Labopharm Receives FDA Response To Recent Appeal Of Approvable Letter For Once-Daily Tramadol



    - FDA Proposes Additional Statistical Analysis of Existing Data as Means
    to Satisfy Agency's Requirements -

    LAVAL, QC, Jan. 24 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ:   DDSS) today
announced that it has received a written response from the U.S. Food and Drug
Administration (FDA) regarding its most recent appeal of the decision in the
Agency's Approvable Letter for its once-daily tramadol formulation through the
Formal Dispute Resolution process. John K. Jenkins, M.D., Director for the
Office of New Drugs, Center for Drug Evaluation and Research, did not overturn
the decision. However, Dr. Jenkins has suggested additional statistical
analysis of existing data as a means to potentially satisfy the Agency's
requirements. The statistical method proposed for the analysis is different
from that previously requested by the FDA since the May 2007 Approvable
Letter. Dr. Jenkins also recommended the Company meet with the Agency prior to
any resubmission.
    "We are encouraged by the FDA's recent communication and are currently
evaluating the proposal outlined in the letter," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "We look forward to
potentially resolving the outstanding issues."

    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
being commercially launched in key markets globally. The Company also has a
robust pipeline of follow-on products in both pre-clinical and clinical
development. Labopharm's vision is to become a fully 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 for drug
approval and the commercialization of the Company's products, 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. The Company disclaims any obligation to
update these forward-looking statements.




For further information:

For further information: At Labopharm, Mark D'Souza, 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: Eric
Bouchard, Tel: (514) 844-7997, ebouchard@equicomgroup.com

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LABOPHARM INC.

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