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"We have maintained the position that our strong body of data warrants theapproval of our once-daily tramadol formulation and believe that theadditional analysis we conducted as proposed by the FDA confirms ourposition," said James R. Howard-Tripp, President and Chief Executive Officer,Labopharm Inc. "We believe that continuing the Formal Dispute Resolutionprocess, as opposed to submitting a complete response, is the most appropriatepath to resolving the outstanding matter and achieving our objective ofcommercialization in the United States."
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As part of the appeal process, Labopharm has requested a meeting with Dr.Janet Woodcock, M.D., the FDA's Director, Center for Drug Evaluation andResearch. The Agency usually grants such requests within 30 days and typicallyprovides a written response to the appellant within 30 days of a meeting.
About the FDA's Formal Dispute Resolution Process
FDA regulations provide a mechanism for those seeking regulatory approvalof a drug product through a New Drug Application (NDA) to obtain formal reviewof any Agency decision through a Formal Dispute Resolution process by raisingthe matter with the supervisor of the employee who made the decision. If theissue is not resolved at the primary supervisory level, the applicant mayrequest that the matter be reviewed at the next higher supervisory level. Thisprocess may continue through the Agency's chain of command, through theCenters to the Commissioner of Food and Drugs. The Formal Dispute Resolutionprocess exists to encourage open, prompt discussion of scientific (includingmedical) disputes and procedural (including administrative) disputes thatarise during the drug development, new drug review, generic drug review, andpost-marketing oversight processes.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existingsmall molecule drugs using its proprietary controlled-release technologies.The Company's lead product, a unique once-daily formulation of tramadol, isbeing commercially launched in key markets globally. The Company also has arobust pipeline of follow-on products in both pre-clinical and clinicaldevelopment. Labopharm's vision is to become an integrated, international,specialty pharmaceutical company with the capability to internally develop andcommercialize its own products. For more information, please visitwww.labopharm.com.
This press release contains forward-looking statements, which reflect theCompany's current expectations regarding future events. The forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including the uncertainties related to the FDA's Formal Dispute Resolutionprocess, the outcomes of clinical trials, the regulatory process in variouscountries for the approval of the Company's products and the successfulcommercialization of the products throughout the world if they are approved.Investors should consult th
