LAVAL, QC, June 29 /CNW/ - 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.
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, firstname.lastname@example.org; French: Eric
Bouchard, Tel: (514) 208-5939, email@example.com