Healthcare Industry News: alvimopan
News Release - October 31, 2006
Adolor Corporation Discontinues Development of Sterile Lidocaine PatchEXTON, Pa.--(HSMN NewsFeed)--Adolor Corporation (Nasdaq:ADLR ) announced today that the company has decided to no longer pursue clinical development of its sterile lidocaine patch for post-surgical incisional pain. Licensed in 2003 from EpiCept Corporation for North America, the product was in Phase 2 clinical development. Adolor expects to transition the program to EpiCept by the end of the year.
"We believe it is important to evaluate development programs at definitive milestones and determine whether it is a productive use of resources to continue development," said David Madden, interim president and chief executive officer, Adolor Corporation. "In this case, we have decided that the company's resources are better allocated to our other clinical and discovery research efforts."
About Adolor Corporation
Adolor Corporation (Nasdaq:ADLR ) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. EnteregŪ (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 EnteregŪ in multiple indications. 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 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 may not obtain FDA approval for the NDA for EnteregŪ(alvimopan) 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 EnteregŪ is clinically meaningful; the adequacy of the results of the Studies 14CL302, 14CL306, 14CL308, 14CL313 and 14CL314 to support FDA approval of EnteregŪ, 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; reliance on third party manufacturers; adverse safety findings; or otherwise; the risk that regulatory approvals for the use of alvimopan in OBD are not achieved; the risk that the results of the EnteregŪ OBD clinical safety study, SB-767905/014 are not positive; 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 EnteregŪ are not positive; the risk that the Phase 1 clinical study of ADL5859 will show 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 Glaxo, in connection with the development and commercialization of EnteregŪ; 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.
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