Message #7 From:
NewsBot Date: November 6, 2006 04:00:00 AM
GSK News FDA Issues Approvable Letter for Entereg(R) (alvimopan) for POI
EXTON, Pa. & PHILADELPHIA--(BUSINESS WIRE)--Adolor Corporation (Nasdaq: ADLR) and GlaxoSmithKline (NYSE: GSK)
announced today that the U.S. Food and Drug Administration (FDA) has
issued a letter stating that the new drug application (NDA) for Entereg
(alvimopan 12mg) for the management of postoperative ileus (POI) is
approvable. The FDA has requested 12-month safety data, including
analysis of serious cardiovascular events, from study 767905/014, an
ongoing safety study in opioid-induced bowel dysfunction (OBD). The FDA
also requested a risk management plan as part of the submission.
Study 014 is an ongoing Phase 3, blinded, long-term (12 month) safety
study conducted by GSK evaluating alvimopan 0.5 mg twice daily for the
treatment of opioid-induced bowel dysfunction in patients with chronic
non-cancer pain. The study is targeted for completion late in the first
quarter of 2007, with final data available in the second quarter.
The FDA’s review of the NDA for POI included
the six-month interim analysis of Study 014. This analysis was submitted
in late September 2006 and showed an increase, which was not
statistically significant, in the reported incidence of serious
cardiovascular adverse events in patients receiving alvimopan relative
to placebo. The reported events were in patients at high risk for
cardiovascular disease, did not appear to be linked to duration of
dosing and were consistent with epidemiological expectations for the
subject population. Combined results from all completed studies in the
chronic population submitted by GSK to the FDA did not support a
conclusion that patients taking alvimopan were at increased risk for
serious cardiovascular events.
“We will meet with the FDA to discuss the
approvable letter and work with GSK to provide the additional
information requested as expeditiously as possible,”
said David Madden, interim president and chief executive officer of
Adolor.
“We continue to believe that Entereg has
significant potential to benefit patients at risk of developing POI and
those suffering from OBD and remain committed to its continued
development,” said Yvonne Greenstreet, Senior
Vice President, Research and Development, GlaxoSmithKline.
Conference Call Information
Adolor will host an audio only conference call on November 6, 2006 at
8:30 a.m. Eastern Time to discuss the NDA approvable letter. To access
this call and have the opportunity to pose questions, dial
1-800-638-4930 for domestic callers, and 1-617-614-3944 for
international callers, and provide the Passcode 55545189. The call will
also be available on the Investor Relations section of the Company's
website, www.adolor.com.
An audio replay of the conference call will be available beginning at
10:30 a.m. Eastern Time on November 6, 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 29264969 or
listen via the website. The replay will be available for one week.
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®
(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 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.
Adolor Corporation Forward-Looking Statements
This release, and oral statements made with respect to information
contained in this release, 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 safety findings from Study 014
may not support regulatory approval of Entereg ®
(alvimopan) for POI, OBD, or any other indication; the risk that final
data for Study 014 will not be available in the second quarter of 2007;
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 Entereg are
not positive; 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 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.
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.
