FDA extends review of NDA for Entereg® (alvimopan)
-- FDA action date now targeted for May 10, 2008 --
FOR IMMEDIATE RELEASE
Issued: Exton and Philadelphia, PA – February 8, 2008
Adolor Corporation (Nasdaq: ADLR) and GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has informed Adolor that the Prescription Drug User Fee Act action date for the New Drug Application (NDA) for Entereg® (alvimopan) has been extended to May 10, 2008. Adolor also today announced the submission to the FDA of a revised Risk Management Program for Entereg.
The NDA for Entereg 12 mg capsules is for in-hospital, short-term use for the management of postoperative ileus (POI). Specifically, the proposed indication is for the acceleration of upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. There are no other FDA approved drugs for this indication.
“Earlier this week, we submitted to the FDA a revised risk management program for Entereg,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “We believe the program provides appropriate measures to ensure that Entereg is used in patients for whom it has demonstrated a favorable benefit:risk profile. We look forward to working with the FDA as it completes its review of our NDA.”
About Adolor Corporation
Adolor Corporation (Nasdaq: ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has two lead product candidates in development: Entereg (alvimopan) for the management of the gastrointestinal side effects associated with opioid use; and novel Delta opioid receptor agonists for a variety of pain indications. Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor and Pfizer are collaborating in the worldwide development and commercialization of two Delta agonists for 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.
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.
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 www.sec.gov and from Adolor at 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 www.adolor.com.
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Contact:
Adolor Corporation
Lizanne Wentz
Corporate Communications
(484) 595-1500
Sam Brown Inc. (Media)
Mike Beyer
(773) 463-4211
GlaxoSmithKline
US Media:
Jeff McLaughlin
(919) 483-2839
US Investor Relations:
Frank Murdolo (215) 751-7002
Tom Curry (215) 751-5419


