Labopharm Reports Results for Second Quarter F... (uct was launched in the U.S. in May unde...)

Labopharm Reports Results for Second Quarter Fiscal 2009

Date:8/7/2009

uct was launched in the U.S. in May under the brand name RYZOLT by Purdue Pharma Products L.P., the Company's licensing and distribution partner. Although RYZOLT was launched into a challenging market, the Company remains confident in the prospects for its product in the U.S.

Product Achieves Number One Position in Canada in May and June - Labopharm's product (marketed under the brand name Tridural(TM) in Canada) ranked number one in Canada among tramadol products (excluding combination products) in terms of prescriptions in May and June 2009 with 39% and 42% market share, respectively. The number of prescriptions written for Labopharm's product in Canada for the second quarter of 2009 increased 24% compared to the first quarter of 2009.

In-Market Sales in Europe Continue to Grow - In-market sales of Labopharm's product in Europe(1) grew 7% for the first five months of 2009 compared to the same period of 2008.

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    (1) Includes France, Germany, the United Kingdom, Spain and Italy.

Novel Trazodone Formulation

Company to Submit Response to FDA - Following discussions with the U.S. Food and Drug Administration (FDA), Labopharm intends to submit its response to the Agency next week. As previously disclosed, the Company received a complete response letter from the FDA indicating that its new drug application (NDA) cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility. The API manufacturer submitted an action plan addressing the deficiencies on Friday, July 24, 2009.

Submitted Regulatory Application in Canada - Labopharm filed a new drug submission (NDS) with the Therapeutic Products Directorate (TPD) of Health Canada on August 4, 2009. Upon acceptance by Health Canada, the Company expects a response to its submission in t
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SOURCE Labopharm Inc.
Copyright©2009 PR Newswire.
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