Labopharm Meets With FDA to Discuss Second Approvable Letter for Once-Daily Tramadol


LAVAL, Canada, June 29 /PRNewswire/ --     Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has met 
with the U.S. Food and Drug Administration (FDA) to discuss the matters 
raised in the Agency's May 30, 2007 Approvable Letter for the Company's 
once-daily formulation of tramadol. The Company believes that the meeting 
with the Agency was productive and that the statistical analysis required by 
the FDA to achieve approval has been clearly delineated. If the existing data 
cannot satisfy these statistical requirements, the Company would be required 
to generate new data through an additional Phase III clinical trial. 
Labopharm will provide additional updates as it continues to interact with 
the FDA, as well as work with its marketing partner for the U.S., Purdue 
Pharma, and its advisors.

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 has a robust
pipeline of follow-on products in both pre-clinical and clinical development.
For more information, please visit www.labopharm.com.

This press release contains forward-looking statements that involve a
number of risks and uncertainties relating to the Company's once-daily
tramadol product in the United States that could cause actual results to
differ materially from those indicated in the forward looking statements.
These statements reflect the Company's current expectations regarding future
events. Specifically the risks and uncertainties the Company faces include 
but are not limited to: the Company's ability to resolve the issues 
identified by the FDA to the FDA's satisfaction in a timely manner; the 
uncertainties related to the regulatory process, including regulatory 
approval, and the commercialization of the drug thereafter. There can be no 
assurance that the Company will be able to resolve the issues identified by 
the FDA using existing data, or at all. If the Company is unable to resolve 
the issues identified by the FDA using existing data, it would need to 
generate additional data in order to obtain FDA approval. The Company's 
once-daily formulation of tramadol may not be legally marketed in the 
United States prior to approval by the FDA. 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.

© PR Newswire Association LLC.

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