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Upon acceptance for review of the response, the FDA will assign an actiondate under the Prescription Drug User Fee Act (PDUFA).
About Labopharm's Once-Daily Tramadol Product
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Labopharm's once-daily tramadol product is based on the Company'sproprietary Contramid(R) technology, which provides a dual matrix deliverysystem allowing both rapid and sustained drug release that maintains bloodlevels within the therapeutic range providing a full 24 hours of pain relief.The Company believes that maintaining drug concentrations within thetherapeutic range has the advantage of fewer and less severe side effectswhile maintaining efficacy. Under its global commercialization program,Labopharm's once-daily tramadol product has been launched in 12 countries,including the five largest markets in Europe and Canada and is approved in 19other countries. Including those countries in which its product has beenlaunched, Labopharm has licensing and distribution agreements in place formore than 50 markets globally.
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 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 the Company's ongoing quarterly filings and annualreports for additional information on risks and uncertainties relating tothese forward-looking statements. The reader is cautioned not to rely on theseforward-looking statements. The Company disclaims any obligation to updatethese forward-looking statements.
SOURCE Labopharm Inc.
