceon, an angiotensin-converting enzyme (ACE) inhibitor that CV recently licensed from Solvay. Aceon hasn`t been a big product in the U.S. to date -- it brought in only about $30 million last year, versus the roughly $500 million it raked in across Europe. But a label expansion may change that. In June, the FDA is expected to decide on a supplemental NDA that would establish Aceon`s benefits in reducing the relative risk of heart attack and cardiovascular death by about 20% in low-risk patients with stable coronary disease. A further study on Aceon was halted in December because when given with a calcium channel blocker (Pfizer`s Norvasc), Aceon was significantly better than a beta blocker/diuretic combination in preventing heart attack or death.
The Aceon licensing deal allows CV to collect a significant royalty (in excess of 50%) on all U.S. sales above the baseline (around $30 million) and also allows the company to ramp up a sales force in anticipation of a Ranexa launch -- a good stroke of forward planning by the management team.
There are other pipeline compounds in development, too, but perhaps most interesting is a new addition -- Aceon, an angiotensin-converting enzyme (ACE) inhibitor that CV recently licensed from Solvay. Aceon hasn`t been a big product in the U.S. to date -- it brought in only about $30 million last year, versus the roughly $500 million it raked in across Europe. But a label expansion may change that. In June, the FDA is expected to decide on a supplemental NDA that would establish Aceon`s benefits in reducing the relative risk of heart attack and cardiovascular death by about 20% in low-risk patients with stable coronary disease. A further study on Aceon was halted in December because when given with a calcium channel blocker (Pfizer`s Norvasc), Aceon was significantly better than a beta blocker/diuretic combination in preventing heart attack or death.
The Aceon licensing deal allows CV to collect a significant royalty (in excess of 50%) on all U.S. sales above the baseline (around $30 million) and also allows the company to ramp up a sales force in anticipation of a Ranexa launch -- a good stroke of forward planning by the management team.
.
endlich auch in € über 20...pfft
endlich auch in € über 20...pfft
Wie geht`s weiter. Was glaubt Ihr bzw. wie hoch wird der Kurs noch gehen??????????????????????????????????????
Aktientrader62? Any comments????
Hallo Schapekop,
Ende März 2004 hatte man ein Zulassungsantrag für Ranexa in Europa gestellt. Das war vor 15. Monate wir kommen in die heiße Phase der Zulassung auch in Europa.
Die Ergebnisse der letzten klinischen Studie für Ranexa dürften bis Mitte Ende 2005 in der USA vorliegen. Die FDA hatte im Juni 2004 ein beschleunigtes Genehmigungsverfahren zugesagt , falls das klinische Material positiv ist. Im April 2005 meldet CVTX Ranexa sei wirksam und gut verträglich. Und es gab keine Ohnmachtsanfälle. Das war auch der Grund warum die FDA mehr klinisches Material anforderte.
Für eine Überraschung könnte aber auch CVT 510 sorgen . In der USA geht man davon aus das 2005 -2006 eine Zulassung erfolgt.
Wegen der Kapitalerhöhung sind 60 USD sehr hoch bezahlt mein KZ.
Aber Ranexa dürfte 400. Mio und CVT 510 250. Mio Umsatz bringen.
Bei 60 USD und jetzt 45. Mio Aktien macht das ein KUV von ca. 4,2.
Bei der Marktkap. steigen auch immer mehr Fonds ein.
Das war´s mehr neues hab ich auch nicht.
Tschau Aktientrader62
Ende März 2004 hatte man ein Zulassungsantrag für Ranexa in Europa gestellt. Das war vor 15. Monate wir kommen in die heiße Phase der Zulassung auch in Europa.
Die Ergebnisse der letzten klinischen Studie für Ranexa dürften bis Mitte Ende 2005 in der USA vorliegen. Die FDA hatte im Juni 2004 ein beschleunigtes Genehmigungsverfahren zugesagt , falls das klinische Material positiv ist. Im April 2005 meldet CVTX Ranexa sei wirksam und gut verträglich. Und es gab keine Ohnmachtsanfälle. Das war auch der Grund warum die FDA mehr klinisches Material anforderte.
Für eine Überraschung könnte aber auch CVT 510 sorgen . In der USA geht man davon aus das 2005 -2006 eine Zulassung erfolgt.
Wegen der Kapitalerhöhung sind 60 USD sehr hoch bezahlt mein KZ.
Aber Ranexa dürfte 400. Mio und CVT 510 250. Mio Umsatz bringen.
Bei 60 USD und jetzt 45. Mio Aktien macht das ein KUV von ca. 4,2.
Bei der Marktkap. steigen auch immer mehr Fonds ein.
Das war´s mehr neues hab ich auch nicht.
Tschau Aktientrader62
Vielen Dank Aktientrader- also BFW, Aktientrader sieht sein Ziel von 60$ auch als "gut bezahlt" an.
Meine eigene Erwartungen sind etwas bescheidener- das 3Q wird schon noch interessant, weil die SPA Ergebnisse über Ranexa eine Monat früher ausgewertet sein sollten (Ende August) und den Aceon-Deal(ACE-Hemmer) mit Solvay doch auch seinen Reiz hat iba auf Salesforce Aufbau usw und in September nach dem Zusatzaudits des FDA´s freigegeben werden sollte. Da sind $30 meines Achtens noch möglich Ende September.
Die endgültige Genehmigung von Ranexa, die ich Ende März 2006 erwarte, nehme ich noch mit- da reden wir meines Achtens von $40-45 für den Wert. Auf die Ergebnisse von ERICA, werde ich jedoch wahrscheinlich nicht mehr warten, das dauert dann noch wieder 1-1,5 Jahr.
Greetz
Sheepshead
Meine eigene Erwartungen sind etwas bescheidener- das 3Q wird schon noch interessant, weil die SPA Ergebnisse über Ranexa eine Monat früher ausgewertet sein sollten (Ende August) und den Aceon-Deal(ACE-Hemmer) mit Solvay doch auch seinen Reiz hat iba auf Salesforce Aufbau usw und in September nach dem Zusatzaudits des FDA´s freigegeben werden sollte. Da sind $30 meines Achtens noch möglich Ende September.
Die endgültige Genehmigung von Ranexa, die ich Ende März 2006 erwarte, nehme ich noch mit- da reden wir meines Achtens von $40-45 für den Wert. Auf die Ergebnisse von ERICA, werde ich jedoch wahrscheinlich nicht mehr warten, das dauert dann noch wieder 1-1,5 Jahr.
Greetz
Sheepshead
Monday, Aug. 8. CV Therapeutics on Monday will report second-quarter earnings after the bell and hold a conference call at 5 P.M. EST. For Chief Executive Louis G. Lange, the long process of developing a new medicine for chronic angina--the tightening chest pain due to a weakening heart--may finally be ending. The U.S. Food and Drug Administration said the drug, called Ranexa, was "approvable" almost two years ago. Yet it took a big, recently completed trial testing Ranexa on top of Pfizer`s Norvasc to give it a shot at becoming the first treatment for chronic angina in 25 years . For Lange, who has stood by the drug through thick and thin, it could be a big payoff. In the meantime, analysts expect the company to post a loss of $1.52 per share on revenue of $6 million.
Und es gab keine Ohnmachtsanfälle. Das war auch der Grund warum die FDA mehr klinisches Material anforderte.
Nee, das ist nicht richtig.
Primär ging es um die verlängerten QT-Intervalle,
sekundär um dem expliziten Nachweis der Erhöhung der Überlebenswahrscheinlichkeit.
Nee, das ist nicht richtig.
Primär ging es um die verlängerten QT-Intervalle,
sekundär um dem expliziten Nachweis der Erhöhung der Überlebenswahrscheinlichkeit.
KUV -Verhältnis ist ja ein komische Größe für die Bewertung einer Biotechaktie. Wenn sie Umsatz macht, dann soll sie gefälligst auch Gewinne erzielen.
Gilead hat ein KUV von 12, DNA von 17, soviel würde ich aber auch nicht bezahlen.
Ist letztendlich auch eine Blase der hochkapitalisierten Biotechwerte, pure Anlagenot.
Gilead hat ein KUV von 12, DNA von 17, soviel würde ich aber auch nicht bezahlen.
Ist letztendlich auch eine Blase der hochkapitalisierten Biotechwerte, pure Anlagenot.
CV Therapeutics A `Compelling` Cardiology Investment
Peter Kang, 08.24.05, 1:16 PM ET
Piper Jaffray maintained an "outperform" rating on CV Therapeutics (nasdaq: CVTX - news - people ) after the biotech firm received U.S. Food and Drug Administration approval to expand the label of heart drug Aceon.
CV Therapeutics said data from the trial, dubbed Europa, indicated a relative risk reduction of cardiovascular events compared with a placebo. Aceon, which is co-marketed with Belgium-based Solvay Pharmaceuticals, a unit of Solvay SA, is now indicated for use in both hypertension and in the secondary prevention of coronary artery disease.
"We believe that the inclusion of the Europa data will reposition Aceon within the ACEI [angiotensin converting enzyme inhibitor] market allowing for a successful re-launch and substantial growth," said Piper Jaffray. "We currently assume a conservative peak sales estimate for Aceon of $100 million in the U.S. and note that there is significant leverage in the model with increasing Aceon sales. Every $10 million in additional Aceon sales would represent approximately $0.05 to our outer year CV Therapeutics sales estimates."
Aceon has annual sales of just $30 million compared with sales of $347 million for Altace, the leading ACEI made by King Pharmaceuticals (nyse: KG - news - people ). The research firm maintained a $34 price target on the stock. "We believe that CV Therapeutics represents a compelling small cap investment in cardiology with three late-stage products to drive upside to the current stock price," said Piper Jaffray.
Peter Kang, 08.24.05, 1:16 PM ET
Piper Jaffray maintained an "outperform" rating on CV Therapeutics (nasdaq: CVTX - news - people ) after the biotech firm received U.S. Food and Drug Administration approval to expand the label of heart drug Aceon.
CV Therapeutics said data from the trial, dubbed Europa, indicated a relative risk reduction of cardiovascular events compared with a placebo. Aceon, which is co-marketed with Belgium-based Solvay Pharmaceuticals, a unit of Solvay SA, is now indicated for use in both hypertension and in the secondary prevention of coronary artery disease.
"We believe that the inclusion of the Europa data will reposition Aceon within the ACEI [angiotensin converting enzyme inhibitor] market allowing for a successful re-launch and substantial growth," said Piper Jaffray. "We currently assume a conservative peak sales estimate for Aceon of $100 million in the U.S. and note that there is significant leverage in the model with increasing Aceon sales. Every $10 million in additional Aceon sales would represent approximately $0.05 to our outer year CV Therapeutics sales estimates."
Aceon has annual sales of just $30 million compared with sales of $347 million for Altace, the leading ACEI made by King Pharmaceuticals (nyse: KG - news - people ). The research firm maintained a $34 price target on the stock. "We believe that CV Therapeutics represents a compelling small cap investment in cardiology with three late-stage products to drive upside to the current stock price," said Piper Jaffray.
Neue Hoffnung für ältere Herzinfarktopfer - PREAMI-Studie zeigt signifikante Wirkung von Coversyl(R) bei älteren Herzinfarktpatienten
STOCKHOLM, Schweden, September 4 /PRNewswire/ -- Ergebnisse der PREAMI-Studie (Perindopril Remodelling in Elderly with
Acute Myocardial Infarction [Perindopril-Remodelling bei älteren Patienten
nach akutem Myokardinfarkt]), die heute auf dem Kongress der European Society
of Cardiology (ESC) veröffentlicht wurden, zeigen, dass der ACE-Hemmer
Coversyl(R) (Perindopril) das Risiko von Tod, Krankenhausaufenthalten
aufgrund von Herzinsuffizienz und kardialem Remodelling für ältere
Herzinfarktpatienten mit erhaltener linksventrikulärer Funktion signifikant
reduziert.(1)
PREAMI ist eine bahnbrechende Studie, bei der ein ACE-Hemmer zum ersten
Mal in dieser älteren Patientenpopulation mit erhaltener linksventrikulärer
Funktion, die in der klinischen Praxis weit verbreitet ist, untersucht wurde.
Die vorteilhafte Wirkung von Perindopril beruht auf einer äusserst
signifikanten Reduzierung (46 %, p<0,001) des kardialen Remodelling im
Vergleich zum Placebo. Akuter Myokardinfarkt (Herzinfarkt, MI) führt zu
fortschreitenden Veränderungen der Herzkammergrösse, -form und -funktion.
Dieser Prozess wird als Remodelling bezeichnet und ist ein asymptomatischer
Hinweis auf zur Herzinsuffizienz führende Herzschwäche. Vorhergehende Studien
demonstrierten die vorteilhafte Wirkung von ACE-Hemmern, jedoch bei jüngeren
Patienten mit eingeschränkter linksventrikulärer Funktion.
"Die Ergebnisse der PREAMI-Studie schliessen eine Lücke in unserem Wissen
über die Wirkung von ACE-Hemmern bei Myokardinfarktpatienten", sagte
Professor R Ferrari vom S Anna Krankenhaus an der Universität Ferrara in
Italien und Forschungsleiter der PREAMI-Studie. "PREAMI hat demonstriert,
dass selbst bei Patienten, die einen Herzinfarkt überlebt haben und die mehr
als 10 Tage nach der akuten Phase eine normale linksventrikuläre Funktion
aufweisen, ein fortschreitendes kardiales Remodelling asymptomatisch
auftritt. Die gute Nachricht ist jedoch, dass Perindopril diese Herzschwäche
in signifikantem Masse verhindern und damit Millionen von älteren
Myokardinfarktopfern zugute kommen kann."
PREAMI ist eine multinationale, doppelblinde, randomisierte, parallele,
multizentrische Studie, in der die Wirkung von Coversyl (8 mg / Tag) bei
älteren Myokardinfarktpatienten mit einer linksventrikulären
Ejektionsfraktion grösser oder gleich 40 % mit der Wirkung des Placebos
verglichen wurde.
An der Studie nahmen 1.252 Patienten mit einem Durchschnittsalter von 73
Jahren teil, die an 109 Zentren in fünf europäischen Ländern untersucht
wurden(2). Myokardinfarktpatienten erhielten die empfohlene normale Therapie
(Antithrombotika, Betablocker, ACE-Hemmer). 1,252 Patienten mit erhaltener
linksventrikulärer Funktion wurden 11+/-4 Tage nach dem Myokardinfarkt
randomisiert und erhielten im ersten Behandlungsmonat entweder 4 mg / Tag
Perindopril oder ein Placebo, gefolgt von 8 mg / Tag Perindopril oder ein
Placebo für die restlichen 11 Monate des Studienzeitraums. Die Behandlung im
Rahmen der Studie erfolgte zusätzlich zur empfohlenen konventionellen
Therapie.
Äusserst signifikante relative Ergebnisse
Die Behandlung mit Coversyl wurde mit einer äusserst signifikanten
relativen Risikoreduktion (RRR) des kombinierten primären Endpunktes (Tod,
Krankenhausaufenthalten aufgrund von Herzinsuffizienz und kardiales
Remodelling) von 38 % (p<0,001) in Verbindung gebracht. Diese erhebliche
Gesamtreduktion des kombinierten Endpunktes der Studie wurde der äusserst
signifikanten Wirkung von Perindopril auf das kardiale Remodelling
zugemessen. Die Ergebnisse zeigten signifikant weniger linksventrikuläres
Remodelling bei der Perindopril-Gruppe im Vergleich zur Placebo-Gruppe (28 %
im Vergleich zu 51 %, p<0,001).
Perindopril wurde trotz des fortgeschrittenen Alters der PREAMI-Patienten
bei einer Dosis von 8 mg pro Tag gut toleriert. Zusätzlich wurde keine
Interaktion mit den begleitenden Behandlungen beobachtet.
Coversyl
Coversyl wurde von Servier erforscht und entwickelt und ist weltweit bei
einer Dosis zwischen 4 und 8 mg zur Behandlung von Bluthochdruck und
Herzinsuffizienz zugelassen. In der Europäischen Union hat die EMEA die
Genehmigung zur Verwendung von Coversyl für eine neue Indikation bei stabiler
Koronararterienerkrankung erteilt, um das Risiko von kardialen Ereignissen
bei Patienten mit Myokardinfarkt und/oder Revaskularisation in der
Vorgeschichte zu reduzieren. In den USA hat die FDA gerade eine
Zulassungserweiterung für Perindopril für eine ähnliche Indikation genehmigt.
Perindopril wird in 118 Ländern unter den Handelsnamen COVERSYL(R),
COVEREX(R), ACERTIL(R), PRESTARIUM(R), PREXANIL(R), PREXUM(R), COVERENE(R),
COVERSUM(R), PROCAPTAN(R) sowie von Solvay Pharmaceutical und CV Therapeutics
in den USA unter dem Handelsnamen ACEON(R) vermarktet
Quellenhinweise:
(1) R Ferrari. PREAMI: Perindopril und Remodelling bei älteren Patienten
nach akutem Myokardinfarkt, ESC Hotline Session 2005
(2) Die fünf an der PREAMI-Studie beteiligten Länder sind Griechenland,
Ungarn, Italien, Rumänien und Spanien.
STOCKHOLM, Schweden, September 4 /PRNewswire/ -- Ergebnisse der PREAMI-Studie (Perindopril Remodelling in Elderly with
Acute Myocardial Infarction [Perindopril-Remodelling bei älteren Patienten
nach akutem Myokardinfarkt]), die heute auf dem Kongress der European Society
of Cardiology (ESC) veröffentlicht wurden, zeigen, dass der ACE-Hemmer
Coversyl(R) (Perindopril) das Risiko von Tod, Krankenhausaufenthalten
aufgrund von Herzinsuffizienz und kardialem Remodelling für ältere
Herzinfarktpatienten mit erhaltener linksventrikulärer Funktion signifikant
reduziert.(1)
PREAMI ist eine bahnbrechende Studie, bei der ein ACE-Hemmer zum ersten
Mal in dieser älteren Patientenpopulation mit erhaltener linksventrikulärer
Funktion, die in der klinischen Praxis weit verbreitet ist, untersucht wurde.
Die vorteilhafte Wirkung von Perindopril beruht auf einer äusserst
signifikanten Reduzierung (46 %, p<0,001) des kardialen Remodelling im
Vergleich zum Placebo. Akuter Myokardinfarkt (Herzinfarkt, MI) führt zu
fortschreitenden Veränderungen der Herzkammergrösse, -form und -funktion.
Dieser Prozess wird als Remodelling bezeichnet und ist ein asymptomatischer
Hinweis auf zur Herzinsuffizienz führende Herzschwäche. Vorhergehende Studien
demonstrierten die vorteilhafte Wirkung von ACE-Hemmern, jedoch bei jüngeren
Patienten mit eingeschränkter linksventrikulärer Funktion.
"Die Ergebnisse der PREAMI-Studie schliessen eine Lücke in unserem Wissen
über die Wirkung von ACE-Hemmern bei Myokardinfarktpatienten", sagte
Professor R Ferrari vom S Anna Krankenhaus an der Universität Ferrara in
Italien und Forschungsleiter der PREAMI-Studie. "PREAMI hat demonstriert,
dass selbst bei Patienten, die einen Herzinfarkt überlebt haben und die mehr
als 10 Tage nach der akuten Phase eine normale linksventrikuläre Funktion
aufweisen, ein fortschreitendes kardiales Remodelling asymptomatisch
auftritt. Die gute Nachricht ist jedoch, dass Perindopril diese Herzschwäche
in signifikantem Masse verhindern und damit Millionen von älteren
Myokardinfarktopfern zugute kommen kann."
PREAMI ist eine multinationale, doppelblinde, randomisierte, parallele,
multizentrische Studie, in der die Wirkung von Coversyl (8 mg / Tag) bei
älteren Myokardinfarktpatienten mit einer linksventrikulären
Ejektionsfraktion grösser oder gleich 40 % mit der Wirkung des Placebos
verglichen wurde.
An der Studie nahmen 1.252 Patienten mit einem Durchschnittsalter von 73
Jahren teil, die an 109 Zentren in fünf europäischen Ländern untersucht
wurden(2). Myokardinfarktpatienten erhielten die empfohlene normale Therapie
(Antithrombotika, Betablocker, ACE-Hemmer). 1,252 Patienten mit erhaltener
linksventrikulärer Funktion wurden 11+/-4 Tage nach dem Myokardinfarkt
randomisiert und erhielten im ersten Behandlungsmonat entweder 4 mg / Tag
Perindopril oder ein Placebo, gefolgt von 8 mg / Tag Perindopril oder ein
Placebo für die restlichen 11 Monate des Studienzeitraums. Die Behandlung im
Rahmen der Studie erfolgte zusätzlich zur empfohlenen konventionellen
Therapie.
Äusserst signifikante relative Ergebnisse
Die Behandlung mit Coversyl wurde mit einer äusserst signifikanten
relativen Risikoreduktion (RRR) des kombinierten primären Endpunktes (Tod,
Krankenhausaufenthalten aufgrund von Herzinsuffizienz und kardiales
Remodelling) von 38 % (p<0,001) in Verbindung gebracht. Diese erhebliche
Gesamtreduktion des kombinierten Endpunktes der Studie wurde der äusserst
signifikanten Wirkung von Perindopril auf das kardiale Remodelling
zugemessen. Die Ergebnisse zeigten signifikant weniger linksventrikuläres
Remodelling bei der Perindopril-Gruppe im Vergleich zur Placebo-Gruppe (28 %
im Vergleich zu 51 %, p<0,001).
Perindopril wurde trotz des fortgeschrittenen Alters der PREAMI-Patienten
bei einer Dosis von 8 mg pro Tag gut toleriert. Zusätzlich wurde keine
Interaktion mit den begleitenden Behandlungen beobachtet.
Coversyl
Coversyl wurde von Servier erforscht und entwickelt und ist weltweit bei
einer Dosis zwischen 4 und 8 mg zur Behandlung von Bluthochdruck und
Herzinsuffizienz zugelassen. In der Europäischen Union hat die EMEA die
Genehmigung zur Verwendung von Coversyl für eine neue Indikation bei stabiler
Koronararterienerkrankung erteilt, um das Risiko von kardialen Ereignissen
bei Patienten mit Myokardinfarkt und/oder Revaskularisation in der
Vorgeschichte zu reduzieren. In den USA hat die FDA gerade eine
Zulassungserweiterung für Perindopril für eine ähnliche Indikation genehmigt.
Perindopril wird in 118 Ländern unter den Handelsnamen COVERSYL(R),
COVEREX(R), ACERTIL(R), PRESTARIUM(R), PREXANIL(R), PREXUM(R), COVERENE(R),
COVERSUM(R), PROCAPTAN(R) sowie von Solvay Pharmaceutical und CV Therapeutics
in den USA unter dem Handelsnamen ACEON(R) vermarktet
Quellenhinweise:
(1) R Ferrari. PREAMI: Perindopril und Remodelling bei älteren Patienten
nach akutem Myokardinfarkt, ESC Hotline Session 2005
(2) Die fünf an der PREAMI-Studie beteiligten Länder sind Griechenland,
Ungarn, Italien, Rumänien und Spanien.
auch heute gibts wieder News aus Schweden:
Zwei neue Fortschritte in der Behandlung von Patienten mit koronarer Herzkrankheit
STOCKHOLM, Schweden, September 6 /PRNewswire/ --
- EMEA gibt grünes Licht´ für die Indikation von Coversyl(R)
(Perindopril) bei stabiler CAD und die Genehmigung zur Vermarktung von
Procoralan(R) (Ivabradin), dem ersten ausschliesslich die Herzfrequenz
senkenden Mittel
Servier gab heute vor der European Society of Cardiology (ESC) zwei grosse
Fortschritte bekannt, die möglicherweise Millionen von Patienten mit
koronarer Herzkrankheit (CAD) helfen.
Der ACE-Hemmer Coversyl(R) (Perindopril) erhielt eine positive
Beurteilung von der EMEA (European Medical Evaluation Agency) mit der
Empfehlung zur Verlängerung der Lizenzindikation für die Behandlung von
Patienten mit stabiler koronarer Herzkrankheit (CAD) zur Reduzierung der
Gefahr sog. Cardiac Events bei Patienten mit der Vorgeschichte eines
Myokardinfarkts und / oder einer Revaskularisation. Die FDA hat nunmehr auch
für eine ähnliche Indikation in den USA eine Erweiterung der Etikettierung
für Perindopril genehmigt(i). Diese neue Indikation gilt zusätzlich zu der
bekannten Position von Coversyl als wirksames Antihypertensivum.
Das Gefässmedikament Procoralan(R) (Ivabradin) von Servier, das erste die
Herzfrequenz senkende Medikament, erhielt ebenfalls eine positive Beurteilung
durch die EMEA für die Behandlung von chronisch stabiler Angina pectoris bei
Patienten mit normalem Sinusrhythmus, die eine Unverträglichkeit gegenüber
Betablockern zeigen bzw. bei denen Betablocker kontraindiziert sind.
Procoralan ist der erste selektive und exklusive IF-Hemmer und bietet einen
wichtigen neuen Ansatz für die Behandlung von Angina pectoris. Anders als
Betablocker als der häufigsten Behandlungsform bei Angina pectoris senkt
Procoralan nur die Herzfrequenz und ist daher mit weniger unerwünschten
Nebenwirkungen verbunden.
Coversyl, neue Indikation
Die EMEA gab grünes Licht´ zur Genehmigung der neuen Indikation für
Coversyl auf der Grundlage der Ergebnisse von EUROPA (The European Trial for
Reduction of Cardiac Events with Perindopril in Stable Coronary Artery
Disease), eine wegweisende Versuchsreihe an 12.218 Patienten mit stabiler CAD
und ohne Herzinsuffizienz; diese zeigte, dass Coversyl das Risiko der
kardiovaskulären Sterblichkeit und des nicht tödlichen Myokardinfarkts im
Vergleich zu einem Placebo (p=0.0003) (1) um 20% reduziert. In der
EUROPA-Studie erhielt der Patient 8 mg Coversyl zusätzlich zur
standardmässigen Präventivtherapie.
Neue EUROPA-Daten
Weitere Merkmale der kardiovaskulären Schutzeigenschaften von Coversyl
wurden durch die neuen auf der diesjährigen ESC-Konferenz vorgestellten Daten
von EUROPA bestätigt. In einer Untergruppe von EUROPA-Patienten (n=7.096),
die eine exakt gemessene Ejektionsfraktion des linken Ventrikels (mittlere
LVEF=57%) aufwiesen, senkte Coversyl das Risiko der kardiovaskulären
Sterblichkeit, des nicht tödlichen Myokardinfarkts und des Herzstillstands um
16% (p< 0,03). Eine weitere Analyse zeigt, dass die günstige Wirkung von
Coversyl 8 mg unabhängig von der Höhe des kardiovaskulären Risikos, vom
Basalblutdruck, von begleitenden Behandlungen (Betablocker, Lipidsenker) oder
der Vorgeschichte einer Revaskularisation war und damit die Genauigkeit der
EUROPA-Ergebnisse im Vergleich zu HOPE, ACTION und PEACE stärkt. (2-4)
" Die Ergebnisse aus der EUROPA-Studie haben extrem wichtige klinische
Implikationen und die neue Indikation für Coversyl bei CAD hilft Ärzten, die
Prognose für CAD-Patienten sogar bei relativ geringem Risiko über die mit
bestehender Standardtherapie hinaus erreichbare Prognose zu verbessern" ,
betonte Prof. Dr. K Fox vom Royal Brompton Hospital, London, VK und
Vorsitzender der EUROPA-Studie. " Die Therapie mit Perindopril sollte
zusätzlich zu anderen präventiven Behandlungen in Betracht gezogen werden,
sogar dann, wenn weder eine Herzinsuffizienz, eine merkliche Reduktion in der
Funktion des linken Ventrikels oder Risikofaktoren für all diese
CAD-Patienten vorliegen."
Procoralan: das erste Medikament einer neuen Klasse
Eine Senkung der Herzfrequenz ist seit vielen Jahren ein therapeutisches
Ziel bei der Behandlung von Angina pectoris. Bestehende Behandlungen senken
jedoch nicht ausschliesslich die Herzfrequenz und ihre Anwendung ist oft mit
unerwünschten pharmakologischen Wirkungen und schlechter Verträglichkeit
verbunden. Im Gegensatz dazu senkt Procoralan durch eine spezielle Wirkung
auf den Sinusknoten ausschliesslich die Herzfrequenz. (5) Das Medikament hat
keinen Einfluss auf die Kontraktilität des Herzens, die atrioventrikuläre
Konduktion und ventrikuläre Repolarisation.
Das Medikament wurde an über 5.000 Patienten getestet und die klinischen
Ergebnisse zeigen, dass Procoralan sowohl eine anti-anginöse als auch eine
anti-ischämische Wirksamkeit besitzt. Eine vergleichbare Wirksamkeit wurde in
zwei grossen randomisierten, kontrollierten Doppelblind-Studien gegenüber
Betablockern und Kalziumantagonisten festgestellt. (6) Procoralan wies ein
ausgezeichnetes Verträglichkeitsprofil bei sehr niedriger Abbruchrate (1%)
auf. (7,8)
" Die Senkung der Herzfrequenz ist als wichtiger Ansatz zur Prävention und
Behandlung von Angina pectoris weithin anerkannt und die reine Senkung der
Herzfrequenz mit Ivabradin bietet eine viel versprechende neue Alternative zu
bestehenden Behandlungsformen" , sagt Professor Fox. " Dieses neuartige Mittel
ist wirksam, sehr gut verträglich und stellt einen der wichtigsten
Fortschritte in der Behandlung kardiovaskulärer Erkrankungen in den letzten
20 Jahren dar."
Servier und die Medikamente gegen Herz-Kreislauf-Erkrankungen
Servier engagiert sich seit vielen Jahren auf dem Gebiet der
Herz-Kreislauf-Erkrankungen und ist unter den weltweit tätigen
pharmazeutischen Firmen insofern einzigartig, dass alle bisher von Servier
auf den Markt gebrachten kardiovaskulären Produkte aus eigener Forschung
stammen.
Coversyl ist das führende Produkt der Firma und in 118 Ländern weltweit
erhältlich. Perindopril wird in 118 Ländern unter den Handelsnamen
COVERSYL(R), COVEREX(R), ACERTIL(R), PRESTARIUM(R), PREXANIL(R), PREXUM(R),
COVERENE(R), COVERSUM(R), PROCAPTAN(R) vermarktet und in den USA von Solvay
Pharmaceutical und CV Therapeutics unter dem Handelsnamen ACEON(R)
vertrieben.
Procoralan hat von der EMEA grünes Licht´ bekommen und sollte vor Ende
des Jahres 2005 die Genehmigung erhalten. Das klinische Entwicklungsprogramm
für Procoralan dauert an und das Medikament wird auf die Risikoprävention bei
CAD und anderen Indikationen untersucht.
Das kardiovaskuläre Profil von Servier umfasst weitere Medikamente wie
Vastarel MR(R) (Trimetazidin) bei stabiler Angina pectoris sowie Hyperium(R)
(Rilmenidin), Natrilix(R) (Indapamid) und Preterax(R) (Perindopril/Indapamid)
bei Hypertonie.
Hinweis für Redakteure:
(i) Genehmigung zur Vermarktung von Coversyl, neue Indikation, und
Procoralan durch die EMEA am 31.7.05 erteilt. Genehmigung für die neue
Indikation durch die US-amerikanische FDA am 23.8.05 erteilt.
Quellenangaben
1) Fox KM; European trial on reduction of cardiac events with perindopril
in stable coronary artery disease investigators. Efficacy of perindopril in
reduction of cardiovascular events among patients with stable coronary artery
diseased: randomized, double-blind, placebo-controlled, multicentre trial
(the EUROPA study). Lancet 2003; 362:782-8
2) Bertrand ME et al. Effects of Perindopril on long-term outcome of
patients with coronary artery disease and preserved left ventricular function
- the EUROPA study. Poster. ESC 2005
3) Deckers JW et al. Treatment benefit by perindopril in patients with
stable coronary artery disease at different levels of risk. Abstract in no.
3663, ESC 2005
4) Ceconi C et al. Effect of perindopril in patients with stable coronary
disease: results on inflammatory and thrombosis markers of the pertinent
study. Abstract in no. 3665, ESC 2005
5) Bucchi A, Baruscotti M, DiFrancesco D. Current-dependent block of
rabbit sino-atrial node If channels by ivabradine. J Gen Physiol 2002;
120:1-13
6) Tardif JC, Ford I, Tendera M et al. Eur Heart J 2003 (Abstract)
7) DiFrancesco D and Camm J. Drugs 2004; 64 (16): 1757-65
8) Borer JS. Nature Clinical Practice. Cardiovascular Medicine. Vol. 1#2,
2004.
Servier
Zwei neue Fortschritte in der Behandlung von Patienten mit koronarer Herzkrankheit
STOCKHOLM, Schweden, September 6 /PRNewswire/ --
- EMEA gibt grünes Licht´ für die Indikation von Coversyl(R)
(Perindopril) bei stabiler CAD und die Genehmigung zur Vermarktung von
Procoralan(R) (Ivabradin), dem ersten ausschliesslich die Herzfrequenz
senkenden Mittel
Servier gab heute vor der European Society of Cardiology (ESC) zwei grosse
Fortschritte bekannt, die möglicherweise Millionen von Patienten mit
koronarer Herzkrankheit (CAD) helfen.
Der ACE-Hemmer Coversyl(R) (Perindopril) erhielt eine positive
Beurteilung von der EMEA (European Medical Evaluation Agency) mit der
Empfehlung zur Verlängerung der Lizenzindikation für die Behandlung von
Patienten mit stabiler koronarer Herzkrankheit (CAD) zur Reduzierung der
Gefahr sog. Cardiac Events bei Patienten mit der Vorgeschichte eines
Myokardinfarkts und / oder einer Revaskularisation. Die FDA hat nunmehr auch
für eine ähnliche Indikation in den USA eine Erweiterung der Etikettierung
für Perindopril genehmigt(i). Diese neue Indikation gilt zusätzlich zu der
bekannten Position von Coversyl als wirksames Antihypertensivum.
Das Gefässmedikament Procoralan(R) (Ivabradin) von Servier, das erste die
Herzfrequenz senkende Medikament, erhielt ebenfalls eine positive Beurteilung
durch die EMEA für die Behandlung von chronisch stabiler Angina pectoris bei
Patienten mit normalem Sinusrhythmus, die eine Unverträglichkeit gegenüber
Betablockern zeigen bzw. bei denen Betablocker kontraindiziert sind.
Procoralan ist der erste selektive und exklusive IF-Hemmer und bietet einen
wichtigen neuen Ansatz für die Behandlung von Angina pectoris. Anders als
Betablocker als der häufigsten Behandlungsform bei Angina pectoris senkt
Procoralan nur die Herzfrequenz und ist daher mit weniger unerwünschten
Nebenwirkungen verbunden.
Coversyl, neue Indikation
Die EMEA gab grünes Licht´ zur Genehmigung der neuen Indikation für
Coversyl auf der Grundlage der Ergebnisse von EUROPA (The European Trial for
Reduction of Cardiac Events with Perindopril in Stable Coronary Artery
Disease), eine wegweisende Versuchsreihe an 12.218 Patienten mit stabiler CAD
und ohne Herzinsuffizienz; diese zeigte, dass Coversyl das Risiko der
kardiovaskulären Sterblichkeit und des nicht tödlichen Myokardinfarkts im
Vergleich zu einem Placebo (p=0.0003) (1) um 20% reduziert. In der
EUROPA-Studie erhielt der Patient 8 mg Coversyl zusätzlich zur
standardmässigen Präventivtherapie.
Neue EUROPA-Daten
Weitere Merkmale der kardiovaskulären Schutzeigenschaften von Coversyl
wurden durch die neuen auf der diesjährigen ESC-Konferenz vorgestellten Daten
von EUROPA bestätigt. In einer Untergruppe von EUROPA-Patienten (n=7.096),
die eine exakt gemessene Ejektionsfraktion des linken Ventrikels (mittlere
LVEF=57%) aufwiesen, senkte Coversyl das Risiko der kardiovaskulären
Sterblichkeit, des nicht tödlichen Myokardinfarkts und des Herzstillstands um
16% (p< 0,03). Eine weitere Analyse zeigt, dass die günstige Wirkung von
Coversyl 8 mg unabhängig von der Höhe des kardiovaskulären Risikos, vom
Basalblutdruck, von begleitenden Behandlungen (Betablocker, Lipidsenker) oder
der Vorgeschichte einer Revaskularisation war und damit die Genauigkeit der
EUROPA-Ergebnisse im Vergleich zu HOPE, ACTION und PEACE stärkt. (2-4)
" Die Ergebnisse aus der EUROPA-Studie haben extrem wichtige klinische
Implikationen und die neue Indikation für Coversyl bei CAD hilft Ärzten, die
Prognose für CAD-Patienten sogar bei relativ geringem Risiko über die mit
bestehender Standardtherapie hinaus erreichbare Prognose zu verbessern" ,
betonte Prof. Dr. K Fox vom Royal Brompton Hospital, London, VK und
Vorsitzender der EUROPA-Studie. " Die Therapie mit Perindopril sollte
zusätzlich zu anderen präventiven Behandlungen in Betracht gezogen werden,
sogar dann, wenn weder eine Herzinsuffizienz, eine merkliche Reduktion in der
Funktion des linken Ventrikels oder Risikofaktoren für all diese
CAD-Patienten vorliegen."
Procoralan: das erste Medikament einer neuen Klasse
Eine Senkung der Herzfrequenz ist seit vielen Jahren ein therapeutisches
Ziel bei der Behandlung von Angina pectoris. Bestehende Behandlungen senken
jedoch nicht ausschliesslich die Herzfrequenz und ihre Anwendung ist oft mit
unerwünschten pharmakologischen Wirkungen und schlechter Verträglichkeit
verbunden. Im Gegensatz dazu senkt Procoralan durch eine spezielle Wirkung
auf den Sinusknoten ausschliesslich die Herzfrequenz. (5) Das Medikament hat
keinen Einfluss auf die Kontraktilität des Herzens, die atrioventrikuläre
Konduktion und ventrikuläre Repolarisation.
Das Medikament wurde an über 5.000 Patienten getestet und die klinischen
Ergebnisse zeigen, dass Procoralan sowohl eine anti-anginöse als auch eine
anti-ischämische Wirksamkeit besitzt. Eine vergleichbare Wirksamkeit wurde in
zwei grossen randomisierten, kontrollierten Doppelblind-Studien gegenüber
Betablockern und Kalziumantagonisten festgestellt. (6) Procoralan wies ein
ausgezeichnetes Verträglichkeitsprofil bei sehr niedriger Abbruchrate (1%)
auf. (7,8)
" Die Senkung der Herzfrequenz ist als wichtiger Ansatz zur Prävention und
Behandlung von Angina pectoris weithin anerkannt und die reine Senkung der
Herzfrequenz mit Ivabradin bietet eine viel versprechende neue Alternative zu
bestehenden Behandlungsformen" , sagt Professor Fox. " Dieses neuartige Mittel
ist wirksam, sehr gut verträglich und stellt einen der wichtigsten
Fortschritte in der Behandlung kardiovaskulärer Erkrankungen in den letzten
20 Jahren dar."
Servier und die Medikamente gegen Herz-Kreislauf-Erkrankungen
Servier engagiert sich seit vielen Jahren auf dem Gebiet der
Herz-Kreislauf-Erkrankungen und ist unter den weltweit tätigen
pharmazeutischen Firmen insofern einzigartig, dass alle bisher von Servier
auf den Markt gebrachten kardiovaskulären Produkte aus eigener Forschung
stammen.
Coversyl ist das führende Produkt der Firma und in 118 Ländern weltweit
erhältlich. Perindopril wird in 118 Ländern unter den Handelsnamen
COVERSYL(R), COVEREX(R), ACERTIL(R), PRESTARIUM(R), PREXANIL(R), PREXUM(R),
COVERENE(R), COVERSUM(R), PROCAPTAN(R) vermarktet und in den USA von Solvay
Pharmaceutical und CV Therapeutics unter dem Handelsnamen ACEON(R)
vertrieben.
Procoralan hat von der EMEA grünes Licht´ bekommen und sollte vor Ende
des Jahres 2005 die Genehmigung erhalten. Das klinische Entwicklungsprogramm
für Procoralan dauert an und das Medikament wird auf die Risikoprävention bei
CAD und anderen Indikationen untersucht.
Das kardiovaskuläre Profil von Servier umfasst weitere Medikamente wie
Vastarel MR(R) (Trimetazidin) bei stabiler Angina pectoris sowie Hyperium(R)
(Rilmenidin), Natrilix(R) (Indapamid) und Preterax(R) (Perindopril/Indapamid)
bei Hypertonie.
Hinweis für Redakteure:
(i) Genehmigung zur Vermarktung von Coversyl, neue Indikation, und
Procoralan durch die EMEA am 31.7.05 erteilt. Genehmigung für die neue
Indikation durch die US-amerikanische FDA am 23.8.05 erteilt.
Quellenangaben
1) Fox KM; European trial on reduction of cardiac events with perindopril
in stable coronary artery disease investigators. Efficacy of perindopril in
reduction of cardiovascular events among patients with stable coronary artery
diseased: randomized, double-blind, placebo-controlled, multicentre trial
(the EUROPA study). Lancet 2003; 362:782-8
2) Bertrand ME et al. Effects of Perindopril on long-term outcome of
patients with coronary artery disease and preserved left ventricular function
- the EUROPA study. Poster. ESC 2005
3) Deckers JW et al. Treatment benefit by perindopril in patients with
stable coronary artery disease at different levels of risk. Abstract in no.
3663, ESC 2005
4) Ceconi C et al. Effect of perindopril in patients with stable coronary
disease: results on inflammatory and thrombosis markers of the pertinent
study. Abstract in no. 3665, ESC 2005
5) Bucchi A, Baruscotti M, DiFrancesco D. Current-dependent block of
rabbit sino-atrial node If channels by ivabradine. J Gen Physiol 2002;
120:1-13
6) Tardif JC, Ford I, Tendera M et al. Eur Heart J 2003 (Abstract)
7) DiFrancesco D and Camm J. Drugs 2004; 64 (16): 1757-65
8) Borer JS. Nature Clinical Practice. Cardiovascular Medicine. Vol. 1#2,
2004.
Servier
Wie geht`s mit CV Therapeutics weiter?
Meinungen????????????
Meinungen????????????
Mir sind in den letzten Wochen diverse Artikel über Aceon in Nicht-Börsenblättern aufgefallen, zb BBC.
Da wird aktuell ziemlich stark die Werbetrommel geschlagen, ohne dass CVTX oder Sanofi dafür bezahlen müssen.
Da wird aktuell ziemlich stark die Werbetrommel geschlagen, ohne dass CVTX oder Sanofi dafür bezahlen müssen.
für regadenoson sieht es ganz gut aus.
gestern wurden gute ph 3 ergebnisse veröffentlicht.
http://biz.yahoo.com/prnews/051002/nysu002.html?.v=22
gestern wurden gute ph 3 ergebnisse veröffentlicht.
http://biz.yahoo.com/prnews/051002/nysu002.html?.v=22
Diese Daten sind eigentlich alt, siehe
http://biz.yahoo.com/prnews/050810/sfw078.html?.v=19
Leider werden auch keine weiteren substanziellen Studiendetails veröffentlicht außer
Regadenoson was generally well tolerated. In this study, the most common adverse events reported in patients who received regadenoson were headache, chest pain, shortness of breath, flushing and gastrointestinal discomfort.
Wenn es dabei bleiben würde, wäre es ja schön.
Wenn ich alleridngs "primäres Studienziel erreicht" höre, dann vermute ich immer, die sekundären targets dann ja wohl nicht. Andersherum wäre aber zugegeben schlimmer...
Ich finde leider nicht auf die schnelle die orginale Studienbeschreibung.
Mich interessiert aktuell eher ACEON. Da wurde in den letzten Wochen so gewaltig die Werbetrommel gerührt, dass dies kaum so völlig ohne Einwirkungen auf den Umsatz bleiben dürfte. Immerhin bekam Aceon einen prima Platz in der Lancet, und die Gesamtmortalität im Vergleich zur Vergelcihsgruppe um 11 % zu senken ist schon ein superdickes Pfund. Den Artikel werde ich mir noch unbedingt zu Gemüte führen.
Allerdings weiß ich nicht, wie hoch die baseline ist, denn im letzten Quartalsbericht steht:
The Company did not record any co-promotion revenues as sales of ACEON(R) did not exceed the baseline specified in the co-promotion agreement.
http://biz.yahoo.com/prnews/050810/sfw078.html?.v=19
Leider werden auch keine weiteren substanziellen Studiendetails veröffentlicht außer
Regadenoson was generally well tolerated. In this study, the most common adverse events reported in patients who received regadenoson were headache, chest pain, shortness of breath, flushing and gastrointestinal discomfort.
Wenn es dabei bleiben würde, wäre es ja schön.
Wenn ich alleridngs "primäres Studienziel erreicht" höre, dann vermute ich immer, die sekundären targets dann ja wohl nicht. Andersherum wäre aber zugegeben schlimmer...
Ich finde leider nicht auf die schnelle die orginale Studienbeschreibung.
Mich interessiert aktuell eher ACEON. Da wurde in den letzten Wochen so gewaltig die Werbetrommel gerührt, dass dies kaum so völlig ohne Einwirkungen auf den Umsatz bleiben dürfte. Immerhin bekam Aceon einen prima Platz in der Lancet, und die Gesamtmortalität im Vergleich zur Vergelcihsgruppe um 11 % zu senken ist schon ein superdickes Pfund. Den Artikel werde ich mir noch unbedingt zu Gemüte führen.
Allerdings weiß ich nicht, wie hoch die baseline ist, denn im letzten Quartalsbericht steht:
The Company did not record any co-promotion revenues as sales of ACEON(R) did not exceed the baseline specified in the co-promotion agreement.
da hast du allerdings recht... ich war zunächst fälschlicherweise davon ausgegangen, es handele sich um die ergebnisse der zweiten studie gleichen designs.
so ist es tatsächlich nur nochmal aufgewärmt, weil`s halt jetzt auf dem kongress präsentiert wurde...
zumindest dem kurs hat`s gut getan...
so ist es tatsächlich nur nochmal aufgewärmt, weil`s halt jetzt auf dem kongress präsentiert wurde...
zumindest dem kurs hat`s gut getan...
Was ist los mit CV Therapeutics? Wie weiter gehts noch runter? Meinungen???????????????
Gestern wurden diverse Biotech Mid-Caps geschlachtet, speziell die, die in meinem Depot sind. BTK -2 %.
Die Vola ist aktuell beängstigend. Einmal 7 % runter dann den nächsten Tag 5 % rauf.
Und das ist nun wirklich nicht die einzige Aktie von diesem Typ.
Als hätten Hedge Fonds darauf gewartet, mal einen Richtungswechsel zu initieren, und andere Hedgefonds wollen das kontakarieren.
Und das ist nun wirklich nicht die einzige Aktie von diesem Typ.
Als hätten Hedge Fonds darauf gewartet, mal einen Richtungswechsel zu initieren, und andere Hedgefonds wollen das kontakarieren.
vielleicht geben ja die zahlen heut after market aufschluß über die ACEON-baseline... im co-promotion agreement wurde auch darüber geschwiegen. wäre zumindest schön, wenn da schonmal ein paar royalties für die co-promotion anfallen würden.
naja, allzu viel darf man wohl nicht erwarten, immerhin hat CVTX keine upfront-zahlungen geleistet und will sich in erster linie eine sales-force für den ranexa-start verschaffen.
naja, allzu viel darf man wohl nicht erwarten, immerhin hat CVTX keine upfront-zahlungen geleistet und will sich in erster linie eine sales-force für den ranexa-start verschaffen.
EMEA hat zusätzliches datenmaterial für eine evtl. zulassung von ranolazine gefordert und damit indirekt den zulassungsantrag abgelehnt.
schön ist das nicht. detailliertere informationen wären interessant, in jedem fall bleibt die hoffnung, daß die fda sich für die us-zulassung (approvable letter, entscheidung bis ende jan) entscheidet.
die geschäftszahlen sind vergleichsweise uninteressant. übrigens weiterhin keine aceon-royalties aufgrund nichtüberschreitung der baseline.
schön ist das nicht. detailliertere informationen wären interessant, in jedem fall bleibt die hoffnung, daß die fda sich für die us-zulassung (approvable letter, entscheidung bis ende jan) entscheidet.
die geschäftszahlen sind vergleichsweise uninteressant. übrigens weiterhin keine aceon-royalties aufgrund nichtüberschreitung der baseline.
Boaah, wie enttäuschend....
Die EMEA-Entscheidung ist ja in der Tat eine totale Zurückweisung, so dass eine Marktzulassung erst 2007/2008 denkbar ist. Das EMEA-Filing war am 30. März 2004, der FDA approvable letter stammt aus dem Oktober 2003.
Sind das jetz die Wehen vom Vioxx-Skandal, oder hat CVTX so geschlampt?
Ich muß mir mal den Conference Call anhören, kann das aber erst morgen abend. Da sind nun jede Menge Fragen offen.
Bei Aceon: Was soll denn jetzt noch passieren? Denn von der Fachpresse war die Unterstützung ja nun stark, und die Marketingaussagen sind wirklich signifkant gestiegen, als dass man sie einfach vernachlässigen kann. Eigentlich hatte CVTX bisher bzgl ACEON ein best-case-Szenario und die verdienen immer noch keinen müden Dollar.
Und so hängt das Schicksal von CVTX enorm von der Entscheidung im Januar ab. Gibt es weitere Verzögerungen, halbiert sich schlicht der Wert. Es erstaunt mich, wie moderat die Nachbörse mit den Infos umgeht.
______________________________________________
CV Drug Fails to Pass Europe Review
Tuesday October 25, 7:08 pm ET
European Regulators Demand Further Trials on CV Therapeutics` Heart Drug; Co. Pulls Application
PALO ALTO, Calif. (AP) -- CV Therapeutics Inc., a developer of drugs to treat heart disease, said Tuesday that European regulators demanded further trials for its experimental drug to treat chronic angina -- a condition in which the heart muscle does not get enough blood -- before they will consider approving the therapy.
Shares of the company shed $2.48, or 9.6 percent, to $23.42 in aftermarket trading, after closing up 27 cents to $25.90 on the Nasdaq.
The European Medicines Agency said the company needs to provide additional clinical data on the drug, called ranolazine, and the company withdrew its application. CV said it plans to resubmit the application once it has conducted additional studies. The European regulatory body does not allow companies to simply add information onto an existing application, CV said.
CV said it plans to conduct one or more additional trials in order to satisfy regulators, but said it does not expect a large or lengthy trial to be necessary.
The company added that it has not determined a target date for resubmitting an application.
U.S. regulators are currently reviewing an application for the drug to treat chronic angina. CV expects to a ruling on this application by Jan. 27.
Die EMEA-Entscheidung ist ja in der Tat eine totale Zurückweisung, so dass eine Marktzulassung erst 2007/2008 denkbar ist. Das EMEA-Filing war am 30. März 2004, der FDA approvable letter stammt aus dem Oktober 2003.
Sind das jetz die Wehen vom Vioxx-Skandal, oder hat CVTX so geschlampt?
Ich muß mir mal den Conference Call anhören, kann das aber erst morgen abend. Da sind nun jede Menge Fragen offen.
Bei Aceon: Was soll denn jetzt noch passieren? Denn von der Fachpresse war die Unterstützung ja nun stark, und die Marketingaussagen sind wirklich signifkant gestiegen, als dass man sie einfach vernachlässigen kann. Eigentlich hatte CVTX bisher bzgl ACEON ein best-case-Szenario und die verdienen immer noch keinen müden Dollar.
Und so hängt das Schicksal von CVTX enorm von der Entscheidung im Januar ab. Gibt es weitere Verzögerungen, halbiert sich schlicht der Wert. Es erstaunt mich, wie moderat die Nachbörse mit den Infos umgeht.
______________________________________________
CV Drug Fails to Pass Europe Review
Tuesday October 25, 7:08 pm ET
European Regulators Demand Further Trials on CV Therapeutics` Heart Drug; Co. Pulls Application
PALO ALTO, Calif. (AP) -- CV Therapeutics Inc., a developer of drugs to treat heart disease, said Tuesday that European regulators demanded further trials for its experimental drug to treat chronic angina -- a condition in which the heart muscle does not get enough blood -- before they will consider approving the therapy.
Shares of the company shed $2.48, or 9.6 percent, to $23.42 in aftermarket trading, after closing up 27 cents to $25.90 on the Nasdaq.
The European Medicines Agency said the company needs to provide additional clinical data on the drug, called ranolazine, and the company withdrew its application. CV said it plans to resubmit the application once it has conducted additional studies. The European regulatory body does not allow companies to simply add information onto an existing application, CV said.
CV said it plans to conduct one or more additional trials in order to satisfy regulators, but said it does not expect a large or lengthy trial to be necessary.
The company added that it has not determined a target date for resubmitting an application.
U.S. regulators are currently reviewing an application for the drug to treat chronic angina. CV expects to a ruling on this application by Jan. 27.
Auf dem Yahoo-Board steht außer dem Europa -Gebashe auch nichts Erhellendes drin. Allenfalls über den Fortschritt der aktuellen MERLIN -Studie für die Ranexa Label-Erweiterung.
Bin raus; nehme an,die Amis werden die heute noch richtig schlachten!
im cc gestern wurde natürlich die bedeutung der emea-ablehnung heruntergespielt... erforderlich seien nur 1 oder 2 kurze pk-studies (pharmacokinetic).
die positive entwicklung der MERLIN-studie hingegen wurde hervorgehoben.
weiterhin wurde mehrfach darauf hingewiesen, daß die salesforce sich auf den ranexa-launch im märz vorbereitet und ACEON eher untergeordnete bedeutung hat...
die positive entwicklung der MERLIN-studie hingegen wurde hervorgehoben.
weiterhin wurde mehrfach darauf hingewiesen, daß die salesforce sich auf den ranexa-launch im märz vorbereitet und ACEON eher untergeordnete bedeutung hat...
Vielen Dank Mr. Arrogance. Ich werde mir den cc trotzdem mal nochmal selber anhören.
Eigentlich platzt mir langsam der Kragen, weil da ist keine Linie in der Unternehmensführung vorhanden ist, und die Kommunikation mit den Investoren ist auch mehr als bescheiden. Die können doch nicht ein fremdes Produkt für nix verkaufen.
Das der Merlin-trial vorwärts geht, dass ist ja irgendwie anzunehmen.
Solche pharmakokinetischen Studien dauern wirklich nicht so lange, aber wenn sich die EMEA wieder 1,5 Jahre Zeit nimmt mit der Entscheidungsfindung....
Andererseits weiß ich auch, dass man mal einen Moment inne halten muß, ob man nicht wieder mal sein eigener Kontraindikator ist.
Bei Amylin/Symlin, ein nicht ganz unähnlicher Fall, war alles noch viel schlimmer, da wurden die Anleger schlicht vom Management mutwillig bzgl. wichtiger Nebenwirkungen getäuscht und gerade nachdem das klar wurde, hat sich die Aktie prima entwickelt (verdoppelt).
Scheinbar erholt sich der Kurs vorbörslich.
Fast alles hängt jetzt vom Januar ab. *Grummel*
Wenn jetzt genügend Hoffnungskäufe kommen sollten, dann stoße ich die Aktie im Vorfeld ab.
Eigentlich platzt mir langsam der Kragen, weil da ist keine Linie in der Unternehmensführung vorhanden ist, und die Kommunikation mit den Investoren ist auch mehr als bescheiden. Die können doch nicht ein fremdes Produkt für nix verkaufen.
Das der Merlin-trial vorwärts geht, dass ist ja irgendwie anzunehmen.
Solche pharmakokinetischen Studien dauern wirklich nicht so lange, aber wenn sich die EMEA wieder 1,5 Jahre Zeit nimmt mit der Entscheidungsfindung....
Andererseits weiß ich auch, dass man mal einen Moment inne halten muß, ob man nicht wieder mal sein eigener Kontraindikator ist.
Bei Amylin/Symlin, ein nicht ganz unähnlicher Fall, war alles noch viel schlimmer, da wurden die Anleger schlicht vom Management mutwillig bzgl. wichtiger Nebenwirkungen getäuscht und gerade nachdem das klar wurde, hat sich die Aktie prima entwickelt (verdoppelt).
Scheinbar erholt sich der Kurs vorbörslich.
Fast alles hängt jetzt vom Januar ab. *Grummel*
Wenn jetzt genügend Hoffnungskäufe kommen sollten, dann stoße ich die Aktie im Vorfeld ab.
würde mich interessieren, was dir noch auffällt, puhvogel.
hab auch nicht alles gehört, nur ne knappe halbe stunde zeit, und einiges ist nicht ganz leicht zu verstehen.
die MERLIN-studie wird jetzt erweitert auf 6500 patienten (von 5500), weil die rekrutierung gut läuft und kaum negative begleiterscheinungen auftreten... so hab ich es verstanden.
hab auch nicht alles gehört, nur ne knappe halbe stunde zeit, und einiges ist nicht ganz leicht zu verstehen.
die MERLIN-studie wird jetzt erweitert auf 6500 patienten (von 5500), weil die rekrutierung gut läuft und kaum negative begleiterscheinungen auftreten... so hab ich es verstanden.
So gestern wollte ich mir endlich die CC anhören da war die schon von der Homepage entfernt worden. Dafür gab es einen Vortrag vor potenziellen Investoren, der gestern gehalten wurde. Da wurde auch viel über die aktuellen Studienverlauf und -planung gesprochen.
Zu Aceon ist noch zu sagen, dass die sales force erst im Oktober "deployed", also ausgeschwärmt, ist, daher kann man noch keine bedeutende Umsatzzahlen für das letzte Quartal erwarten.
Merlin soll in der zweiten Hälfte 2006 fertig sein.
Zu Aceon ist noch zu sagen, dass die sales force erst im Oktober "deployed", also ausgeschwärmt, ist, daher kann man noch keine bedeutende Umsatzzahlen für das letzte Quartal erwarten.
Merlin soll in der zweiten Hälfte 2006 fertig sein.
also heisst es weiter ausharren !!!
PS:
Der Vortrag kam schon sehr professionell und selbstsicher rüber. Man muss aufpassen, dass man sich nicht mitreissen lässt.
Wenn das alles eintritt, wie der CEO sich das so vorstellt, dann wird CVTX eine Multimilliarden-Firma.
Der Vortrag kam schon sehr professionell und selbstsicher rüber. Man muss aufpassen, dass man sich nicht mitreissen lässt.
Wenn das alles eintritt, wie der CEO sich das so vorstellt, dann wird CVTX eine Multimilliarden-Firma.
Obwohl die Analysten die Aktie auf strong buy sehen
kommt der Wert nicht in Schwung ich wollte erst noch ein paar Positionen aufbauen habe es aber dann letztendlich gelassen !!!
kommt der Wert nicht in Schwung ich wollte erst noch ein paar Positionen aufbauen habe es aber dann letztendlich gelassen !!!
oder mache ich es doch noch mal ?
Bei CVTX bin ich irgentwie Feuer und flamme
Bei CVTX bin ich irgentwie Feuer und flamme
Also mit 1,2 Mrd USD ist das kein no-Brainer mehr, speziell wenn die Firma noch keine eigengenerierten Umsätze hat. Für 2,7 Mrd $ bekommt man immerhin eine blitzblanke Cephalon mit 1,1 Mrd USD Umsatz, bei der irgendwo aber ein Wurm drin stecken muss.
Die Euphorie der Analysten spricht in der Tat auch gegen die Aktie, ohne Frage.
Ich spekuliere kurzfristig auf Neugierkäufe im Vorfeld der FDA-Entscheidung. Sollte das aufgehen, werde ich die bisherigen Gewinne steuerfrei mitnehmen, solange es noch geht.
Aber : Herz-Kreislauf-Medikamente sind oft große Umsatzgeneratoren, entsprechende Firmen mit neuen Produkten sind beliebte Übernahmekandidaten von Pharmafirmen , so dass die Aktie durchaus noch Potenzial hat. Ich habe als Vergleichsfirma Scios im Kopf, die mit dem für mich wenig aufregenden Natrecor heutzutage 400 Millionen USD umsetzen und die von J&J für satte 2,4 Mrd $ gekauft wurden.
Wie ich heute lesen durfte, investieren die Pharmas ja lieber in die sales force als in anderen unwichtigeren Sparten.
Ob Dir die Story genügt ...musst Du selber wissen!
Die Euphorie der Analysten spricht in der Tat auch gegen die Aktie, ohne Frage.
Ich spekuliere kurzfristig auf Neugierkäufe im Vorfeld der FDA-Entscheidung. Sollte das aufgehen, werde ich die bisherigen Gewinne steuerfrei mitnehmen, solange es noch geht.
Aber : Herz-Kreislauf-Medikamente sind oft große Umsatzgeneratoren, entsprechende Firmen mit neuen Produkten sind beliebte Übernahmekandidaten von Pharmafirmen , so dass die Aktie durchaus noch Potenzial hat. Ich habe als Vergleichsfirma Scios im Kopf, die mit dem für mich wenig aufregenden Natrecor heutzutage 400 Millionen USD umsetzen und die von J&J für satte 2,4 Mrd $ gekauft wurden.
Wie ich heute lesen durfte, investieren die Pharmas ja lieber in die sales force als in anderen unwichtigeren Sparten.
Ob Dir die Story genügt ...musst Du selber wissen!
so ist es... sehe ich bis ins detail genauso!
im augenblick tendiere ich auch dazu, vor der ranexa-entscheidung zu verkaufen. vielleicht kauft ja auch einer vorher... aber wer kauft schon die katze im sack für 1,5mrd+x? übernahmephantasie ist zweifellos vorhanden, hinterher wird`s halt ein paar hundert mio teurer.
vom jetzigen niveau aus denke ich, man kann bei einer positiven entscheidung annähernd soviel gewinnen, wie man bei einer negativen entscheidung mindestens verlieren wird...
im augenblick tendiere ich auch dazu, vor der ranexa-entscheidung zu verkaufen. vielleicht kauft ja auch einer vorher... aber wer kauft schon die katze im sack für 1,5mrd+x? übernahmephantasie ist zweifellos vorhanden, hinterher wird`s halt ein paar hundert mio teurer.
vom jetzigen niveau aus denke ich, man kann bei einer positiven entscheidung annähernd soviel gewinnen, wie man bei einer negativen entscheidung mindestens verlieren wird...
Guten Morgen,
wann genau ist die FDA-Entscheidung? Welcher Analyst hat
CVTX auf "strong buy" gesetzt und bei welcher Kursspanne würdet Ihr verkaufen?
Danke im voraus.
wann genau ist die FDA-Entscheidung? Welcher Analyst hat
CVTX auf "strong buy" gesetzt und bei welcher Kursspanne würdet Ihr verkaufen?
Danke im voraus.
Die Analystenbewertungen findest Du zB hier:
http://www.finanznachrichten.de/nachrichten-aktien/cv-therap…
Zum Datum:
"The NDA amendment was submitted as a complete response to an October 2003 approvable letter, and the Prescription Drug User Fee Act date for FDA action on the NDA is January 27, 2006."
Den Verkaufspreis möchte ich nicht so statisch sehen, sondern da fliessen Dynamik und Marktumfeld ein. Aktuell würde ich die ohne Produkt auf dem Markt wohl so bei 1,5-1,8 Mrd USD verkaufen.
Aber wenn aber zB GM Ärger macht, dann muss ich kleinere Brötchen backen.
@Mr. arrogance: Dann wollen wir mal hoffen, dass nicht zu viele so denken, ansonsten verkaufen wir zum Tiefstkurs.
http://www.finanznachrichten.de/nachrichten-aktien/cv-therap…
Zum Datum:
"The NDA amendment was submitted as a complete response to an October 2003 approvable letter, and the Prescription Drug User Fee Act date for FDA action on the NDA is January 27, 2006."
Den Verkaufspreis möchte ich nicht so statisch sehen, sondern da fliessen Dynamik und Marktumfeld ein. Aktuell würde ich die ohne Produkt auf dem Markt wohl so bei 1,5-1,8 Mrd USD verkaufen.
Aber wenn aber zB GM Ärger macht, dann muss ich kleinere Brötchen backen.
@Mr. arrogance: Dann wollen wir mal hoffen, dass nicht zu viele so denken, ansonsten verkaufen wir zum Tiefstkurs.
800 ist im NasBio eine hartnäckige Marke.
Schietkram.
CV Therapeutics May See Strong Ranexa Potential
Piper Jaffray reiterated an "outperform" rating and $33 target price on CV Therapeutics , citing increased confidence in the peak estimate for the drug company`s angina treatment, Ranexa.
The research firm said recent discussions with doctors have increased its confidence in the peak sales estimate of $350 million or more for Ranexa.
In addition, "there could be upside from other applications of Ranexa beyond second-line refractory angina and from [CV`s hypertension treatment] Aceon," Piper analyst Thomas Wei wrote in a recent report.
Piper said cardiologists estimate that 5% to 15% of their patients would be eligible for Ranexa and that the drug would be a valuable add-on therapy in refractory angina as it does not affect blood pressure or heart rate.
The research firm added that "higher penetration of Ranexa in niche populations where current anti-anginals are used cautiously may represent upside to our current estimates."
For fiscal 2006 and 2007, Piper estimates losses per share for CV of $4.64 and $2.12, respectively.
The FDA action date for Ranexa is Jan. 27, and "we continue to expect a launch in the second quarter of 2006," Piper said.
CV Therapeutics May See Strong Ranexa Potential
Piper Jaffray reiterated an "outperform" rating and $33 target price on CV Therapeutics , citing increased confidence in the peak estimate for the drug company`s angina treatment, Ranexa.
The research firm said recent discussions with doctors have increased its confidence in the peak sales estimate of $350 million or more for Ranexa.
In addition, "there could be upside from other applications of Ranexa beyond second-line refractory angina and from [CV`s hypertension treatment] Aceon," Piper analyst Thomas Wei wrote in a recent report.
Piper said cardiologists estimate that 5% to 15% of their patients would be eligible for Ranexa and that the drug would be a valuable add-on therapy in refractory angina as it does not affect blood pressure or heart rate.
The research firm added that "higher penetration of Ranexa in niche populations where current anti-anginals are used cautiously may represent upside to our current estimates."
For fiscal 2006 and 2007, Piper estimates losses per share for CV of $4.64 and $2.12, respectively.
The FDA action date for Ranexa is Jan. 27, and "we continue to expect a launch in the second quarter of 2006," Piper said.
Die (vorerst) Ablehnung in Europa hat den Markt erstaunlich ungerührt gelassen. Ich glaub, man hat bereits ein wenig damit gerechnet, aber IMO noch wichtiger, man traut dem preisregulierten Europamarkt sowieso nicht zu, große Gewinnbeiträge zu liefern.
was ist los mit CVTX. Neuigkeiten?
Langsam aber sicher erreichen wir noch die 20 € Marke wenn da Halt gemacht wird kann es wieder weiter gehen !!!
Aber eigentlich ist es ja ständig so bei dem Wert !!!
Er klettert bis 23 / 24 €uronen und ehe man gucken kann stürtz der Wert wieder ab !!!
Mal sehen wann die MAGIC 24er Marke entlich mal überwunden wird.
Es kann ja auch mal was positives folgen an Nachrichten,
wird echt mal Zeit !!!
Gruß
Aber eigentlich ist es ja ständig so bei dem Wert !!!
Er klettert bis 23 / 24 €uronen und ehe man gucken kann stürtz der Wert wieder ab !!!
Mal sehen wann die MAGIC 24er Marke entlich mal überwunden wird.
Es kann ja auch mal was positives folgen an Nachrichten,
wird echt mal Zeit !!!
Gruß
Was macht CV Therapeutics im Jahr 2006?
Meinungen?
Meinungen?
24. Annual Healthcare Conference 2006
San Francisco
09 - 12.01.2006
Da könnte es was neues zu Ranexa geben ???
Tschüss
Aktientrader62
San Francisco
09 - 12.01.2006
Da könnte es was neues zu Ranexa geben ???
Tschüss
Aktientrader62
Wichtig ist diesen Monat einzig die FDA-Entscheidung.
und die fda-entscheidung rückt immer näher, spätestens in gut 2 wochen heißt es hop oder top.
umso unangenehmer ist die seit wochen deutliche underperformance von CVTX gegenüber dem BTK.
CVTX ist das sorgenkind in meinem depot... einen guten verkaufspreis vor der entscheidung werden wir wohl nicht mehr bekommen...
umso unangenehmer ist die seit wochen deutliche underperformance von CVTX gegenüber dem BTK.
CVTX ist das sorgenkind in meinem depot... einen guten verkaufspreis vor der entscheidung werden wir wohl nicht mehr bekommen...
Richtig, meine Spekulation ist leider nicht aufgegangen, wobei ich eine drastische underperformance nicht sehe. Eine CVTX ist keine AMGN oder DNA. CVTX wird noch als Midcap behandelt, ein Segment dass noch massgeblich durch das erwartete Zinsniveau (wegen des zukünftigen Kapitalbedarfs) beeinflusst wird.
Biotech-Smallcaps haben im letzten Jahr schlecht performt, aufgrund des Zinsanstiegs keineswegs unbegründet.
Midcap letztes Jahr -34 %, Smallcap -15 %, Largecap +23%
Fast alle IPOs sind im Minus.
Man muss sich im Vorfeld positionieren, ob man bei der Entscheidung und beim nicht unerheblichen Risiko der FDA-Entscheidung dabei sein will oder nicht.
Biotech-Smallcaps haben im letzten Jahr schlecht performt, aufgrund des Zinsanstiegs keineswegs unbegründet.
Midcap letztes Jahr -34 %, Smallcap -15 %, Largecap +23%
Fast alle IPOs sind im Minus.
Man muss sich im Vorfeld positionieren, ob man bei der Entscheidung und beim nicht unerheblichen Risiko der FDA-Entscheidung dabei sein will oder nicht.
[posting]19.632.078 von puhvogel am 10.01.06 10:04:09[/posting]die jahresperformance von CVTX ist ganz in ordnung, aber seit etwa mitte november geht die schere auseinander, das ist beunruhigend.
http://finance.yahoo.com/q/bc?t=1y&s=CVTX&l=on&z=m&q=l&c=%5E…
das die small- und midcaps so schlecht performt haben, wundert mich sehr, wenn ich auf meine werte schaue. CELG und GILD zählen natürlich zu den large caps, aber BMRN, ITMN, IDEV, TNOX... alle auf jahreshoch... INKP/SLXP lief ganz ordentlich, auch DSCO kommt in schwung. CVTX selbst liegt auf`s jahr gesehen auch im plus.
http://finance.yahoo.com/q/bc?t=1y&s=CVTX&l=on&z=m&q=l&c=%5E…
das die small- und midcaps so schlecht performt haben, wundert mich sehr, wenn ich auf meine werte schaue. CELG und GILD zählen natürlich zu den large caps, aber BMRN, ITMN, IDEV, TNOX... alle auf jahreshoch... INKP/SLXP lief ganz ordentlich, auch DSCO kommt in schwung. CVTX selbst liegt auf`s jahr gesehen auch im plus.
In welcher Kursspanne bewegt sich CVTX bei einer "positiven" oder "negativen" Entscheidung der FAD?
Meinungen?
Meinungen?
Bei einer Übertreibung nach oben sind 60 bis 70 Dollar vorstellbar........
Geht es daneben sind um die 10 Dollar auch drin.
OSIP - AMLN - KOS Pharma - IMCL haben das schon hinter sich hoch oder runter die Ausschläge waren riesig..........
Aktientrader62
Geht es daneben sind um die 10 Dollar auch drin.
OSIP - AMLN - KOS Pharma - IMCL haben das schon hinter sich hoch oder runter die Ausschläge waren riesig..........
Aktientrader62
Wer sich über die Kursbewegung gestern wunderte:
Es gab eine verklausulierte Verkaufsempfehlung von der Citibank gestern:
. On Jan. 27, Ranexa is widely expected to be approved for refractory angina, a relatively small U.S. market (~$600M).
. Our physician consultants note that Ranexa will be a niche product due to narrow label and marginal clinical benefit (only symptomatic relief). Since investors largely share this outlook, we believe that expectations are low.
. While ACEON has recently received label expansion due to EUROPA label, ACE inhibitor market is competitive and dominated by KG/WYE’s Altace, a tough competitor to unseat. This should translate into modest sales.
. However, modest investor expectations for Ranexa and ACEON should moderate downside pressure on the stock. But we also do not expect signif. NT appreciation since upside surprise to estimates is only possible if the ongoing MERLIN study shows positive data in late ‘06/early ’07. Thus, we are initiating coverage with Hold/Speculative rating and $30 target price.
Es gab eine verklausulierte Verkaufsempfehlung von der Citibank gestern:
. On Jan. 27, Ranexa is widely expected to be approved for refractory angina, a relatively small U.S. market (~$600M).
. Our physician consultants note that Ranexa will be a niche product due to narrow label and marginal clinical benefit (only symptomatic relief). Since investors largely share this outlook, we believe that expectations are low.
. While ACEON has recently received label expansion due to EUROPA label, ACE inhibitor market is competitive and dominated by KG/WYE’s Altace, a tough competitor to unseat. This should translate into modest sales.
. However, modest investor expectations for Ranexa and ACEON should moderate downside pressure on the stock. But we also do not expect signif. NT appreciation since upside surprise to estimates is only possible if the ongoing MERLIN study shows positive data in late ‘06/early ’07. Thus, we are initiating coverage with Hold/Speculative rating and $30 target price.
und warum steigt dann CVTX heute?
Der 27. Januar....
Rot oder Schwarz..............
Wann kommt heute die Entscheidung?
Wann kommt heute die Entscheidung?
Bei Forbes heißt es nun plötzlich Montag. CVTX hatte heute als Entscheidungstag erklärt, s.u.
Nach Insiderverkäufen sieht das jedenfalls alles nicht aus.
Erwarte aber uach nicht zu viel Bewegung nach oben wenn in solchen Artikeln "approval expected" steht. ICh erwarte es ja auch, aber man weiß nie...
Nach Insiderverkäufen sieht das jedenfalls alles nicht aus.
Erwarte aber uach nicht zu viel Bewegung nach oben wenn in solchen Artikeln "approval expected" steht. ICh erwarte es ja auch, aber man weiß nie...
ranexa zugelassen!
nachbörslich wird zunächst mal verkauft...
nachbörslich wird zunächst mal verkauft...
Woher hast Du die Nachricht wegen der Zulassung von ranexa?
Warum fällt dann CVTX nachbörslich?
Wie gehts weiter. Meinungen?
Warum fällt dann CVTX nachbörslich?
Wie gehts weiter. Meinungen?
Hallo, die Zulassung ist durch.
http://finance.yahoo.com/q?s=CVTX&d=t
Mit dem Kursverfall wurden meiner Meinung nach mal wieder
"stoploss" abgefischt, die Angst vor dem WE hatten.
Gruss neanderchen
http://finance.yahoo.com/q?s=CVTX&d=t
Mit dem Kursverfall wurden meiner Meinung nach mal wieder
"stoploss" abgefischt, die Angst vor dem WE hatten.
Gruss neanderchen
morgen 4pm findet ein CC zur ranexa-zulassung statt.
wer am freitag AH unter $24 gekauft hat, wird damit imo gut leben können. auch mit zunächst nur eingeschränktem label ist ranexa gut für umsätze in der größenordnung $300 mio. bei guten MERLIN-resultaten hat ranexa blockbuster-potential.
ein weiterer gedanke:
durch die zulassung wird CVTX als übernahmekandidat wesentlich attraktiver, da ein unsicherheitsfaktor beseitigt ist.
wer am freitag AH unter $24 gekauft hat, wird damit imo gut leben können. auch mit zunächst nur eingeschränktem label ist ranexa gut für umsätze in der größenordnung $300 mio. bei guten MERLIN-resultaten hat ranexa blockbuster-potential.
ein weiterer gedanke:
durch die zulassung wird CVTX als übernahmekandidat wesentlich attraktiver, da ein unsicherheitsfaktor beseitigt ist.
!
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Lehman Updae
1) We are increasing our price target on CVTX to $40 from $37 and maintaining our Overweight rating following approval of novel angina drug Ranexa. We believe the prescribing label is better-thanexpected and should support a strong launch into a large market with significant unmet need.
2)CVTX announced late Friday that Ranexa had been approved for the treatment of chronic angina in patients inadequately managed with existing anti-anginals. Of note, approval of 2nd-line combi-nation use with Beta blockers, calcium blockers or nitrates was less restrictive than anticipated.
3) With prior focus on Ranexa`s adverse event (AE) profile, the absence of a black box warning on QT prolongation and the lack of warning on syncope or arrhythmia risk provided further upside to the label. Indeed, the AE profile for Ranexa compares favorably to that of any other anti-anginal.
4)Overall, we believe the prescribing label for Ranexa positions it well in the medical management of 6.5M chronic angina sufferers. While advances with drug-eluting stents have limited growth of existing antianginals, we would suggest that the availability of a new anti-anginal will expand the role of medical
management.
Die Marketing-Maschenerie läuft seit Herbst schon unter Volldampf, d.h. wir sollten auch ziemlich bald Umsätze sehen. Ich denke jetzt kommen die Shorties etwas Dampf...
1) We are increasing our price target on CVTX to $40 from $37 and maintaining our Overweight rating following approval of novel angina drug Ranexa. We believe the prescribing label is better-thanexpected and should support a strong launch into a large market with significant unmet need.
2)CVTX announced late Friday that Ranexa had been approved for the treatment of chronic angina in patients inadequately managed with existing anti-anginals. Of note, approval of 2nd-line combi-nation use with Beta blockers, calcium blockers or nitrates was less restrictive than anticipated.
3) With prior focus on Ranexa`s adverse event (AE) profile, the absence of a black box warning on QT prolongation and the lack of warning on syncope or arrhythmia risk provided further upside to the label. Indeed, the AE profile for Ranexa compares favorably to that of any other anti-anginal.
4)Overall, we believe the prescribing label for Ranexa positions it well in the medical management of 6.5M chronic angina sufferers. While advances with drug-eluting stents have limited growth of existing antianginals, we would suggest that the availability of a new anti-anginal will expand the role of medical
management.
Die Marketing-Maschenerie läuft seit Herbst schon unter Volldampf, d.h. wir sollten auch ziemlich bald Umsätze sehen. Ich denke jetzt kommen die Shorties etwas Dampf...
genau, keine black box (wurde vielfach erwartet), und aus sicht vieler analysten ein besser als erwartetes label. das waren die wichtigsten erkenntnisse aus dem CC.
bin auch sehr zufrieden, und werde meine anteile auf jeden fall noch eine weile halten...
bin auch sehr zufrieden, und werde meine anteile auf jeden fall noch eine weile halten...
das ML-downgrade von gestern gefällt mir ausgezeichnet.
damit sollte CVTX z.zt. ein klarer kauf sein.
werde vermutlich heute meinen GNTA-verkaufserlös von gestern zum aufstocken bei CVTX nutzen.
damit sollte CVTX z.zt. ein klarer kauf sein.
werde vermutlich heute meinen GNTA-verkaufserlös von gestern zum aufstocken bei CVTX nutzen.
Ich werde mir die Pressekonferenz vom letzten Sonntag noch ein zweites mal anhören, vielleicht habe ich ja irgendeine Nuance überhört. Ansonsten macht speziell dieser downgrade super wenig Sinn, denn negative Meldungen, auf die es zu reagieren gäbe, sind mir nicht weiter aufgefallen. Entweder sieht der Analyst nach Durchlesen von Konkurrenzanalysen plötzlich die Marktchancen geringer, oder hat sich die klinischen Daten das erste mal ernsthaft angeschaut oder hat Angst vor der eigenen Courage und geht mit den Lemmingen. Alles spricht nicht gerade für Qualität.
In den nächsten Monaten besteht Dank der Merlin-Studie die reelle Chance, aus Ranexa ein Präparat der ersten Wahl zu machen.
Nochmal zitiert aus den Studiendetails (Merlin TIMI 36):
The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
....
Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based treatment of ACS and for long-term prevention of ACS in patients that present at the hospital with ACS and are treated and discharged.
Importantly, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the large safety database could support potential approval of Ranexa as
first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. As part of this SPA agreement, CV Therapeutics also has committed to perform a separate clinical evaluation of
higher doses of Ranexa to support potential use as first-line therapy for chronic angina.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=…
Mit 5500 Patienten ist die Zahl der Studienteilnehmer wohl groß genug, um Unterschiede zu detektieren, sofern ein Unterschied zu Placebo existiert. Die kleinste Hürde erscheint mir nicht gerade groß. Ich fühle mich aktuell sauwohl mit diesem Investment.
In den nächsten Monaten besteht Dank der Merlin-Studie die reelle Chance, aus Ranexa ein Präparat der ersten Wahl zu machen.
Nochmal zitiert aus den Studiendetails (Merlin TIMI 36):
The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
....
Under the SPA agreement, if statistical significance on the primary endpoint is achieved, Ranexa could gain approval for hospital-based treatment of ACS and for long-term prevention of ACS in patients that present at the hospital with ACS and are treated and discharged.
Importantly, under the same SPA agreement, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the large safety database could support potential approval of Ranexa as
first-line chronic angina therapy, even if statistical significance on the primary endpoint is not achieved. As part of this SPA agreement, CV Therapeutics also has committed to perform a separate clinical evaluation of
higher doses of Ranexa to support potential use as first-line therapy for chronic angina.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=…
Mit 5500 Patienten ist die Zahl der Studienteilnehmer wohl groß genug, um Unterschiede zu detektieren, sofern ein Unterschied zu Placebo existiert. Die kleinste Hürde erscheint mir nicht gerade groß. Ich fühle mich aktuell sauwohl mit diesem Investment.
[posting]19.972.527 von Mr.Arrogance am 31.01.06 12:43:12[/posting]nochmal im detail:
der street consensus bzgl. der ranexa-umsätze liegt bei
2006e $ 39 mio
2007e $120 mio
mehrere teilnehmer am CC haben bestätigt, daß das label besser als erwartet ausfiel.
ML hatte vor der zulassung folgende erwartungen:
2006e $ 65 mio
2007e $190 mio
2008e $333 mio
und halbiert diese nun auf
2006e $ 33 mio
2007e $ 89 mio
2008e $154 mio
der street consensus bzgl. der ranexa-umsätze liegt bei
2006e $ 39 mio
2007e $120 mio
mehrere teilnehmer am CC haben bestätigt, daß das label besser als erwartet ausfiel.
ML hatte vor der zulassung folgende erwartungen:
2006e $ 65 mio
2007e $190 mio
2008e $333 mio
und halbiert diese nun auf
2006e $ 33 mio
2007e $ 89 mio
2008e $154 mio
Kleine Korrektur: Wird doch wohl bis Ende dieses Jahres dauern....
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=…
Study Details
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients will be enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also will receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa to be used in MERLIN have been studied in previous Phase 3 clinical trials.
In addition to performing periodic safety assessments, an independent data safety monitoring board overseeing MERLIN will conduct a blinded interim efficacy analysis, based on the endpoint of cardiovascular death, which is anticipated to occur after approximately half of the specified cardiovascular events have been observed. A p-value of 0.001 would be required to stop the study early at the time of the interim efficacy analysis. The company believes it would be unlikely for an outcomes study such as MERLIN to achieve this p- value with only approximately half of the patients enrolled, and so it does not expect the study to be stopped at the time of the interim efficacy analysis.
A blinded interim assessment of sample size also will occur, which will permit the overall study size to expand to approximately 6,500 patients, if the overall mortality rate needed to complete the study is significantly lower
than anticipated.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=…
Study Details
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients will be enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with oral Ranexa or placebo. All patients also will receive standard therapy during both hospital-based and outpatient treatment. The oral doses of Ranexa to be used in MERLIN have been studied in previous Phase 3 clinical trials.
In addition to performing periodic safety assessments, an independent data safety monitoring board overseeing MERLIN will conduct a blinded interim efficacy analysis, based on the endpoint of cardiovascular death, which is anticipated to occur after approximately half of the specified cardiovascular events have been observed. A p-value of 0.001 would be required to stop the study early at the time of the interim efficacy analysis. The company believes it would be unlikely for an outcomes study such as MERLIN to achieve this p- value with only approximately half of the patients enrolled, and so it does not expect the study to be stopped at the time of the interim efficacy analysis.
A blinded interim assessment of sample size also will occur, which will permit the overall study size to expand to approximately 6,500 patients, if the overall mortality rate needed to complete the study is significantly lower
than anticipated.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.
bin jetzt voll investiert.
Hallo,
kann mir das bitte einer kurz übersetzen?
Und warum fällt CVTX trotz der Zuslassung.
Danke im voraus!
Gruß
BFW
kann mir das bitte einer kurz übersetzen?
Und warum fällt CVTX trotz der Zuslassung.
Danke im voraus!
Gruß
BFW
Das ist nur das schon lange veröffentlichte Studiendesign der aktuellen Merlin-Studie, mit der Ranexa seine Fähigkeit zum Schutz von Patienten vor Herztod, Herzinfarkt oder anderen Vorfällen nachweisen soll, wenn sie nach einem Angina pectoris -Vorfall in ihrem Hospital aufschlagen und dann mit Ranexa-iv oder eben mit Placebo behandelt werden.
Zum einen gibt es eine Zwischenanalyse in den nächsten Monaten, allerdings reicht wohl das statistische Gewicht der Studie bis dahin wohl - jedenfalls nach Aussagen des CVTX-Managements- kaum dafür aus, um bis dahin ein hinreichend eindeutiges Ergebnis zu erzielen. Daher müssen wir uns bis zur finalen Analyse etwa Ende des Jahres gedulden.
Der Knüller ist, dass selbst wenn kein Unterschied zu Placebo feststellbar wäre, die Ergebnisse trotzdem ausreichen könnten, um als Grundlage von Ranexas Zulassung als Präparat der ersten Wahl zu dienen.
Gestern wurde Ranexa wohlgemerkt nur für die Patienten zugelassen, bei denen die gängigen Standards wie Nitroglycerin und Betablockern bislang nicht ausreichend geholfen haben.
Warum der Kurs gefallen ist, kann ich nur ahnen. Es interessiert mich aber eigentlich auch nicht. Merrill Lynch hat die Aktie aus nicht nachvollziehbaren Gründen von Kaufen auf Halten herabgestuft und vielleicht ist es auch das übliche "Sell on good news".
Zum einen gibt es eine Zwischenanalyse in den nächsten Monaten, allerdings reicht wohl das statistische Gewicht der Studie bis dahin wohl - jedenfalls nach Aussagen des CVTX-Managements- kaum dafür aus, um bis dahin ein hinreichend eindeutiges Ergebnis zu erzielen. Daher müssen wir uns bis zur finalen Analyse etwa Ende des Jahres gedulden.
Der Knüller ist, dass selbst wenn kein Unterschied zu Placebo feststellbar wäre, die Ergebnisse trotzdem ausreichen könnten, um als Grundlage von Ranexas Zulassung als Präparat der ersten Wahl zu dienen.
Gestern wurde Ranexa wohlgemerkt nur für die Patienten zugelassen, bei denen die gängigen Standards wie Nitroglycerin und Betablockern bislang nicht ausreichend geholfen haben.
Warum der Kurs gefallen ist, kann ich nur ahnen. Es interessiert mich aber eigentlich auch nicht. Merrill Lynch hat die Aktie aus nicht nachvollziehbaren Gründen von Kaufen auf Halten herabgestuft und vielleicht ist es auch das übliche "Sell on good news".
Vielen Dank für die Zusammenfassung.
MERLIN - timeline laut CC:
aktuell >5000 pts rekrutiert, voraussichtlich rekrutierung komplett im 2.quartal.
studienende q 4.
top-line data end 06/ anfang 07.
ergebnisse einer interimsanalyse möglicherweise noch in diesem quartal.
---------
sehr schlecht zu verstehen war der ML-analyst, der aber immerhin gratulierte und in einer frage zum pricing von einem "strong label" sprach...
aktuell >5000 pts rekrutiert, voraussichtlich rekrutierung komplett im 2.quartal.
studienende q 4.
top-line data end 06/ anfang 07.
ergebnisse einer interimsanalyse möglicherweise noch in diesem quartal.
---------
sehr schlecht zu verstehen war der ML-analyst, der aber immerhin gratulierte und in einer frage zum pricing von einem "strong label" sprach...
SC 13G - filing von heute:
http://phx.corporate-ir.net/phoenix.zhtml?c=109908&p=irol-SE…
http://phx.corporate-ir.net/phoenix.zhtml?c=109908&p=irol-SE…
Die Interimsergebnisse sind da und das Wunder ausgeblieben. Schade, hätte ein schönes Kursfeuerwerk gegeben...
CV Therapeutics Announces MERLIN TIMI-36 Study to Continue as Planned Based on Interim Analysis
PALO ALTO, Calif., Feb. 9 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa(TM) (ranolazine extended-release tablets) will continue as planned based on the results of an interim efficacy analysis.
As specified in the MERLIN TIMI-36 study protocol, the independent Data Safety Monitoring Board (DSMB) overseeing the study conducted an interim efficacy analysis as well as a periodic safety assessment when approximately half of the anticipated major cardiovascular events occurred. A statistically significant drug treatment effect on the rate of cardiovascular death with a p-value of less than 0.001 was pre-specified as being required for the DSMB to consider a recommendation to stop the study early. The Company has been informed that the DSMB recommended that the study continue as planned.
Preliminary study results for the MERLIN TIMI-36 study could be available in the fourth quarter of 2006 or the first quarter of 2007.
[...BlaBlaBla und nochmal die Studiendetails...]
CV Therapeutics Announces MERLIN TIMI-36 Study to Continue as Planned Based on Interim Analysis
PALO ALTO, Calif., Feb. 9 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa(TM) (ranolazine extended-release tablets) will continue as planned based on the results of an interim efficacy analysis.
As specified in the MERLIN TIMI-36 study protocol, the independent Data Safety Monitoring Board (DSMB) overseeing the study conducted an interim efficacy analysis as well as a periodic safety assessment when approximately half of the anticipated major cardiovascular events occurred. A statistically significant drug treatment effect on the rate of cardiovascular death with a p-value of less than 0.001 was pre-specified as being required for the DSMB to consider a recommendation to stop the study early. The Company has been informed that the DSMB recommended that the study continue as planned.
Preliminary study results for the MERLIN TIMI-36 study could be available in the fourth quarter of 2006 or the first quarter of 2007.
[...BlaBlaBla und nochmal die Studiendetails...]
CV Therapeutics has set the wholesale acquisition cost, or WAC, of Ranexa at $5.50 per day at the 500 mg b.i.d. starting dose.
die planmäßige fortsetzung von MERLIN nach DSMB-analyse war eine gute nachricht, wenn auch erwartet. auf das "wunder" (vorzeitiger stop aufgrund überwältigender effektivität) mußte zwar erwartungsgemäß verzichtet werden, doch daß es anscheinend keine größeren probleme im nebenwirkungsbereich gab, ist erfreulich.
das pricing ist ambitioniert, etwas höher als erwartet.
bei anwendung der anfänglichen dosis 2 * 500g täglich (kann gesteigert werden bis 2* 1000g) entspricht dies jährlichen behandlungskosten von etwa $2000.
üblicherweise haben wir es oft mit langzeitpatienten zu tun (behandlung länger als 2 jahre).
die zielgruppe bei aktuellem label umfaßt etwa 600.000 - 1.600.000 pts.
würden etwa 200.000 pts täglich mit ranexa behandelt, vielleicht in 2 - 3 jahren, entpräche dies schon umsätzen in höhe von $400 mio.
das pricing ist ambitioniert, etwas höher als erwartet.
bei anwendung der anfänglichen dosis 2 * 500g täglich (kann gesteigert werden bis 2* 1000g) entspricht dies jährlichen behandlungskosten von etwa $2000.
üblicherweise haben wir es oft mit langzeitpatienten zu tun (behandlung länger als 2 jahre).
die zielgruppe bei aktuellem label umfaßt etwa 600.000 - 1.600.000 pts.
würden etwa 200.000 pts täglich mit ranexa behandelt, vielleicht in 2 - 3 jahren, entpräche dies schon umsätzen in höhe von $400 mio.
Ja der Preis ist deutlich teurer als vorher vermutet wurde. Ich hatte als gehandelte Zahl so 1000 $/a in Erinnerung.
Bei den potenziellen Zahl der passenden Patienten -ich hatte dieselbe Idee mit der Usmatzschätzung- habe ich mir bei der Eigenrecherche die Zähne ausgebissen. Die Prävalenzzahlen variieren in der Fachliteraur enorm. Generell wird meistens die Zahl der betroffenen Patieten überschätzt, nicht zuletzt um Forschungsgelder locker zu machen. Im Schnitt sind wir sowieso alle krank.
Ich sehe die Fortsetzung der Studie als neutral. Auch Nebenwirkungen benötigen eine hinreichend große Zahl an Patienten/Probanden um deutlich hervorzutreten. Wenn 2 Personen in der Behandlungsgruppe meinetwegen an Niereninsuffiziens erkranken, dann wird man nicht die Studie erschrocken beenden. Bei einem Zulassungsverfahren wird das dann aber bis zum Exzess durchgekaut. Man könnte nur etwas in den Kursanstieg hineingeheimnissen, denn dass es Insidertrading gibt, das weiß ich nun aus erster Hand, aber eigentlich ist die Bewegung dafür nicht auffällig genug.
Bei den potenziellen Zahl der passenden Patienten -ich hatte dieselbe Idee mit der Usmatzschätzung- habe ich mir bei der Eigenrecherche die Zähne ausgebissen. Die Prävalenzzahlen variieren in der Fachliteraur enorm. Generell wird meistens die Zahl der betroffenen Patieten überschätzt, nicht zuletzt um Forschungsgelder locker zu machen. Im Schnitt sind wir sowieso alle krank.
Ich sehe die Fortsetzung der Studie als neutral. Auch Nebenwirkungen benötigen eine hinreichend große Zahl an Patienten/Probanden um deutlich hervorzutreten. Wenn 2 Personen in der Behandlungsgruppe meinetwegen an Niereninsuffiziens erkranken, dann wird man nicht die Studie erschrocken beenden. Bei einem Zulassungsverfahren wird das dann aber bis zum Exzess durchgekaut. Man könnte nur etwas in den Kursanstieg hineingeheimnissen, denn dass es Insidertrading gibt, das weiß ich nun aus erster Hand, aber eigentlich ist die Bewegung dafür nicht auffällig genug.
hab bisher nur gelesen...beobachte aber Aktie schon lang........
aber heute fällt mir nur das ein
Was ist heute los?
Die Umsätze sind auch ziemlich hoch?!
Sind das nur die Auswirkungen des höher als erwartet ausgefallen Verlustes?
Oder..................
Die Umsätze sind auch ziemlich hoch?!
Sind das nur die Auswirkungen des höher als erwartet ausgefallen Verlustes?
Oder..................
Ein Analyst von Morgan Stanley hat sich nochmal gemeldet und seine Verkaufsempfehlung wiederholt. Im Kern sagt er, dass die Verkaufsschätzungen wohl zu hoch sind und dass der Verkauf von Ranexa langsamer angeht als viele jetzt noch denken. Vielleicht hat er Recht!
Das ist für mich ganz schwer abzuschätzen, denn die Verkaufsdynamik hängt im Wesentlichen von der Qualität der Sales Force ab als auch von der Resistenz der Fachärzte gegenüber Neuerungen. Nicht umsonst stellen Manager der Pharmabranche immer noch fest, dass sie eher den Forschungsetat reduzieren würden als den der Verkaufsabteilung. Langfristig ist so etwas natürlich fatal und auch mit ein Hauptgrund für den Niedergang der großen Pharmariesen. Dieser Fehler sollte uns Biotechinvestoren freuen.
Um die Verkaufsperspektive von Ranexa ernsthaft abschätzen zu können, müsste man representative Umfragen bei den Fachärzten machen. Der Verlust ist sicher kein Verkaufsgrund, denn noch macht CVTX noch kaum Verkaufsumsätze. Die Verkaufszahlen von Aceon sind aber für mich bisher enttäuschend, wobei Aceon erst seit etwa einem Quartal ernsthaft beworben wurde. Man müsste also ungefähr mal 4 rechnen, um die Umsatzzahlen zu vergleichen.
Er gibt aber selbst zu, dass die Merlin Studie alles fundamental auf den Kopf stellen kann. Ob das einen Verkaufsempfehlung rechtfertigt, dass möchte ich mal bezweifeln. Widerspruch, neue Ideen und Korrekturen erwünscht.
Hier der Text
Morgan Stanley reiterated an "underweight" rating on CV Therapeutics after the biotech firm reported a wider-than-expected loss for the fourth quarter.
CV Therapeutics posted a loss of $1.65 per share on revenue of $3.4 million. A consensus of analysts expected a loss of $1.42 per share on revenue of $5.3 million.
The company said operating expenses rose 25% from the year-ago period, attributing the increase to the launch of a new indication for heart drug Aceon.
"Expectations for operating expenses are increasing, the bottom-line impact of Aceon royalties remains negligible, and we believe Ranexa will have a slow launch," said analyst Steven Harr of Morgan Stanley.
"The $30 to $50 per month co-pay combined with the drug`s current data set leads us to believe this drug could have difficulty meeting long-term Street expectations."
The analyst widened the forecasted loss in 2006 to $5.87 per share from $4.98, and said the next catalyst for the stock will be expectations of favorable safety data for Ranexa from a trial known as Merlin. Results are expected by the first quarter of next year.
"Lack of Aceon contribution and expected slow uptake may put modest negative pressure on the stock in 2006," he said. "However, 12 to 18 month returns are more likely dependent on the Merlin outcome and their impact on sales, and we are not optimistic that this drug can be big enough to lead to meaningful profitability for this company."
Aceon has annual sales of less than $30 million compared with sales of $347 million for Altace, the leading angiotensin-converting enzyme inhibitor made by King Pharmaceuticals. Aceon is co-marketed with Belgium-based Solvay Pharmaceuticals, a unit of Solvay SA.
Elsewhere in the sector, Harr rates the following companies at "overweight": ImClone Systems, Onyx Pharmaceuticals and Xenoport.
Das ist für mich ganz schwer abzuschätzen, denn die Verkaufsdynamik hängt im Wesentlichen von der Qualität der Sales Force ab als auch von der Resistenz der Fachärzte gegenüber Neuerungen. Nicht umsonst stellen Manager der Pharmabranche immer noch fest, dass sie eher den Forschungsetat reduzieren würden als den der Verkaufsabteilung. Langfristig ist so etwas natürlich fatal und auch mit ein Hauptgrund für den Niedergang der großen Pharmariesen. Dieser Fehler sollte uns Biotechinvestoren freuen.
Um die Verkaufsperspektive von Ranexa ernsthaft abschätzen zu können, müsste man representative Umfragen bei den Fachärzten machen. Der Verlust ist sicher kein Verkaufsgrund, denn noch macht CVTX noch kaum Verkaufsumsätze. Die Verkaufszahlen von Aceon sind aber für mich bisher enttäuschend, wobei Aceon erst seit etwa einem Quartal ernsthaft beworben wurde. Man müsste also ungefähr mal 4 rechnen, um die Umsatzzahlen zu vergleichen.
Er gibt aber selbst zu, dass die Merlin Studie alles fundamental auf den Kopf stellen kann. Ob das einen Verkaufsempfehlung rechtfertigt, dass möchte ich mal bezweifeln. Widerspruch, neue Ideen und Korrekturen erwünscht.
Hier der Text
Morgan Stanley reiterated an "underweight" rating on CV Therapeutics after the biotech firm reported a wider-than-expected loss for the fourth quarter.
CV Therapeutics posted a loss of $1.65 per share on revenue of $3.4 million. A consensus of analysts expected a loss of $1.42 per share on revenue of $5.3 million.
The company said operating expenses rose 25% from the year-ago period, attributing the increase to the launch of a new indication for heart drug Aceon.
"Expectations for operating expenses are increasing, the bottom-line impact of Aceon royalties remains negligible, and we believe Ranexa will have a slow launch," said analyst Steven Harr of Morgan Stanley.
"The $30 to $50 per month co-pay combined with the drug`s current data set leads us to believe this drug could have difficulty meeting long-term Street expectations."
The analyst widened the forecasted loss in 2006 to $5.87 per share from $4.98, and said the next catalyst for the stock will be expectations of favorable safety data for Ranexa from a trial known as Merlin. Results are expected by the first quarter of next year.
"Lack of Aceon contribution and expected slow uptake may put modest negative pressure on the stock in 2006," he said. "However, 12 to 18 month returns are more likely dependent on the Merlin outcome and their impact on sales, and we are not optimistic that this drug can be big enough to lead to meaningful profitability for this company."
Aceon has annual sales of less than $30 million compared with sales of $347 million for Altace, the leading angiotensin-converting enzyme inhibitor made by King Pharmaceuticals. Aceon is co-marketed with Belgium-based Solvay Pharmaceuticals, a unit of Solvay SA.
Elsewhere in the sector, Harr rates the following companies at "overweight": ImClone Systems, Onyx Pharmaceuticals and Xenoport.
Alle meine Aussagen wieder zurück, die mit Aceon zu tun haben.
Die 30 Millionen $ sind die Summe, die Solvay bisher in den USA mit Aceon pro Jahr umgesetzt hat.
Cvtx hat die Vermarktungsrechte von Aceon dann übernommen und bezahlt bei Umsätzen unterhalb eines definierten Sockelbeitrag immer Ertragserlöse an Solvay aus. Alle Gewinne bei Umsätzen darüber dürfen die dann behalten. So wollen sie die Auslastung ihrer Sales Force verbessern. Wie hoch dieser Sockelbetrag konkret ist, wissen wir nicht, sicher auch nicht der MS-Analyst.
Außerdem möchte ich noch auf 2 spannende Kommentare aus dem Yahoo-Board verweisen:
1 und 2
Die 30 Millionen $ sind die Summe, die Solvay bisher in den USA mit Aceon pro Jahr umgesetzt hat.
Cvtx hat die Vermarktungsrechte von Aceon dann übernommen und bezahlt bei Umsätzen unterhalb eines definierten Sockelbeitrag immer Ertragserlöse an Solvay aus. Alle Gewinne bei Umsätzen darüber dürfen die dann behalten. So wollen sie die Auslastung ihrer Sales Force verbessern. Wie hoch dieser Sockelbetrag konkret ist, wissen wir nicht, sicher auch nicht der MS-Analyst.
Außerdem möchte ich noch auf 2 spannende Kommentare aus dem Yahoo-Board verweisen:
1 und 2
quo vadis CVTX?
Nichts mehr los im Thread.
Nichts mehr los im Thread.
Ein Beitrag aus dem Wallstreet Journal. Ich habe die für mich neuen Inhalte fett markiert.
Heart Beat
For discouraged angina sufferers, a new drug offers modest hope
By RON WINSLOW
March 20, 2006; Page R4
Doctors call them "no option" patients.
They have tried every remedy from the conventional to the quirky to find relief for chronic, recurring chest pain called angina -- the telltale sign of coronary artery disease. They may feel better for a while, but eventually the crushing sensation in their chest returns. They can`t walk to the bathroom or climb a flight of stairs without their nitroglycerin pills close at hand. They long to lift a grandchild into their arms.
So they go back to the doctor again and again, hoping for a different result, but there is nothing more to do.
See the complete Personal Health report. Now, for the first time in more than two decades, there is a new pill in the medicine cabinet for angina sufferers. Called Ranexa, and known generically as ranolazine, it was approved in January by the Food and Drug Administration and is being introduced this month by CV Therapeutics Inc., a Palo Alto, Calif., drug company.
While clearly a boon for some patients, the drug is entering a skeptical marketplace -- reflecting both uncertainty about its benefits and the daunting tenacity with which angina can take over the lives of its sufferers.
`Emotional Creature`
Angina is the pain that results when the heart`s muscle, which is responsible for pumping blood to the rest of the body, doesn`t get enough blood for itself. It is deprived by disease of the continuous fresh supply of oxygen it needs to keep healthy.
"The heart is a very emotional creature," says Diane Norman, a 65-year-old Jacksonville, Fla., woman who has battled angina for more than 20 years. "If it doesn`t get what it wants and when it wants it, it shows itself up pretty bad."
Few other medical conditions are as debilitating. "You`re worse than you ever thought you could be and still walk," Mrs. Norman says.
Yet surprisingly, the death rate for such patients is relatively low. A new study of 1,200 no-option patients found that only 11% died after five years, and only half of those were from heart-related causes.Es wird also alles andere als leicht, mit statistischen Methoden einen Überlebensvorteil aufzuzeigen! By comparison, other research indicates that 50% of patients with congestive heart failure, also a frequent consequence of advanced heart disease, die within five years.
Angina patients "are not dying, they`re coming into the hospital every month," says Timothy Henry, a researcher at the Minneapolis Heart Institute who presented the new data last week at a meeting of the American College of Cardiology. All the more reason to find something to help improve their quality of life, he says.
More than six million Americans suffer from some stage of angina, according to the American Heart Association. By some estimates, that results in 13 million episodes of chest pain a week. How many patients are in the no-option category is hard to say, though many believe it is growing. Some 400,000 new angina cases are diagnosed each year.
The mainstay treatment in the U.S. is bypass surgery or balloon angioplasty combined with insertion of a metal sleeve called a stent to prop open treated arteries. These strategies, hallmark procedures of modern cardiology, relieve pain by restoring the supply of blood to the heart muscle. But in many cases, the disease and pain eventually return and there comes a point where nothing else can be done.
Standard drug therapy includes nitrates, beta blockers and calcium channel blockers -- all medicines that lower blood pressure or reduce the heart rate, mitigating pain by reducing demand on the heart. The drugs reduce, but typically don`t eliminate, angina episodes. Many patients can`t tolerate aggressive doses because their blood pressure falls too low.
Success and Skepticism
Enter ranolazine, which is taken twice daily and has a wholesale cost of $2.75 a pill. Exactly how it works isn`t clear, but it appears to enable heart cells to work more efficiently with the oxygen they have without further reducing blood pressure. "We see it as something that will be helpful for people who are already on everything else," says Christopher Cannon, a cardiologist at Brigham and Women`s Hospital, Boston, whose research group is leading a new study of the drug.
In one of the trials that led to approval, the drug reduced the weekly number of angina episodes to an average of about 2.5 from 4.5, while patients taking a placebo reported a decrease of one episode per week. Ranolazine had a similar advantage in reducing the need for nitroglycerin to manage an angina episode.
The more frequent a patient`s angina episodes at the beginning of the study, the better ranolazine seemed to work, says Peter Stone, another researcher at Brigham who was principal investigator for the largest study of the drug so far.
So why the skepticism? Some doctors question whether patients will consider eliminating one more angina episode per week than a dummy pill to be a meaningful benefit. Moreover, studies of the drug were dominated by patients from Eastern Europe, who were much less likely than U.S. patients to have undergone bypass or angioplasty procedures or to be taking heart drugs called statins as part of their standard therapy.
There is "no way, no how" that the data apply to typical no-option patients in the U.S, says Douglas Losordo, chief of cardiovascular research at St. Elizabeth`s Medical Center, Boston. He is leading a new study of stem-cell therapy in intractable angina patients.
Finally, because of theoretical concerns that ranolazine could increase risk of dangerous irregular heartbeats, the drug is approved only for patients for whom the other drugs don`t do the job. (The drug`s proponents think future studies might show it prevents irregular heartbeats, but that is another story.)
"We will need more experience and more studies to get a better sense where ranolazine will fit into our choice of medicines," Dr. Stone says, "but it is very helpful to have another medicine available."
Back on the Dance Floor
Mrs. Norman certainly agrees. Despite quintuple-bypass surgery in 1987 and a variety of other treatments since, her angina was so persistent she was afraid even to put her bottle of "nitro" pills in her pocket lest it take her too long to get one out.
Her doctor enrolled her in a clinical trial of the drug. Eight months after she began taking it, she went to a wedding where she danced for the first time in 10 years.
"I can`t do the beach bop, like I did when I was 17," she says, "but I can slow-dance and walk up stairs." She still relies on her nitro and says she tires easily. "But I don`t have the angina anything like I had before."
____________________________________________
Heart Beat
For discouraged angina sufferers, a new drug offers modest hope
By RON WINSLOW
March 20, 2006; Page R4
Doctors call them "no option" patients.
They have tried every remedy from the conventional to the quirky to find relief for chronic, recurring chest pain called angina -- the telltale sign of coronary artery disease. They may feel better for a while, but eventually the crushing sensation in their chest returns. They can`t walk to the bathroom or climb a flight of stairs without their nitroglycerin pills close at hand. They long to lift a grandchild into their arms.
So they go back to the doctor again and again, hoping for a different result, but there is nothing more to do.
See the complete Personal Health report. Now, for the first time in more than two decades, there is a new pill in the medicine cabinet for angina sufferers. Called Ranexa, and known generically as ranolazine, it was approved in January by the Food and Drug Administration and is being introduced this month by CV Therapeutics Inc., a Palo Alto, Calif., drug company.
While clearly a boon for some patients, the drug is entering a skeptical marketplace -- reflecting both uncertainty about its benefits and the daunting tenacity with which angina can take over the lives of its sufferers.
`Emotional Creature`
Angina is the pain that results when the heart`s muscle, which is responsible for pumping blood to the rest of the body, doesn`t get enough blood for itself. It is deprived by disease of the continuous fresh supply of oxygen it needs to keep healthy.
"The heart is a very emotional creature," says Diane Norman, a 65-year-old Jacksonville, Fla., woman who has battled angina for more than 20 years. "If it doesn`t get what it wants and when it wants it, it shows itself up pretty bad."
Few other medical conditions are as debilitating. "You`re worse than you ever thought you could be and still walk," Mrs. Norman says.
Yet surprisingly, the death rate for such patients is relatively low. A new study of 1,200 no-option patients found that only 11% died after five years, and only half of those were from heart-related causes.Es wird also alles andere als leicht, mit statistischen Methoden einen Überlebensvorteil aufzuzeigen! By comparison, other research indicates that 50% of patients with congestive heart failure, also a frequent consequence of advanced heart disease, die within five years.
Angina patients "are not dying, they`re coming into the hospital every month," says Timothy Henry, a researcher at the Minneapolis Heart Institute who presented the new data last week at a meeting of the American College of Cardiology. All the more reason to find something to help improve their quality of life, he says.
More than six million Americans suffer from some stage of angina, according to the American Heart Association. By some estimates, that results in 13 million episodes of chest pain a week. How many patients are in the no-option category is hard to say, though many believe it is growing. Some 400,000 new angina cases are diagnosed each year.
The mainstay treatment in the U.S. is bypass surgery or balloon angioplasty combined with insertion of a metal sleeve called a stent to prop open treated arteries. These strategies, hallmark procedures of modern cardiology, relieve pain by restoring the supply of blood to the heart muscle. But in many cases, the disease and pain eventually return and there comes a point where nothing else can be done.
Standard drug therapy includes nitrates, beta blockers and calcium channel blockers -- all medicines that lower blood pressure or reduce the heart rate, mitigating pain by reducing demand on the heart. The drugs reduce, but typically don`t eliminate, angina episodes. Many patients can`t tolerate aggressive doses because their blood pressure falls too low.
Success and Skepticism
Enter ranolazine, which is taken twice daily and has a wholesale cost of $2.75 a pill. Exactly how it works isn`t clear, but it appears to enable heart cells to work more efficiently with the oxygen they have without further reducing blood pressure. "We see it as something that will be helpful for people who are already on everything else," says Christopher Cannon, a cardiologist at Brigham and Women`s Hospital, Boston, whose research group is leading a new study of the drug.
In one of the trials that led to approval, the drug reduced the weekly number of angina episodes to an average of about 2.5 from 4.5, while patients taking a placebo reported a decrease of one episode per week. Ranolazine had a similar advantage in reducing the need for nitroglycerin to manage an angina episode.
The more frequent a patient`s angina episodes at the beginning of the study, the better ranolazine seemed to work, says Peter Stone, another researcher at Brigham who was principal investigator for the largest study of the drug so far.
So why the skepticism? Some doctors question whether patients will consider eliminating one more angina episode per week than a dummy pill to be a meaningful benefit. Moreover, studies of the drug were dominated by patients from Eastern Europe, who were much less likely than U.S. patients to have undergone bypass or angioplasty procedures or to be taking heart drugs called statins as part of their standard therapy.
There is "no way, no how" that the data apply to typical no-option patients in the U.S, says Douglas Losordo, chief of cardiovascular research at St. Elizabeth`s Medical Center, Boston. He is leading a new study of stem-cell therapy in intractable angina patients.
Finally, because of theoretical concerns that ranolazine could increase risk of dangerous irregular heartbeats, the drug is approved only for patients for whom the other drugs don`t do the job. (The drug`s proponents think future studies might show it prevents irregular heartbeats, but that is another story.)
"We will need more experience and more studies to get a better sense where ranolazine will fit into our choice of medicines," Dr. Stone says, "but it is very helpful to have another medicine available."
Back on the Dance Floor
Mrs. Norman certainly agrees. Despite quintuple-bypass surgery in 1987 and a variety of other treatments since, her angina was so persistent she was afraid even to put her bottle of "nitro" pills in her pocket lest it take her too long to get one out.
Her doctor enrolled her in a clinical trial of the drug. Eight months after she began taking it, she went to a wedding where she danced for the first time in 10 years.
"I can`t do the beach bop, like I did when I was 17," she says, "but I can slow-dance and walk up stairs." She still relies on her nitro and says she tires easily. "But I don`t have the angina anything like I had before."
____________________________________________
Ich hab gerade die folgende Meldung im Netz gefunden.
Kann mir das bitte einer von Euch kurz übersetzen.
CV Therapeutics Launches Ranexa
PALO ALTO, Calif., March 24 /PRNewswire-FirstCall/ -- CV Therapeutics, (Nachrichten) Inc. announced today that its sales force is now promoting Ranexa(TM) (ranolazine extended-release tablets) to cardiology specialists in the United States. The product is now available in pharmacies.
Ranexa is approved as second-line treatment for chronic angina and has antianginal and anti-ischemic effects that do not depend upon reductions in heart rate or blood pressure.
"This is a long-awaited day for angina patients, their families and the cardiology community who have hoped for a new pharmaceutical approach to treat chronic angina," said Louis G. Lange, M.D., Ph.D., CV Therapeutics chairman and chief executive officer. "I would also like to thank our employees and collaborators who have been dedicated to bringing this important new therapy to patients."
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. Approximately 6.5 million people in the United States have chronic angina, and 400,000 new cases are diagnosed annually, according to the American Heart Association.
Ranexa is approved for the treatment of chronic angina. According to the approved labeling, because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs. Ranexa should be used in combination with amlodipine, beta-blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.
Complete prescribing information for Ranexa, including detailed safety and dosage information are available at http://www.ranexa.com/.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.
CV Therapeutics' approved products include Ranexa(TM) (ranolazine extended-release tablets) and ACEON(R) (perindopril erbumine) Tablets. Ranexa is approved for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. In addition, CV Therapeutics co-promotes ACEON(R), an ACE inhibitor, for reduction of the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease and treatment of essential hypertension.
CV Therapeutics also has other clinical and preclinical drug development candidates and programs, including regadenoson, which is being developed for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies. Regadenoson has not been approved for marketing by any regulatory authorities.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; special protocol assessment agreements; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2005. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
Kann mir das bitte einer von Euch kurz übersetzen.
CV Therapeutics Launches Ranexa
PALO ALTO, Calif., March 24 /PRNewswire-FirstCall/ -- CV Therapeutics, (Nachrichten) Inc. announced today that its sales force is now promoting Ranexa(TM) (ranolazine extended-release tablets) to cardiology specialists in the United States. The product is now available in pharmacies.
Ranexa is approved as second-line treatment for chronic angina and has antianginal and anti-ischemic effects that do not depend upon reductions in heart rate or blood pressure.
"This is a long-awaited day for angina patients, their families and the cardiology community who have hoped for a new pharmaceutical approach to treat chronic angina," said Louis G. Lange, M.D., Ph.D., CV Therapeutics chairman and chief executive officer. "I would also like to thank our employees and collaborators who have been dedicated to bringing this important new therapy to patients."
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. Approximately 6.5 million people in the United States have chronic angina, and 400,000 new cases are diagnosed annually, according to the American Heart Association.
Ranexa is approved for the treatment of chronic angina. According to the approved labeling, because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs. Ranexa should be used in combination with amlodipine, beta-blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.
Complete prescribing information for Ranexa, including detailed safety and dosage information are available at http://www.ranexa.com/.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.
CV Therapeutics' approved products include Ranexa(TM) (ranolazine extended-release tablets) and ACEON(R) (perindopril erbumine) Tablets. Ranexa is approved for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. In addition, CV Therapeutics co-promotes ACEON(R), an ACE inhibitor, for reduction of the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease and treatment of essential hypertension.
CV Therapeutics also has other clinical and preclinical drug development candidates and programs, including regadenoson, which is being developed for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies. Regadenoson has not been approved for marketing by any regulatory authorities.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; regulatory review and approval of our products; special protocol assessment agreements; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2005. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
Kurz: Ranexa ist ab jetzt in den Apotheken erhältlich und die Pharmareferenten promoten es auch erst jetzt. Mehr nicht.
Was meint Ihr wie weit geht es noch runter ?
Ìst das Ende der Talfahrt nah ?
Wieso gibt der Wert so stark nach ?
Ìst das Ende der Talfahrt nah ?
Wieso gibt der Wert so stark nach ?
Antwort auf Beitrag Nr.: 21.001.594 von Biotech110 am 29.03.06 23:01:29Der Wert zeigt in den letzten Wochen in der Tat eine verdriesliche Underperformance.
Ursache könnte ein Großpaketverkauf sein
(halte ich für am wahrscheinlichsten),
oder es ist eine Reaktion auf die ersten Verkaufszahlen von Ranexa
oder weil zu viele enttäuscht sind, dass der Wert sich nicht nach Zulassung nach oben entwickelt,
oder weil eine Kapitalerhöhung ansteht, und die institutionellen Geldgeber dieser Kapitalerhöhung schon mal Aktien leerverkaufen , weil sie wissen, dass sie ihre Aktien billiger zurückkaufen können.
CVTX verbrennt in hohen Maße Geld, muss es aber auch weil die Patente für Ranexa wohl nicht ewig halten werden.
Da ich weiß, dass meine Kommentare gerne als negativ interpretiert werden (ich zähle bei einer long-Postition nur gerne die negativen Aspekte auf) verlinke ich mal eine postive Schätzung.
Wie der Wert sich weiterentwickelt? Wenn ich das immer so genau wüsste, dann säße ich in der Karibik neben drei netten Schönheiten. Ich sehe unvermindert halt sehr gute Chancen für CVTX. Es ist eine Massenkrankheit und die Patienten werden aus eigenem Antrieb danach verlangen und eine gute Persistance haben.
Ursache könnte ein Großpaketverkauf sein
(halte ich für am wahrscheinlichsten),
oder es ist eine Reaktion auf die ersten Verkaufszahlen von Ranexa
oder weil zu viele enttäuscht sind, dass der Wert sich nicht nach Zulassung nach oben entwickelt,
oder weil eine Kapitalerhöhung ansteht, und die institutionellen Geldgeber dieser Kapitalerhöhung schon mal Aktien leerverkaufen , weil sie wissen, dass sie ihre Aktien billiger zurückkaufen können.
CVTX verbrennt in hohen Maße Geld, muss es aber auch weil die Patente für Ranexa wohl nicht ewig halten werden.
Da ich weiß, dass meine Kommentare gerne als negativ interpretiert werden (ich zähle bei einer long-Postition nur gerne die negativen Aspekte auf) verlinke ich mal eine postive Schätzung.
Wie der Wert sich weiterentwickelt? Wenn ich das immer so genau wüsste, dann säße ich in der Karibik neben drei netten Schönheiten. Ich sehe unvermindert halt sehr gute Chancen für CVTX. Es ist eine Massenkrankheit und die Patienten werden aus eigenem Antrieb danach verlangen und eine gute Persistance haben.
Der Grund kann ganz einfach sein , man ist unter dem 50 und 200 Tageschnitt gefallen.
hallo,und sollte ich jetzt erneut einsteigen,hatte sie vor Jahren schon einmal..
schönes langes WE.
schönes langes WE.
soll das ne Frage sein ?
Ich versteh diese Aktie nicht !!!
Mich persönlich nervt dieses Papier !!!
Ich würde noch warten die fallen garantiert erstmal noch bis 12 €
Dann könnte man sich wieder ein paar in depot legen !!!
ciao
Ich versteh diese Aktie nicht !!!
Mich persönlich nervt dieses Papier !!!
Ich würde noch warten die fallen garantiert erstmal noch bis 12 €
Dann könnte man sich wieder ein paar in depot legen !!!
ciao
Bin gestern zu 15,22€ rein. Kurs scheint sih nämlich zu stabilisieren.
Was ist denn heute los??????????????
Heute noch einmal zu 13,83€ nachgekauft. Es gibt keine news. Da regiert wohl nur die blanke Panik!
Danke denen, welche mir heute morgen noch welche zu 13,46€ gegeben haben!!
Mal sehen wann die 12 geknackt werden ???
Local Money
Dowpharma key producer in new heart medication
Kathie Marchlewski, Midland Daily News 05/08/2006
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A California biotech company with plans -- and FDA approval -- to revolutionize heart therapies has paired up with Dowpharma to produce the primary ingredient for its newest drug, Ranexa. The drug reduces pain from angina and is available in pharmacies now.
Palo Alto, Calif.-based CV Therapeutics has a sales force at work contacting the top prescribing physicians across the country and spreading the news about the drug it launched in March. Lauding it as a novel approach to angina -- the first new pharmaceutical approach in 20 years -- CVT expects the drug to reach 4 percent of the 6.4 million U.S. patients suffering from chronic angina in its first year. By 2009, it hopes to reach 16 percent of those patients.
Dowpharma, a business unit of The Dow Chemical Co., also has a work force in place at its Midland operations site, producing the drug's active pharmaceutical ingredient, which makes up 70 percent of the content of the peach-colored tablets. Dowpharma has been on board with CVT since October 2000, producing batches of the ingredients for Ranexa trials and the federal Food and Drug Administration approval process.
That process was complete in January, and Dowpharma now has produced 72 tons of the active ingredient, generically known as Ranolazine, at its 827 building. That's enough for 11 million tablets.
Angina-reducing drugs on the market before Ranexa typically work by reducing the heart rate and reducing the blood pressure in the heart. Ranexa, however, uses small molecule technology to allow the heart to work more efficiently. It also reduces the use of nitroglycerin medications, which heart patients typically would take at the onset of pain.
Ranexa is not intended as a replacement to other heart drugs, but instead is a supplement. "We're not asking them to take patients off anything," said Peter Strumph, vice president at CVT. "We're asking them to add Ranolazine."
In clinical trials using treadmill stress tests, patients taking Ranexa could go farther before pain set in. In their daily lives, they could be more active, doing things without pain that they couldn't do before.
"It delays that imbalance between a muscle getting more oxygen than is being supplied to it," Strumph said. "The patients actually feel the difference. The doctors actually see the difference."
In another test of 6,400 Ranexa users that is in progress and due for completion in 2007, CVT hopes to find that along with preventing pain, the drug also has a positive health benefit -- that patients who take it have a lower mortality rate than those who don't. That could change the way the drug is marketed, making it a first line of defense rather than a supplement.
"It becomes a drug that not only helps you feel better, but helps you live longer," Strumph said.
CVT originally entered into contract with Dowpharma as a secondary supplier. As the relationship developed, the other manufacturer was dropped, and Dow became the primary. According to the company, Ranolazine is poised to become one of the major products in the Dowpharma small molecules portfolio.
"We're looking forward to many more years of working on this project," said Jeff Legge, contract manager at Dowpharma.
Dowpharma also might partner with the company for other products it has in the works. CVT leaders hope to create an entire line of heart-related medications.
"We like to create partnerships where the best place to go, the easiest place to go, is somewhere we've already had products (produced)," Strumph said.
Ranexa marks CVT's third FDA approval in fewer than 12 months.
Dowpharma key producer in new heart medication
Kathie Marchlewski, Midland Daily News 05/08/2006
Email to a friendPost a CommentPrinter-friendly
A California biotech company with plans -- and FDA approval -- to revolutionize heart therapies has paired up with Dowpharma to produce the primary ingredient for its newest drug, Ranexa. The drug reduces pain from angina and is available in pharmacies now.
Palo Alto, Calif.-based CV Therapeutics has a sales force at work contacting the top prescribing physicians across the country and spreading the news about the drug it launched in March. Lauding it as a novel approach to angina -- the first new pharmaceutical approach in 20 years -- CVT expects the drug to reach 4 percent of the 6.4 million U.S. patients suffering from chronic angina in its first year. By 2009, it hopes to reach 16 percent of those patients.
Dowpharma, a business unit of The Dow Chemical Co., also has a work force in place at its Midland operations site, producing the drug's active pharmaceutical ingredient, which makes up 70 percent of the content of the peach-colored tablets. Dowpharma has been on board with CVT since October 2000, producing batches of the ingredients for Ranexa trials and the federal Food and Drug Administration approval process.
That process was complete in January, and Dowpharma now has produced 72 tons of the active ingredient, generically known as Ranolazine, at its 827 building. That's enough for 11 million tablets.
Angina-reducing drugs on the market before Ranexa typically work by reducing the heart rate and reducing the blood pressure in the heart. Ranexa, however, uses small molecule technology to allow the heart to work more efficiently. It also reduces the use of nitroglycerin medications, which heart patients typically would take at the onset of pain.
Ranexa is not intended as a replacement to other heart drugs, but instead is a supplement. "We're not asking them to take patients off anything," said Peter Strumph, vice president at CVT. "We're asking them to add Ranolazine."
In clinical trials using treadmill stress tests, patients taking Ranexa could go farther before pain set in. In their daily lives, they could be more active, doing things without pain that they couldn't do before.
"It delays that imbalance between a muscle getting more oxygen than is being supplied to it," Strumph said. "The patients actually feel the difference. The doctors actually see the difference."
In another test of 6,400 Ranexa users that is in progress and due for completion in 2007, CVT hopes to find that along with preventing pain, the drug also has a positive health benefit -- that patients who take it have a lower mortality rate than those who don't. That could change the way the drug is marketed, making it a first line of defense rather than a supplement.
"It becomes a drug that not only helps you feel better, but helps you live longer," Strumph said.
CVT originally entered into contract with Dowpharma as a secondary supplier. As the relationship developed, the other manufacturer was dropped, and Dow became the primary. According to the company, Ranolazine is poised to become one of the major products in the Dowpharma small molecules portfolio.
"We're looking forward to many more years of working on this project," said Jeff Legge, contract manager at Dowpharma.
Dowpharma also might partner with the company for other products it has in the works. CVT leaders hope to create an entire line of heart-related medications.
"We like to create partnerships where the best place to go, the easiest place to go, is somewhere we've already had products (produced)," Strumph said.
Ranexa marks CVT's third FDA approval in fewer than 12 months.
Es ist wahrlich nicht plausibel was momentan bei CVTX läuft- habe mich nicht all zu lange Zeit her bei 23 verabschiedet, weil ich nicht auf MERLIN warten wollte und jetzt dieser Kursverfall.
Habe wohl nur Glück gehabt- keiner konnte sowas ahnen. Ist auch klar das der Wert jetzt langsam ein "screaming buy" wird. Aber dann nur wenn die Wende sichtbar wird, da soll man nicht gierig sein und dafür etwas mehr bezahlen wollen.
Werde bestimmt bald wieder CVTX -Anteilhaber sein. Ist doch klar
Habe wohl nur Glück gehabt- keiner konnte sowas ahnen. Ist auch klar das der Wert jetzt langsam ein "screaming buy" wird. Aber dann nur wenn die Wende sichtbar wird, da soll man nicht gierig sein und dafür etwas mehr bezahlen wollen.
Werde bestimmt bald wieder CVTX -Anteilhaber sein. Ist doch klar
Antwort auf Beitrag Nr.: 21.628.759 von Schapekop am 17.05.06 20:43:46Na dann viel Glück. Bin ja nun schon länger drin zum Durchschnitt von 13,83€ was ich immer noch als sehr günstig sehe. In ein paar Wochen stehen wir wieder deutlich höher!
hallo zusammen,
habe cvtx vor ca. 5 jahren mal bei glaube ich 55 € gekauft, sind dann abgestürzt und ich bin raus bei 36 €, schöner mist, versteht ihr sicher.
habe cvtx immer im auge behalten, zwar nicht mehr so genau, aber immer mal wieder geschaut.
haben die jetzt eigentlich dieses angina pektoris mittel schon auf dem markt ?, mir ist der name leider entfallen, ranexan oder so ähnlich glaube ich.
wenn nicht, dann verstehe ich den kursverlauf schon, die waren doch damit schon vor 2 jahren in phase 3 oder ?
na ja wie dem auch sei, medarex bekommt ja auch ordentlich auf den hut, andere bios ja auch.
ich wünsch euch viel glück mit cvtx
lotto
habe cvtx vor ca. 5 jahren mal bei glaube ich 55 € gekauft, sind dann abgestürzt und ich bin raus bei 36 €, schöner mist, versteht ihr sicher.
habe cvtx immer im auge behalten, zwar nicht mehr so genau, aber immer mal wieder geschaut.
haben die jetzt eigentlich dieses angina pektoris mittel schon auf dem markt ?, mir ist der name leider entfallen, ranexan oder so ähnlich glaube ich.
wenn nicht, dann verstehe ich den kursverlauf schon, die waren doch damit schon vor 2 jahren in phase 3 oder ?
na ja wie dem auch sei, medarex bekommt ja auch ordentlich auf den hut, andere bios ja auch.
ich wünsch euch viel glück mit cvtx
lotto
PALO ALTO, Calif., May 25 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that patient enrollment in the MERLIN TIMI-36 study of ranolazine is now complete, with over 6,500 patients enrolled. The company expects top line data from the study could be available in the first quarter of 2007.
According to a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), if treatment with Ranexa® (ranolazine extended-release tablets) in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, the study's safety database could support potential approval of Ranexa as first-line chronic angina therapy, even if the primary endpoint is not met. In addition, if the primary endpoint is met, Ranexa could potentially also be approved for treatment of acute coronary syndromes (ACS) and secondary prevention.
"We are extremely pleased to have reached a significant landmark for this important clinical trial and appreciate the hard work of all of the MERLIN-TIMI 36 investigators and research coordinators worldwide," said Eugene Braunwald, M.D., distinguished Hersey Professor of Medicine, Harvard Medical School, Chairman, TIMI Study Group Brigham and Women's Hospital.
Study Details
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation ACS treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with Ranexa extended-release tablets or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.
The completion of MERLIN TIMI-36 is based on achieving specific numbers of events. The trial is expected to continue until a pre-specified number of cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and a pre-determined number of deaths from any cause have occurred. Slower than anticipated event rates could delay our schedule for trial completion and results.
Hört sich doch gut an- Ende Q1 07 sind die Ergebnisse zu erwarten- überschaubar, meine ich. Shortpositions sind gewachsen, also, bleibt potentiell hoch explosiv.
Melde Aufbau erste Posis.
According to a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), if treatment with Ranexa® (ranolazine extended-release tablets) in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, the study's safety database could support potential approval of Ranexa as first-line chronic angina therapy, even if the primary endpoint is not met. In addition, if the primary endpoint is met, Ranexa could potentially also be approved for treatment of acute coronary syndromes (ACS) and secondary prevention.
"We are extremely pleased to have reached a significant landmark for this important clinical trial and appreciate the hard work of all of the MERLIN-TIMI 36 investigators and research coordinators worldwide," said Eugene Braunwald, M.D., distinguished Hersey Professor of Medicine, Harvard Medical School, Chairman, TIMI Study Group Brigham and Women's Hospital.
Study Details
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation ACS treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients are enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with Ranexa extended-release tablets or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.
The completion of MERLIN TIMI-36 is based on achieving specific numbers of events. The trial is expected to continue until a pre-specified number of cases of cardiovascular death, myocardial infarction or severe recurrent ischemia have been observed, and a pre-determined number of deaths from any cause have occurred. Slower than anticipated event rates could delay our schedule for trial completion and results.
Hört sich doch gut an- Ende Q1 07 sind die Ergebnisse zu erwarten- überschaubar, meine ich. Shortpositions sind gewachsen, also, bleibt potentiell hoch explosiv.
Melde Aufbau erste Posis.
Antwort auf Beitrag Nr.: 21.815.311 von Schapekop am 26.05.06 15:45:11Irgendwie ist das alles was heute passiert nicht unlogisch- aber timing ist schon wichtig
Antwort auf Beitrag Nr.: 21.815.311 von Schapekop am 26.05.06 15:45:11bin auch dabei
Antwort auf Beitrag Nr.: 21.907.746 von allespaletti am 01.06.06 16:34:48ohne Kommentar aus dem Yahoo-Board,
Today, Lehman Brothers gave an update on the Regadenoson Phase III Trial progress and commented on Ranexa. The body of the report:
"CVTX announced this morning that it had completed enrollment in a confirmatory phase III trial of its selective A2A-adenosine agonist Regadenoson in patients under going pharmacologic stress myocardial perfusion imaging (MPI) studies. As with the prior successful phase III trial reported in August, 2005 this trial will assess comparability of scans between Regadenoson and Astellas's approved market leader Adenoscan. Given the 95% confidence level of comparability demonstrated in the first phase III trial and the identical trial design in this study, we expect positive results to be reported by YE06.
"While little attention has been devoted to Regadenoson during the recent launch of CVTX's lead anti-anginal Ranexa, we believe that this product alone could support upside from current valuation levels. With roughly $350M in US sales for Adenoscan, a profile for Regadenoson of quicker infusion time (10 second IV push vs. 6 minute slow infusion) with superior safety, and motivation of its partner Astellas to grow the market and replace its own Adenoscan with Regadenoson, we believe that rapid uptake to at least $400M in sales is likely within two years of a potential 4Q07 launch.
"Ultimately, with primary attention resting on Ranexa launch, we remain encouraged by early trends for this product, which we continue to believe are exceeding those for recent cardiovascular launches such as NTMDs Bidil. With a 2nd-line approval, differentiated hemodynamically-neutral profile, superior tolerability and at least 2.5M patients taking more poorly tolerated 3rd-line long acting nitrates(LANs) we believe Ranexa success is inevitable. With further upside potential to the Regadenoson commercial opportunity and an emerging pipeline of adenosine based drugs for cardiorespiratory disease, CVTX remains a top pick for 2006."
Lehman confirmed yet again their contention, as I reported earlier, that Regadenoson "alone could support upside from current valuation levels."
I COMPLETELY AGREE with Lehman's comment on Ranexa: "Ranexa success is INEVITABLE."
Connect the dots and forget the noise.
ValueSleuth
Ausbau erste Posis vorgesehen
Today, Lehman Brothers gave an update on the Regadenoson Phase III Trial progress and commented on Ranexa. The body of the report:
"CVTX announced this morning that it had completed enrollment in a confirmatory phase III trial of its selective A2A-adenosine agonist Regadenoson in patients under going pharmacologic stress myocardial perfusion imaging (MPI) studies. As with the prior successful phase III trial reported in August, 2005 this trial will assess comparability of scans between Regadenoson and Astellas's approved market leader Adenoscan. Given the 95% confidence level of comparability demonstrated in the first phase III trial and the identical trial design in this study, we expect positive results to be reported by YE06.
"While little attention has been devoted to Regadenoson during the recent launch of CVTX's lead anti-anginal Ranexa, we believe that this product alone could support upside from current valuation levels. With roughly $350M in US sales for Adenoscan, a profile for Regadenoson of quicker infusion time (10 second IV push vs. 6 minute slow infusion) with superior safety, and motivation of its partner Astellas to grow the market and replace its own Adenoscan with Regadenoson, we believe that rapid uptake to at least $400M in sales is likely within two years of a potential 4Q07 launch.
"Ultimately, with primary attention resting on Ranexa launch, we remain encouraged by early trends for this product, which we continue to believe are exceeding those for recent cardiovascular launches such as NTMDs Bidil. With a 2nd-line approval, differentiated hemodynamically-neutral profile, superior tolerability and at least 2.5M patients taking more poorly tolerated 3rd-line long acting nitrates(LANs) we believe Ranexa success is inevitable. With further upside potential to the Regadenoson commercial opportunity and an emerging pipeline of adenosine based drugs for cardiorespiratory disease, CVTX remains a top pick for 2006."
Lehman confirmed yet again their contention, as I reported earlier, that Regadenoson "alone could support upside from current valuation levels."
I COMPLETELY AGREE with Lehman's comment on Ranexa: "Ranexa success is INEVITABLE."
Connect the dots and forget the noise.
ValueSleuth
Ausbau erste Posis vorgesehen
Antwort auf Beitrag Nr.: 22.006.226 von Schapekop am 08.06.06 13:45:07Kulmbach (aktiencheck.de AG) - Nach Ansicht der Experten vom Anlegermagazin "Der Aktionär" eignet sich die Aktie von CV Therapeutics (ISIN US1266671049/ WKN 912268) als eine spekulative Depotbeimischung.
Kein anderer Pharmakonzern habe so viele Blockbuster, also Medikamente mit einem Jahresumsatz von mehr als 1 Mrd. USD, im Programm wie Pfizer. Zu den Verkaufsschlagern würden neben dem Cholesterinsenker Lipitor auch das Herz-Kreislauf-Medikament Norvasc und das Potenzmittel Viagra zählen. Allerdings drücke genau auf der Produktseite der Schuh. Die Top-Seller von heute würden für morgen nur wenige Wachstumsaussichten bieten. Zwar sei die Entwicklungspipeline von Pfizer gut gefüllt, doch die Auswahl an neuen Medikamenten mit Blockbuster-Potenzial sei überschaubar. Keines der 17 Pfizer-Medikamente, die seit 2001 zugelassen worden seien, habe mehr als 1 Mrd. USD Umsatz pro Jahr erreicht.
Anzeige:
Was haben Brasilien, Russland, Indien und China gemeinsam? Wachstum! Profitieren Sie mit dem
DWS-Funds-BRIC Rainbow vom Aufschwung der 4 Schwellenländer! Der DWS-Fonds mit 90% Erstanteilwert-Garantie!
Gelöst werden solle das Problem bei Pfizer mit einer Kaufoffensive. Durch die Veräußerung der Sparte mit rezeptfreien Medikamenten Ende Juni an Johnson & Johnson sei die Kriegskasse noch praller gefüllt. So bewege sich der Barbestand bei fast 30 Mrd. USD. Mit 17 Mrd. USD wolle man nun auf Einkaufstour gehen. Bis 2007 wolle Pfizer neue Medikamentkandidaten und Technologien erwerben - und notfalls die entwickelnden Unternehmen gleich mit.
Eines der Unternehmen welches nach Meinung von Analysten ganz oben auf der Einkaufsliste von Pfizer stehen könnte sei CV Therapeutics. Dabei gehe es um den Wirkstoff Ranexa - ein Mittel zur Behandlung von chronischer Herzkranzgefäßverengung. Das Medikament habe dabei Potenzial zum Standardtherapeutikum und zum Blockbuster zu werden. Mit einem Börsenwert von unter 600 Mio. USD sei das Unternehmen momentan günstig zu haben.
Ein Übernahmeopfer sei auch die Biotech-Schmiede Incyte Pharmaceuticals. Die Gründe hierfür würden auf der Hand liegen. Bereits jetzt mache das Unternehmen aus Wilmington im US-Staat Delaware mit dem Pharma-Riesen gemeinsame Sache bei der Entwicklung eines experimentellen Wirkstoffs, der unter anderem gegen Rheuma und Diabetes eingesetzt werden solle. Entsprechende klinische Tests der Phase II würden derzeit laufen. Zwar würden noch einige Jahre vergehen, bis das Präparat marktreif sei. Doch wegen der derzeitigen Kursschwäche sei es nicht unwahrscheinlich, dass Pfizer im Rahmen seiner Einkaufstour bei Incyte schon in Kürze zugreife. Kurzfristig könnten Spekulationen um eine mögliche Übernahme durch Pfizer die Aktien von CV Therapeutics und Incyte beflügeln.
Nach Ansicht der Experten von "Der Aktionär" eignet sich die Aktie von CV Therapeutics als spekulative Depotbeimischung. Das Kursziel sehe man bei 20 EUR. (19.07.2006/ac/a/a)
Das wär was, wenn da was werden würde..$$$$$$$
Vorstellbar ist es zumindest schon..
Die Zahlen kommen am 3. August.. Mal sehen..
Kein anderer Pharmakonzern habe so viele Blockbuster, also Medikamente mit einem Jahresumsatz von mehr als 1 Mrd. USD, im Programm wie Pfizer. Zu den Verkaufsschlagern würden neben dem Cholesterinsenker Lipitor auch das Herz-Kreislauf-Medikament Norvasc und das Potenzmittel Viagra zählen. Allerdings drücke genau auf der Produktseite der Schuh. Die Top-Seller von heute würden für morgen nur wenige Wachstumsaussichten bieten. Zwar sei die Entwicklungspipeline von Pfizer gut gefüllt, doch die Auswahl an neuen Medikamenten mit Blockbuster-Potenzial sei überschaubar. Keines der 17 Pfizer-Medikamente, die seit 2001 zugelassen worden seien, habe mehr als 1 Mrd. USD Umsatz pro Jahr erreicht.
Anzeige:
Was haben Brasilien, Russland, Indien und China gemeinsam? Wachstum! Profitieren Sie mit dem
DWS-Funds-BRIC Rainbow vom Aufschwung der 4 Schwellenländer! Der DWS-Fonds mit 90% Erstanteilwert-Garantie!
Gelöst werden solle das Problem bei Pfizer mit einer Kaufoffensive. Durch die Veräußerung der Sparte mit rezeptfreien Medikamenten Ende Juni an Johnson & Johnson sei die Kriegskasse noch praller gefüllt. So bewege sich der Barbestand bei fast 30 Mrd. USD. Mit 17 Mrd. USD wolle man nun auf Einkaufstour gehen. Bis 2007 wolle Pfizer neue Medikamentkandidaten und Technologien erwerben - und notfalls die entwickelnden Unternehmen gleich mit.
Eines der Unternehmen welches nach Meinung von Analysten ganz oben auf der Einkaufsliste von Pfizer stehen könnte sei CV Therapeutics. Dabei gehe es um den Wirkstoff Ranexa - ein Mittel zur Behandlung von chronischer Herzkranzgefäßverengung. Das Medikament habe dabei Potenzial zum Standardtherapeutikum und zum Blockbuster zu werden. Mit einem Börsenwert von unter 600 Mio. USD sei das Unternehmen momentan günstig zu haben.
Ein Übernahmeopfer sei auch die Biotech-Schmiede Incyte Pharmaceuticals. Die Gründe hierfür würden auf der Hand liegen. Bereits jetzt mache das Unternehmen aus Wilmington im US-Staat Delaware mit dem Pharma-Riesen gemeinsame Sache bei der Entwicklung eines experimentellen Wirkstoffs, der unter anderem gegen Rheuma und Diabetes eingesetzt werden solle. Entsprechende klinische Tests der Phase II würden derzeit laufen. Zwar würden noch einige Jahre vergehen, bis das Präparat marktreif sei. Doch wegen der derzeitigen Kursschwäche sei es nicht unwahrscheinlich, dass Pfizer im Rahmen seiner Einkaufstour bei Incyte schon in Kürze zugreife. Kurzfristig könnten Spekulationen um eine mögliche Übernahme durch Pfizer die Aktien von CV Therapeutics und Incyte beflügeln.
Nach Ansicht der Experten von "Der Aktionär" eignet sich die Aktie von CV Therapeutics als spekulative Depotbeimischung. Das Kursziel sehe man bei 20 EUR. (19.07.2006/ac/a/a)
Das wär was, wenn da was werden würde..$$$$$$$
Vorstellbar ist es zumindest schon..
Die Zahlen kommen am 3. August.. Mal sehen..
Antwort auf Beitrag Nr.: 23.041.475 von wallstreetcrash am 25.07.06 16:29:57Jetzt für deutlich weniger als 9€ zu haben!!
7,68€
Antwort auf Beitrag Nr.: 23.041.475 von wallstreetcrash am 25.07.06 16:29:57der aktionär hat cvtx 99/2000 auch schon spekulativen anlegern empfolen, bin zu 54 € rein und bei 37 € wieder raus, damals gab es den ersten crach wegen eines in phase 2 befindlichen medikaments welches noch weiter probanten brauchte, erinnere mich noch gut daran.
die miesen würde ich gerne mit cvtx wieder gut machen, aber wo ist der boden ????
die kosten genau so viel wie medx, wo seht ihr mehr potenzial ???
grüße
lotto
die miesen würde ich gerne mit cvtx wieder gut machen, aber wo ist der boden ????
die kosten genau so viel wie medx, wo seht ihr mehr potenzial ???
grüße
lotto
Antwort auf Beitrag Nr.: 23.041.475 von wallstreetcrash am 25.07.06 16:29:57der aktionär hat cvtx 99/2000 auch schon spekulativen anlegern empfolen, bin zu 54 € rein und bei 37 € wieder raus, damals gab es den ersten crach wegen eines in phase 2 befindlichen medikaments welches noch weiter probanten brauchte, erinnere mich noch gut daran.
die miesen würde ich gerne mit cvtx wieder gut machen, aber wo ist der boden ????
die kosten genau so viel wie medx, wo seht ihr mehr potenzial ???
grüße
lotto
die miesen würde ich gerne mit cvtx wieder gut machen, aber wo ist der boden ????
die kosten genau so viel wie medx, wo seht ihr mehr potenzial ???
grüße
lotto
ach, de lotto
mich würd so auf die schnelle interessieren, ob die noch mehr blockbusterkandidaten ham.
mich würd so auf die schnelle interessieren, ob die noch mehr blockbusterkandidaten ham.
meines erachtens ist cvtx völlig unterbewerte, ganau vie medx
radusel, bist du auch in bios ??
grüße
lotto
Antwort auf Beitrag Nr.: 24.036.658 von lottojan10 am 19.09.06 10:31:418 € scheint hier der boden zu sein, mal sehen ob wir sie noch mal testen
lotto
lotto
es ist noch nicht die zeit für einen wiedereinstieg, obwohl es danach aussieht, man bedenke wo wir herkommen.
lotto
lotto
CV Therapeutics Agent Does Well in Trial
Monday December 4, 8:31 am ET
CV Therapeutics' Regadenoson Meets Goal in Late-Stage Trial, Company Plans Mid-2007 Application
PALO ALTO, Calif. (AP) -- Shares of CV Therapeutics Inc. rose in premarket trading on Monday after the drugmaker said it will file a new drug application to the U.S. Food and Drug Administration for its regadenoson agent in mid-2007 following positive results from a late-stage trial.
Regadenoson is used in myocardial perfusion imaging studies, or studies on coronary artery disease. CV Therapeutics said in late-stage trials regadenoson was comparable to Adenoscan, another drug used in MPI studies.
If regadenoson is approved by the FDA, Astellas Pharma US Inc. will be responsible for commercial activities for regadenoson in the U.S., while CV Therapeutics retails rights to the drug outside of North America.
Shares rose 36 cents, or 3 percent, to $12.42 during premarket electronic trading on the Nasdaq, after closing at $12.06 on Friday on the Nasdaq.
Monday December 4, 8:31 am ET
CV Therapeutics' Regadenoson Meets Goal in Late-Stage Trial, Company Plans Mid-2007 Application
PALO ALTO, Calif. (AP) -- Shares of CV Therapeutics Inc. rose in premarket trading on Monday after the drugmaker said it will file a new drug application to the U.S. Food and Drug Administration for its regadenoson agent in mid-2007 following positive results from a late-stage trial.
Regadenoson is used in myocardial perfusion imaging studies, or studies on coronary artery disease. CV Therapeutics said in late-stage trials regadenoson was comparable to Adenoscan, another drug used in MPI studies.
If regadenoson is approved by the FDA, Astellas Pharma US Inc. will be responsible for commercial activities for regadenoson in the U.S., while CV Therapeutics retails rights to the drug outside of North America.
Shares rose 36 cents, or 3 percent, to $12.42 during premarket electronic trading on the Nasdaq, after closing at $12.06 on Friday on the Nasdaq.
bei 8,10 € denke ich kann man was rein stellen.
es bleibt spannend.
gibts außer mir eigentlich noch jemanden den cvtx interessiert ??
grüße
lotto
es bleibt spannend.
gibts außer mir eigentlich noch jemanden den cvtx interessiert ??
grüße
lotto
MERLIN verfehlt den ACS-endpoint, und muß nun mit "studie gescheitert" überschriften leben.
allerdings war das erreichen dieses hauptziels nicht unbedingt erwartet worden, und die daten zur sicherheit von ranexa (arrhythmia) scheinen vorteilhaft zu sein.
interessant wird sein zu beobachten, wie hoch der kursrückschlag morgen ausfällt, und wie schnell bzw. ob sich der kurs wieder erholt.
mein rat für die, die bis jetzt durchgehalten haben:
nicht in den ersten stunden morgen verkaufen.
möglicherweise ergeben sich gar gute einstiegschancen im zuge von unbegründeten panikverkäufen, denn immerhin könnte MERLIN eine labelerweiterung auf 1rst-line angina möglich machen.
allerdings war das erreichen dieses hauptziels nicht unbedingt erwartet worden, und die daten zur sicherheit von ranexa (arrhythmia) scheinen vorteilhaft zu sein.
interessant wird sein zu beobachten, wie hoch der kursrückschlag morgen ausfällt, und wie schnell bzw. ob sich der kurs wieder erholt.
mein rat für die, die bis jetzt durchgehalten haben:
nicht in den ersten stunden morgen verkaufen.
möglicherweise ergeben sich gar gute einstiegschancen im zuge von unbegründeten panikverkäufen, denn immerhin könnte MERLIN eine labelerweiterung auf 1rst-line angina möglich machen.
V THERAPEUTICS EUR 6.60 7.00 -2.67 -28.8% 9.27
Autsch, wäre gestern fast eingestiegen!
Autsch, wäre gestern fast eingestiegen!
Antwort auf Beitrag Nr.: 28.157.386 von Mr.Arrogance am 07.03.07 00:10:36Vielleicht wird der Abschlag bei den Amis auch nicht so hoch wie gerade bei uns. Dann wäre jetzt ein Einstieg verlockend!
Versuche es mal mit einem Kaufauftrag zu 5,50€!
aus Investor Village- Beitrag von User Wooten.
Investment Conclusion
CVTX should benefit from positive MERLIN safety
data as well as efficacy subset data for antianginal
drug Ranexa. While the phase IV study did
not support expanded efficacy in acute coronary
patients, we believe clean safety and absence of
arrythmia should provide improved labeling in its
current chronic angina indication
Summary
CVTX reported topline results from the MERLIN
TIMI-36 trial yesterday after market close meeting
the primary safety endpoint with no excess death
or arrythmia but failing to demonstrate a reduction
in composite time to death, MI and recurrent
ischemia in patients with acute coronary syndrome
While these topline results will not likely support
expanded indication beyond chronic angina, the
results should support improved labeling around
arrythmia potential as well as expanded labeling
for frontline use. We would note that with 9mln
chronic angina patients and roughly 2.5mln 3rd line
patients that neither 2nd line calcium blockers or
3rd line nitrates have shown reduced ACS events
With full MERLIN data at ACC on March 27th we
would highlight prior benefits on ischemia,
arrythmia and diabetes as providing potential
upside on subset data to be presented.
=======
Lehman kept their $40 price target.
There is a more extensive lehman write up that follows the summary I posted above.
I guess if the majority of the short sellers shorted because they did not think the drug was safe, then they are in sort of an awkward position ... they have a profit + an awkward position ... the longs however, even those who bought in the 12s, have a loss + an awkward position.
The market will remove awkward from this equation pretty quickly.
Ich meine auch, dass die Marktreaktion übertrieben war gestern nach Börsenschluss- vll irre ich mich da, aber eine kleine Wette von ein paar hundert Stücke ist es schon wert- also habe ich gekauft. Mal schauen- first line treatment gegen Angina ist einiges und das kann noch werden.
Investment Conclusion
CVTX should benefit from positive MERLIN safety
data as well as efficacy subset data for antianginal
drug Ranexa. While the phase IV study did
not support expanded efficacy in acute coronary
patients, we believe clean safety and absence of
arrythmia should provide improved labeling in its
current chronic angina indication
Summary
CVTX reported topline results from the MERLIN
TIMI-36 trial yesterday after market close meeting
the primary safety endpoint with no excess death
or arrythmia but failing to demonstrate a reduction
in composite time to death, MI and recurrent
ischemia in patients with acute coronary syndrome
While these topline results will not likely support
expanded indication beyond chronic angina, the
results should support improved labeling around
arrythmia potential as well as expanded labeling
for frontline use. We would note that with 9mln
chronic angina patients and roughly 2.5mln 3rd line
patients that neither 2nd line calcium blockers or
3rd line nitrates have shown reduced ACS events
With full MERLIN data at ACC on March 27th we
would highlight prior benefits on ischemia,
arrythmia and diabetes as providing potential
upside on subset data to be presented.
=======
Lehman kept their $40 price target.
There is a more extensive lehman write up that follows the summary I posted above.
I guess if the majority of the short sellers shorted because they did not think the drug was safe, then they are in sort of an awkward position ... they have a profit + an awkward position ... the longs however, even those who bought in the 12s, have a loss + an awkward position.
The market will remove awkward from this equation pretty quickly.
Ich meine auch, dass die Marktreaktion übertrieben war gestern nach Börsenschluss- vll irre ich mich da, aber eine kleine Wette von ein paar hundert Stücke ist es schon wert- also habe ich gekauft. Mal schauen- first line treatment gegen Angina ist einiges und das kann noch werden.
Antwort auf Beitrag Nr.: 28.163.213 von Schapekop am 07.03.07 12:41:48Zu welchem Kurs konntest Du kaufen? Ist ja ein wenig schwierig einen guten Kurs zu bekommen(grosser spread).
Also ich bin jetzt zu 3 Sprüngen rein 7,4 7,2 und 6,9 jeweils 1500 Stück. denke, der Kurssturz ist nicht gerechtfertigt.
Antwort auf Beitrag Nr.: 28.168.044 von Fraindt am 07.03.07 16:30:31Ich versuche es bei 6,60! geht ja gerade deutlich runter!
Hier sind mit etwas Geduld leicht die 20% von heute wieder aufzuholen.
Das Ergebnis der Testreihe war ja eh nicht unbedingt positiv erwartet worden. Kurzschluß-Börse.
Das Ergebnis der Testreihe war ja eh nicht unbedingt positiv erwartet worden. Kurzschluß-Börse.
Antwort auf Beitrag Nr.: 28.169.611 von Fraindt am 07.03.07 17:36:12Bin zu 6,95 gestern komischerweise nicht reingekommen. Warte die USA Eröffnung ab und dann eventuell rein!
Zu 7 euronen heute rein!
hätte nicht gedacht, dass es noch weiter runtergeht!!
Heute gehts aber nochmal richtig zur Sache!
altime-Kurse
Datum Zeit Bid Ask
23.03. 15:57:01 6,20 EUR 6,39 EUR
Letzte Kursänderung: 15:51:41
Irgendwelche news, kann nichts finden!
altime-Kurse
Datum Zeit Bid Ask
23.03. 15:57:01 6,20 EUR 6,39 EUR
Letzte Kursänderung: 15:51:41
Irgendwelche news, kann nichts finden!
Was geht hier bloss ab????
ealtime-Kurse
Datum Zeit Bid Ask
23.03. 17:27:06 6,01 EUR 6,19 EUR
Letzte Kursänderung: 17:27:03
ealtime-Kurse
Datum Zeit Bid Ask
23.03. 17:27:06 6,01 EUR 6,19 EUR
Letzte Kursänderung: 17:27:03
von größerer bedeutung dürfte folgende erkenntnis sein:
http://www.acc.org/2007ann%5Fmeeting/i2%5F07/pdfs/414%2D9%5F…
http://www.acc.org/2007ann%5Fmeeting/i2%5F07/pdfs/414%2D9%5F…
courage war gestern schon bekannt ja- doppelt Vitamine?
Antwort auf Beitrag Nr.: 28.496.412 von Schapekop am 26.03.07 11:50:46Everett- der Kardiologe aus dem Investor Village Board ist schon wach:
Re: Merlin results published by some apparent error-
Amazing. Somebody's going to hang for leaking this stuff.
This was the key thing I was looking for. If MERLIN missed on the Primary - did it at least hit on the Recurrent Ischemia component? It did. Big, big relief.
It means MERLIN confirms that Ranexa works superbly in chronic angina - with the most stringent, difficult chronic angina endpoint ever seen in a clinical trial.
It also means the p value on the Primary will likely be a near miss - a solid trend (p between 0.05 and 0.10). Not like hitting it, but a big help.
And a lot of data to come.
Re: Merlin results published by some apparent error-
Amazing. Somebody's going to hang for leaking this stuff.
This was the key thing I was looking for. If MERLIN missed on the Primary - did it at least hit on the Recurrent Ischemia component? It did. Big, big relief.
It means MERLIN confirms that Ranexa works superbly in chronic angina - with the most stringent, difficult chronic angina endpoint ever seen in a clinical trial.
It also means the p value on the Primary will likely be a near miss - a solid trend (p between 0.05 and 0.10). Not like hitting it, but a big help.
And a lot of data to come.
Antwort auf Beitrag Nr.: 28.496.412 von Schapekop am 26.03.07 11:50:46Bei 8,18 $ wird aktuell geschmissen (mit ner iceberg-order).
Antwort auf Beitrag Nr.: 28.497.700 von barabo am 26.03.07 13:06:21In 2,5 Stunden wissen wir mehr. Ich gehe von steigenden Kursen aus!
Antwort auf Beitrag Nr.: 28.497.700 von barabo am 26.03.07 13:06:21Order hat jetzt fertig
Es wurden 9600 Stück gehandelt.
Es wurden 9600 Stück gehandelt.
Antwort auf Beitrag Nr.: 28.497.933 von barabo am 26.03.07 13:19:18Na dann.
L&S ist jedenfalls auch verunsichert!
Datum Zeit Bid Ask
26.03. 13:28:54 6,10 EUR 6,60 EUR
Letzte Kursänderung: 13:28:49
Datum Zeit Bid Ask
26.03. 13:28:54 6,10 EUR 6,60 EUR
Letzte Kursänderung: 13:28:49
flyonthewall schreibt von downgrade durch db mit kursziel $2.
das wäre einer der größten lacher der letzten monate...
das wäre einer der größten lacher der letzten monate...
Antwort auf Beitrag Nr.: 28.498.495 von Mr.Arrogance am 26.03.07 13:52:18Was den Analysten wohl geritten hat!
Antwort auf Beitrag Nr.: 28.498.734 von Isabartels am 26.03.07 14:06:44Schätze mal, dass der bald auf jobsuche ist!
Gleich wissen wir mehr!!
Antwort auf Beitrag Nr.: 28.500.463 von Isabartels am 26.03.07 15:30:30morgen wissen wir mehr!
15:36:51 5,65 5,47
Antwort auf Beitrag Nr.: 28.500.650 von Mr.Arrogance am 26.03.07 15:37:08Ich meinte, was den Kurs betrifft!
Scheiße, bei 7,20 rein ! das ist hart.
hatte mir eigentlich vorgenommen, meine kleine position nicht auszubauen. kein nachkauf bei cvtx!
habe jedoch eine vorliebe für fallende messer nach analysten-downgrades!
nachkauf bei $7,35.
habe jedoch eine vorliebe für fallende messer nach analysten-downgrades!
nachkauf bei $7,35.
Ich glaube das alles nicht!
Antwort auf Beitrag Nr.: 28.501.010 von Fraindt am 26.03.07 15:49:01Dollar oder Euro??
Euro, sonst wärs eher ned schlimm. hab grad 1400 nachgekauft.
Antwort auf Beitrag Nr.: 28.501.323 von Fraindt am 26.03.07 16:00:46das konnte man leider auch nicht ahnen!
Antwort auf Beitrag Nr.: 28.501.633 von Isabartels am 26.03.07 16:13:39War heute unterwegs- aber Erklärung kann nur sein, DB kennt das Bericht noch net und der Analyst wird bald entlassen.
Morgen ist die Präsentation und geht die Achterbahn weiter- ich habe gerade beigekauft.
Die Fakten liegen aufm Tisch, nur keiner findet sie anscheinend.
Morgen ist die Präsentation und geht die Achterbahn weiter- ich habe gerade beigekauft.
Die Fakten liegen aufm Tisch, nur keiner findet sie anscheinend.
Antwort auf Beitrag Nr.: 28.503.191 von Schapekop am 26.03.07 17:21:04Sehr mysteriös
Eine Analyse mit downgrade von 8 auf 2 $ ist extrem ungewöhnlich und das auch noch einen Tag vor der geplanten Veröffentlichung der Präsentation
Warum hat man nicht diesen einen Tag abgewartet ?
Oder handelt es sich um ein abgekartetes Spiel der übelsten Art : Heute noch die Kleinanlegerscharen rausdrücken und später schön Kasse machen
Eine Analyse mit downgrade von 8 auf 2 $ ist extrem ungewöhnlich und das auch noch einen Tag vor der geplanten Veröffentlichung der Präsentation
Warum hat man nicht diesen einen Tag abgewartet ?
Oder handelt es sich um ein abgekartetes Spiel der übelsten Art : Heute noch die Kleinanlegerscharen rausdrücken und später schön Kasse machen
Antwort auf Beitrag Nr.: 28.503.374 von barabo am 26.03.07 17:29:39weiss ich auch net- ist wohl sehr übel und extrem. haben wohl eine gute rechtsabteilung.
Kann nur die Meinung von Everett wiederholen- ich kenne mir da auch wohl aus, aber er 10x besser.
Re: Merlin results published by some apparent error-
Amazing. Somebody\'s going to hang for leaking this stuff.
This was the key thing I was looking for. If MERLIN missed on the Primary - did it at least hit on the Recurrent Ischemia component? It did. Big, big relief.
It means MERLIN confirms that Ranexa works superbly in chronic angina - with the most stringent, difficult chronic angina endpoint ever seen in a clinical trial.
It also means the p value on the Primary will likely be a near miss - a solid trend (p between 0.05 and 0.10). Not like hitting it, but a big help.
And a lot of data to come
Kann nur die Meinung von Everett wiederholen- ich kenne mir da auch wohl aus, aber er 10x besser.
Re: Merlin results published by some apparent error-
Amazing. Somebody\'s going to hang for leaking this stuff.
This was the key thing I was looking for. If MERLIN missed on the Primary - did it at least hit on the Recurrent Ischemia component? It did. Big, big relief.
It means MERLIN confirms that Ranexa works superbly in chronic angina - with the most stringent, difficult chronic angina endpoint ever seen in a clinical trial.
It also means the p value on the Primary will likely be a near miss - a solid trend (p between 0.05 and 0.10). Not like hitting it, but a big help.
And a lot of data to come
Antwort auf Beitrag Nr.: 28.503.485 von Schapekop am 26.03.07 17:35:05Passend zu deiner Einschätzung empfehle ich dir diesen Schein :
YJHAB
gültig bis 19.01.2008
Basis = 10 $
aktueller Kurs = 0,55 $
Freitag kostete er noch 1,25 $
YJHAB
gültig bis 19.01.2008
Basis = 10 $
aktueller Kurs = 0,55 $
Freitag kostete er noch 1,25 $
Antwort auf Beitrag Nr.: 28.503.693 von barabo am 26.03.07 17:46:41Oder gefällt es dir so besser ?
UXCER
gültig bis 19.05.2007
Basis = 7,50 $
aktueller Kurs = 0,45 $
Freitag waren es noch 1,55 $
UXCER
gültig bis 19.05.2007
Basis = 7,50 $
aktueller Kurs = 0,45 $
Freitag waren es noch 1,55 $
Antwort auf Beitrag Nr.: 28.503.485 von Schapekop am 26.03.07 17:35:05Vielleicht ist das Downgrade ein deal mit den shortsellern
CVTX $ 6.72
CV Therapeutics Inc. - Common Stock -1.85
Shares Short 16,256,941
Days to Cover (Short Ratio) 11.3
Short % of Float 28.23 %
Shares Short - Prior 16,343,727
Short % Increase / Decrease -0.53 %
Squeeze Ranking™ -198
% from 52-Wk HIGH ( 23.47 ) -249.26 %
% from 52-Wk LOW ( 8.00 ) -19.05 %
% from 200-Day MA ( 12.34 ) -83.63 %
% from 50-Day MA ( 11.50 )
-71.13 %
Price % Change (52-Wk) -62.10 %
Trading Volume - Today 9,208,583
Trading Volume - Average 1,438,927
Trading Volume Vs. Avg. 639.96 %
Total Shares - Float 57,590,000
Total Shares - Outstanding 59,327,444
% Held by Insiders 6.97 %
% Held by Institutions %
Market Cap 398,680,411
EPS -5.49
PE Ratio
Sector: Healthcare
Industry: Biotechnology
SI Record Date 2007-Feb
Information Provided Without Warranty
CVTX $ 6.72
CV Therapeutics Inc. - Common Stock -1.85
Shares Short 16,256,941
Days to Cover (Short Ratio) 11.3
Short % of Float 28.23 %
Shares Short - Prior 16,343,727
Short % Increase / Decrease -0.53 %
Squeeze Ranking™ -198
% from 52-Wk HIGH ( 23.47 ) -249.26 %
% from 52-Wk LOW ( 8.00 ) -19.05 %
% from 200-Day MA ( 12.34 ) -83.63 %
% from 50-Day MA ( 11.50 )
-71.13 %
Price % Change (52-Wk) -62.10 %
Trading Volume - Today 9,208,583
Trading Volume - Average 1,438,927
Trading Volume Vs. Avg. 639.96 %
Total Shares - Float 57,590,000
Total Shares - Outstanding 59,327,444
% Held by Insiders 6.97 %
% Held by Institutions %
Market Cap 398,680,411
EPS -5.49
PE Ratio
Sector: Healthcare
Industry: Biotechnology
SI Record Date 2007-Feb
Information Provided Without Warranty
Antwort auf Beitrag Nr.: 28.504.321 von barabo am 26.03.07 18:17:25Vielleicht ist das Downgrade ein deal mit den shortsellern
man findet viel Theorien im Board momentan- dies ist einer davon. Wie auch immer, lese gerade die hunderte Postings im Investor Village Board durch (wo die Experten sind)- da ist die Hölle los- aber die "Experten" schweigen- ich denke die machen ein Einkaufsbummel.
Keine offizielle Reaktion auf den Leak, also warten alle auf das Announcement von morgen. Irgendwie blöd- habe vor DB 1,4k gekauft, aber gerade noch was mehr. Scheine brauche ich nicht-nicht mein Ding.
man findet viel Theorien im Board momentan- dies ist einer davon. Wie auch immer, lese gerade die hunderte Postings im Investor Village Board durch (wo die Experten sind)- da ist die Hölle los- aber die "Experten" schweigen- ich denke die machen ein Einkaufsbummel.
Keine offizielle Reaktion auf den Leak, also warten alle auf das Announcement von morgen. Irgendwie blöd- habe vor DB 1,4k gekauft, aber gerade noch was mehr. Scheine brauche ich nicht-nicht mein Ding.
Antwort auf Beitrag Nr.: 28.506.259 von Schapekop am 26.03.07 19:42:45Beitrag von Gooiedag- "holländischer" Ami anscheinend bei Investor Village- meine Gedanken sehr nah kommend- dabei ist seine Ausbildung gut für meine #1 Wert CYTX:
Re: I'm buying
I don't know how much science you know - I confess to a PH.D in Molecular Biology - but the entire universe is governed by two principles. One is that all processes , i.e, all events that we can discern, occur at some rate. That's kinetics. The second class of principles involve thermodynamics. They tell us what will inevitably happen. Here's the kicker. Although thermodynamicists can say what will happen they generally haven't a clue as to when or how fast an event or process will take place. They can't provide acurate time lines. Traders are kineticists. They try to gauge the "instananeous" changes in share prices by looking at charts, reacting to analysts, reading tea leaves etc. They are looking for bottoms, tops, buy signals, sell signals etc. I wish them luck. Most loose at that game. I'm a thermodynamicist, i.e an investor. I try to guage what a company is worth and buy when I think it is worth more than its current price. I might be wrong and often am. But I look at the available data on the company - not the charts - and try to predict the outcome, not the pathway. I'm happy if I buy at $6, the stock goes to $4 but one year later it goes to $10 (my target price, lets say). That's a 70% return in a year. I can and do change my mind when I get new thermodynamic data - sales, finances, increasing or decreasing market share, lower or higher margins etc.). But I regard the day to day events in the market as noise and thank G for the traders. In my experience they usually create the best buying opportunities provided you know thermodynamics.
Re: I'm buying
I don't know how much science you know - I confess to a PH.D in Molecular Biology - but the entire universe is governed by two principles. One is that all processes , i.e, all events that we can discern, occur at some rate. That's kinetics. The second class of principles involve thermodynamics. They tell us what will inevitably happen. Here's the kicker. Although thermodynamicists can say what will happen they generally haven't a clue as to when or how fast an event or process will take place. They can't provide acurate time lines. Traders are kineticists. They try to gauge the "instananeous" changes in share prices by looking at charts, reacting to analysts, reading tea leaves etc. They are looking for bottoms, tops, buy signals, sell signals etc. I wish them luck. Most loose at that game. I'm a thermodynamicist, i.e an investor. I try to guage what a company is worth and buy when I think it is worth more than its current price. I might be wrong and often am. But I look at the available data on the company - not the charts - and try to predict the outcome, not the pathway. I'm happy if I buy at $6, the stock goes to $4 but one year later it goes to $10 (my target price, lets say). That's a 70% return in a year. I can and do change my mind when I get new thermodynamic data - sales, finances, increasing or decreasing market share, lower or higher margins etc.). But I regard the day to day events in the market as noise and thank G for the traders. In my experience they usually create the best buying opportunities provided you know thermodynamics.
die anteile hätte ich auch 10% billiger bekommen können...
nun gut.
wird also interessant morgen. schauen wir mal, ob die gute jenny tatsächlich mehr weiß, oder ob sie ein paar shorties gefällig war...
birchenough von lb jedenfalls bleibt bei seiner auffassung... zunächst.
nun gut.
wird also interessant morgen. schauen wir mal, ob die gute jenny tatsächlich mehr weiß, oder ob sie ein paar shorties gefällig war...
birchenough von lb jedenfalls bleibt bei seiner auffassung... zunächst.
Antwort auf Beitrag Nr.: 28.510.521 von Mr.Arrogance am 27.03.07 00:59:47ist schon aufregend das ganze...hätte sie auch 3% günstiger haben können
bin mal gespannt, wie der tag heut verläuft. nachbörslich ging es ja in us ja wieder ein paar cent rauf. und lehmann brothers ist ja auch kein unbekannter laden.
http://biz.yahoo.com/ap/070326/cv_therapeutics_mover.html
bin mal gespannt, wie der tag heut verläuft. nachbörslich ging es ja in us ja wieder ein paar cent rauf. und lehmann brothers ist ja auch kein unbekannter laden.
http://biz.yahoo.com/ap/070326/cv_therapeutics_mover.html
Ich meine, wenn Jenny sich so extrem aus dem Fenster legt?? Ob die sich das ohne irgendwelche Infos wagen würde? Ihr Abschlag ist dermassen extrem, dass ich davon ausgehe dass sie vielleicht etwas mehr weiss. Schaun mer mal!
http://www.nytimes.com/2007/03/27/health/27stent.html?_r=1&h…
NYT-artikel zum thema drugs vs stents.
Dr. Nissen, who termed the new study a blockbuster, said it sent a clear message that doctors and patients should feel secure about relying on modern drugs as a “very safe, reasonable and cost-effective strategy” for treating coronary artery disease. The findings raised new questions about the role of angioplasty and stenting, which has been used in six million patients around the world since the mid-’90s and is especially popular in the United States.
NYT-artikel zum thema drugs vs stents.
Dr. Nissen, who termed the new study a blockbuster, said it sent a clear message that doctors and patients should feel secure about relying on modern drugs as a “very safe, reasonable and cost-effective strategy” for treating coronary artery disease. The findings raised new questions about the role of angioplasty and stenting, which has been used in six million patients around the world since the mid-’90s and is especially popular in the United States.
so rt 5,37€
+8,5%
so kann es heute weiter gehen
+8,5%
so kann es heute weiter gehen
Antwort auf Beitrag Nr.: 28.518.291 von zip_3009 am 27.03.07 14:20:38.a. 15:33:35 5,30 5,18
15:39:58 5,13 5,09
Sieht nicht gut aus!
Sieht nicht gut aus!
Wieso ist der Spread bei dem Wert eigentlich so klein. War sonst doch extrem hoch?
Jetzt stimmts wieder
15:43:28 5,24 5,09
15:43:28 5,24 5,09
Antwort auf Beitrag Nr.: 28.520.114 von Isabartels am 27.03.07 15:44:12
na mal schauen und immer ruhig blut ...wir bewegen uns schon wieder auf die 7$ zu. war noch irgendwo ein gap zu schliessen?
na mal schauen und immer ruhig blut ...wir bewegen uns schon wieder auf die 7$ zu. war noch irgendwo ein gap zu schliessen?
Wenn ein Wert mit +5% oder so eröffnet, ist die Wahrscheinlichkeit sehr hoch, dass dieses Tagesgap dann auch geschlossen wird. so wars gerade auch. jetzt wird es bis Handelsende ca. 10% hochgehen. mein Tip. der von der Deutschen Bank gehört eingelocht !:O
Ahead of the Bell: CV Therapeutics
Tuesday March 27, 9:26 am ET
CV Therapeutics Rebounds As Analysts Mull Future of Angina Drug Ranexa
NEW YORK (AP) -- Shares of CV Therapeutics bounced back from a 52-week low in premarket trading Tuesday, as investors considered the future of its angina treatment Ranexa.
The Palo Alto, Calif.-based company is set to present full safety data from Ranexa trials Tuesday at the American College of Cardiology conference in New Orleans.
Lehman Brothers analyst Jim Birchenough said data showed Ranexa was useful in treating conditions that could precede bigger problems for heart disease patients.
"Opinions from cardiologists attending the poster presentation were that recurrent ischemia does matter and that anti-ischemic effects of Ranexa in acute coronary syndrome patients were of interest to those in attendance," he said.
Ischemia is a condition of reduced blood flow due to a blockage.
"We continue to believe that CV Therapeutics will emerge from ACC in a better position and would advise buying on recent headline weakness," he added.
Piper Jaffray analyst Thomas Wei was less certain about Ranexa's future. He said although data shows stents are no more effective than medication in treating angina patients, doctors would still use stents. Wei said more data was needed to determine how much Ranexa would benefit from the news.
CV Therapeutics shares rose 25 cents, or 3.7 percent, to $7 in the premarket. The stock hit a new 52-week low of $6.43 during Monday's session.
Tuesday March 27, 9:26 am ET
CV Therapeutics Rebounds As Analysts Mull Future of Angina Drug Ranexa
NEW YORK (AP) -- Shares of CV Therapeutics bounced back from a 52-week low in premarket trading Tuesday, as investors considered the future of its angina treatment Ranexa.
The Palo Alto, Calif.-based company is set to present full safety data from Ranexa trials Tuesday at the American College of Cardiology conference in New Orleans.
Lehman Brothers analyst Jim Birchenough said data showed Ranexa was useful in treating conditions that could precede bigger problems for heart disease patients.
"Opinions from cardiologists attending the poster presentation were that recurrent ischemia does matter and that anti-ischemic effects of Ranexa in acute coronary syndrome patients were of interest to those in attendance," he said.
Ischemia is a condition of reduced blood flow due to a blockage.
"We continue to believe that CV Therapeutics will emerge from ACC in a better position and would advise buying on recent headline weakness," he added.
Piper Jaffray analyst Thomas Wei was less certain about Ranexa's future. He said although data shows stents are no more effective than medication in treating angina patients, doctors would still use stents. Wei said more data was needed to determine how much Ranexa would benefit from the news.
CV Therapeutics shares rose 25 cents, or 3.7 percent, to $7 in the premarket. The stock hit a new 52-week low of $6.43 during Monday's session.
für's erste läuft es schonmal recht gut.
volumen hat auch angezogen vor einer halben stunde.
volumen hat auch angezogen vor einer halben stunde.
Form 8-K for CV THERAPEUTICS INC
--------------------------------------------------------------------------------
27-Mar-2007
Other Events, Financial Statements and Exhibits
Item 8.01. Other Events
On March 27, 2007, the American College of Cardiology, or ACC, disseminated a press release in connection with the presentation of results of the MERLIN TIMI-36 study at the American College of Cardiology Annual Scientific Sessions in New Orleans on March 27, 2007 at 8:50 a.m. Central Time.
As presented at ACC, in the MERLIN TIMI-36 study ranolazine did not produce a statistically significant reduction in the composite endpoint of cardiovascular death, heart attack and recurrent ischemia, the primary efficacy endpoint of the study (p value = 0.11). Ranolazine did not impact the rate of cardiovascular death or myocardial infarction, however, ranolazine showed a statistically significant reduction in recurrent ischemia alone (p value = 0.030). In addition, in the ranolazine group there was a statistically significant reduction in the worsening of angina requiring intensification of therapy (p value = 0.023) and a statistically significant reduction in the increase in or addition of anti-anginal therapy (p value = 0.006).
As provided in the ACC press release, the MERLIN TIMI-36 data showed no adverse trend in death or arrhythmia in patients receiving ranolazine. Additional safety results from the study were presented, including: there were 175 deaths from any cause in the placebo group, compared to 172 deaths from any cause in the ranolazine group; there were 1,065 occurrences of the composite of deaths from any cause or any cardiovascular hospitalizations in the placebo group, compared to 1,037 in the ranolazine group; and throughout the duration of the study there were 102 symptomatic documented arrhythmias in the placebo group compared to 99 symptomatic documented arrhythmias in the ranolazine group. In addition, comparing the relative frequency of clinically significant arrhythmias observed during Holter monitoring over the first 7 days of the study participation, the rate of such incidence was 83.1% in the placebo group, compared to a statistically significantly lower rate of 73.7% in the ranolazine group (p value less than 0.001). The adverse events that occurred more frequently in the ranolazine group (greater than 4% incidence) were similar to those in several prior clinical studies of ranolazine: dizziness, nausea, constipation, asthenia, and syncope.
The forgoing description is qualified in its entirety by reference to the ACC press release dated March 27, 2007, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
*****
Forward-Looking Statements. Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including regulatory review and approval of our products; special protocol assessment agreement; the conduct, timing and results of clinical trials; commercialization of products; market acceptance of products; product labeling; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2006. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
99.1 Press Release dated March 27, 2007.
--------------------------------------------------------------------------------
27-Mar-2007
Other Events, Financial Statements and Exhibits
Item 8.01. Other Events
On March 27, 2007, the American College of Cardiology, or ACC, disseminated a press release in connection with the presentation of results of the MERLIN TIMI-36 study at the American College of Cardiology Annual Scientific Sessions in New Orleans on March 27, 2007 at 8:50 a.m. Central Time.
As presented at ACC, in the MERLIN TIMI-36 study ranolazine did not produce a statistically significant reduction in the composite endpoint of cardiovascular death, heart attack and recurrent ischemia, the primary efficacy endpoint of the study (p value = 0.11). Ranolazine did not impact the rate of cardiovascular death or myocardial infarction, however, ranolazine showed a statistically significant reduction in recurrent ischemia alone (p value = 0.030). In addition, in the ranolazine group there was a statistically significant reduction in the worsening of angina requiring intensification of therapy (p value = 0.023) and a statistically significant reduction in the increase in or addition of anti-anginal therapy (p value = 0.006).
As provided in the ACC press release, the MERLIN TIMI-36 data showed no adverse trend in death or arrhythmia in patients receiving ranolazine. Additional safety results from the study were presented, including: there were 175 deaths from any cause in the placebo group, compared to 172 deaths from any cause in the ranolazine group; there were 1,065 occurrences of the composite of deaths from any cause or any cardiovascular hospitalizations in the placebo group, compared to 1,037 in the ranolazine group; and throughout the duration of the study there were 102 symptomatic documented arrhythmias in the placebo group compared to 99 symptomatic documented arrhythmias in the ranolazine group. In addition, comparing the relative frequency of clinically significant arrhythmias observed during Holter monitoring over the first 7 days of the study participation, the rate of such incidence was 83.1% in the placebo group, compared to a statistically significantly lower rate of 73.7% in the ranolazine group (p value less than 0.001). The adverse events that occurred more frequently in the ranolazine group (greater than 4% incidence) were similar to those in several prior clinical studies of ranolazine: dizziness, nausea, constipation, asthenia, and syncope.
The forgoing description is qualified in its entirety by reference to the ACC press release dated March 27, 2007, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
*****
Forward-Looking Statements. Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including regulatory review and approval of our products; special protocol assessment agreement; the conduct, timing and results of clinical trials; commercialization of products; market acceptance of products; product labeling; and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2006. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
99.1 Press Release dated March 27, 2007.
schaut ja heut lecker aus!!!
ich hab kreislauf!!!
rt ffm 6,33€
+ 27,9%
hat man die analystin von deutsche bank securities schon entlassen???
rt ffm 6,33€
+ 27,9%
hat man die analystin von deutsche bank securities schon entlassen???
CV Therapeutics Shares Up on Study Data
Tuesday March 27, 12:05 pm ET
CV Therapeutics Shares Rise on Mixed News From Late-Stage Ranexa Study, Outlook
NEW YORK (AP) -- Shares of biopharmaceutical company CV Therapeutics Inc. jumped Tuesday despite news that its drug Ranexa failed to meet its primary goal in a late stage study.
The stock gained $1.25, or 18.5 percent, to $8 on the Nasdaq Stock Market in midday trading. A day earlier, the stock dipped to a 52-week low of $6.43 on expectations the company would report weak study results.
While the drug, already approved for chronic angina, did not stem overall incidence of heart attacks, death and recurrent ischemia, it did show a statistically significant reduction in recurrent ischemia alone. Ischemia is a condition in which the heart doesn't get enough oxygen because of blocked blood flow.
The study also showed the drug to be safe compared with placebo.
Analysts highlighted that bit of the study as a positive development for the company, and said it piqued interest at the annual meeting of the American College of Cardiology.
"Overall, interest level in Ranexa at the CV Therapeutics booth has been high with regular flow and a mix of questions on safety, efficacy and drug mechanism and anecdotes of success from some physicians, particularly success with anginal equivalents like shortness of breath and exertional fatigue," wrote Lehman Brothers analyst Dr. Jim Birchenough in a note to investors.
The company will likely leave the conference in a better position than when it went into it, he said. He maintained a "Overweight" rating with a $40 price target.
Tuesday March 27, 12:05 pm ET
CV Therapeutics Shares Rise on Mixed News From Late-Stage Ranexa Study, Outlook
NEW YORK (AP) -- Shares of biopharmaceutical company CV Therapeutics Inc. jumped Tuesday despite news that its drug Ranexa failed to meet its primary goal in a late stage study.
The stock gained $1.25, or 18.5 percent, to $8 on the Nasdaq Stock Market in midday trading. A day earlier, the stock dipped to a 52-week low of $6.43 on expectations the company would report weak study results.
While the drug, already approved for chronic angina, did not stem overall incidence of heart attacks, death and recurrent ischemia, it did show a statistically significant reduction in recurrent ischemia alone. Ischemia is a condition in which the heart doesn't get enough oxygen because of blocked blood flow.
The study also showed the drug to be safe compared with placebo.
Analysts highlighted that bit of the study as a positive development for the company, and said it piqued interest at the annual meeting of the American College of Cardiology.
"Overall, interest level in Ranexa at the CV Therapeutics booth has been high with regular flow and a mix of questions on safety, efficacy and drug mechanism and anecdotes of success from some physicians, particularly success with anginal equivalents like shortness of breath and exertional fatigue," wrote Lehman Brothers analyst Dr. Jim Birchenough in a note to investors.
The company will likely leave the conference in a better position than when it went into it, he said. He maintained a "Overweight" rating with a $40 price target.
Antwort auf Beitrag Nr.: 28.524.206 von zip_3009 am 27.03.07 18:38:51
The company will likely leave the conference in a better position than when it went into it, he said. He maintained a "Overweight" rating with a $40 price target.
Das sind ja nur 38$ Unterschied zur Deutschen Bank.
The company will likely leave the conference in a better position than when it went into it, he said. He maintained a "Overweight" rating with a $40 price target.
Das sind ja nur 38$ Unterschied zur Deutschen Bank.
Für den mehr medizinisch Orientierten unter uns- die Zusammenfassung von Everett aus dem Investor Village Board (Kardiologe aus Seattle- extrem postiv eingestellt zu Ranexa wegen seinen Erfahrungen mit dem Medikament bei seinen eigenen Patienten und natürlich seine viele Anteile an CVTX ):
Re: ACC Info Release NEW EFFICACY INFO and its possible significance
1. Ranexa is a highly effective treatment for chronic angina.
Recurrent ischemia was a solid win, because pateints randomized to Ranexa were far less likely to have worsened chronic angina (Component 4 of Recurrent Ischemia).
This is a critical win, because it provides important new evidence of Ranexa efficacy in chronic angina.
Note especially the reduced need for additional angina medicines.
What we did NOT hear but - given the above results - what MUST be part of the data
Markedly better exercise time on treadmill tests, which all patients had on 2 occasions in the trial
Marked reduction in angina frequency and nitroglycerin use
Marked improvement in Quality of Life (scores on Seattle Angina Questionnaire and SF-36)
2. Ranexa doesn't cause arrhythmias - it reduces them.
The largest efficacy margin of all was in arrhythmia reduction during the 1st 7 days.
During this time, an ACS patient is a "red-hot" arrhythmia factory.
The reduction in arrhythmias produced by Ranexa is huge and undeniable
This result is likely to have an important impact on physician thinking
We don't know exactly what arrhytmias were reduced. I'm hoping it was atrial fibrillation.
3. Important trend in reduction of hospitalization.
there were 890 hospitalizations from any cause in the placebo group, 865 in the Ranexa group. This is a small but solid trend - and important because of its effect on Ranexa economics
4. The Economic and Quality of Life substudy now has a compelling argument for Ranexa cost-effectiveness
the above data provides the EQOL substudy with compelling cost-effectiveness data that will extend prior studies by Vetrovec et al. Such data will include improved QOL, reduced use of outpatient healthcare resources (for example, reduced need for antianginal meds, but many other things as well), reduced use of inpatient healthcare resources (note the reduction in hospitalizations; likely there's a similar favorable trend in revascularization), less time off from work, and many other factors.
Meanwhile, Weintraub's cost-effectiveness data from COURAGE will further expose chronic angina treatment with stents as a bloated, complete waste of health care dollars.
Note that the above criticism of stents only applies for stents used to treat chronic angina without other clear indications such as ACS treatment. Stents have an established role many situations besides chronic angina, and nothing about the COURAGE data challenges these established roles. Nor do I challenge them.
Re: ACC Info Release NEW EFFICACY INFO and its possible significance
1. Ranexa is a highly effective treatment for chronic angina.
Recurrent ischemia was a solid win, because pateints randomized to Ranexa were far less likely to have worsened chronic angina (Component 4 of Recurrent Ischemia).
This is a critical win, because it provides important new evidence of Ranexa efficacy in chronic angina.
Note especially the reduced need for additional angina medicines.
What we did NOT hear but - given the above results - what MUST be part of the data
Markedly better exercise time on treadmill tests, which all patients had on 2 occasions in the trial
Marked reduction in angina frequency and nitroglycerin use
Marked improvement in Quality of Life (scores on Seattle Angina Questionnaire and SF-36)
2. Ranexa doesn't cause arrhythmias - it reduces them.
The largest efficacy margin of all was in arrhythmia reduction during the 1st 7 days.
During this time, an ACS patient is a "red-hot" arrhythmia factory.
The reduction in arrhythmias produced by Ranexa is huge and undeniable
This result is likely to have an important impact on physician thinking
We don't know exactly what arrhytmias were reduced. I'm hoping it was atrial fibrillation.
3. Important trend in reduction of hospitalization.
there were 890 hospitalizations from any cause in the placebo group, 865 in the Ranexa group. This is a small but solid trend - and important because of its effect on Ranexa economics
4. The Economic and Quality of Life substudy now has a compelling argument for Ranexa cost-effectiveness
the above data provides the EQOL substudy with compelling cost-effectiveness data that will extend prior studies by Vetrovec et al. Such data will include improved QOL, reduced use of outpatient healthcare resources (for example, reduced need for antianginal meds, but many other things as well), reduced use of inpatient healthcare resources (note the reduction in hospitalizations; likely there's a similar favorable trend in revascularization), less time off from work, and many other factors.
Meanwhile, Weintraub's cost-effectiveness data from COURAGE will further expose chronic angina treatment with stents as a bloated, complete waste of health care dollars.
Note that the above criticism of stents only applies for stents used to treat chronic angina without other clear indications such as ACS treatment. Stents have an established role many situations besides chronic angina, and nothing about the COURAGE data challenges these established roles. Nor do I challenge them.
Antwort auf Beitrag Nr.: 28.527.095 von Schapekop am 27.03.07 20:59:12angesichts derr gestrigen news und der vorherigen kursturbulenzen ist die reaktion bisher recht schwach ausgefallen. werde die markteroeffnun abwarten und dann wohl nen stopploss setzen....
cu gulliver
cu gulliver
Antwort auf Beitrag Nr.: 28.539.672 von Gulliver am 28.03.07 12:06:41Man kann sehr unglücklich rausgekegelt werden. Eigentlich gehe ich davon aus, dass wir bis Freitag das GAP im Bereich 12 $ kurz berühren sollten. Dafür bräuchte es aber offensichtlich ein positiveres Experten-update
UPDATE 1-CV Therapeutics angina drug may win broader use
By Deena Beasley
LOS ANGELES, March 27 (Reuters) - An angina drug made by CV Therapeutics Inc. (CVTX.O: Quote, Profile , Research) failed to prove effective as a treatment for acute coronary syndrome, but favorable safety data could broaden its use, researchers said on Tuesday.
While the market potential remains uncertain, CV shares closed almost 18 percent higher on Tuesday but were still down about 36 percent since March 6 when the company announced disappointing results from a large trial of Ranexa, also known as ranolazine.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
The drug was approved last year to treat chronic angina, the chest pain caused by an insufficient supply of oxygen to the heart, in patients who have not achieved an adequate response with other drugs.
The latest 6,500-patient trial was designed to study the drug in a type of heart disease known as acute coronary syndrome and to see if it was safe to use as a first-line treatment for chronic angina.
"Now you have four times as many patients as in trials that got it approved," said Dr. Chris Cannon, a prominent cardiologist at Brigham and Women's Hospital in Boston.
"There had been questions of QT prolongation and hence arrhythmia and mortality, and issues of its angina efficacy in women. All of those were set up to be addressed in this study," Cannon said.
Ranexa's approval in chronic angina had been delayed for years over safety concerns, including indications that it prolonged the "QT interval" -- the time it takes the heart to electrically recharge itself.
The drug works without dropping blood pressure, a common side effect of other treatments for angina.
The study showed that Ranexa did not significantly reduce the combined risk of cardiovascular death, heart attack and recurrent ischemia, a condition in which blood flow, and thus oxygen, is restricted.
However, the study did show a statistically significant reduction in recurrent ischemia alone, investigators said in a statement.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
FIRST CHOICE
The results, presented at a meeting in New Orleans of the American College of Cardiology, also showed no adverse trend in death or arrhythmia in patients receiving Ranexa.
Based on an agreement with U.S. health regulators, Palo Alto, California-based CV said it believes the study could support expansion of Ranexa's approved uses to include the drug as a first choice treatment for angina.
The trial results "support our belief that Ranexa is an effective anti-angina agent ... we project continued growth in Ranexa prescriptions and sales," Cantor Fitzgerald analyst George Zavoico said in research note on Tuesday.
But there are dissenters.
"The main takeaway is the safety," said Dr. Ravi Dave, associate professor in cardiology at the University of California, Los Angeles.
He said use of Ranexa "will go up," but the drug is unlikely to be used extensively in the group of patients who took part in the trial, which excluded those who had suffered severe heart attacks.
"It is going to be used more in patients who have already had heart attacks and continue to have recurrent angina," Dave said.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
Deutsche Bank analyst Jennifer Chao said in a research note on Tuesday that "we continue to believe it will be challenging for Ranexa to be viewed as a first-line agent."
She downgraded CV shares to "sell," lowered sales estimates for Ranexa, and warned that "even with corporate restructuring, it may be challenging for CV Therapeutics to achieve earnings profitability and to continue to satisfy debt obligations."
UPDATE 1-CV Therapeutics angina drug may win broader use
By Deena Beasley
LOS ANGELES, March 27 (Reuters) - An angina drug made by CV Therapeutics Inc. (CVTX.O: Quote, Profile , Research) failed to prove effective as a treatment for acute coronary syndrome, but favorable safety data could broaden its use, researchers said on Tuesday.
While the market potential remains uncertain, CV shares closed almost 18 percent higher on Tuesday but were still down about 36 percent since March 6 when the company announced disappointing results from a large trial of Ranexa, also known as ranolazine.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
The drug was approved last year to treat chronic angina, the chest pain caused by an insufficient supply of oxygen to the heart, in patients who have not achieved an adequate response with other drugs.
The latest 6,500-patient trial was designed to study the drug in a type of heart disease known as acute coronary syndrome and to see if it was safe to use as a first-line treatment for chronic angina.
"Now you have four times as many patients as in trials that got it approved," said Dr. Chris Cannon, a prominent cardiologist at Brigham and Women's Hospital in Boston.
"There had been questions of QT prolongation and hence arrhythmia and mortality, and issues of its angina efficacy in women. All of those were set up to be addressed in this study," Cannon said.
Ranexa's approval in chronic angina had been delayed for years over safety concerns, including indications that it prolonged the "QT interval" -- the time it takes the heart to electrically recharge itself.
The drug works without dropping blood pressure, a common side effect of other treatments for angina.
The study showed that Ranexa did not significantly reduce the combined risk of cardiovascular death, heart attack and recurrent ischemia, a condition in which blood flow, and thus oxygen, is restricted.
However, the study did show a statistically significant reduction in recurrent ischemia alone, investigators said in a statement.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
FIRST CHOICE
The results, presented at a meeting in New Orleans of the American College of Cardiology, also showed no adverse trend in death or arrhythmia in patients receiving Ranexa.
Based on an agreement with U.S. health regulators, Palo Alto, California-based CV said it believes the study could support expansion of Ranexa's approved uses to include the drug as a first choice treatment for angina.
The trial results "support our belief that Ranexa is an effective anti-angina agent ... we project continued growth in Ranexa prescriptions and sales," Cantor Fitzgerald analyst George Zavoico said in research note on Tuesday.
But there are dissenters.
"The main takeaway is the safety," said Dr. Ravi Dave, associate professor in cardiology at the University of California, Los Angeles.
He said use of Ranexa "will go up," but the drug is unlikely to be used extensively in the group of patients who took part in the trial, which excluded those who had suffered severe heart attacks.
"It is going to be used more in patients who have already had heart attacks and continue to have recurrent angina," Dave said.
Reuters Pictures
Editors Choice: Best pictures
from the last 24 hours.
View Slideshow
Deutsche Bank analyst Jennifer Chao said in a research note on Tuesday that "we continue to believe it will be challenging for Ranexa to be viewed as a first-line agent."
She downgraded CV shares to "sell," lowered sales estimates for Ranexa, and warned that "even with corporate restructuring, it may be challenging for CV Therapeutics to achieve earnings profitability and to continue to satisfy debt obligations."
Antwort auf Beitrag Nr.: 28.540.168 von barabo am 28.03.07 12:33:08Diese Antwort aus dem yahoo-board ist gar nicht verkehrt :
Jennifer will end up right after a couple weeks trading for one reason - financials read the reports and play down the hyp
figure out exactly what this company needs to survive
do your d.d.
Let me tell you why Jennifer Chao is not right. She made a fundamental mistake when she predicted that the results of Merlin would be bad a day before the presentation. Most people, including me, thought that she had inside information that would me confirmed the next day. Guess what, the results were better than expected and proved her wrong in her fundamental premise. Everything else she said is now questioned because she was WRONG regarding the results. Furthermore, she said CVT would not be able to get a partner because the data would be bad, which means that since the data is good, the line for potential partners is getting bigger and bigger. Actually, there are bona fide accounts to the effect that Lou already suggested that a co-promote deal is on the way. If I were you I would cover immediately.
Jennifer will end up right after a couple weeks trading for one reason - financials read the reports and play down the hyp
figure out exactly what this company needs to survive
do your d.d.
Let me tell you why Jennifer Chao is not right. She made a fundamental mistake when she predicted that the results of Merlin would be bad a day before the presentation. Most people, including me, thought that she had inside information that would me confirmed the next day. Guess what, the results were better than expected and proved her wrong in her fundamental premise. Everything else she said is now questioned because she was WRONG regarding the results. Furthermore, she said CVT would not be able to get a partner because the data would be bad, which means that since the data is good, the line for potential partners is getting bigger and bigger. Actually, there are bona fide accounts to the effect that Lou already suggested that a co-promote deal is on the way. If I were you I would cover immediately.
Antwort auf Beitrag Nr.: 28.540.379 von barabo am 28.03.07 12:44:00Da ist ein Citibank downgrade zu 6$ aus- ein anderer CVTX-Feind-Analyst. (Yaron)- also- stop-loss wird wohl greifen.
Antwort auf Beitrag Nr.: 28.541.573 von Schapekop am 28.03.07 13:51:07Und schon gehts runter!
Datum Zeit Bid Ask
28.03. 14:15:22 5,67 EUR 5,87 EUR
Letzte Kursänderung: 14:15:02
Datum Zeit Bid Ask
28.03. 14:15:22 5,67 EUR 5,87 EUR
Letzte Kursänderung: 14:15:02
Antwort auf Beitrag Nr.: 28.541.573 von Schapekop am 28.03.07 13:51:07shit
Kann mich nicht damit anfreunden. - Aber danach geht´s ja leider nicht. Was haltet ihr von der Überlegung, dass es heute kein neues Gap geben wird ? ==> also von Anfang an mit Limit 7,90 $ Order aufgeben und für den Notfall stop im Hinterkopf.
Hm, aber welche stop-marke
Der Kurs dreht dann oft exakt dem Ausstieg folgend.
Kann mich nicht damit anfreunden. - Aber danach geht´s ja leider nicht. Was haltet ihr von der Überlegung, dass es heute kein neues Gap geben wird ? ==> also von Anfang an mit Limit 7,90 $ Order aufgeben und für den Notfall stop im Hinterkopf.
Hm, aber welche stop-marke
Der Kurs dreht dann oft exakt dem Ausstieg folgend.
die analystenhörigkeit ist bei den amis wesentlich verbreiteter als bei uns. kein wunder bei einem volk, an dem seit jahrzehnten gehirnwäsche betrieben und das eigene denken unterdrückt wird.
das yaron w. nochmal draufhaut ist absolut keine überraschung.
über die zugrundeliegenden motive von jenny und yaron kann wohl kaum ein zweifel bestehen, da ihre klientel massiv auf der short-seite hockt...
das yaron w. nochmal draufhaut ist absolut keine überraschung.
über die zugrundeliegenden motive von jenny und yaron kann wohl kaum ein zweifel bestehen, da ihre klientel massiv auf der short-seite hockt...
Antwort auf Beitrag Nr.: 28.542.250 von Mr.Arrogance am 28.03.07 14:28:02Man kann daraus ja einen schönen trade machen.
Meine Vorhersage :
Man kommt für mindestens 7,75 $ raus und sieht zu, bei 6,56 $ wieder einzusteigen.
Meine Vorhersage :
Man kommt für mindestens 7,75 $ raus und sieht zu, bei 6,56 $ wieder einzusteigen.
die begründungen sind mehr als fadenscheinig angesichts der überraschend guten details, die MERLIN produziert hat.
neben den veröffentlichten einzelheiten scheint auch die HbA1c-reduction eindeutig statistisch signifikant zu sein, ein punkt von großem interesse. wenn man der lehman-zusammenfassung des conference calls glauben schenkt.
zudem ist anscheinend eine baldige ranexa co-promotion im gespräch, was dem schüren von liquiditätsängsten ein ende bereiten würde.
neben den veröffentlichten einzelheiten scheint auch die HbA1c-reduction eindeutig statistisch signifikant zu sein, ein punkt von großem interesse. wenn man der lehman-zusammenfassung des conference calls glauben schenkt.
zudem ist anscheinend eine baldige ranexa co-promotion im gespräch, was dem schüren von liquiditätsängsten ein ende bereiten würde.
Antwort auf Beitrag Nr.: 28.542.354 von barabo am 28.03.07 14:32:31ich werd mal ein kauflimit unter 7$ einstellen...
Man kommt vorbörslich zu 7,50$ rein, und der Kurs wird zur Eröffnung auf jeden Fall auf 8$ steigen. Dann wird das Volk der Gehirnwäsche wieder auf das Analystengewäsch hören und den Kurs ca. 5% runterjagen. Im Laufe der nä. Wochen wird dieses Geschwätz aber wieder aus den Köpfen verschwinden und CV wird das Gap bei 9$ schließen
Jetzt kaufen oder nicht??
Habe jedenfalls vorgestern zu 5,41€ gekauft und bin nach dem gestrigen Verlauf froh darüber.
Hallo, habe meinen EK auch auf 6,20 Euro gedrückt und daher keine Zweifel, bald wieder dick in der Pluszone zu sein.
die umsätze sind nicht mehr sehr hoch gewesen nach den zwei neuerlichen downgrades (citi + first albany), und der kurs hat sich zunächst eingependelt zwischen 7 und 8$.
vermutlich sind noch einige shorts draußen, die covern möchten.
die gelegenheit ist noch ganz gut, solange die ranexa-umsätze nicht wesentlich steigen und es keinen promotion-deal gibt.
in den letzten wochen stagnieren die ranexa-umsätze, nicht gerade ántrieb für steigende kurse. die letzte märzwoche wird vermutlich auch nicht viel bringen, dann aber wird es interessant, wie sich die umsätze im april entwickeln (post-MERLIN).
dazu gab es heute immerhin eine ermutigende meldung:
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…
vermutlich sind noch einige shorts draußen, die covern möchten.
die gelegenheit ist noch ganz gut, solange die ranexa-umsätze nicht wesentlich steigen und es keinen promotion-deal gibt.
in den letzten wochen stagnieren die ranexa-umsätze, nicht gerade ántrieb für steigende kurse. die letzte märzwoche wird vermutlich auch nicht viel bringen, dann aber wird es interessant, wie sich die umsätze im april entwickeln (post-MERLIN).
dazu gab es heute immerhin eine ermutigende meldung:
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…
meine kommentare zu CVTX künftig in einem anderen aktienboard.
Ist was im Busch ?
Ich finde es merkwürdig, dass heute plötzlich eine große Nachfrage nach meinem Optionsschein YJHAB aufgekommen ist und ein heftiger Aufpreis bezahlt wird.
36,6 % Aufgeld für 9 Monate Restlaufzeit und doppelt so großes Handelsvolumen gegenüber der Aktie.
Ich finde es merkwürdig, dass heute plötzlich eine große Nachfrage nach meinem Optionsschein YJHAB aufgekommen ist und ein heftiger Aufpreis bezahlt wird.
36,6 % Aufgeld für 9 Monate Restlaufzeit und doppelt so großes Handelsvolumen gegenüber der Aktie.
Antwort auf Beitrag Nr.: 28.861.046 von barabo am 17.04.07 16:56:47Spekulatieve Geisten wahrscheinlich.
ACC zeigt ein wenig Wirkung- wahrscheinlich "dank" COURAGE" (Stents verlängern das Leben nicht bei Angina Pectoris Patienten), sind die J&J Stent Verkäufe 35% runter.
Soll eigentlich Ranexa irgendwann zu Gute kommen.
ACC zeigt ein wenig Wirkung- wahrscheinlich "dank" COURAGE" (Stents verlängern das Leben nicht bei Angina Pectoris Patienten), sind die J&J Stent Verkäufe 35% runter.
Soll eigentlich Ranexa irgendwann zu Gute kommen.
CV THERAPEUTICS INC. (CVTX.O: Quote, Profile , Research)
Current Prior Rating Buy Neutral
--First Albany Capital said the upgrade of the biopharmaceutical company's stock is based on better-than-expected sales of angina drug Ranexa, sooner-than-expected publication of the MERLIN trial results, and planned reductions of operating expenses.
--The brokerage's new price target on the stock is $13. (Reporting by Ratul Ray Chaudhuri in Bangalore)
Current Prior Rating Buy Neutral
--First Albany Capital said the upgrade of the biopharmaceutical company's stock is based on better-than-expected sales of angina drug Ranexa, sooner-than-expected publication of the MERLIN trial results, and planned reductions of operating expenses.
--The brokerage's new price target on the stock is $13. (Reporting by Ratul Ray Chaudhuri in Bangalore)
Wird der Kurs reagieren ?
CV Therapeutics has added a news release to its Investor Relations website.
Title: CV Therapeutics Announces Five Abstracts Accepted for Presentation at Annual Scientific Sessions of Heart Rhythm Society
Date: 5/3/2007 7:00:00 AM
For a complete listing of our news releases, please click here
PALO ALTO, Calif., May 3 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(Nasdaq: CVTX) announced today that five abstracts on preclinical studies of
ranolazine have been accepted for presentation at the annual scientific
sessions of the Heart Rhythm Society, taking place in Denver, CO from May 9-
12, 2007. These abstracts are:
-- Ranolazine Prevents Clofilium- induced Torsade de Pointes in Rabbits.
Featured Poster; Abstract # 4422; Wednesday, May 9, 5:45 p.m. - 7:00
p.m. MT.
-- Antiarrhythmic Effects of Ranolazine in Canine Pulmonary Vein Sleeves.
Poster, Abstract # 5146; Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
-- Preferential Block of Late Sodium Current by Ranolazine. Poster,
Abstract # 4318; Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
-- Ranolazine and Propafenone Both Suppress Atrial Fibrillation but
Ranolazine unlike Propafenone Does it Without Prominent Effects on
Ventricular Myocardium. Poster; Abstract # 5942; Thursday, May 10,
9:30 a.m. - 10:30 a.m. MT.
-- Sodium Channels of Canine Atrial and Ventricular Cells Differ with
Respect to Voltage Dependence of Inactivation. Poster; Abstract # 5956;
Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
Additional information regarding the Heart Rhythm 2007 Scientific Sessions
can be accessed at http://www.heartrhythm2007.org.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-release
tablets), is indicated for the treatment of chronic angina in patients who
have not achieved an adequate response with other antianginal drugs, and
should be used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug development
candidates and programs, including regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial perfusion imaging
studies, and CVT-6883, which is being developed as a potential treatment for
asthma and other conditions. These product candidates have not been determined
by any regulatory authorities to be safe or effective in humans for any use.
Except for the historical information contained herein, the matters set
forth in this press release, including statements as to research and
development, are forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties that
may cause actual results to differ materially, including operating losses and
fluctuations in operating results; capital requirements; regulatory review and
approval of our products; the conduct and timing of clinical trials; and other
risks detailed from time to time in CV Therapeutics' SEC reports, including
its Annual Report on Form 10-K for the quarter ended December 31, 2006. CV
Therapeutics disclaims any intent or obligation to update these forward-
looking statements.
CV Therapeutics has added a news release to its Investor Relations website.
Title: CV Therapeutics Announces Five Abstracts Accepted for Presentation at Annual Scientific Sessions of Heart Rhythm Society
Date: 5/3/2007 7:00:00 AM
For a complete listing of our news releases, please click here
PALO ALTO, Calif., May 3 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(Nasdaq: CVTX) announced today that five abstracts on preclinical studies of
ranolazine have been accepted for presentation at the annual scientific
sessions of the Heart Rhythm Society, taking place in Denver, CO from May 9-
12, 2007. These abstracts are:
-- Ranolazine Prevents Clofilium- induced Torsade de Pointes in Rabbits.
Featured Poster; Abstract # 4422; Wednesday, May 9, 5:45 p.m. - 7:00
p.m. MT.
-- Antiarrhythmic Effects of Ranolazine in Canine Pulmonary Vein Sleeves.
Poster, Abstract # 5146; Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
-- Preferential Block of Late Sodium Current by Ranolazine. Poster,
Abstract # 4318; Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
-- Ranolazine and Propafenone Both Suppress Atrial Fibrillation but
Ranolazine unlike Propafenone Does it Without Prominent Effects on
Ventricular Myocardium. Poster; Abstract # 5942; Thursday, May 10,
9:30 a.m. - 10:30 a.m. MT.
-- Sodium Channels of Canine Atrial and Ventricular Cells Differ with
Respect to Voltage Dependence of Inactivation. Poster; Abstract # 5956;
Thursday, May 10, 9:30 a.m. - 10:30 a.m. MT.
Additional information regarding the Heart Rhythm 2007 Scientific Sessions
can be accessed at http://www.heartrhythm2007.org.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-release
tablets), is indicated for the treatment of chronic angina in patients who
have not achieved an adequate response with other antianginal drugs, and
should be used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug development
candidates and programs, including regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial perfusion imaging
studies, and CVT-6883, which is being developed as a potential treatment for
asthma and other conditions. These product candidates have not been determined
by any regulatory authorities to be safe or effective in humans for any use.
Except for the historical information contained herein, the matters set
forth in this press release, including statements as to research and
development, are forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties that
may cause actual results to differ materially, including operating losses and
fluctuations in operating results; capital requirements; regulatory review and
approval of our products; the conduct and timing of clinical trials; and other
risks detailed from time to time in CV Therapeutics' SEC reports, including
its Annual Report on Form 10-K for the quarter ended December 31, 2006. CV
Therapeutics disclaims any intent or obligation to update these forward-
looking statements.
Antwort auf Beitrag Nr.: 29.111.091 von barabo am 03.05.07 13:14:35Arg komisch- Hasen Pre-klinik Ergebnisse nach 9-10 Jahre klinische Studien an Ranexa. Weiss wirklich nicht was das soll, sicherlich nicht weil 75% von den MERLIN-Daten noch nicht raus sind.
Habe 50% meine CVTXén mit kleinem Gewinn wider in CYTX verwandelt. Mal schauen- Kursraketen sind vorläufig nicht zu erwarten bei CVT, vermute ich mal.
Habe 50% meine CVTXén mit kleinem Gewinn wider in CYTX verwandelt. Mal schauen- Kursraketen sind vorläufig nicht zu erwarten bei CVT, vermute ich mal.
gestern sogar intraday 10 $ übersprungen. Leider hatte ich meine Optionen mit ca. 130% Gewinn wiedermal viel zu schnell zu Gunsten Cytori verkauft. - Jetzt wären schon fast 300% möglich - vielen Dank für deinen Tip Schapekop !
Grund des Anstieges muss wohl der FDA-Antrag zu Regadenoson gewesen sein :
Title: CV Therapeutics Submits New Drug Application For Regadenoson
Date: 5/14/2007 4:01:00 PM
For a complete listing of our news releases, please click here
PALO ALTO, Calif. and DEERFIELD, Ill., May 14 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (Nasdaq: CVTX) and Astellas Pharma US, Inc. announced today
that CV Therapeutics has submitted a new drug application (NDA) to the U.S.
Food and Drug Administration (FDA) seeking approval of regadenoson for use in
myocardial perfusion imaging (MPI) studies. The NDA submission triggers a $7
million milestone payment from Astellas to CV Therapeutics.
Regadenoson is a selective A2A-adenosine receptor agonist under
development for use as a pharmacologic stress agent in MPI studies.
Regadenoson has been designed to be delivered as a rapid bolus with no dose
adjustment required by weight, and to selectively stimulate the A2A-adenosine
receptor, the receptor responsible for coronary vasodilation.
"We are very pleased to have submitted an NDA for regadenoson, which, if
approved in 2008, would represent the second innovative cardiovascular product
CV Therapeutics will have brought to market in a two year period," said Louis
G. Lange, M.D., Ph.D., chairman and chief executive officer of CV
Therapeutics.
"As the market leader in pharmacologic stress testing, we look forward to
the market introduction of regadenoson. We are seeing a continued increase in
demand for myocardial perfusion imaging tests in the United States and, upon
approval, we believe both patients and physicians will benefit from the
clinical profile of regadenoson," said Yoshihiko Hatanaka, president and chief
executive officer of Astellas Pharma US, Inc.
If regadenoson is approved by the FDA, Astellas Pharma US, Inc. will be
responsible for all commercial activities for regadenoson in the United
States. CV Therapeutics retains all rights to regadenoson outside of North
America.
The NDA contains data from two identically designed Phase 3 clinical
trials. In both Phase 3 trials, regadenoson met the primary endpoint by
showing with 95 percent confidence that MPI studies conducted with regadenoson
were comparable to MPI studies conducted with Adenoscan(R) (adenosine
injection).
Regadenoson was generally well tolerated in both Phase 3 studies. The most
common adverse events reported in patients who received regadenoson were
shortness of breath, headache, flushing, chest discomfort and dizziness.
Phase 3 Design
Patients 18 years or older with the clinical need for an MPI study were
eligible to participate in the Phase 3 clinical trials. Individuals who had
an acute myocardial infarction or unstable angina within three months, or
coronary revascularization within six months, were not permitted to
participate in the study.
All study participants received a clinically indicated baseline MPI study
using Adenoscan(R) (adenosine injection). Participants then were randomized to
receive either regadenoson or Adenoscan(R) (adenosine injection) in a double
blinded fashion during a second MPI study. Each patient's scans were
classified as indicating normal, moderate or severe ischemia. Baseline and
blinded scans then were evaluated to determine if the scans were comparable.
Myocardial perfusion imaging studies
MPI studies help detect and characterize coronary artery disease by
identifying areas of poor blood flow in the heart. In 2005, approximately 9.3
million patients in the United States underwent MPI studies.
Astellas Pharma US, Inc. / CV Therapeutics Inc. Collaboration
Under a license and collaboration agreement providing Astellas with
exclusive North American rights to regadenoson, CV Therapeutics manages the
development program and Astellas is responsible for all commercial activities
for regadenoson in North America, if the product is approved for marketing.
Under the arrangement, Astellas owes CV Therapeutics a $7 million milestone
upon NDA submission and a $12 million milestone upon FDA approval, and
reimburses CV Therapeutics for 75 percent of development costs. CV
Therapeutics will receive a royalty on product sales of regadenoson, if
approved, and may receive a royalty on another product. CV Therapeutics owns
the rights for regadenoson outside of North America.
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S.
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global category leader in focused
areas by combining outstanding R&D and marketing capabilities. In the U.S.,
Astellas markets products in the areas of immunology, urology, anti-
infectives, cardiovascular and dermatology. For more information about
Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.
Astellas currently markets Adenoscan(R) (adenosine injection), the leading
agent for MPI studies in the United States. Adenoscan is indicated as an
adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable
to exercise adequately. The most common side effects include flushing, chest
discomfort, and dyspnea. Less frequent side effects reported in patients
administered Adenoscan include second and third degree AV block, fatal cardiac
arrest, ventricular tachycardia, and nonfatal myocardial infarction. For full
prescribing information, please visit www.adenoscan.com.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-release
tablets) is indicated for the treatment of chronic angina in patients who have
not achieved an adequate response with other antianginal drugs, and should be
used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug development
candidates and programs, including regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial perfusion imaging
studies and CVT-6883, which is being developed as a potential treatment for
asthma and other conditions. Regadenoson and CVT-6883 have not been determined
by any regulatory authorities to be safe or effective in humans for any use.
Trademarks listed belong to their respective owners.
Except for the historical information contained herein, the matters set
forth in this press release are forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially, including;
the conduct and timing of studies; timing of regulatory submissions; timing of
regulatory review and approval; commercialization of products; market
acceptance of products; dependence on collaborative partners; intellectual
property protection and disputes; and other risks detailed from time to time
in CV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q
for the quarter ended March 31, 2007. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
-0- 05/14/2007
/CONTACT: Investor and Media: John Bluth, Senior Director, Corporate
Communications and Investor Relations, CV Therapeutics, Inc., +1-650-384-8850;
Astellas Media: Maribeth Landwehr, Assistant Director, Corporate
Communications, Astellas Pharma US, Inc., +1-847-317-8988/
/Web site: http://www.cvt.com
http://www.adenoscan.com /
(CVTX)
CO: CV Therapeutics, Inc.; Astellas Pharma US, Inc.
ST: California, Illinois
IN: MTC BIO HEA
SU:
Grund des Anstieges muss wohl der FDA-Antrag zu Regadenoson gewesen sein :
Title: CV Therapeutics Submits New Drug Application For Regadenoson
Date: 5/14/2007 4:01:00 PM
For a complete listing of our news releases, please click here
PALO ALTO, Calif. and DEERFIELD, Ill., May 14 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (Nasdaq: CVTX) and Astellas Pharma US, Inc. announced today
that CV Therapeutics has submitted a new drug application (NDA) to the U.S.
Food and Drug Administration (FDA) seeking approval of regadenoson for use in
myocardial perfusion imaging (MPI) studies. The NDA submission triggers a $7
million milestone payment from Astellas to CV Therapeutics.
Regadenoson is a selective A2A-adenosine receptor agonist under
development for use as a pharmacologic stress agent in MPI studies.
Regadenoson has been designed to be delivered as a rapid bolus with no dose
adjustment required by weight, and to selectively stimulate the A2A-adenosine
receptor, the receptor responsible for coronary vasodilation.
"We are very pleased to have submitted an NDA for regadenoson, which, if
approved in 2008, would represent the second innovative cardiovascular product
CV Therapeutics will have brought to market in a two year period," said Louis
G. Lange, M.D., Ph.D., chairman and chief executive officer of CV
Therapeutics.
"As the market leader in pharmacologic stress testing, we look forward to
the market introduction of regadenoson. We are seeing a continued increase in
demand for myocardial perfusion imaging tests in the United States and, upon
approval, we believe both patients and physicians will benefit from the
clinical profile of regadenoson," said Yoshihiko Hatanaka, president and chief
executive officer of Astellas Pharma US, Inc.
If regadenoson is approved by the FDA, Astellas Pharma US, Inc. will be
responsible for all commercial activities for regadenoson in the United
States. CV Therapeutics retains all rights to regadenoson outside of North
America.
The NDA contains data from two identically designed Phase 3 clinical
trials. In both Phase 3 trials, regadenoson met the primary endpoint by
showing with 95 percent confidence that MPI studies conducted with regadenoson
were comparable to MPI studies conducted with Adenoscan(R) (adenosine
injection).
Regadenoson was generally well tolerated in both Phase 3 studies. The most
common adverse events reported in patients who received regadenoson were
shortness of breath, headache, flushing, chest discomfort and dizziness.
Phase 3 Design
Patients 18 years or older with the clinical need for an MPI study were
eligible to participate in the Phase 3 clinical trials. Individuals who had
an acute myocardial infarction or unstable angina within three months, or
coronary revascularization within six months, were not permitted to
participate in the study.
All study participants received a clinically indicated baseline MPI study
using Adenoscan(R) (adenosine injection). Participants then were randomized to
receive either regadenoson or Adenoscan(R) (adenosine injection) in a double
blinded fashion during a second MPI study. Each patient's scans were
classified as indicating normal, moderate or severe ischemia. Baseline and
blinded scans then were evaluated to determine if the scans were comparable.
Myocardial perfusion imaging studies
MPI studies help detect and characterize coronary artery disease by
identifying areas of poor blood flow in the heart. In 2005, approximately 9.3
million patients in the United States underwent MPI studies.
Astellas Pharma US, Inc. / CV Therapeutics Inc. Collaboration
Under a license and collaboration agreement providing Astellas with
exclusive North American rights to regadenoson, CV Therapeutics manages the
development program and Astellas is responsible for all commercial activities
for regadenoson in North America, if the product is approved for marketing.
Under the arrangement, Astellas owes CV Therapeutics a $7 million milestone
upon NDA submission and a $12 million milestone upon FDA approval, and
reimburses CV Therapeutics for 75 percent of development costs. CV
Therapeutics will receive a royalty on product sales of regadenoson, if
approved, and may receive a royalty on another product. CV Therapeutics owns
the rights for regadenoson outside of North America.
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S.
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global category leader in focused
areas by combining outstanding R&D and marketing capabilities. In the U.S.,
Astellas markets products in the areas of immunology, urology, anti-
infectives, cardiovascular and dermatology. For more information about
Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.
Astellas currently markets Adenoscan(R) (adenosine injection), the leading
agent for MPI studies in the United States. Adenoscan is indicated as an
adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable
to exercise adequately. The most common side effects include flushing, chest
discomfort, and dyspnea. Less frequent side effects reported in patients
administered Adenoscan include second and third degree AV block, fatal cardiac
arrest, ventricular tachycardia, and nonfatal myocardial infarction. For full
prescribing information, please visit www.adenoscan.com.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-release
tablets) is indicated for the treatment of chronic angina in patients who have
not achieved an adequate response with other antianginal drugs, and should be
used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug development
candidates and programs, including regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial perfusion imaging
studies and CVT-6883, which is being developed as a potential treatment for
asthma and other conditions. Regadenoson and CVT-6883 have not been determined
by any regulatory authorities to be safe or effective in humans for any use.
Trademarks listed belong to their respective owners.
Except for the historical information contained herein, the matters set
forth in this press release are forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially, including;
the conduct and timing of studies; timing of regulatory submissions; timing of
regulatory review and approval; commercialization of products; market
acceptance of products; dependence on collaborative partners; intellectual
property protection and disputes; and other risks detailed from time to time
in CV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q
for the quarter ended March 31, 2007. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
-0- 05/14/2007
/CONTACT: Investor and Media: John Bluth, Senior Director, Corporate
Communications and Investor Relations, CV Therapeutics, Inc., +1-650-384-8850;
Astellas Media: Maribeth Landwehr, Assistant Director, Corporate
Communications, Astellas Pharma US, Inc., +1-847-317-8988/
/Web site: http://www.cvt.com
http://www.adenoscan.com /
(CVTX)
CO: CV Therapeutics, Inc.; Astellas Pharma US, Inc.
ST: California, Illinois
IN: MTC BIO HEA
SU:
Antwort auf Beitrag Nr.: 29.320.164 von barabo am 15.05.07 10:08:09unter anderem...
Antwort auf Beitrag Nr.: 29.320.164 von barabo am 15.05.07 10:08:09Ausgestellte Rezepten für Ranexa steigen jetzt kontinuierlich mit schönen Wachstumsraten. Dazu Kosteneinsparungen (Vertrieb) und die Aussichten, dass ein Vertriebspartner dazu stößt später im Jahr.
CVT wird ein Value-play- langsam aber stätig - jedoch bleibt natürlich äußerst volatil als Biowert mit riesigen Short-Positionen.
CVT wird ein Value-play- langsam aber stätig - jedoch bleibt natürlich äußerst volatil als Biowert mit riesigen Short-Positionen.
Hedgefund Manager Daniel Loeb (sehr aktiver Mensch) hat jetzt 10% von CVTX. Jetzt wird wohl arg dampf gemacht.
http://www.thestreet.com/_yahoo/newsanalysis/biotech/1035757…
Langfristig sieht alles prima aus- werde mich doch bei 13-14$ verabschieden weil ich andere Interessen habe.
http://www.thestreet.com/_yahoo/newsanalysis/biotech/1035757…
Langfristig sieht alles prima aus- werde mich doch bei 13-14$ verabschieden weil ich andere Interessen habe.
13-14$ sind heute dick drinne.
Jim Cramer liebt CVTX auf einmal- das hilft arg stark.
Jim Cramer liebt CVTX auf einmal- das hilft arg stark.
Antwort auf Beitrag Nr.: 29.992.209 von Schapekop am 18.06.07 10:59:21Na ja- so arg wars auch wieder nicht- $12,60 reicht auch. CVTX ist ein prima Wert und wird seinen Weg gehen in die nächste Jahre- KZ von $16-18 auf Jahressicht erscheint mir sehr gut möglich durch das Wachstum von Ranexa Rezepte und Zulassung von Reganendon.
Ich verabschiede mich jedoch und stelle meine Kommentare hier ein.
Viel Glück alle Investierten.
Ich verabschiede mich jedoch und stelle meine Kommentare hier ein.
Viel Glück alle Investierten.
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