EXTON, Pa., Dec. 29 /PRNewswire-FirstCall/ -- Adolor Corporation announced today that it has submitted an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for ADL5859, a novel, oral compound that targets the Delta opioid receptor. Delta receptor agonists are thought to offer benefits over other approaches to the management of pain.
“ADL5859 was discovered by Adolor’s research organization, reflecting the effectiveness of the company’s strategy to have a productive internal research effort as well as an active effort to in-license and develop product candidates from outside the company,” said James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corporation. “If the IND becomes effective by the FDA without delay or the need for additional studies, Adolor expects to initiate a Phase 1 clinical trial program in the first half of 2006. ADL5859 will represent Adolor’s third program in human clinical testing and is an important component of the company’s growing pipeline.”
The Delta receptor is one of three opioid receptors that modulate pain and may have application in other indications. Adolor has discovered a series of selective, novel Delta agonists. ADL5859 has shown activity and an attractive safety profile in preclinical evaluation and is under development for the potential relief of inflammatory and neuropathic pain. There are no selective Delta agonists approved by the FDA.
About Adolor Corporation
Adolor Corporation 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 Corporation is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit http://www.adolor.com.
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 will need to do additional preclinical testing on ADL5859 before the FDA will allow the IND to go effective; the risk that Phase 1 testing of ADL5859 does not begin in the first half of 2006; 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.
Adolor Corporation
CONTACT: Lizanne Wentz, Corporate Communications, Adolor Corporation,+1-484-595-1500; Mike Beyer, Sam Brown Inc. (media) +1-773-463-4211; LilianStern, Stern Investor Relations (investors), +1-212-362-1200
Web site: http://www.adolor.com/
