Adolor Announces Investigational New Drug Application for Novel Delta Agonist ADL5747

Business Wire, Dec 28, 2007

EXTON, Pa. -- Adolor Corporation (Nasdaq:ADLR) announced today that clinical testing will be permitted under an Investigational New Drug Application (IND) for ADL5747, a novel oral compound that targets the Delta opioid receptor. Adolor expects to initiate Phase 1 clinical testing in the first quarter of 2008.

ADL5747 is the second delta compound that will enter clinical investigation under Adolor's worldwide collaboration with Pfizer Inc (NYSE:PFE) to develop novel pain compounds. A lead compound, ADL5859, is in Phase 2 clinical testing in several pain conditions.

About the Delta Receptor Program

The Delta receptor is one of three opioid receptors. Through a proprietary research platform based on cloned, human opioid receptors, Adolor has identified a series of novel, orally active Delta agonists - compounds that selectively stimulate the Delta opioid receptor. Delta compounds may have a number of potential advantages, including an improved side effect profile, as compared to mu opioid receptor agonists. On the basis of preclinical evaluation in animal models of human conditions, one might expect a Delta agonist to show effect in inflammatory pain, among other pain conditions. In addition, Delta agonists are thought to modulate other biological processes that may manifest themselves in disease states or conditions such as cardioprotection, overactive bladder, and depression.

There are currently no selective Delta agonists approved by the FDA.

About the Delta Collaboration

Adolor and Pfizer Inc (NYSE:PFE) are collaborating on the worldwide development and commercialization of two novel Delta opioid agonist compounds, ADL5859 and ADL5747, for the treatment of pain.

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[R] (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.

Adolor Forward-Looking Statement

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 our Delta product candidates ADL5859 and ADL5747 will show adverse safety findings that make them unsuitable for further development; the risk that our Delta product candidates do not show utility in treating pain or any other clinical indications; the risk that we do not initiate further clinical studies for our product candidate ADL5859 or initiate clinical studies for our product candidate ADL5747; the risk that filing targets for regulatory filings are not met; 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 Pfizer in connection with the development and commercialization of Adolor's Delta product candidates; the risks associated with Adolor's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its Delta product candidates; market acceptance of Adolor's products, if regulatory approval is achieved; reliance on third party manufacturers; product liability claims; 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.