11th Jun 2007 12:00
GlaxoSmithKline (LSE and NYSE:GSK) and Adolor Corporation(Nasdaq:ADLR) today provided an update on the alvimopan(Entereg/Entrareg(R)) development program. £ The U.S. Food and Drug Administration (FDA) has requested thatadditional data be submitted as part of the complete response to theNovember 6, 2006 approvable letter for alvimopan in postoperativeileus (POI). These additional data include the final results of Study101684, an extension of the Phase 2b Study 008 of alvimopan in cancerpain patients with opioid-induced bowel dysfunction (OBD), furtheranalysis of results from Study 014 and the final study reports fromthe two-year carcinogenicity studies in rats and mice, which wereconducted to support the OBD indication. The FDA also requested safetydata from Adolor's co-administered study of alvimopan(alvimopan/hydrocodone/APAP), Study 228, as part of the completeresponse. Adolor has discontinued Study 228 to enable final datacollection and analysis. £ The FDA has placed the alvimopan Investigational New DrugApplications (INDs) on clinical hold pending submission and analysisof the requested information and notification by the FDA that clinicalstudies with alvimopan may resume. GSK and Adolor currently have nostudies ongoing with alvimopan. £ "We are working closely with GSK to complete analyses of thesestudies and satisfy all requests for data for our complete response,"said Michael R. Dougherty, president and chief executive officer ofAdolor. "We now expect that this submission will occur in the thirdquarter of 2007." £ GSK anticipates providing an update on the development plan foralvimopan in OBD in the third quarter of 2007. £ About Adolor Corporation £ Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical companyspecializing in the discovery, development and commercialization ofnovel prescription pain management products. Entereg(R) (alvimopan) isAdolor's lead product candidate under development for the managementof the gastrointestinal side effects associated with opioid use.Adolor and GlaxoSmithKline (GSK) are collaborating in the worldwidedevelopment and commercialization of Entereg(R) in multipleindications. Adolor also has a number of discovery research programsfocused on the identification of novel compounds for the treatment ofpain. By applying its knowledge and expertise in pain management,along with ingenuity, Adolor is seeking to make a positive differencefor patients, caregivers and the medical community. For moreinformation, visit www.adolor.com. £ About GlaxoSmithKline £ GlaxoSmithKline is one of the world's leading research-basedpharmaceutical and healthcare companies and is committed to improvingthe quality of human life by enabling people to do more, feel betterand live longer. For more information, visit GlaxoSmithKline on theWorld Wide Web at www.gsk.com. £ Adolor Forward-Looking Statements £ This release, and oral statements made with respect to informationcontained in this release, may constitute forward-looking statementswithin the meaning of the Private Securities Litigation Reform Act of1995. Such forward-looking statements include those which expressplan, anticipation, intent, contingency, goals, targets or futuredevelopment and/or otherwise are not statements of historical fact.These statements are based upon management's current expectations andare subject to risks and uncertainties, known and unknown, which couldcause actual results and developments to differ materially from thoseexpressed or implied in such statements. Such known risks anduncertainties relate to, among other factors: the risk that thealvimopan Investigational New Drug Applications (INDs) remain onclinical hold indefinitely; the risk that Adolor may not receiveregulatory approval of Entereg (R) (alvimopan) for POI, OBD, or anyother indication; the risk that Adolor may not be able to adequatelyaddress the deficiencies in the November 2006 FDA approvable letter;the risk that a risk management plan could materially adversely affectthe commercial prospects for Entereg, if regulatory approval isachieved; the risk that Adolor may not obtain FDA approval for Enteregin POI, whether due to Adolor's inability to provide additional datasatisfactory to the FDA to obtain approval for the NDA, the adequacyof the safety and efficacy data from all of the Entereg studies,changing regulatory requirements, the risk that the FDA may not agreewith Adolor's and GSK's analyses of the Entereg studies (includingStudy 014) and may evaluate the results of these studies by differentmethods or conclude that the results from the studies, whether or notstatistically significant, do not support safety, efficacy, afavorable risk/benefit profile, or there were human errors in theconduct of the studies, or otherwise; adverse safety findings in anyEntereg studies; the risk that regulatory approvals for the use ofEntereg in OBD are not achieved; the risk that filing targets forregulatory submissions or user fee goal dates are not met; the riskthat the results of other clinical trials of Adolor's drug productcandidates, including Entereg, are not positive; the risk of productliability claims; reliance on third party manufacturers; the costs,delays and uncertainties inherent in scientific research, drugdevelopment, clinical trials and the regulatory approval process;Adolor's history of operating losses since inception and its need foradditional funds to operate its business; Adolor's reliance on itscollaborators, including GSK, in connection with the development andcommercialization of Entereg; market acceptance of Adolor's products,if regulatory approval is achieved; competition; and securitieslitigation. £ Further information about these and other relevant risks anduncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and10-K filed with the U.S. Securities and Exchange Commission. Adolorurges you to carefully review and consider the disclosures found inits filings which are available in the SEC EDGAR database athttp://www.sec.gov and from Adolor at http://www.adolor.com. Given theuncertainties affecting pharmaceutical companies in the developmentstage, you are cautioned not to place undue reliance on any suchforward-looking statements, any of which may turn out to be wrong dueto inaccurate assumptions, unknown risks, uncertainties or otherfactors. Adolor undertakes no obligation to (and expressly disclaimsany such obligation to) publicly update or revise the statements madeherein or the risk factors that may relate thereto whether as a resultof new information, future events, or otherwise. £ GlaxoSmithKline Forward-Looking Statements £ Under the safe harbor provisions of the US Private SecuritiesLitigation Reform Act of 1995, the company cautions investors that anyforward-looking statements or projections made by the company,including those made in this announcement, are subject to risks anduncertainties that may cause actual results to differ materially fromthose projected. Factors that may affect the Group's operations aredescribed under 'Risk Factors' in the Business and Prospects in thecompany's Annual Report on Form 20-F for 2006. Copyright Business Wire 2007Related Shares:
Glaxosmithkline