Labopharm Reports Results for Third Quarter F...(s marketing partner Paladin Labs Inc. la...),Health

Date:11/9/2007

s marketing partner, Paladin Labs Inc., launched once-daily tramadol in Canada under the brand name Tridural(TM). The Company also completed licensing and distribution agreements for once-daily tramadol for South Korea with WhanIn Pharmaceutical Co., Ltd., for Greece with Lavipharm S.A. and for Israel with Dexcel Pharma Technologies Ltd. Labopharm expects its product to be launched in the South Korean and Greek markets in 2008. Labopharm's formulation is currently under regulatory review in Israel and the Company expects a response from the Israeli regulatory authority by mid-2008.

To date, Labopharm has secured marketing partners for its once-daily tramadol in more than 50 countries worldwide and regulatory approval in 25 countries. The Company's partners will continue to launch its product in additional markets, globally, throughout 2008.

In the U.S., Labopharm continues to vigorously pursue regulatory approval of its once-daily tramadol, appealing the U.S. Food and Drug Administration's (FDA) decision in its Approvable Letter through initiation of the Agency's Formal Dispute Resolution process. The Company believes that it has met the statutory standards for approval of its formulation and that appealing the FDA's decision through this process represents its best opportunity to expeditiously resolve this matter.

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(1) Labopharm's target market consists of the market for

immediate-release, twice-daily, once-daily and drop formulations of

tramadol.

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

Once-Daily Trazodone Development Program

Labopharm has completed patient enrolment in its North American Phase III clinical trial for its once-daily formulation of the antidepressant trazodone, ahead of schedule. More than 400 patients are enrolled in the study.

"Our once-daily formulation represents the opportunity to address significant unmet needs in t
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SOURCE Labopharm Inc. Copyright©2007 PR Newswire. All rights reserved

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