Labopharm announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA

Labopharm announces that its trazodone API supplier has resolved outstanding
manufacturing issues with the FDA

LAVAL, QC, Oct. 7 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ:
DDSS) today announced that it has been informed by Angelini, the manufacturer
of the active pharmaceutical ingredient (API) for the Company's novel
trazodone formulation, that it has received a letter from the U.S. Food and
Drug Administration (FDA) stating that Angelini has appropriately addressed
all deficiencies cited by the FDA following its inspection of the
manufacturing facility in June and July of this year. The letter further
states that Angelini's manufacturing facility has been classified as
acceptable.
Labopharm received a complete response letter from the FDA on July 17, 2009
indicating the Company's new drug application (NDA) for its novel trazodone
formulation could not be approved in its present form due to the deficiencies
at the API supplier's manufacturing facility. The letter did not raise any
efficacy or safety issues.
Labopharm's novel formulation of trazodone is currently under regulatory
review in the U.S. with an action date under the Prescription Drug Users Fee
Act (PDUFA) of February 11, 2010.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing
small molecule drugs using its proprietary controlled-release technologies.
The Company's lead product, a unique once-daily formulation of tramadol, is
now available in 17 countries around the world, including the U.S., Canada,
major European markets and Australia. The Company's second product, a novel
formulation of trazodone for the treatment of major depressive disorder, is
under regulatory review in the U.S. by the FDA. The Company also has a robust
pipeline of follow-on products in both pre-clinical and clinical development.
Labopharm's vision is to become an integrated, international, specialty
pharmaceutical company with the capability to internally develop and
commercialize its own products. For more information, please visit
www.labopharm.com.

This press release contains forward-looking statements, which reflect the
Company's current expectations regarding future events. The forward-looking
statements involve risks and uncertainties. Actual events could differ
materially from those projected herein and depend on a number of factors,
including the uncertainties related to the regulatory process in various
countries for the approval of the Company's products and the successful
commercialization of the products throughout the world if they are approved.
Investors should consult the Company's ongoing quarterly filings and annual
reports for additional information on risks and uncertainties relating to
these forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. Except as required by law, the Company undertakes
no obligation and does not intend to update these forward-looking statements.

SOURCE Labopharm Inc.

At Labopharm: Mark D'Souza, Senior Vice-President and Chief Financial Officer,
Tel: (450) 686-0207; At The Equicom Group: Jason Hogan, Media and Investor
Relations, Tel: (416) 815-0700, jhogan@equicomgroup.com; French: Joe
Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com