- Company in Discussions to Complete Canadian Licensing and Distribution
Agreement for Once-Daily Tramadol Product -
LAVAL, QC, June 18 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced that it has received a Notice of Compliance (NOC) from the
Therapeutic Products Directorate (TPD) of Health Canada for 100 mg, 200 mg and
300 mg tablets of its once-daily formulation of tramadol for the management of
pain of moderate severity in adults who require treatment for several days or
more. The NOC allows the marketing and sale of Labopharm's once-daily tramadol
product in Canada.
"With more than 26 million prescriptions written for pain products in
2006, the Canadian market represents an important component of our global
commercialization plan for our once-daily tramadol product," said James R.
Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We
believe that our once-daily tramadol product offers physicians and patients an
efficacious and safe option for treatment of pain of moderate severity, with
the added benefit of once-a-day dosing."
Labopharm's New Drug Submission (NDS) to Health Canada for its once-daily
formulation of tramadol included data from the Company's global clinical
development program, including six Phase III clinical studies in which 14
Canadian centers participated, and 12 pharmacokinetic studies. Combined, more
than 2400 patients have been administered the product in clinical studies.
Labopharm is in active discussions to complete a licensing and
distribution agreement for its once-daily tramadol product in Canada, under
which the Company will retain the right to co-promote the product to certain
specialties through its own sales force. Labopharm expects the product to be
launched in Canada later this year.
About Labopharm's Once-Daily Tramadol Product
Labopharm's once-daily tramadol product is based on the Company's
proprietary Contramid(R) technology, which provides a dual matrix delivery
system allowing both rapid and sustained drug release that maintains blood
levels within the therapeutic range providing a full 24 hours of pain relief.
The Company believes that maintaining drug concentrations within the
therapeutic range has the advantage of fewer and less severe side effects
while maintaining efficacy. Under its global commercialization program,
Labopharm's once-daily tramadol product has been approved in 27 countries and
a broad European launch is underway.
Tramadol is a centrally acting analgesic for the treatment of moderate to
severe pain. Tramadol has a 30-year history of efficacy and safety and is
currently marketed in more than 70 countries worldwide, primarily in
formulations that require multiple doses per day. Studies have shown that
tramadol provides relief from both acute and chronic pain conditions,
including osteoarthritis pain, low back pain, cancer pain, post-operative pain
and dental pain. Tramadol avoids the potentially serious side effects such as
gastrointestinal bleeding that may be caused by NSAIDs and the potential
cardiovascular events recently attributed to COX-2 inhibitors. Compared to
stronger opioids, tramadol has, in clinical studies, demonstrated a lower
incidence of major side effects, such as respiratory depression.
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, 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 ability to reach agreement with a
Canadian distributor for once-daily tramadol, the regulatory process and the
commercialization of the Company's products thereafter, 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, firstname.lastname@example.org; French: Eric
Bouchard, Tel: (514) 208-5939, email@example.com