ViroPharma mit News - 500 Beiträge pro Seite (Seite 12)
eröffnet am 11.05.04 16:05:25 von
neuester Beitrag 08.07.08 15:51:08 von
neuester Beitrag 08.07.08 15:51:08 von
Beiträge: 5.542
ID: 858.309
ID: 858.309
Aufrufe heute: 37
Gesamt: 217.825
Gesamt: 217.825
Aktive User: 0
ISIN: US9282411084 · WKN: 903906
Werte aus der Branche Biotechnologie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,9000 | +59,66 | |
| 0,6000 | +57,48 | |
| 1,9200 | +23,87 | |
| 5,4500 | +19,00 | |
| 6,9300 | +17,46 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 4,3600 | -13,49 | |
| 1,6900 | -14,50 | |
| 2,8150 | -15,21 | |
| 2,2900 | -17,63 | |
| 2,2600 | -30,25 |
Feedback!
Dieser Beitrag wurde moderiert. Grund: Provokation
und hier wie aus dem lehrbuch:
Are These Perfect Pharma Acquisitions?
By Brian Lawler August 20, 2007
4
Recommendations
On Friday, we examined which characteristics improve the odds of a successful pharmaceutical acquisition. With so many mid-cap and large-cap pharmas like Endo Pharmaceuticals (Nasdaq: ENDP) or ViroPharma (Nasdaq: VPHM) publicly stating their intent to spend their growing cash balances on acquisitions, it's important for Fools to predict whether an acquisition will use shareholder resources wisely.
Because of the relatively short (but hugely profitable) marketing life of its products, the pharmaceutical industry depends on the abilities of its research and development teams to bring new drugs onto the market. If a drugmaker can't successfully shepherd new molecules into the clinical trial process with its in-house R&D team, its can only otherwise grow its pipeline through acquisitions.
As we discussed in greater depth on Friday, an Emory University study found four main characteristics that correlate to pharmaceutical deals that subsequently boost the acquirer's share price:
The buyer has worked closely with its purchase in the past and knows its operations well.
The buyer and purchase pursue complementary lines of work.
The deal involves equity, instead of cash.
The purchaser is not desperate to pad out its pipeline.
Let's use these criteria to evaluate several recent blockbuster acquisitions.
AstraZeneca and MedImmune
When AstraZeneca (NYSE: AZN) announced its intention to absorb MedImmune back in April, shares fell 5% the following day. Many analysts opined that AstraZeneca offered too high a premium for the smaller biopharma.
While it will be years before any definitive statements can be made about the deal, the MedImmune buyout doesn't bode well by the standards above. The companies had no prior relationships before the deal, and the nearly $16 billion offer was an all-cash deal (for MedImmune shareholders).
After several flameouts with late-stage drug candidates it had partnered on over the past 12 months, AstraZeneca was also getting desperate for mid- and late-stage pipeline products to spur future sales growth, with only four new chemical entities in phase 3 testing at the time.
In the acquisition's favor, AstraZeneca does market blockbuster asthma treatment Symbicort, so it's familiar with both MedImmune's key research focus on respiratory conditions, and with its lead drug Synagis. On balance, though, the other factors suggest this deal won't help AstraZeneca's shares.
Shire and New River Pharmaceuticals
Earlier in the year, I was shocked to see Shire Pharmaceuticals (Nasdaq: SHPGY) pay $2.6 billion for New River Pharmaceuticals, considering the relative valuation of New River's competitors.
Nonetheless, this deal seems promising, based on our four factors. Shire and New River previously worked together on New River's lead drug Vyvanse in 2005. New River's pipeline was relatively bare, so gaining access to the full revenue stream from Vyvanse was the main reason for the acquisition, as Shire pointed out when it made the deal.
Vyvanse is a treatment for attention-deficit hyperactivity disorder (ADHD). Shire had already done its due diligence on the main component of the buyout, and it was well aware of the therapeutic area that it treats. Integrating the drug into its existing ADHD sales force should be no problem.
Since Vyvanse just entered the market in late June, it's too soon to say how well sales of the drug will fare, or whether Shire overpaid for New River. According to the journal article's criteria, though, this acquisition is most likely correlated with future stock success.
Gilead and Myogen
Last year, Gilead Sciences (Nasdaq: GILD) announced its intention to purchase Myogen and its two development-stage hypertension drug candidates, ambrisentan (now known as Letairis) and darusentan. The market didn't like this piece of news, dropping Gilead shares 7% on the day the deal was announced.
This acquisition has already started bearing fruit for Gilead with the June approval of Letairis. But if Encysive Pharmaceuticals (Nasdaq: ENCY) had gained FDA approval for its very similar compound, Gilead investors probably wouldn't be so happy about the large $2.5 billion cash deal for Myogen.
The all-cash deal was a bad sign to start with, and Myogen's research focus on cardiovascular indications also fell outside of Gilead's core competency in treating HIV/AIDS. In addition, the drugmakers had no prior experience working with each other.
Even though this deal looks less than promising, shares of Gilead are so undervalued right now that it will still likely outperform the market going forward. Investors should put the company on notice for any future deals, though. According to one journal article, drugmakers that made at least two acquisitions in the previous three years had their shares gain 3% less than their non-acquisition-happy pharma peers.
Deal or no deal
Even after a few years' time lends greater insight into these acquisitions' success, it will still be hard to say whether they were a better or worse use of a drugmaker's cash than an equivalent share buyback or dividend. Nonetheless, investors can use the above characteristics to help them evaluate whether a pharma is putting its money or equity to good use.
Looking for more Foolish drug stock coverage? Check out the Fool's market-beating Rule Breakers newsletter. You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool's disclosure policy has a bright future ahead.
Are These Perfect Pharma Acquisitions?
By Brian Lawler August 20, 2007
4
Recommendations
On Friday, we examined which characteristics improve the odds of a successful pharmaceutical acquisition. With so many mid-cap and large-cap pharmas like Endo Pharmaceuticals (Nasdaq: ENDP) or ViroPharma (Nasdaq: VPHM) publicly stating their intent to spend their growing cash balances on acquisitions, it's important for Fools to predict whether an acquisition will use shareholder resources wisely.
Because of the relatively short (but hugely profitable) marketing life of its products, the pharmaceutical industry depends on the abilities of its research and development teams to bring new drugs onto the market. If a drugmaker can't successfully shepherd new molecules into the clinical trial process with its in-house R&D team, its can only otherwise grow its pipeline through acquisitions.
As we discussed in greater depth on Friday, an Emory University study found four main characteristics that correlate to pharmaceutical deals that subsequently boost the acquirer's share price:
The buyer has worked closely with its purchase in the past and knows its operations well.
The buyer and purchase pursue complementary lines of work.
The deal involves equity, instead of cash.
The purchaser is not desperate to pad out its pipeline.
Let's use these criteria to evaluate several recent blockbuster acquisitions.
AstraZeneca and MedImmune
When AstraZeneca (NYSE: AZN) announced its intention to absorb MedImmune back in April, shares fell 5% the following day. Many analysts opined that AstraZeneca offered too high a premium for the smaller biopharma.
While it will be years before any definitive statements can be made about the deal, the MedImmune buyout doesn't bode well by the standards above. The companies had no prior relationships before the deal, and the nearly $16 billion offer was an all-cash deal (for MedImmune shareholders).
After several flameouts with late-stage drug candidates it had partnered on over the past 12 months, AstraZeneca was also getting desperate for mid- and late-stage pipeline products to spur future sales growth, with only four new chemical entities in phase 3 testing at the time.
In the acquisition's favor, AstraZeneca does market blockbuster asthma treatment Symbicort, so it's familiar with both MedImmune's key research focus on respiratory conditions, and with its lead drug Synagis. On balance, though, the other factors suggest this deal won't help AstraZeneca's shares.
Shire and New River Pharmaceuticals
Earlier in the year, I was shocked to see Shire Pharmaceuticals (Nasdaq: SHPGY) pay $2.6 billion for New River Pharmaceuticals, considering the relative valuation of New River's competitors.
Nonetheless, this deal seems promising, based on our four factors. Shire and New River previously worked together on New River's lead drug Vyvanse in 2005. New River's pipeline was relatively bare, so gaining access to the full revenue stream from Vyvanse was the main reason for the acquisition, as Shire pointed out when it made the deal.
Vyvanse is a treatment for attention-deficit hyperactivity disorder (ADHD). Shire had already done its due diligence on the main component of the buyout, and it was well aware of the therapeutic area that it treats. Integrating the drug into its existing ADHD sales force should be no problem.
Since Vyvanse just entered the market in late June, it's too soon to say how well sales of the drug will fare, or whether Shire overpaid for New River. According to the journal article's criteria, though, this acquisition is most likely correlated with future stock success.
Gilead and Myogen
Last year, Gilead Sciences (Nasdaq: GILD) announced its intention to purchase Myogen and its two development-stage hypertension drug candidates, ambrisentan (now known as Letairis) and darusentan. The market didn't like this piece of news, dropping Gilead shares 7% on the day the deal was announced.
This acquisition has already started bearing fruit for Gilead with the June approval of Letairis. But if Encysive Pharmaceuticals (Nasdaq: ENCY) had gained FDA approval for its very similar compound, Gilead investors probably wouldn't be so happy about the large $2.5 billion cash deal for Myogen.
The all-cash deal was a bad sign to start with, and Myogen's research focus on cardiovascular indications also fell outside of Gilead's core competency in treating HIV/AIDS. In addition, the drugmakers had no prior experience working with each other.
Even though this deal looks less than promising, shares of Gilead are so undervalued right now that it will still likely outperform the market going forward. Investors should put the company on notice for any future deals, though. According to one journal article, drugmakers that made at least two acquisitions in the previous three years had their shares gain 3% less than their non-acquisition-happy pharma peers.
Deal or no deal
Even after a few years' time lends greater insight into these acquisitions' success, it will still be hard to say whether they were a better or worse use of a drugmaker's cash than an equivalent share buyback or dividend. Nonetheless, investors can use the above characteristics to help them evaluate whether a pharma is putting its money or equity to good use.
Looking for more Foolish drug stock coverage? Check out the Fool's market-beating Rule Breakers newsletter. You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool's disclosure policy has a bright future ahead.
Antwort auf Beitrag Nr.: 31.248.107 von miristegal am 21.08.07 23:21:43Hört sich sehr positiv an!
PS: Hattest du eigentlich nicht versprochen, hier nicht mehr zu schreiben, wenn du keine Aktien hast? Das Gleiche gilt für Amorphis!
Bitte an die Versprechen halten!
PS: Hattest du eigentlich nicht versprochen, hier nicht mehr zu schreiben, wenn du keine Aktien hast? Das Gleiche gilt für Amorphis!
Bitte an die Versprechen halten!
Antwort auf Beitrag Nr.: 31.244.534 von amorphis am 21.08.07 19:08:19WHAAAT?!?!
Bitte mit den Provokationen aufhören! Was soll denn dieses Geschrei in einem Börsenforum? Hier gibt es Regeln, also halte dich dran!
Außerdem hattest du versprochen nicht mehr hier zu schreiben!
Bitte mit den Provokationen aufhören! Was soll denn dieses Geschrei in einem Börsenforum? Hier gibt es Regeln, also halte dich dran!
Außerdem hattest du versprochen nicht mehr hier zu schreiben!
nein, habe ich nicht. was denkst du eigentlich - das ich hier nicht poste - nur weil DU hier bist???
Trading Spotlight
Antwort auf Beitrag Nr.: 31.249.379 von Pliscon am 22.08.07 08:27:22Wo kommst Du denn her? Wenn Du dein eigenes Forum mit deinen Regeln willst und dich am liebsten selber liest, dann mach ne eigen Plattform auf. Ich denke, jeder sollte selber entscheiden können, was er schreibt und denjenigen die dieses dann lesen ist doch wohl zuzutrauen,herausfiltern zu können, welche Informationen sachhaltig sind und wo man besser drüber weglesen sollte. Außerdem sind dies hier alles nur Anregungen, die einem bei Entscheidungen helfen können, oder eben nur so dahingeschrieben sind. Ich für meinen Teil finde es gut wenn hin und wieder mal etwas wertvolles geschrieben wird, aber dabei solls dann auch bleiben, Entscheidungen trifft auf dieser Grundlage wohl nur ein geringer Teil. Wer wirkliche Infos sucht, muß schon etwas nehr recherchieren als bei WO zu finden ist. In diesem Sinne auf die MEINUNGSFREIHEIT und immer locker bleiben, ist doch alles únpersönlich hier
Antwort auf Beitrag Nr.: 31.249.707 von ridethehype am 22.08.07 08:59:39Du kennst die Vorgeschichte nicht! Kannst mir gerne eine PN schreiben!
Aber hier sollte man ausschließlich über Viropharma diskutieren!
Aber hier sollte man ausschließlich über Viropharma diskutieren!
Antwort auf Beitrag Nr.: 31.249.707 von ridethehype am 22.08.07 08:59:39Was schätzt du eigentlich die Insiderkäufe bei Viropharma ein?
Die letzten 5 Tage konnte man schönes Geld mit Viropharma verdienen.
Aber auch langfristig ist hier viel mehr drin und Viropharma steht weit unter wert. Die haben immerhin ein KGV von 5 und mittlerweile jede Menge Cash auf dem Konto (über 200 Mio bei Marktkap von 600 Mio) und das als Biotechwert! Selbst wenn übernächstes Jahr Konkurrenz auftritt, wären sie mit einem KGV von 10, 20 oder 30 immer noch niedrig bewertet.
Die letzten 5 Tage konnte man schönes Geld mit Viropharma verdienen.
Aber auch langfristig ist hier viel mehr drin und Viropharma steht weit unter wert. Die haben immerhin ein KGV von 5 und mittlerweile jede Menge Cash auf dem Konto (über 200 Mio bei Marktkap von 600 Mio) und das als Biotechwert! Selbst wenn übernächstes Jahr Konkurrenz auftritt, wären sie mit einem KGV von 10, 20 oder 30 immer noch niedrig bewertet.
Antwort auf Beitrag Nr.: 31.251.804 von Pliscon am 22.08.07 11:12:32Halt ich in diesem Fall nicht das meiste von, bei solchen volatilen Titeln, kann das auch nur eine kurzfristige Spekulation der Beteildigten sein. Für mich genommen sehe ich in Viro ein vielversprechendes kleines Pharmaunternehmen, dass sich aufgrund der Pipeline auf den Markt von Morgen gut vorbereitet hat und die sollten die Studien zu den neuen Medikamenten abgeschlossen und positiv sein, wird hier sicher noch was gehen. Auf diesem Niveau kann man bei der derzeitigen ENtwicklung auf dem Pharmasektor allgemein nicht viel verkehrt machen und auch Viro wird sich langsam in diesen ständig wachsenden Markt eingliedern und sich mit diesem entwickeln. Die Demographie in der Welt zeigt eine eindeutige Richtung, was die Medizinische Versorgung angeht, diese wird jährlich steigen müssen.
schon jemand den XETRA Kurs gesehen?
Antwort auf Beitrag Nr.: 31.252.660 von ridethehype am 22.08.07 12:05:06Ich denke, dass sie auch wieder mal ein fertiges Patent kaufen könnten oder eventuell auch selber Generika anderer Medikamente auf den Markt bringen könnten! Immerhin haben sie ne menge Cash die letzten 2 Jahre angesammelt!
PS: In München sind wir auch schon über 7 Euro!
PS: In München sind wir auch schon über 7 Euro!
Viropharma macht wieder mal Freude! +5 %
Antwort auf Beitrag Nr.: 31.261.824 von Pliscon am 22.08.07 22:10:49gehe davon aus, dass der Kurs in den nächsten Wochen weiter steigen wird.
Antwort auf Beitrag Nr.: 31.249.373 von Pliscon am 22.08.07 08:26:21PS: Hattest du eigentlich nicht versprochen, hier nicht mehr zu schreiben, wenn du keine Aktien hast? Das Gleiche gilt für Amorphis!
Bitte an die Versprechen halten!
wem soll ich es versprochen haben????DIR???oder einem MOD??
Noch mal zum kapierren:
-ist nioht DEIN TH
-ich muss nicht ivestiert werden, um hier posten zu dürfen
-meine letzten postings waren informativ hier reingestellt
-dies kann man von deiner "informativen" weise leider nicht erkennen.
-das viro cash hat, wiessen wir schon seit zwei jahren
-das viro konkurrenz hat -DITO
-das viro mit dem vorhandenem geld bis nun kein deal gemacht hat, wiessen wir auch
-das ich hier mindestens ein jahr vor dir gepostet und amorphis auch, wiessen die wenigstens hier
-das ich mit viro damals gutes geld verdient habe, weiss ich nur selber
-das du nun in dicken minus bist, wiessen hier alle,
oder soll ich dich daran errinern??
also halte mal den ball flach.
Bitte an die Versprechen halten!
wem soll ich es versprochen haben????DIR???oder einem MOD??
Noch mal zum kapierren:
-ist nioht DEIN TH
-ich muss nicht ivestiert werden, um hier posten zu dürfen
-meine letzten postings waren informativ hier reingestellt
-dies kann man von deiner "informativen" weise leider nicht erkennen.
-das viro cash hat, wiessen wir schon seit zwei jahren
-das viro konkurrenz hat -DITO
-das viro mit dem vorhandenem geld bis nun kein deal gemacht hat, wiessen wir auch
-das ich hier mindestens ein jahr vor dir gepostet und amorphis auch, wiessen die wenigstens hier
-das ich mit viro damals gutes geld verdient habe, weiss ich nur selber
-das du nun in dicken minus bist, wiessen hier alle,
oder soll ich dich daran errinern??
also halte mal den ball flach.
Antwort auf Beitrag Nr.: 31.252.660 von ridethehype am 22.08.07 12:05:06genau. voll deiner meinung.
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
man muss auch zwischen den zeilen lesen , um sich ein bild von einer firma bilden und nicht nachplapern und fragen stellen.
gruss
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
man muss auch zwischen den zeilen lesen , um sich ein bild von einer firma bilden und nicht nachplapern und fragen stellen.
gruss
Antwort auf Beitrag Nr.: 31.262.899 von miristegal am 23.08.07 01:32:49Sowas gehört hier nicht rein!
1. Du solltest mich doch nie wieder anschreiben und schon garnicht im Forum!
2. So ein Müll gehört hier nicht rein, hier gehts um Viropharma! Leb deine Minderwertigkeitskomplexe doch bitte woanders aus. Hier wollen Leute über Viropharma diskutieren, die in diese Aktie investiert sind oder investieren wollen!
1. Du solltest mich doch nie wieder anschreiben und schon garnicht im Forum!
2. So ein Müll gehört hier nicht rein, hier gehts um Viropharma! Leb deine Minderwertigkeitskomplexe doch bitte woanders aus. Hier wollen Leute über Viropharma diskutieren, die in diese Aktie investiert sind oder investieren wollen!
Antwort auf Beitrag Nr.: 31.262.916 von miristegal am 23.08.07 01:47:12genau. voll deiner meinung.
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
Ich persönlich finde es voll korrekt, wenn ridethehype die Kurse angibt, immerhin hatte das auch einen Hintergrund!
Ich bitte dich doch, die Boardteilnehmern, die eine ernsthafte Interesse an Viropharma haben, in Ruhe zu lassen!
Jeder darf hier den Kurs von Viropharma posten so oft er möchte! Und gerade gestern war es sehr wichtig!
Was nicht korrekt sind, sind solche Beiträge, die du hier reinstellst!
Reine Provokation! Wenn du an Viropharma nicht interessiert bist (investiert bist du ja sowieso nicht), oder erst zu Fantasiekursen von 1 Euro, dann komm doch bitte erst wieder, wenn der Kurs auf 1 Euro steht!
Danke!
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
Ich persönlich finde es voll korrekt, wenn ridethehype die Kurse angibt, immerhin hatte das auch einen Hintergrund!
Ich bitte dich doch, die Boardteilnehmern, die eine ernsthafte Interesse an Viropharma haben, in Ruhe zu lassen!
Jeder darf hier den Kurs von Viropharma posten so oft er möchte! Und gerade gestern war es sehr wichtig!
Was nicht korrekt sind, sind solche Beiträge, die du hier reinstellst!
Reine Provokation! Wenn du an Viropharma nicht interessiert bist (investiert bist du ja sowieso nicht), oder erst zu Fantasiekursen von 1 Euro, dann komm doch bitte erst wieder, wenn der Kurs auf 1 Euro steht!
Danke!
Kann Viro dauerhaft die 10 Dollarmarke durchbrechen? 
Antwort auf Beitrag Nr.: 31.263.032 von Pliscon am 23.08.07 07:03:11genau. voll deiner meinung.
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
hier habe ich DICH gemeint. DU hast das wieder super verstanden.
man dreht den spies um und blässt zur attacke.
Lese mal noch mal #5623 sorgfälltig durch.vielleicht hilft es dir.
ansonsten:
http://biz.yahoo.com/prnews/070830/neth056.html?.v=20
also 6.09.07 die anderen links findest du da auch.
herzlichen gruss
PS. ja wann dauerhaft die 10 dollaros erreicht werden???haste eine meinung dazu???
aber alle 2 stunden den kursanstieg hier anzugeben, finde ich persönlich nicht korrekt.
hier habe ich DICH gemeint. DU hast das wieder super verstanden.
man dreht den spies um und blässt zur attacke.
Lese mal noch mal #5623 sorgfälltig durch.vielleicht hilft es dir.
ansonsten:
http://biz.yahoo.com/prnews/070830/neth056.html?.v=20
also 6.09.07 die anderen links findest du da auch.
herzlichen gruss
PS. ja wann dauerhaft die 10 dollaros erreicht werden???haste eine meinung dazu???
Antwort auf Beitrag Nr.: 31.378.734 von miristegal am 03.09.07 23:21:21Bitte etwas über das Thema, also Viropharma, schreiben und mit den Provokationen aufhören! 
10-Dollar-Marke offensichtlich geknackt!
Aufwärtstrend hält an.
Aufwärtstrend hält an.
Antwort auf Beitrag Nr.: 31.379.648 von Pliscon am 04.09.07 08:32:24Bitte etwas über das Thema, also Viropharma, schreiben und mit den Provokationen aufhören!
haste meinen link nicht angeklickt? Na dann viel spass beim lesen:
Press Release Source: ViroPharma Incorporated
ViroPharma to Present at Three Upcoming Healthcare Conferences
Thursday August 30, 1:10 pm ET
EXTON, Pa., Aug. 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that Vincent Milano, vice-president, chief operating officer and chief financial officer of ViroPharma, will present at the Thomas Weisel Partners 2007 Healthcare Conference at 8:00 A.M. ET on Wednesday, September 5, 2007. The conference is being held at the Four Seasons Hotel in Boston, MA.
ADVERTISEMENT
Mr. Milano will also present at the 14th Annual BioCentury Newsmakers in the Biotech Industry Conference at 1:30 P.M. ET on Thursday, September 6, 2007. The conference is being held at the Millennium Broadway Hotel in New York.
ViroPharma also announced that Michel de Rosen, president and chief executive officer of ViroPharma, will present at the Bear Stearns 20th Annual Healthcare Conference at 3:30 P.M. ET on Monday, September 10, 2007. The conference is being held at the Grand Hyatt in New York.
ViroPharma's presentations will be webcast live for investors through www.viropharma.com and available for a period of 14 days following the conference.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at www.viropharma.com.
haste meinen link nicht angeklickt? Na dann viel spass beim lesen:
Press Release Source: ViroPharma Incorporated
ViroPharma to Present at Three Upcoming Healthcare Conferences
Thursday August 30, 1:10 pm ET
EXTON, Pa., Aug. 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that Vincent Milano, vice-president, chief operating officer and chief financial officer of ViroPharma, will present at the Thomas Weisel Partners 2007 Healthcare Conference at 8:00 A.M. ET on Wednesday, September 5, 2007. The conference is being held at the Four Seasons Hotel in Boston, MA.
ADVERTISEMENT
Mr. Milano will also present at the 14th Annual BioCentury Newsmakers in the Biotech Industry Conference at 1:30 P.M. ET on Thursday, September 6, 2007. The conference is being held at the Millennium Broadway Hotel in New York.
ViroPharma also announced that Michel de Rosen, president and chief executive officer of ViroPharma, will present at the Bear Stearns 20th Annual Healthcare Conference at 3:30 P.M. ET on Monday, September 10, 2007. The conference is being held at the Grand Hyatt in New York.
ViroPharma's presentations will be webcast live for investors through www.viropharma.com and available for a period of 14 days following the conference.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at www.viropharma.com.
Antwort auf Beitrag Nr.: 31.392.149 von miristegal am 04.09.07 23:16:39Hi Plis. hier kann dir geholfen werden:
http://www.viropharma.com/therapeutic/pipeline.asp
http://www.viropharma.com/docs/Vancocin_pi_2007.htm
Bin zwar noch nicht investiert , aber was nicht ist , kann noch werden.Ist es so schwer zu verstehen?
http://www.viropharma.com/therapeutic/pipeline.asp
http://www.viropharma.com/docs/Vancocin_pi_2007.htm
Bin zwar noch nicht investiert , aber was nicht ist , kann noch werden.Ist es so schwer zu verstehen?
Bei Viro gehts endlich wieder nach oben, wurde ja auch Zeit nach dem was hier mit dem Kurs veranstaltet wurde. Absolut nicht gerechtfertigt, entwickelt man doch schließlich Generika, die sich ja im Zuge der Gesundheitsreformen und der demographischen Entwicklung immer mehr zu Kassenschlagern entwickeln und bei den Krankenkassen immer beliebter werden.
Antwort auf Beitrag Nr.: 31.392.149 von miristegal am 04.09.07 23:16:39O.K.
PS: Warum bist du eigentlich nicht eingestiegen? Du hättest jetzt schon über 30 % Gewinn gemacht.
PS: Warum bist du eigentlich nicht eingestiegen? Du hättest jetzt schon über 30 % Gewinn gemacht.
hier ist es ja doch sehr ruhig geworden. Bei den momentanen Newsflow und den damit verbundenen Kursbewegungen allerdings auch nicht verwunderlich.
hier mal stellvertretend für alle biotechs.
Wann werden die Werte endlich wieder vom Markt entdeckt?
Schaut man CEPH und Actelion an, könnte man schon jammern
Wann werden die Werte endlich wieder vom Markt entdeckt?
Schaut man CEPH und Actelion an, könnte man schon jammern
Antwort auf Beitrag Nr.: 31.970.288 von Mmmaulheld am 13.10.07 17:44:26Die Zeit wird uns recht geben.
Aktuell läuft der Kurs bei ELAN und BIOGEN schon ganz gut.
Aktuell läuft der Kurs bei ELAN und BIOGEN schon ganz gut.
ist in dieser Aktie noch jemand (außer mir) investiert?
Ich
Antwort auf Beitrag Nr.: 32.261.875 von Tankist am 02.11.07 20:34:36nun ja, dann sind wir immerhin noch zu zweit.
Der Kursverlauf nach den Zahlen ist ja nicht besonders erfreulich gewesen.
Allerings finde ich die Zahlen gar nicht so schlecht.
Der Kursverlauf nach den Zahlen ist ja nicht besonders erfreulich gewesen.
Allerings finde ich die Zahlen gar nicht so schlecht.
Hallo Poppholz,
das ist nach den Quartalszahlen doch schon eine geraume Weile so. Die Analysten bemänglen halt immer wieder das selbe:
Viro hat nur ein Produkt ! Also anfällig für Generika
Ich aber glaube, dass die Forschungen für weitere Produkte bald Früchte tragen oder, dass man sich von dem gewaltigen Cash Polster die Rechte an einem weiteren Medikament zulegt.
Eine Übernahme sehe ich nicht, dafür hat Viro zu wenig zú bieten.
Gruß
Tankist
das ist nach den Quartalszahlen doch schon eine geraume Weile so. Die Analysten bemänglen halt immer wieder das selbe:
Viro hat nur ein Produkt ! Also anfällig für Generika
Ich aber glaube, dass die Forschungen für weitere Produkte bald Früchte tragen oder, dass man sich von dem gewaltigen Cash Polster die Rechte an einem weiteren Medikament zulegt.
Eine Übernahme sehe ich nicht, dafür hat Viro zu wenig zú bieten.
Gruß
Tankist
ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM) EXTON, Pa., Nov. 12 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has granted orphan drug designation for CAMVIA for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell-mediated immunity. The EMEA's "Orphan Medicinal Product Designation" is designed to promote the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as "life-threatening or very serious conditions."
Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant. Finally, when a Pediatric Investigation Plan is completed, an additional two years of exclusivity could be granted for a product with orphan medicinal product designation.
"We are very pleased to receive orphan designation for CAMVIA from the EMEA," commented Thierry Darcis, M.D., ViroPharma's vice president and general manager, Europe. "This designation clearly recognizes the potential to address great unmet medical needs with CAMVIA as we work to maximize the global value of the drug. This designation from the EMEA adds additional momentum as we continue to develop CAMVIA for transplant-related cytomegalovirus disease. We commend the European Commission for providing incentives for the development of drugs for rare and life threatening diseases."
"ViroPharma is in a period of great global progress with CAMVIA," added Michel de Rosen, ViroPharma's chief executive officer. " We initiated one pivotal Phase 3 study in stem cell transplant patients in late 2006; presented excellent and unequivocal Phase 2 data at the 2006 meeting of the American Society of Hematology; were granted Orphan Drug Designation from the U.S. Food and Drug Administration this year; and began dosing in our second pivotal phase 3 study in solid organ liver transplant patients in September. We are generating strong excitement from US and European transplant physicians and this European designation marks yet another important positive step as we move diligently toward our goal of regulatory filings in the US and Europe in 2009."
Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant. Finally, when a Pediatric Investigation Plan is completed, an additional two years of exclusivity could be granted for a product with orphan medicinal product designation.
"We are very pleased to receive orphan designation for CAMVIA from the EMEA," commented Thierry Darcis, M.D., ViroPharma's vice president and general manager, Europe. "This designation clearly recognizes the potential to address great unmet medical needs with CAMVIA as we work to maximize the global value of the drug. This designation from the EMEA adds additional momentum as we continue to develop CAMVIA for transplant-related cytomegalovirus disease. We commend the European Commission for providing incentives for the development of drugs for rare and life threatening diseases."
"ViroPharma is in a period of great global progress with CAMVIA," added Michel de Rosen, ViroPharma's chief executive officer. " We initiated one pivotal Phase 3 study in stem cell transplant patients in late 2006; presented excellent and unequivocal Phase 2 data at the 2006 meeting of the American Society of Hematology; were granted Orphan Drug Designation from the U.S. Food and Drug Administration this year; and began dosing in our second pivotal phase 3 study in solid organ liver transplant patients in September. We are generating strong excitement from US and European transplant physicians and this European designation marks yet another important positive step as we move diligently toward our goal of regulatory filings in the US and Europe in 2009."
Viropharma - hochspekulativer Geheimtipp!
Fundamental
Viropharma hatte bis ins Jahr 2000 hinein einen hochinteressanten Impfstoff in der Entwicklung, der jedoch in den klinischen Phasen scheiterte. Daraufhin wurde die Aktie natürlich in den Keller geschickt und mutierte lange Zeit sogar zu einem sogenannten Pennystock.
Doch nach einiger Zeit schaffte man es durch Einlizenzierung neuer Medikamente sowie der Weiterentwicklung von eigenen Medikamenten, den Turn-Around hinzubekommen. So wächst das Unternehmen schon seit einiger Zeit sowohl beim Umsatz wie auch beim Gewinn deutlich und der Aktienkurs konnte deutlich zulegen.
Seit einiger Zeit jedoch hat die Aktie den Rückwärtsgang eingelegt und ist aktuell so billig wie zuletzt vor etwa einem Jahr. So wird das Unternehmen aktuell mit einem KUV von etwa 1 und einem KGV von gerade mal 7 bewertet, was für ein profitabel wachsendes Biotechunternehmen in den USA als sehr günstig einzustufen ist. Somit ist die Aktie fundamental ganz klar mit STRONG BUY einzustufen...
Charttechnik
Wie eben schon geschrieben, ist die Aktie aktuell auf den Stand von vor einem Jahr zurückgekommen. Damit sieht alles nach der Ausbildung eines Doppelbodens aus. Von diesem ausgehend könnte es dann wieder deutlich aufwärts gehen. Die günstige Bewertung spricht sicherlich dafür, dass die Bodenbildung gelingen könnte. Die Charttechnik jedoch deutet nicht unbedingt darauf hin. Denn auf dem Weg nach oben stehen nicht nur sämtliche Gleitenden Durchschnitte im Wege, sondern auch die Indikatorenlage ist noch bestenfalls als neutral einzustufen. Aus charttechnischer Sicht ist die Viropharma Aktie daher eine Halteposition.
Sentimentbetrachtung
Zur Betrachtung der Stimmungslage habe ich heute mal einen neuartigen Chart mitgebracht, der neben dem Kursverlauf auch alle Empfehlungen der letzten Zeit enthält.
Wie man erkennen kann, beobachten nur sehr wenige Analysten diese Aktie. Die wenigen Analysten, die die Aktie aber beobachten, sind alle positiv gestimmt. Das Sentiment ist daher für einen Anstieg eigentlich zu positiv, aber da nur wenige Analysten die Aktie auf dem Radar haben ist dies wenig aussagekräftig. Somit schenke ich dem Sentiment hier wenig Bedeutung.
Ergebnis der Analysen
Fundamental ist die Viropharma Aktie mit einem KUV von 1 und einem KGV von 7 ein klarer Kauf. Vergleichbare Unternehmen werden in den USA normalerweise mit KUVs von 3 bis 4 und KGVs von 40 und mehr bewertet. Charttechnisch ist die Aktie angeschlagen, aber noch ist alles in Ordnung. Das eigentlich zu gute Sentiment ist in diesem Fall bedeutungslos, da einfach zu wenige Analysten die Company überhaupt verfolgen.
Ich vergebe daher folgende Einschätzungen für die Biotechcompany Viropharma: SHORT TERM STRONG BUY SPECULATIVE, Price Target: 8 Euro und LONG TERM STRONG BUY SPECULATIVE, Price Target: 10 Euro. Denn Stoppkurs muss man in diesem Fall jedoch sehr eng unter den aktuellen Kursen platzieren - also bei knapp unter 5 Euro. Somit kann man die Chancen nach oben ggfs. nutzen und das bei einem sehr niedrigen Risiko von maximal ca. 5%.
Wichtig ist jedoch, dass man diesen engen Stoppkurs konsequent einhält!
Fundamental
Viropharma hatte bis ins Jahr 2000 hinein einen hochinteressanten Impfstoff in der Entwicklung, der jedoch in den klinischen Phasen scheiterte. Daraufhin wurde die Aktie natürlich in den Keller geschickt und mutierte lange Zeit sogar zu einem sogenannten Pennystock.
Doch nach einiger Zeit schaffte man es durch Einlizenzierung neuer Medikamente sowie der Weiterentwicklung von eigenen Medikamenten, den Turn-Around hinzubekommen. So wächst das Unternehmen schon seit einiger Zeit sowohl beim Umsatz wie auch beim Gewinn deutlich und der Aktienkurs konnte deutlich zulegen.
Seit einiger Zeit jedoch hat die Aktie den Rückwärtsgang eingelegt und ist aktuell so billig wie zuletzt vor etwa einem Jahr. So wird das Unternehmen aktuell mit einem KUV von etwa 1 und einem KGV von gerade mal 7 bewertet, was für ein profitabel wachsendes Biotechunternehmen in den USA als sehr günstig einzustufen ist. Somit ist die Aktie fundamental ganz klar mit STRONG BUY einzustufen...
Charttechnik
Wie eben schon geschrieben, ist die Aktie aktuell auf den Stand von vor einem Jahr zurückgekommen. Damit sieht alles nach der Ausbildung eines Doppelbodens aus. Von diesem ausgehend könnte es dann wieder deutlich aufwärts gehen. Die günstige Bewertung spricht sicherlich dafür, dass die Bodenbildung gelingen könnte. Die Charttechnik jedoch deutet nicht unbedingt darauf hin. Denn auf dem Weg nach oben stehen nicht nur sämtliche Gleitenden Durchschnitte im Wege, sondern auch die Indikatorenlage ist noch bestenfalls als neutral einzustufen. Aus charttechnischer Sicht ist die Viropharma Aktie daher eine Halteposition.
Sentimentbetrachtung
Zur Betrachtung der Stimmungslage habe ich heute mal einen neuartigen Chart mitgebracht, der neben dem Kursverlauf auch alle Empfehlungen der letzten Zeit enthält.
Wie man erkennen kann, beobachten nur sehr wenige Analysten diese Aktie. Die wenigen Analysten, die die Aktie aber beobachten, sind alle positiv gestimmt. Das Sentiment ist daher für einen Anstieg eigentlich zu positiv, aber da nur wenige Analysten die Aktie auf dem Radar haben ist dies wenig aussagekräftig. Somit schenke ich dem Sentiment hier wenig Bedeutung.
Ergebnis der Analysen
Fundamental ist die Viropharma Aktie mit einem KUV von 1 und einem KGV von 7 ein klarer Kauf. Vergleichbare Unternehmen werden in den USA normalerweise mit KUVs von 3 bis 4 und KGVs von 40 und mehr bewertet. Charttechnisch ist die Aktie angeschlagen, aber noch ist alles in Ordnung. Das eigentlich zu gute Sentiment ist in diesem Fall bedeutungslos, da einfach zu wenige Analysten die Company überhaupt verfolgen.
Ich vergebe daher folgende Einschätzungen für die Biotechcompany Viropharma: SHORT TERM STRONG BUY SPECULATIVE, Price Target: 8 Euro und LONG TERM STRONG BUY SPECULATIVE, Price Target: 10 Euro. Denn Stoppkurs muss man in diesem Fall jedoch sehr eng unter den aktuellen Kursen platzieren - also bei knapp unter 5 Euro. Somit kann man die Chancen nach oben ggfs. nutzen und das bei einem sehr niedrigen Risiko von maximal ca. 5%.
Wichtig ist jedoch, dass man diesen engen Stoppkurs konsequent einhält!
Sind die nicht total unterbewertet?
KGV von 7 laut Comdirekt!
Und Außerdem haben sie laut quote.yahoo.com über 500 Mio Dollar in Cash und Short-Term-Investments!
Eine Bilanzsumme von 743 Mio Dollar aber eine Marktkapitalisierung von nur 590 Mio Dollar!
KGV von 7 laut Comdirekt!
Und Außerdem haben sie laut quote.yahoo.com über 500 Mio Dollar in Cash und Short-Term-Investments!
Eine Bilanzsumme von 743 Mio Dollar aber eine Marktkapitalisierung von nur 590 Mio Dollar!
Antwort auf Beitrag Nr.: 32.788.550 von Vanilidium am 17.12.07 10:26:35Yeo, VPHM steht auf mein "Strong Watch" liste für 2008
technische Erholung oder doch mehr?
VioPharma Inc. (VPHM:VPHM
News, chart, profile, more
Last:
Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
VPHM, , ) expects 2008 product sales of $210 million to $235 million. The Exton, Pa., drug company said 2007 sales of Vancocin, which treats bacterial infections of the lower digestive tract, should be within the company's estimated range of $202 million to $208 million, an increase of at least 21% from a year earlier.
News, chart, profile, more
Last:
Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
VPHM, , ) expects 2008 product sales of $210 million to $235 million. The Exton, Pa., drug company said 2007 sales of Vancocin, which treats bacterial infections of the lower digestive tract, should be within the company's estimated range of $202 million to $208 million, an increase of at least 21% from a year earlier.
ViroPharma Q4 Earnings Increase; Revenues Up; Provides FY08 Forecast [VPHM]
2/27/2008 10:49:12 AM Wednesday morning, biopharmaceutical company ViroPharma Inc. (VPHM) announced financial results for the fourth quarter, reporting a rise in earnings, helped by increase in total revenues and lower income tax expense. The company also provided outlook for the fiscal year 2008.
The Exton, Pennsylvania-based ViroPharma's net income for the fourth quarter increased to $20.4 million from $18.0 million in the same quarter of last year. Earnings per share remained flat at $0.25, mainly due to increase in share count from 71.1 million to 83.8 million. On average, twelve analysts polled by First Call/Thomson Financial projected earnings of $0.20 per share.
Total revenues for the fourth quarter were $47.7 million, higher than $38.6 million in the equivalent quarter of the previous year. Ten analysts' average revenue projection was $50.38 million.
Research and development expenses increased to $12.5 million from $3.1 million in the same quarter of the prior year. Marketing, general and administrative expenses grew to $12.7 million from $7.1 million in the year-ago quarter.
Operating income for the fourth quarter was $19.0 million, down from $25.1 million in the same quarter a year before, particularly due to higher costs partially offset by the higher net sales.
Income before income taxes fell to $24.8 million from $29.9 million in the corresponding quarter of the preceding year.
The company said that the primary drivers of the change in net income for the fourth quarter were the effects of decreased operating income, partially offset by increased interest income and a lower effective tax rate.
For the fiscal year 2007, ViroPharma's net income of $95.4 million or $1.21 per share was higher than $66.7 million or $0.95 per share in the previous year. Twelve analysts, on average, estimated earnings of $1.15 per share.
Total revenues for the fiscal year improved to $203.8 million from $167.2 million in the preceding year. Eleven analysts, on average, targeted the company to report revenues of $205.87 million.
Moving ahead, ViroPharma projects fiscal year 2008 net product sales to range between $210 million and $235 million. Nine analysts, on average, expect the company to report revenues of $210.35 million. The company also expects research and development expenses, excluding the impact of SFAS 123R, of $105 - $115 million.
VPHM's shares are currently trading at $9.30, up 7 cents or 0.76% from its previous closing
2/27/2008 10:49:12 AM Wednesday morning, biopharmaceutical company ViroPharma Inc. (VPHM) announced financial results for the fourth quarter, reporting a rise in earnings, helped by increase in total revenues and lower income tax expense. The company also provided outlook for the fiscal year 2008.
The Exton, Pennsylvania-based ViroPharma's net income for the fourth quarter increased to $20.4 million from $18.0 million in the same quarter of last year. Earnings per share remained flat at $0.25, mainly due to increase in share count from 71.1 million to 83.8 million. On average, twelve analysts polled by First Call/Thomson Financial projected earnings of $0.20 per share.
Total revenues for the fourth quarter were $47.7 million, higher than $38.6 million in the equivalent quarter of the previous year. Ten analysts' average revenue projection was $50.38 million.
Research and development expenses increased to $12.5 million from $3.1 million in the same quarter of the prior year. Marketing, general and administrative expenses grew to $12.7 million from $7.1 million in the year-ago quarter.
Operating income for the fourth quarter was $19.0 million, down from $25.1 million in the same quarter a year before, particularly due to higher costs partially offset by the higher net sales.
Income before income taxes fell to $24.8 million from $29.9 million in the corresponding quarter of the preceding year.
The company said that the primary drivers of the change in net income for the fourth quarter were the effects of decreased operating income, partially offset by increased interest income and a lower effective tax rate.
For the fiscal year 2007, ViroPharma's net income of $95.4 million or $1.21 per share was higher than $66.7 million or $0.95 per share in the previous year. Twelve analysts, on average, estimated earnings of $1.15 per share.
Total revenues for the fiscal year improved to $203.8 million from $167.2 million in the preceding year. Eleven analysts, on average, targeted the company to report revenues of $205.87 million.
Moving ahead, ViroPharma projects fiscal year 2008 net product sales to range between $210 million and $235 million. Nine analysts, on average, expect the company to report revenues of $210.35 million. The company also expects research and development expenses, excluding the impact of SFAS 123R, of $105 - $115 million.
VPHM's shares are currently trading at $9.30, up 7 cents or 0.76% from its previous closing
Auf dem Weg zur 12$
ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Last update: 9:00 a.m. EDT July 8, 2008
EXTON, Pa., July 8, 2008 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM:VPHM
News, chart, profile, more
Last:
Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
VPHM, , ) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.
Based on FDA's statements to ViroPharma regarding the purpose of this meeting, made by both Committee staff and FDA's Office of Chief Counsel, ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting GI drugs. Among other things, ViroPharma's letter notes important issues that must be addressed in this complex area of bioequivalence method development, and attaches for the Committee's review a letter sent to FDA last year by the Infectious Diseases Society of America (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/OGDpetition/.
FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."
ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.
ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/OGDpetition/.
About Clostridium difficile
One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most common and devastating HAIs. The incidence of C. difficile observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-term care patients, or those that have a serious underlying illness, are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea, fever, nausea and abdominal pain and dehydration, though cases can lead to life threatening complications such as megacolon, peritonitis and perforation of the colon.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/Products.aspx)." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV) and C. difficile. For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company's understanding that the meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) and that additional opportunity for public input regarding bioequivalence methods for Vancocin will occur or that ViroPharma will ensure that the points in its letter to the advisory committee will be brought forward to this committee. There can be no assurance that the FDA will continue with its stated plans regarding the subject matter of the Advisory Committee meeting, that the FDA will conduct public process specifically for Vancocin, that the FDA will agree with the positions stated in ViroPharma's Vancocin related submissions or that ViroPharma's efforts to oppose the OGD's March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either ViroPharma's citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
SOURCE ViroPharma Incorporated
http://www.viropharma.com
Copyright (C) 2008 PR Newswire. All rights reserved
Last update: 9:00 a.m. EDT July 8, 2008
EXTON, Pa., July 8, 2008 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM:VPHM
News, chart, profile, more
Last:
Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
VPHM, , ) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.
Based on FDA's statements to ViroPharma regarding the purpose of this meeting, made by both Committee staff and FDA's Office of Chief Counsel, ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting GI drugs. Among other things, ViroPharma's letter notes important issues that must be addressed in this complex area of bioequivalence method development, and attaches for the Committee's review a letter sent to FDA last year by the Infectious Diseases Society of America (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/OGDpetition/.
FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."
ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.
ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/OGDpetition/.
About Clostridium difficile
One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most common and devastating HAIs. The incidence of C. difficile observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-term care patients, or those that have a serious underlying illness, are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea, fever, nausea and abdominal pain and dehydration, though cases can lead to life threatening complications such as megacolon, peritonitis and perforation of the colon.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/Products.aspx)." target="_blank" rel="nofollow ugc noopener">http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV) and C. difficile. For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company's understanding that the meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) and that additional opportunity for public input regarding bioequivalence methods for Vancocin will occur or that ViroPharma will ensure that the points in its letter to the advisory committee will be brought forward to this committee. There can be no assurance that the FDA will continue with its stated plans regarding the subject matter of the Advisory Committee meeting, that the FDA will conduct public process specifically for Vancocin, that the FDA will agree with the positions stated in ViroPharma's Vancocin related submissions or that ViroPharma's efforts to oppose the OGD's March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either ViroPharma's citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
SOURCE ViroPharma Incorporated
http://www.viropharma.com
Copyright (C) 2008 PR Newswire. All rights reserved
DurchsuchenBeitrag zu dieser Diskussion schreiben
Zu dieser Diskussion können keine Beiträge mehr verfasst werden, da der letzte Beitrag vor mehr als zwei Jahren verfasst wurde und die Diskussion daraufhin archiviert wurde.
Bitte wenden Sie sich an feedback@wallstreet-online.de und erfragen Sie die Reaktivierung der Diskussion oder starten Sie eine neue Diskussion.
Investoren beobachten auch:
| Wertpapier | Perf. % |
|---|---|
| +0,18 | |
| -1,35 | |
| -3,45 | |
| -0,32 | |
| -0,07 | |
| +0,57 | |
| -0,75 | |
| -0,40 | |
| -0,94 | |
| -1,47 |
Meistdiskutiert
| Wertpapier | Beiträge | |
|---|---|---|
| 220 | ||
| 104 | ||
| 93 | ||
| 77 | ||
| 47 | ||
| 43 | ||
| 41 | ||
| 40 | ||
| 31 | ||
| 31 |
