Girindus- für Adolor und GSK hergestellter Wirkstoff kurz vor Zulassung - 500 Beiträge pro Seite

[Salem88]

Adolor moves closer to FDA decision on drug
Wednesday May 31, 9:36 am ET


The Food and Drug Administration accepted as complete Adolor Corp.'s response to the agency's request for additional information regarding its new drug application for Entereg.
Entereg is Adolor's flagship new drug candidate. It is being developed initially to treat post-operative ileus or POI. POI is a gastrointestinal impairment experienced by many patients following abdominal surgery. The condition can be exacerbated and prolonged by multiple factors including the use of opioid analgesics for pain relief. POI is characterized by abdominal distension and pain, nausea and vomiting, reduced desire to eat, and an inability to pass gas or stool.

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The FDA issued an approvable letter for Entereg last summer, contingent upon Adolor of Exton, Pa., submitting additional clinical trial data for the product supporting its proposed use following bowel resection surgery.

Adolor (NASDAQ: ADLR - News) , which is developing Entereg in a partnership with GlaxoSmithKline (NYSE: GSK - News), expects to receive a final FDA decision on its application in November.

Published May 31, 2006 by the Philadelphia Business Journal



Den Wirkstoff Alvimopan, Entereg(TM) stellt Girindus für Adolor und Glaxo her und wäre nach langen Jahren des wartens der erste marktreife Wirkstoff der Künsebeck verlässt.


http://www.girindus.com/de/ir/press01032004.html

[Salem88]

Als die letzte fehlende Studie (P314) von Adolor veröffentlicht wurde, ging ADLR mit 50% als Tagessieger an der NASDAQ aus dem Handel.

[Salem88]

AP

FDA Restarts Review of Entereg

Wednesday May 31, 11:10 am ET

FDA Resuming Review of Adolor, GlaxoSmithKline Drug for Intestinal Blockages


PHILADELPHIA (AP) -- Pharmaceutical companies Adolor Corp. and GlaxoSmithKline Plc on Wednesday said regulators will resume reviewing the companies' application for a drug to treat intestinal obstructions after new data from a study reaffirmed the drug's effectiveness.

In July 2005, Adolor submitted a new drug application to the Food and Drug Administration for Entereg to treat postoperative ileus, or bowel obstruction caused by surgery.

The agency said it would not approve the application until the company provided additional proof of the drug's effectiveness in speeding up recovery of gastrointestinal function after bowel surgery.

Adolor said the agency agreed to resume its review based on positive results from a study, originally reported in February.

Shares in Adolor, which is codeveloping the drug with GlaxoSmithKline, rose 46 cents to $23.45 in midday trading on the Nasdaq. The stock has moved between $8.27 and $27.80 in the past 52 weeks.

GlaxoSmithKline shares rose 25 cents to $55.28 on the New York Stock Exchange. The 52-week range is $46.20 to $58.40.

---------------------------------------------------------------

Stellt sich für uns die Frage, wieviel Girindus daran verdient?

Einen ordentliche Milestonezahlung, der eine Massenfertigung von Alvimopan folgt ist selbstverständlich. Man findet im Internet sogar die Verträge zwischen Adolor, GSK und Girindus vom 23. Sep. 04; also rel. frisch. Leider ohne Zahlen. Nur will ich sie hier nicht veröffentlichen. Wer aber unter google ensprechend sucht, findet sie. Girindus AND Adolor AND BX7

Ist da sogar üblich Vertragstexte ins Internet zu stellen.

Dem Anwendungsbereich POI wird nicht das grosse Marktpotential eingeräumt wie OBD, wo Alvimopan auch sehr gut (besser) wirkt. Nur für GIR würde auch das erstmal reichen denke ich.

Hier ist nochmal die aktuellste *.pdf mit Zeitplan.

http://www.wrhambrecht.com/sector/biotech/notes/adlr20060505…

[Salem88]

Jetzt bei etwas freundlicheren Börsen fängt man bei Adolor langsam einzupreisen, dass Alvimopan (Entereg) zu 99% zugelassen ist. Obwohl wenn man ehrlich ist, die Zulassung schon nach Veröffentlichung der Studie eingepreist war. So langsam sollte GIR mal an der Reihe sein.

...expects to receive a final FDA decision on its application in November.

Vielleicht lässt sich auf der HV ein wenig entlocken, so im kleinen Kreis.

[Salem88]

Man rüstet sich vor den bevorstehenden Aufgaben im November.

Adolor Corporation Appoints Scott T. Megaffin as Vice President, Marketing

EXTON, Pa.--(BUSINESS WIRE)--June 28, 2006--Adolor Corporation (NASDAQ: ADLR) announced today the appointment of Scott T. Megaffin as vice president, marketing. Mr. Megaffin will be responsible for the development of the strategic marketing efforts for the company's product candidates. Mr. Megaffin brings over 20 years of experience in marketing and selling of hospital products; his broad based experience extends to specialty and primary care.

"We are pleased to welcome Scott to our management team," said Roger D. Graham, Jr., senior vice president, sales and marketing, Adolor Corporation. "Scott has tremendous experience developing and implementing strategies for products in pain management and in launches for new products. Scott's expertise is a wonderful fit for Adolor."

Mr. Megaffin has demonstrated achievement throughout his career in driving growth within brand marketing units and launching several major products. Mr. Megaffin served most recently as a senior director of marketing at Schering-Plough, where he led the re-positioning and messaging of PegIntron(R) globally. Prior to that, Mr. Megaffin developed the platform for key commercial activities for the launch of Vaprisol(R) as a director of marketing for Yamanouchi Pharma America.

"I am delighted to join the management team of Adolor," Mr. Megaffin stated. "Adolor is at a very exciting stage of corporate development, with a portfolio of attractive product opportunities that are focused on patient benefit in the management of pain and a solid financial position with which to advance these opportunities."

[humm]

Zur Adolors Meldung:

>> Adolor Corporation Appoints Scott T. Megaffin as Vice President, Marketing<<

wozu brauchen sie Marketing?
Für „Entereg(R) (Alvimopan)“ wenn die FDA die Zulassung in November erteilen wird.
Dass die Zulassung kommt ist schon eine abgemachte Sache.
Ich hoffe dass der Marketing-Mann auch verkaufen kann.
Mögen sie VIEL Entereg verkaufen.

[humm]

Antwort auf Beitrag Nr.: 22.345.170 von humm am 29.06.06 19:08:07

ups, falsches thread... :O

[Salem88]

Im Adolorforum bei yahoo können se es auch kaum noch erwarten das Entereg im Nov. zugelassen wird. Geht es denen ja wie uns. Übrigens ist es wohl möglich, dass Entereg nach der Zulassung für post operativ illeus (POI) auch bereits off-label für opioid bowl dysfunction (OBD) eingesetzt werden kann. Ist aber aufgeschnappt und ohne Gewähr.

Irgendwo in den Zahlen ist auch GIR´s Anteil versteckt.



Adolor Corporation Reports Second Quarter 2006 Financial Results

EXTON, Pa.--(BUSINESS WIRE)--July 31, 2006--Adolor Corporation (Nasdaq:ADLR) today reported financial results for the three and six months ended June 30, 2006.

For the three months ended June 30, 2006, the company reported a net loss of $15.7 million or $0.35 per basic and diluted share, compared to a net loss of $13.8 million or $0.35 per basic and diluted share in the three months ended June 30, 2005. For the six month period ended June 30, 2006, the company reported a net loss of $33.2 million or $0.76 per basic and diluted share, compared to a net loss of $25.7 million or $0.66 per basic and diluted share for the same period in 2005.

Contract revenues were approximately $3.0 million and $3.8 million for the three months ended June 30, 2006 and 2005, respectively, and were approximately $5.5 million and $6.7 million for the six months ended June 30, 2006 and 2005, respectively. The decrease in revenues for the quarter was primarily due to a decrease in co-promotion revenues of $0.7 million from our Arixtra(R) co-promotion agreement with Glaxo. The decrease for the six months ended June 30, 2006, was primarily the result of a decrease in revenues of $0.9 million relating to expenses reimbursable by Glaxo under our collaboration agreement.

Research and development expenses were approximately $13.0 million and $10.8 million for the three months ended June 30, 2006 and 2005, respectively, and were approximately $27.6 million and $20.8 million for the six months ended June 30, 2006 and 2005, respectively. Expenses were higher primarily as a result of compensation expense from the implementation of FAS 123R, expense reimbursements owed Glaxo for Entereg(R) in opioid bowel dysfunction (OBD) and greater cost for our sterile lidocaine patch program, delta opioid agonist program and alvimopan/opioid combination product development program. These were partially offset by the absence of phase 3 clinical trial expenses for Study 314 in postoperative ileus (POI).

Marketing, general and administrative expenses were approximately $8.2 million and $7.7 million for the three months ended June 30, 2006 and 2005, respectively, and were approximately $15.6 million and $13.3 million for the six months ended June 30, 2006 and 2005, respectively. Expense increases in 2006 were principally the result of increased personnel expenses including the adoption of FAS 123R. In addition, we incurred greater expense for our sales force and other marketing related expenses.

As of June 30, 2006, the Company had approximately $217.4 million in cash, cash equivalents and short-term investments.

About Adolor Corporation

Adolor Corporation (NASDAQ:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg(R) (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor and GlaxoSmithKline (GSK) are collaborating in the worldwide development and commercialization of Entereg(R) in multiple indications. Adolor is developing a sterile lidocaine patch which is in Phase 2 clinical development for post-surgical incisional pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.

Arixtra(R) is a trademark of GlaxoSmithKline.

This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that Adolor may not obtain FDA approval for the NDA for Entereg(R) in POI, whether due to the risk that: Adolor is not able to provide additional data satisfactory to the FDA to obtain approval for the NDA; Adolor is not able to justify that the median reduction in time to gastrointestinal (GI) recovery seen in bowel resection patients treated with Entereg(R) is clinically meaningful; the adequacy of the results of the Studies 14CL302, 14CL306, 14CL308, 14CL313 and 14CL314 to support FDA approval of Entereg(R), the results from other clinical trials of Entereg(R), including the Glaxo Phase 3 Study 001, the adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, reliance on third party manufacturers, adverse safety findings or otherwise; the risk that the FDA may not agree with Adolor's analyses of Studies 14CL302, 14CL306, 14CL308, 14CL313 and 14CL314 and may evaluate the results of these studies by different methods or conclude that the results from the studies are not statistically significant, clinically meaningful or do not support safety or that there were human errors in the conduct of the studies or otherwise; the risk that further studies of Entereg(R) in OBD are not positive; the risk that the results of Study 001 do not support a submission of a marketing approval application for alvimopan in Europe for POI; the risk of unfavorable results of trials in other indications; the risk that filing targets for regulatory submissions are not met; the risk that FDA does not remove the clinical hold on the Delta IND; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including Glaxo, in connection with the development and commercialization of Entereg(R); market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation.

Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.

This press release is available on the website http://www.adolor.com.

(Financial data table follows)



ADOLOR CORPORATION
STATEMENTS OF OPERATIONS DATA
(Unaudited)

FOR THE THREE MONTHS FOR THE SIX MONTHS
ENDED JUNE 30, ENDED JUNE 30,
--------------------------- ---------------------------

2006 2005 2006 2005
------------- ------------- ------------- -------------

REVENUES
Contract
revenues $2,958,478 $3,807,638 $5,527,095 $6,723,958

OPERATING
EXPENSES
Research and
development 12,958,802 10,759,893 27,565,420 20,823,133
Marketing,
general and
administra-
tive 8,155,290 7,677,782 15,610,632 13,285,456
------------- ------------- ------------- -------------

Total
operating
expenses 21,114,092 18,437,675 43,176,052 34,108,589
------------- ------------- ------------- -------------

Loss from
operations (18,155,614) (14,630,037) (37,648,957) (27,384,631)
Interest
income and
other, net 2,450,199 854,581 4,498,055 1,641,134
------------- ------------- ------------- -------------
Net loss ($15,705,415) ($13,775,456) ($33,150,902) ($25,743,497)
============= ============= ============= =============

Basic and
diluted net
loss per
share ($0.35) ($0.35) ($0.76) ($0.66)
============= ============= ============= =============

Shares used in
computing
basic and
diluted net
loss per
share 45,471,294 39,086,902 43,595,808 39,086,524
============= ============= ============= =============


BALANCE SHEET DATA
(Unaudited)

JUNE 30, DECEMBER 31,
2006 2005

Cash, cash
equivalents
and short-
term
investments $217,369,321 $103,075,119
Working
capital 207,228,068 89,664,249
Total assets 229,643,338 117,236,617
Total
stockholders'
equity 185,178,709 66,693,290

CONTACT: Adolor Corporation
Thomas P. Hess, 484-595-1500
or
Media:
Sam Brown, Inc.
Mike Beyer, 773-463-4211

SOURCE: Adolor Corporation

[Salem88]

Antwort auf Beitrag Nr.: 21.891.376 von Salem88 am 31.05.06 15:58:44

Postoperative Ileus (POI) Clinical
Development Program

In July 2005, we announced the receipt of an approvable letter from the FDA for Entereg® 12 mg capsules, under review for the management of POI by acceleration of GI function following bowel resection surgery. An approvable letter is a letter from the FDA to an NDA applicant indicating that the FDA may approve the NDA if specific additional information is submitted or specific conditions are agreed upon. The approvable letter indicated that before the application for Entereg® may be approved, it will be necessary to provide additional proof of efficacy to the FDA to support the use of Entereg® following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and that this could potentially be addressed with positive results from our Study 14CL314 (Study 314). The FDA also indicated that we must provide justification that the median reduction in time to gastrointestinal recovery seen in bowel resection patients treated with Entereg® is clinically meaningful.


After a meeting with the FDA regarding the approvable letter, we reported that the FDA confirmed that the Study 314 design represented an adequate and well controlled study, the results of which could potentially provide the additional proof of efficacy requested by the FDA in the approvable letter. The FDA confirmed that the “GI2” endpoint, representing time to recovery of GI function, and defined as the last to occur of upper GI recovery (solid food) and lower GI recovery (bowel movement), was acceptable as the primary endpoint of the study. As it was with our previous studies, the FDA confirmed that the hazard ratio will be the measure used to determine statistical significance.

In February 2006, we announced top line results of Study 314. The Phase 3 study enrolled 654 patients scheduled to undergo large or small bowel resection surgery. For the primary GI2 endpoint of Study 314, a statistically significant difference was achieved as compared to placebo (Cox proportional hazard model) hazard ratio = 1.53; P<0.001. A statistically significant difference in favor of Entereg® was achieved for each of the secondary time to event endpoints.

Adolor has filed a complete response to the FDA and has received a target review date from the FDA of November 9, 2006.

Unser Lichtblick in diesen trostlosen Zeiten.

[humm]

Antwort auf Beitrag Nr.: 23.340.325 von Salem88 am 07.08.06 12:59:54

>>Unser Lichtblick in diesen trostlosen Zeiten.<<

Wundert mich nur dass bei GIR keine größere Kaufbereitschaft zu sehen ist.
Wenn die Meldung kommt dann ist es zu spät um zu kaufen.

[Salem88]

Antwort auf Beitrag Nr.: 23.340.854 von humm am 07.08.06 13:49:36

Ein bisschen Zeit bleibt ja auch noch. Aber nicht viel.

Der Markt wird und MUSS irgendwann diese Beziehung und die zukünftigen Erlöse einpreisen. Sonst versteh ich die Welt nicht mehr und lass mich in die geshlossene Anstalt einliefern.

[humm]

muss muss...

nix muss.

ich verstehe auch nicht warum es so komisch läuft, so ist es aber.
Früher oder später wird sich die Lage aber die Realität anpassen.
Davon bin ich sehr überzeugt.

[Salem88]

GlaxoSmithKline and Adolor Report Top-Line Results From Phase 3 Studies of Alvimopan (Entereg/Entrareg(R)); Adolor to Host an Investor Conference Call and Webcast at 8:45 am ET on Tuesday, September 5, 2006
LONDON & EXTON, Pa.--(BUSINESS WIRE)--Sept. 5, 2006--GlaxoSmithKline (LSE:GSK)(NYSE:GSK) and Adolor Corporation (Nasdaq:ADLR) today announced top-line results from two identically designed Phase 3 registration studies (012 and 013) of alvimopan (Entereg(R)/Entrareg(R)) for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic non-cancer pain. Study 012 achieved statistical significance in its primary endpoint. While Study 013 did not achieve statistical significance, the data showed supportive evidence in a key secondary endpoint of change in average weekly frequency of spontaneous bowel movement (SBMs). Top-line results from a Phase 2b investigation of the effect of alvimopan in patients with cancer pain treated with opioid analgesics are also reported.

"These results are encouraging for the millions of people currently using opioids chronically. The effects on spontaneous bowel movement frequency as well as the overall safety and tolerability are consistent across all the alvimopan studies in this patient population and give a clear indication of potential benefit," said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline. "We will continue to investigate the data to better understand the difference in the 767905/013 study when compared with results from 012 and the earlier 011 study (767905/011). We remain focused on bringing this important new medicine to patients as soon as possible."

Study 767905/012, enrolled 518 patients with chronic non-cancer pain who had experienced symptoms of OBD, defined as having less than 3 SBMs a week plus one or more bowel movement symptoms (incomplete evacuation, straining, hard/small pellets) for 25% of bowel movements. This study achieved statistical significance for the primary endpoint -- the proportion of patients who had a weekly average of three or more spontaneous bowel movements (SBM) defined as bowel movements with no laxative in the previous 24 hours and an increase from baseline of one or more SBMs a week over the 12-week treatment period. In patients treated with alvimopan 0.5 mg twice daily, 72% met the primary endpoint compared with 48% of patients receiving placebo (p less than 0.001). In patients treated with alvimopan 0.5 mg once daily, 61% met the primary endpoint compared with 48% of patients receiving placebo (p=0.065).

Alvimopan treatment in Study 012 resulted in greater increases in SBM frequency than placebo. The average weekly change from baseline was 3.5 and 3.4 SBMs for patients treated with alvimopan 0.5 mg twice daily and once daily respectively, compared with 2.0 SBMs in patients receiving placebo (p less than 0.001). These changes were evident by the first week of treatment, were sustained throughout the 12-week treatment period and returned towards baseline following discontinuation of treatment. These findings are consistent with the results of the Phase IIb Study (767905/011) previously reported, which showed a change from baseline of 3.6 SBMs per week following treatment with alvimopan 0.5 mg twice daily compared with 1.7 SBM per week in patients receiving placebo (p less than 0.001).

The second, Phase 3 study, 767905/013, enrolled 485 patients with chronic non-cancer pain. In both groups of patients treated with alvimopan, 0.5 mg twice and once daily, over the 12-week treatment period, 63% met the primary endpoint compared with 56% of patients receiving placebo (p=0.214 & p=0.259 respectively). As in 767905/011 and 767905/012 the weekly change from baseline in SBM frequency was numerically greater in both groups of alvimopan treated patients (0.5 mg once and twice daily), averaging 3.1 and 3.2 SBMs per week respectively, compared with 2.2 SBMs per week for those treated with placebo (p less than or equal to 0.005). These changes were evident by the first week of treatment, were sustained throughout the 12-week treatment period and returned to baseline following discontinuation of treatment.

Alvimopan was generally well tolerated in these studies. Adverse events (AEs) affecting the gastrointestinal (GI) tract were the most common in both studies occurring in 24-33% of alvimopan-treated patients, compared with 22% on placebo. These included abdominal pain, diarrhea, nausea and vomiting and the incidence was generally similar between alvimopan and placebo groups. There was no evidence of antagonism of opioid analgesia based upon pain intensity scores and opioid consumption.

Companies also Report on Phase 2b Study

GSK and Adolor are also reporting top-line results from a Phase 2b Study 767905/008 trial of 233 patients with chronic cancer pain taking opioids and experiencing the symptoms associated with OBD. The primary endpoint in this study was the change in frequency of spontaneous complete bowel movements (SCBMs), defined as a bowel movement with no laxative use in the previous 24 hours that provides the subject with a feeling of complete evacuation. The average weekly change from baseline for the three week treatment period was 1.9, 1.8 and 2.1 SCBMs for patients treated with alvimopan 0.5 mg twice daily, 1.0 mg once and twice daily respectively, compared to 1.6 SCBMs in those receiving placebo. These differences were not statistically significant. There was, however, a clear positive difference in the key secondary endpoint of SBM frequency consistent with all of the alvimopan OBD studies, where this endpoint was measured with average weekly changes from baseline for the three week treatment period of 2.8, 2.7, and 3.1 SBMs for patients treated with alvimopan 0.5 mg twice daily, 1.0 mg once and twice daily respectively, compared to 1.6 SBMs for those receiving placebo (P less than 0.05 for 0.5 mg and 1.0 mg BID). These data, together with the data in the other clinical trials of alvimopan, support a finding of potential benefit in the chronic cancer pain patient population.

The safety and tolerability of alvimopan in this cancer pain study were similar to that seen in the placebo group and consistent with observations in the non-cancer pain studies.

"The results of these studies add to the growing body of evidence showing the positive impact of alvimopan on patients using opioid analgesics for the treatment of chronic pain," said James Barrett, PhD, Senior Vice President Research and Development, and Chief Scientific Officer, Adolor Corporation. "We will work closely and expeditiously with GSK to further advance alvimopan in this indication."

Conference Call Information

Adolor will be hosting a conference call and webcast on September 5, 2006 at 8:45 a.m. Eastern Time to discuss these results. To participate in the audio portion and have the opportunity to pose questions, dial 1-866-510-0710 for domestic callers, and 1-617-597-5378 for international callers, and provide the Passcode 30783030. Slides accompanying the call, as well as a webcast of the audio portion of the call, will be available on the Investor Relations section of the Company's website, www.adolor.com.

An audio replay of the conference call and an archived version of the webcast will be available beginning at 10:45 a.m. Eastern Time on September 5, 2006. To listen to a replay of the conference call, dial 1-888-286-8010 (domestic callers) or 1-617-801-6888 (international callers) with a Passcode of 46486817 or listen via the website. The replay will be available for one week.

About Opioid-induced Bowel Dysfunction (OBD)

Opioids, such as morphine, are highly effective in the treatment of pain. They are widely used to treat moderate to severe pain, such as pain associated with or as a result of back pain, arthritis, cancer and other pain conditions.

When taken daily, particularly over a long period of time, opioids can cause a range of GI side effects, known collectively as opioid-induced bowel dysfunction (OBD). OBD is characterized by a range of symptoms including constipation -- infrequent, difficult or incomplete bowel movements, abdominal pain and discomfort, bloating, acid reflux and loss of appetite. These effects tend to persist while patients take their opioids.

Opioids reduce pain by binding to opioid receptors in the brain. However, there are also opioid receptors throughout the GI tract. OBD occurs because the opioids used do not selectively target the receptors in the brain, but also bind to the mu-opioid receptors in the gut, reducing GI motility and secretions.

In patients affected by OBD, constipation is the most common, persistent and often debilitating symptom. Almost every other patient who takes an opioid will suffer with opioid-induced constipation although its prevalence and impact are seriously under-recognized by healthcare professionals. OBD can be distressing for patients, causing a significant burden of illness and reduced quality of life. Constipation is ranked by most cancer patients as an even more common source of distress than the pain they are suffering. Some patients receiving long-term opioid treatment for pain would rather endure their pain than the constipation that opioids may cause.

There is currently no approved drug specifically for the treatment of the gastrointestinal side effects associated with OBD. Taking stool softeners, bowel stimulants, increasing daily fluid and fiber intake and increasing exercise are methods often used to manage this condition. Laxatives may provide limited relief for some patients, but can also be associated with side effects such as abdominal cramping, bloating and unpredictability of effect, and are not recommended for long-term use.

About Alvimopan (Entereg(R)/ Entrareg(R))

Alvimopan is an investigational peripherally acting mu-opioid receptor (PAM-OR) antagonist designed to inhibit the negative effects of opioids, like morphine or codeine, on the gastrointestinal system without interfering with the analgesic effects on the central nervous system. Alvimopan is the first of this new class of compounds with a New Drug Application (NDA) that has been accepted for review by the U.S. Food and Drug Administration (FDA) for postoperative ileus (POI).

Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialization of alvimopan for POI and OBD.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

About Adolor Corporation

Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg(R) (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor is developing a sterile lidocaine patch which is in Phase 2 clinical development for post-surgical incisional pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.

GlaxoSmithKline Forward-Looking Statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.

Adolor Corporation Forward-Looking Statements

This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that regulatory approvals for use of alvimopan (Entereg(R)) in patients taking opioids for chronic pain who have experienced symptoms of opioid-induced bowel dysfunction (OBD) are not achieved; the risk that Adolor may not obtain FDA approval for the new drug application for Entereg(R) in postoperative ileus (POI); the risk that further studies of Entereg(R) are not positive or have adverse safety findings; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GlaxoSmithKline in connection with the development and commercialization of Entereg(R); market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation.

Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings, which are available in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.

[Salem88]

Mixed results...das mag man ja gar nicht.

Das wird heute ganz schön rumpeln bei Adolor.

Das hat aber mit der Zulassung im November nix zu tun.

[Salem88]

Unter 15$...


Was ihr denen da hingeschickt? Kuhpisse?

[Salem88]

Antwort auf Beitrag Nr.: 23.770.308 von Salem88 am 05.09.06 14:11:25

20$ bis November ist drin. Bei der letzen Studie (P314) die noch beschissener war als die heutige, ging es auch erstmal 50% in die roten Zahlen, um dann später wie ne V2 empor zu steigen.

P.S. Die Bensberger sind Würste!

[Salem88]

Noch gut 3 Wochen bis zur Adolor Zulassung (Entereg) und dann werden wir sehen was es wert war so viele Jahre auf dieses soooo spezielle Ereignis zu warten. Gut für die zig Milliarden Patienten die dann nach der OP mit Entereg vollgestopft werden, um 5 Minuten früher wieder aufs Klo gehen zu können.

Nee, so banal ist Entereg dann doch nicht. Es hilft den Patienten, indem die Darmfunktion nach der OP früher als sonst wieder beginnt und den Krankenhäusern hilft es, dass se die Patienten schnell wieder los sind. Oje, ist das ein Blockbuster... Passt aber zu Girindus finde ich gut.

[Salem88]

Written by DVOowner, yahoo.com.

ADLR/Glaxo have a joint partnership to get approval for Entereg ... Entereg(alvimopan) was designed to reverse the effects of opiates/pain killers on the g/i tract (gut).

Opiates send signals to the brain to cut off all signals (pain, breathing, g/i function, etc etc). Opiates are used in patients for operations, post operations (POI), and also for dieing patients who are in pain, as well as for chronic pain patients who are not terminal (OBD). Since the opiates shut off all signals to the brain, pain is reduced, but also the g/i tract doesnt work as it should due to signals to stop it the same as pain, breathing etc etc -- all signals are slowly shut down. If given to much opiates, your breathing will stop.

So, we have 3 major groups of patients who use opiates which have problems with their g/oi tracts: (1st - Post operative patients ('POI'); 2nd - Terminal/dieing patients such as cancer/hiv, cardo, any Advanced Medical Illness (AMI)- any ternmial conditon that requires pain control and results in Opiate induced Bowel Dysfunction ('OBD'); and 3rd - chronc pain patients who take opiates for intractable pain (OBD).

All 3 of these large groups of patients exist, but the OBD patients are severely under-reported and undermanaged (the OBD/AMI patients die in 2-6 months, but the OBD chronic pain patients have to deal with g/i dsyfunction 24/7. POI patients only have to deal with limited OBD since they are only taking opiates for a short while for an operation, and the POI patients do not develop severe on-going OBD.

There has been no drug approved to reverse OBD - none (thre are laxatives, etc etc which help with the symptoms of OBD, but not reverse OBD. In 1979 a pharmicist/Dr. used naltrexone (the anitdote to opiates) and he invented methylnaltrexone (MNTX). he did this to help a dieing fellow Dr/friend at the Univ. of Chicago. MNTX works by reversing the action of opiates throughout (peripherally) the body, but MNTX doesnt work in the brain thus, MNTX doesnt interfer with pain control.

MNTX was used for year at the Univ. Hospital (see JAMA 2000 article). ADLR acquired a drug that works like MNTX (alvinopan/Entereg) so they could use it to combat POI & OBD worldwide. Progenics (PGNX) acquired the rights to MNTX and partnered with Wyeth to do the same thing.

So, we have to drug and 2 companies who are working toward getting a cure for OBD & POI which are very big markets. Both drugs work, but MNTX is in a subcue shot form while Entereg is in a pill form. Treatment of POI requires high doses of the drug, BUT OBD requires low doses since OBD patient's bodies are physically dependent on opiates thus, a large dose would cause them to have adverse reactions (hard cramping) if given more then 1mg of Entereg ... while POI patients need higher doses to help their g/i tracts to work (6 - 12mg).

Entereg & MNTX work significantly better for OBD relative to POI (since OBD patients have a much more acute g/i problem) -- so, it is harder to demonstrate how well the drugs work for POI vs OBD, but they do work.

It has taken a long time to get all the data and trials to deomostrate how Entereg works for POI (but it does work), and ditto for OBD where it's results are much more obvious.

I own both PGNX and ADLR and i see both companies getting approval for POI and OBD with time .... there have been set backs with the trials etc, but the drug is novel and truely a break-through medication for a very under reported and grossly undermanaged medical condition (OBD). Hope this helps .... regards

[Salem88]

Time to Buy Shares of Adolor? Ja Du Arsch!

By Brian Lawler
February 28, 2007
2006 was a tumultuous year for drug developer Adolor (Nasdaq: ADLR). After announcing mixed clinical trial results for its lead compound, Entereg, earlier in the year, Adolor was then given the smackdown by the Food and Drug Administration when it received a second approvable letter for the drug as a treatment for postoperative ileus in November.

Yesterday, Adolor announced its fourth-quarter and year-end financial results. It ended 2006 with $186 million in cash and investments, after burning through $52 million in the year. With clinical trials winding down and the dissolution of its 35-person sales force in December, its burn rate should decline in 2007.

The good news for Adolor investors is that it plans on submitting a response to its latest approvable letter for the drug in the second quarter of this year. Also, more data should arrive in a few months from the Entereg safety study in opioid-induced bowel dysfunction that partner GlaxoSmithKline (NYSE: GSK) is running, and Adolor will update investors on the next steps for the drug in this indication later this quarter.

Shares of Adolor are getting tres cheap. It's sporting a market cap barely higher than $300 million, which is more than 50% supported by its cash and investments on hand. The higher level of cardiac incidences in the latest study 14 notwithstanding, its drug has been proven safe in multiple moderately sized clinical trials in thousands of patients. If Entereg can get approved, it will have a strong marketing partner in GlaxoSmithKline.

The end game is nearing for Entereg, with the study 14 data coming out in the next couple of months, so it won't be long until we know whether Adolor has a potential hit or miss on its hands.

GlaxoSmithKline is an Income Investor recommendation. You can find out why with a 30-day free trial.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.



Kursziel: 1.000.000€

[Salem88]

Ahoihoi


Nicht ganz unbedeutend für GIR, ADLR und GSK. Die Konkurrenz hat auch Rückschläge. Das ist für Aktionäre beider Unternehmen ein richtige interessanter Wettk(r)ampf. Adolor wird aber gewinnen.


Progenics to Restart Drug Trial
Wednesday March 7, 2:29 pm ET
Progenics Pharmaceuticals Tumbles on Testing Delay for Painkiller


NEW YORK (AP) -- Shares of Progenics Pharmaceuticals Inc. plunged Wednesday after the company said it will start testing a new formulation of oral methylnaltrexone, a treatment for constipation caused by pain medication.
ADVERTISEMENT


Progenics and Wyeth, its partner in developing the drug, said Tuesday that mid-stage trials showed oral methylnaltrexone was safe, but not effective enough to advance to late-stage testing.

Intravenous and injectable versions of the drug were more successful in clinical tests. If new tests on the oral version are successful, the companies could file a new drug application with the Food and Drug Administration in late 2009 or early 2010.

Stifel Nicolaus & Co. analyst Edward Nash lowered his 2010 revenue estimate for Progenics, projecting a one-year delay in the drug's launch. He believes the drug will take market share from Adolor Corp.'s Entereg, an oral treatment. Nash set a "Buy" rating and $33 price target for Progenics shares.

"We see this as a temporary delay for oral methylnaltrexone and do not view it as permanently damaging to the eventual market opportunity of the oral formulation drug," he said.

Piper Jaffray & Co. analyst Caroline Stewart said the delay could be good news for Adolor. She lowered her price target on Progenics shares from $34 to $28.

Progenics shares fell $4.27, or 16 percent, to $22.43 on the Nasdaq Stock Market.

Wyeth shares gave up 11 cents to $49.24 on the New York Stock Exchange.

Adolor stock lost 9 cents to $6.78 on the Nasdaq.

[pegeha]

Antwort auf Beitrag Nr.: 23.340.854 von humm am 07.08.06 13:49:36

dann sollte man bereits drin sein, sonst kommt man erst
wesentlich teurer rein!

[Salem88]

Wenn Du ADLR meinst, dann ja, nur sollte man die enormen Risiken beachten. Falls die Studie von GSK gut wird und eine Zulassung wahrscheinlicher wird, dann wird ADLR wieder im Rennen sein. Falls nicht, siehts düster aus. Wie sich das auf GIR auswirkt, hat sich die letzten Jahre immer wieder gezeigt, dass vermutlich gar nix passieren wird.


ADLR

+niedrige MK 320 Mio$
+Wirkstoff mit enormen Marktpotential
+GSK starker Partner
+viel Cash
+grosser Insti Anteil
+10% des GK ist short (nat. nur pos. wenn gecovert wird)

-Unsicherheit nach Herzaufälligkeiten (lt. GSK nicht signif., Beweis steht aus)
-Konkurrenz hat aufgeholt
-2 FDA approvable letters

[Salem88]

Progenics Gets Backed Up


By Brian Lawler
March 9, 2007
Developing new drugs is a complicated process; delays and setbacks are often an inevitable part of the process of bring new compounds to market. Earlier in the week, Progenics Pharmaceutics (Nasdaq: PGNX) and drugmaker giant Wyeth (NYSE: WYE) announced a delay in one of their methylnaltrexone programs.

Progenics is developing its altered version of naltrexone in various dosage forms as a treatment for a variety of gastrointestinal disorders. The largest market opportunity for its methylnaltrexone compound is in treating opioid-induced bowel dysfunction (OBD) and which it was running a phase 2 study in.

After this week, though, it's back the drawing boards as the oral version of methylnaltrexone failed to "exhibit sufficient clinical activity" in its phase 2 testing. (The drug is also being tested in subcutaneous and intravenous administration.) Now, the new timeline for the oral version is for a New Drug Application in late 2009 or early 2010, which pushes possible approval out until 2011.

The biggest winner from the Progenics drug delay is definitely Adolor (Nasdaq: ADLR) (Und die Fruchtzwerge aus Bensberg namens Girindus GIR gehören dann log. auch zu den Gewinnern. Anm. von Salem) -- if results from the Entereg phase 3 study that it is running with GlaxoSmithKline (NYSE: GSK) are positive. The Progenics delay could give Adolor a marketing start of a year or more for Entereg as an OBD treatment, if it doesn't experience any more delays in its program. An update on the orally-administered Entereg's path forward as an OBD treatment is expected later this quarter, although off-label use in OBD could start as soon as the first half of next year if it gets approved to treat another gastrointestinal disorder.

Alles was da steht gilt auch für Girindus.(Anm. von Salem)

The good news for Progenics shareholders is that the company is sticking to the timeline to file marketing applications with the FDA for the subcutaneous and intravenous forms of methylnaltrexone in 2007. If Progenics and Wyeth can't develop a much more convenient oral formulation of the drug, though, its market potential and use will be quite limited.

GlaxoSmithKline is an Income Investor recommendation. Want to get paid to invest? Analyst James Early and other investors like you can show you how to find companies with good dividends with a 30-day free trial to Motley Fool Income Investor.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.


Quelle: yahoo.com

[humm]

Antwort auf Beitrag Nr.: 28.213.339 von Salem88 am 09.03.07 21:50:56

>>if results... ...are positive.<<

IF IF IF
Wenn das Wort "WENN" nicht wäre...

[Salem88]

Antwort auf Beitrag Nr.: 28.216.905 von humm am 10.03.07 08:09:03

Werden wir in ca. 3 Wochen sehen.

[Salem88]

LAUF DU SAU!!!


GSK übt Schulterschluss mit ADLR.
Tests sind sicher und effektiv.

Lt Healthcareconference die gerade läuft.

So wird GIR auch mal abgehen, wenn das zugelassen wird. Da bin ick mir 100pro sicher.

[Salem88]

Oleole


Form 8-K for ADOLOR CORP


--------------------------------------------------------------------------------

12-Mar-2007

Other Events



Item 8.01 Other Events.
On March 12, 2007, Adolor Corporation (the Company) presented at the Cowen and Company 27th Annual Health Care Conference in Boston, Massachusetts. At the conference, the Company provided an update on the Phase III clinical development program for Entereg® (alvimopan) in chronic opioid bowel dysfunction (OBD). The Company reported that Glaxo Group Limited (Glaxo) has planned an additional Phase III study, Study SB-767905-015 (Study 015) to evaluate the efficacy and safety of alvimopan 0.5mg BID for the treatment of OBD in adults taking opioid therapy for persistent non-cancer pain. The Company further reported that Glaxo has submitted a Special Protocol Assessment (SPA) for Study 015 to seek U.S. Food and Drug Administration (FDA) review and agreement on the design and size of Study 015. The Company reported that Glaxo has targeted commencement of Study 015 in the 2nd quarter of 2007.

This report and oral statements made with respect to information contained in this report may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that the FDA does not agree with proposed Study 015, the risk that the request for Special Protocol Assessment (SPA) results in a delay in initiating Study 015,the risk that Study 015 proceeds prior to receipt of an SPA, the risk that Adolor may not receive regulatory approval of Entereg® (alvimopan) for POI, OBD, or any other indication; the risk that Adolor may not be able to adequately address the deficiencies in the November 2006 FDA approvable letter; the risk that a risk management plan could materially adversely affect the commercial prospects for Entereg, if regulatory approval is achieved; the risk that Adolor may not obtain FDA approval for Entereg in POI, whether due to Adolor's inability to provide additional data satisfactory to the FDA to obtain approval for the NDA, the adequacy of the safety and efficacy data from all of the Entereg studies, the risk that the FDA may not agree with Adolor's and GSK's analyses of the Entereg studies (including Study 014) and may evaluate the results of these studies by different methods or conclude that the results from the studies, whether or not statistically significant, do not support safety, efficacy, a favorable risk/benefit profile, or there were human errors in the conduct of the studies, or otherwise; adverse safety findings in any Entereg studies; the risk that regulatory approvals for the use of Entereg in OBD are not achieved; the risk that filing targets for regulatory submissions or user fee goal dates are not met; the risk that the results of other clinical trials of Adolor's drug product candidates, including Entereg are not positive; the risk of changing regulatory requirements; the risk of product liability claims; reliance on third party manufacturers; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GSK, in connection with the development and commercialization of Entereg; market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation.

Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due

[Salem88]

Bronze für Adolor. Hat auch schon mal gewonnen. Das war damals ein 50% Husarenritt. Der kommt aber noch.

Also short ist mord am heuteigen Tag bei ADLR; und ca. 4 Mio shares waren es. Haben die Bestatter heute noch was zu tun in Amiland.

[Salem88]

03.13.07
adlr: GSK TO MOVE FORWARD WITH ENTEREG IN OBD; REITERATE BUY RATING AND $19 PRICE TARGET
We view the decision to initiate an additional Phase III Entereg trial in opioid-induced bowel dysfunction (OBD) as a positive for two reasons: 1) it suggests the cardiotoxicity event-rate for the last six months of Study 014 was the same or lower than the first six months; and 2) the additional expenditures and opportunity costs associated with this program is a demonstration of partner GlaxoSmithKline's commitment to Entereg. Indeed, if the event-rate were higher in last six months, then we believe GSK would be inclined to cease further development and place its resources in other programs. During Q2, we expect the final analysis of Study 014 to be submitted to the FDA in response to the approvable letter in post-operative ileus. With $4 per share in cash, we believe present levels provide a compelling risk-reward. We are reiterating our Buy rating and $19 price target, which is based on 35x our FY:11 EPS estimate of $1.10 and a 20% discount rate.


Quelle: http://www.wrhambrecht.com/research/biotech/adlr.html

Sehts mal so, auch wenn die Reaktion bei GIR wie nicht anders zu erwarten dürftig ist, so wird früher oder später die Zulassung kommen. Und das werden die Bensberger mit Sicherheit was sagen. Die jetzt laufenden Grossstudien funzen und GIR verdient auch jetzt schon gut mit.

[humm]

>>GSK and Adolor Announce Preliminary Results from Phase 3 Safety Study of Alvimopan (ENTEREG/ENTRAREG(R))
--Current development program for OBD on-hold while findings from long-term safety study are evaluated - --Adolor investor conference call and webcast at 5:00 p.m. on April 9, 2007 ET--
LONDON & EXTON, Pa., Apr 09, 2007 (BUSINESS WIRE) -- GlaxoSmithKline (LSE and NYSE:GSK) and Adolor Corporation (Nasdaq:ADLR) today announced data from Study 767905/014 and provided an update on the clinical development program for alvimopan (Entereg/Entrareg(R)).

Study 014, a Phase 3, double blind, placebo-controlled (12 month) study, was designed to evaluate the long-term safety and tolerability of alvimopan 0.5 mg twice daily in patients taking opioids for chronic non-cancer pain and experiencing opioid-induced bowel dysfunction (OBD). A total of 805 patients were enrolled into the study and randomized 2:1; a total of 538 patients received alvimopan and 267 received placebo.

Consistent with findings from previous studies the most common adverse events observed in Study 014 were those affecting the gastrointestinal (GI) tract, including abdominal pain and diarrhea. The incidence of GI adverse events observed was similar between patients treated with alvimopan (40%) and placebo (35%).

While the proportion of patients experiencing serious adverse events was similar between those treated with alvimopan (13%) and placebo (11%), a numerical imbalance was observed in the number of cardiovascular (CV) and neoplasm cases categorized as serious adverse events among alvimopan-treated patients.

Preliminary findings from Study 014 are outlined below, together with information regarding actions taken by GSK and Adolor regarding the two ongoing alvimopan studies.

Cardiovascular Adverse Events

Results from a six-month interim analysis of Study 014, previously announced in November 2006, showed an increase which was not statistically significant in the reported incidence of serious CV adverse events in patients receiving alvimopan relative to placebo. Results from completed Study 014 showed an increase in myocardial infarctions and all CV SAEs reported by patients treated with alvimopan compared to placebo. These are outlined in the table below, together with aggregate data from other non-cancer OBD studies. The CV data from Study 014 are currently under review by an Independent Drug Monitoring Committee (IDMC).

Non-Cancer Non-Cancer
OBD Studies* OBD Studies*
Study 014 (w/o Study 014) (w/Study 014)
----------------------------------------------------------------------
Placebo Alvimopan Placebo Alvimopan Placebo Alvimopan
(N=267) (N=538) (N=523) (N=1190) (N=790) (N=1728)
----------------------------------------------------------------------
Myocardial
Infarction - (0) 7 (1.30%)2 (0.38%) 1 (0.08%)2 (0.25%) 8 (0.46%)
----------------------------------------------------------------------
All Cardio -
vascular
SAEs 3 (1.12%)14 (2.60%)5 (0.96%)14 (1.18%)8 (1.01%)28 (1.62%)
----------------------------------------------------------------------

*Includes Studies 011, 012, 013, 217, and 304



The CV SAEs reported in Study 014 occurred in patients with established or at high risk for CV disease. Five of seven myocardial infarctions occurred at two investigational sites. Additionally, the incidence of myocardial infarctions does not appear to be linked to the duration of dosing, with the majority of reported events in Study 014 occurring within the first 12 weeks of treatment.

Neoplasm Events

Study 014 showed an imbalance in the incidence of neoplasms (benign, malignant, skin cancers and unspecified, including polyps), with 15 neoplasms reported in patients receiving alvimopan (2.8%) and 2 in patients receiving placebo (0.7%). Of these, 4 alvimopan (0.7%) and 1 placebo (0.4%) neoplasms were categorized as serious adverse events.

Fracture Events

An increase in the incidence of fractures was also observed in patients receiving alvimopan. This data is in contrast to previously conducted studies that showed a similar or lower incidence of fractures in patients receiving alvimopan relative to placebo.

Preliminary Conclusions and Next Steps

As the findings outlined were observed during the preliminary evaluation of data from Study 014, and a full analysis has not yet been completed, further details are not yet available. Additional data are being collected and further analyses, which will include all alvimopan OBD studies, will be undertaken as soon as possible to better understand these findings.

Pending completion of these analyses, the protocol for an additional Phase 3 safety and efficacy study in patients with OBD (Study 015), which had been submitted to regulatory authorities, is being withdrawn by GSK.

As a precautionary measure, GSK has taken the decision to stop Study 101684, an extension of Study 008 in a cancer pain population, which currently has 15 patients receiving treatment. Clinical investigators involved in this study have been informed.

"Patient well-being is always our primary concern. These unexpected findings are not yet fully understood and require further analyses to ascertain the significance of the data. We are working to gain a better understanding of these findings, which will help guide our future development," said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline.

Adolor has also suspended enrollment in Study 228 in rotator cuff surgery patients, a co-administration study being conducted as part of Adolor's Combination Product Development Program, until a more complete understanding of these data are available. Clinical investigators involved in these studies are being informed. GSK and Adolor currently have no other ongoing studies with alvimopan.

"We continue to believe in the clinical benefit of Entereg and look forward to the further analyses of these preliminary Study 014 results," said Michael R. Dougherty, President and Chief Executive Officer of Adolor. "We are committed to working with GSK to provide an update on further clinical development plans in the opioid-induced bowel dysfunction program as soon as is possible. With regard to the POI program, we continue to target the second quarter of 2007 to submit to the FDA a Complete Response to the November 2006 approvable letter."

Conference Call Information

Adolor will be hosting a conference call and webcast on April 9, 2007 at 5:00 p.m. Eastern Time 2:00 p.m. Pacific Time to discuss these results. To participate in the audio portion and have the opportunity to pose questions, dial 1-866-383-7989 for domestic callers, and 1-617-597-5328 for international callers, and provide the Passcode 76912495. Slides accompanying the call, as well as a webcast of the audio portion of the call, will be available on the Investor Relations section of the Company's website, www.adolor.com.

A replay of the conference call will be available beginning at 7:00 PM Eastern Time on April 9, 2007. To listen to a replay of the conference call, dial 1-888-286-8010 (domestic callers) or 1-617-801-6888 (international callers) with a Passcode of 78747273 or listen via the website. The replay will be available for one week. ...<<

[humm]

>>Monday, April 09, 2007
Adolor crushed in after hours

Drug company Adolor (ADLR) is currently trading down $5.00 (60%) in after hours trading. Adolor and partner GlaxoSmithKline said they would halt studies of the drug Entereg which was to be used to treat bowel dysfunction in cancer patients receiving opioids. Adolor and Glaxo just weeks ago announced plans to go forward with their studies on Entereg. This enticed many, including myself, to get into the stock. The stock ran 40% on that news. Two very sharp hedge funds, DE Shaw and SAC Capital, have 5 and 8 percent stakes respectively in Adolor. SAC just reported their stake two weeks ago. I have historically avoided biotech and small drug stocks because of this kind of development. Playing these stocks typically equates to putting your cash on the roulette wheel. Adolor seemed different. After many had given up hope they declared that with Glaxo as a partner they would go forward with additional testing. At the same time sharp players were taking aggressive stakes. Obviously not that sharp this time. Lesson learned. I will most likely sell my position tomorrow and I will go back to avoiding the small drug and biotechs !!

Posted by Don Riley at 4/09/2007 08:46:00 PM <<

http://stocksense.blogspot.com/2007/04/adolor-crushed-in-aft…

Tut mir leid für dich Salem.

[Salem88]

Antwort auf Beitrag Nr.: 28.734.473 von humm am 10.04.07 08:04:29

Ich hatte 500 Stk. das überlebe ich.

Gott sei dank bin ich gestern früh ins Bett gegangen und musste das Elend nicht mehr mit erleben. Mal sehen was jetzt kommt.

Tja und GIR...

[Salem88]

Das klingt ja grausig. Tausende Patienten wurden bisher ohne Probleme getestet und plötzlich sowas. Wieder Rückschlag Minimum 1 Jahr.

[humm]

>>Tja und GIR... <<

GIR wird es überleben.
Es läuft zwar nicht wie geplant, es wird aber dank Solvay laufen.
Genau deshalb habe ich auf GIR gesetzt und nicht auf ADLR.
ADLR ist Glücksspiel, bei GIR gibt es, trotz all der Schwierigkeiten, ein Fundament namens Solvay…

[Salem88]

Es geht in dieser Studie um 21 von 538 Patienten, wo es zu Schwulitäten kam. Aber die adverse effects haben es in sich. Brrr, grausig alles. Meist handelt es sich unm Patienten, die auch andere schwere Medikamente nehmen und der Mix macht´s wahrscheinlich. Tja verkaufen oder nicht?

[humm]

Antwort auf Beitrag Nr.: 28.734.997 von Salem88 am 10.04.07 09:14:37

Verkaufen oder nicht - wer kann dir das schon sagen?
das musst du selber dir beantworten...

[Salem88]

Krass ist auch, dass diese beiden Hedge Fonds DE Shaw and SAC Capital, so elendig viele Aktien halten. Letzterer hat diese noch vor Tagen eigesackt. Arme Irre. Und die ganzen Rentenfonds... Oje..

[Salem88]

Antwort auf Beitrag Nr.: 28.735.088 von humm am 10.04.07 09:20:58

Wieder zurück in GIR mit dem Rest? Aber ich habe eh schon genug GIR im Depot und wenn die erstmal in Fahrt kommt...!

Vielleicht schmeissen se diese Woche wieder was raus und dann geht die Post ab.


Gut 1.250$ nasse, hatte ich bei GIR auch schon.

[Salem88]

Am besten die lösen ADLR uff und zahlen die 180 Mio$ bar aus. Macht gute 4$/share und finito. Und so könnte es kommen.

[humm]

Antwort auf Beitrag Nr.: 28.737.429 von Salem88 am 10.04.07 12:10:51

Na ihr Trotteln von GIR-Aktien-Verkäufern, was sagt ihr jetzt???

ADLR hat gute Chancen die Zulassung zu erhalten, der FDA sagt "ja"...

>>FDA Accepts for Review Complete Response to Approvable Letter for Entereg(R) (alvimopan) for POI
- Adolor and GSK Also Submitted Complete Response to Request the Release of the Clinical Hold for INDs -
EXTON, Pa. & PHILADELPHIA, Aug 28, 2007 (BUSINESS WIRE) -- Adolor Corporation (Nasdaq:ADLR) and GlaxoSmithKline (NYSE:GSK) announced today that the U. S. Food and Drug Administration (FDA) has accepted as complete, Adolor's response to the November 2006 New Drug Application (NDA) approvable letter for Entereg(R) (alvimopan) for the management of postoperative ileus (POI). The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008.
"We are very pleased that the FDA has accepted for review the complete response for POI," said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "We remain committed to our goal of bringing this novel treatment to patients and surgeons and look forward to working with the FDA throughout the review."
Adolor and GSK have also submitted complete responses to the FDA requesting a release of the clinical holds for all alvimopan Investigational New Drug Applications (INDs). The complete responses were received by the Agency on August 13, 2007. A decision with regard to these requests is pending from the FDA. A release of the clinical holds by the FDA is required before the companies can re-initiate any clinical development activities.
"We are continuing to work with Adolor and the regulatory agencies on both the opioid induced bowel dysfunction (OBD) and POI programs," said Yvonne Greenstreet, senior vice president of the medicines development centre at GSK. "GSK has conducted analyses to fully understand the findings from the OBD program and believe these support the initial step of submitting the request to release the clinical hold." <<

[humm]

>>"We are continuing to work with Adolor and the regulatory agencies on both the opioid induced bowel dysfunction (OBD) and POI programs," said Yvonne Greenstreet, senior vice president of the medicines development centre at GSK. "GSK has conducted analyses to fully understand the findings from the OBD program and believe these support the initial step of submitting the request to release the clinical hold."<<

http://phx.corporate-ir.net/phoenix.zhtml?c=120919&p=irol-ne…

[Salem-]

Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)

Wednesday November 28, 11:08 am ET


EXTON, Pa. & PHILADELPHIA--(BUSINESS WIRE)--Adolor Corporation (Nasdaq:ADLR - News) and GlaxoSmithKline (NYSE:GSK - News) announced today that the Gastrointestinal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) will review Adolor’s New Drug Application (NDA) for Entereg® (alvimopan) for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis on January 23, 2008 from 8:00 AM to 5:00 PM. The meeting will take place at the Hilton Washington DC/Silver Spring, Maryland Ballroom in Silver Spring, Maryland.
About Adolor Corporation

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Adolor Corporation (Nasdaq:ADLR - News) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg® (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor also has a number of discovery and clinical research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.


About GlaxoSmithKline


GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.


Wird bei sowas nicht immer der Handel ausgesetzt?

[Salem-]

Da es ja morgen soweit ist, noch ne kleine Zusammenfassung. Olle Brian hat auch schon grössere Skepsis gehabt. Sind sich scheinbar alle nicht ganz sicher.

Adolor Under the FDA's Spotlight


By Brian Lawler January 22, 2008
0
Recommendations
Drugmaker Adolor (Nasdaq: ADLR) got a bit of surprising good news from the FDA on Friday, only a few weeks ahead of an upcoming FDA decision on whether to approve the company's lead drug.

The good news Adolor received was in the form of a briefing document that the FDA released. In the document, which was released prior to the upcoming advisory panel discussion on Adolor's potential post-operative ileus (POI) treatment, Entereg, the agency gave what appeared to be a relatively positive review.

POI is a condition best described as constipation that occurs following abdominal surgery. For patients who have just had major surgical work on their bowels, it can be a serious and painful side effect of the surgery and can prolong post-surgery hospital stays.

Adolor has been trying to get Entereg approved to treat POI since 2005, and has already received two approvable letters for the drug. The first approvable letter from the FDA came in 2005, asking for more efficacy data, and the second approvable letter, in 2006, was a result of some cardiovascular safety issues that occurred in an opioid-induced constipation study by Adolor's partner GlaxoSmithKline (NYSE: GSK).

Despite a lack of resolution to the cardiovascular issues, as well as some worrisome new issues that popped up in the drug's long-term use, Adolor went ahead and filed for a third FDA review for Entereg last year. Tomorrow's advisory panel hearing and the Feb. 10 PDUFA date are the results of this third attempt at getting Entereg approved.

In the briefing documents (PDF) posted by the FDA's gastrointestinal review division ahead of the advisory committee hearing, the agency appears ready to approve Entereg to treat POI if it can prevent off-label usage of the drug. The FDA review team seemed satisfied that Entereg worked, noting the "positive efficacy results across several studies," and seemed relatively satisfied that the multiple safety issues that have popped up after the long-term use of Entereg may not be an issue in short-term POI use.

The biggest sticking point holding up approval of Entereg is that the FDA's gastrointestinal review team doesn't want Entereg prescribed off-label or outside the hospital. Almost all the safety questions asked by the FDA review team for the advisory panel were related to these issues:

Regarding safety, we are interested in the Committee's opinion regarding the short-term use of (Entereg). Are there safety concerns? Will the potential cardiovascular risk be minimized sufficiently by the proposed Risk Management Plan? Can longer term use and outpatient use of (Entereg) be prevented by limiting sales by wholesaler to hospitals only? What other aspects of such a plan need to be included?

Any chance of future Entereg approval for opioid-induced constipation looks dead in the water, so rivals Progenics Pharmaceuticals (Nasdaq: PGNX) and Wyeth (NYSE: WYE) will likely have that market to themselves if the FDA approves their competing drug when their April 30 PDUFA date comes up.

Previously, I thought Entereg's chances with the FDA were minimal in POI. On balance, the briefing docs seem to signal that approval to treat POI may be on the way, but with a very restrictive label that will not allow for any off-label usage of the drug in other indications. I probably don't need to say, though, that marketing approval is never a sure thing when it comes to the FDA. The agency still has a few Entereg safety-related questions to mull over, but if the advisory panel can help come up with some answers to further appease the FDA review team, then it looks like Entereg regulatory approval will occur either outright or after a short approvable letter.


http://www.fool.com/investing/high-growth/2008/01/22/adolor-…

[Salem-]

Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for ENTEREG(R) (alvimopan) for the Management of Postoperative Ileus in Bowel Resection
Wednesday January 23, 5:15 pm ET


EXTON, Pa. & PHILADELPHIA--(BUSINESS WIRE)--Adolor Corporation (Nasdaq:ADLR - News) and GlaxoSmithKline (NYSE:GSK - News) today announced that a majority (9-6) of the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) voted that the overall benefits of treatment with Entereg® (alvimopan), an investigational mu-opioid receptor antagonist, outweighed potential risks for short-term, in-hospital use in patients following partial large or small bowel resection surgery with primary anastomosis. The FDA is reviewing Adolor’s New Drug Application (NDA) for ENTEREG for the proposed indication of acceleration of upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis. There are no drugs approved for this indication.
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With regard to the specific questions posed by the FDA to the committee, members voted 13-0, with two abstentions, that the efficacy results from the submitted studies in postoperative ileus (POI) were clinically meaningful. Although the panel voted (8 to 6 with one abstention) that a potential cardiovascular risk signal seen in one long-term OBD study (Study 014) remained a concern for short-term use in managing POI, a majority (9-6) agreed that the overall benefits of treatment with alvimopan outweighed the potential risks for short-term in-hospital use in the proposed bowel resection patient population. The panel voted 14 to 0 with one abstention that the preliminary risk management plan proposed by Adolor was not adequate to address potential risks.

“This is an important milestone for ENTEREG and we are pleased with the favorable outcome of the Committee meeting,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “This is further validation of our confidence in ENTEREG and our belief in the clinical benefit offered by ENTEREG in this indication. I would like to commend the significant effort of the combined Adolor and GSK development team. We look forward to working with the FDA, including the further development of a risk management plan, as they complete the review of the NDA for ENTEREG.”

The Committee’s recommendation, although not binding, will be considered by the FDA as it completes its review of the NDA for ENTEREG. The Prescription Drugs User Fee Act (PDUFA) action date for the NDA is February 10, 2008.

“A majority of the Committee agreed that ENTEREG produced clinically meaningful acceleration in GI recovery in bowel resection patients,” said Yvonne Greenstreet, senior vice president of the medicine development centre at GlaxoSmithKline. “Postoperative ileus can be uncomfortable for the patient, hinder post surgical recovery and delay hospital discharge in bowel resection patients. If approved, ENTEREG would be the first medication to address this common and burdensome complication.”


www.adolor.com