Health Canada Approves
OXYTROL(R), an Innovative Patch for Overactive Bladder Treatment (OAB)
MONTREAL, June 23, 2004
- CNW Telbec
2.9 Million Canadians affected by OAB to benefit from the availability of
Oxytrol(R) in Canada
Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical
company, today announced that the
Therapeutic Products Directorate of Health Canada has approved OXYTROL(R) (oxybutynin
transdermal system). This novel transdermal patch has been developed for
people suffering from an overactive bladder (OAB) and experiencing symptoms
such as urge urinary incontinence, urgency, and frequency. "We expect to
launch OXYTROL(R) (oxybutynin transdermal system) in Canada in the fourth
quarter 2004," said Jonathan Ross Goodman, President & CEO Paladin Labs. "We
believe the OXYTROL(R) patch represents a breakthrough in the treatment of
OAB. Its patented transdermal system delivers oxybutynin - the gold standard
OAB treatment - in a manner which results in powerful
efficacy and an incidence of anticholinergic side effects, including dry
mouth, comparable to placebo." According to the Canadian Continence
Foundation, approximately 2.9 million Canadians suffer from overactive
bladder and, according to IMS Canada, the total Canadian market for
overactive bladder exceeded $46 million in 2003. "Overactive bladder
symptoms can have a negative impact on patients' quality of life. As the
number of Canadians suffering from OAB continues to grow, physicians are
increasingly faced with the challenge of providing successful treatment,"
said Dr. Sender Herschorn, Chairman of Urology, at the University of
Toronto. "The oxybutynin patch is an innovative method that has been shown
to be effective with less dry mouth than oral immediate release oxybutynin."
OXYTROL(R) was developed by Watson Pharmaceuticals, Inc. to treat overactive
bladder. Paladin entered into a licensing agreement with Watson
Pharmaceuticals to market OXYTROL(R) in January 2004. Watson Pharmaceuticals
had previously filed a new drug submission for OXYTROL(R) with the
Therapeutic Products Directorate of Health Canada in May 2003.
About OXYTROL(R)
OXYTROL(R) is a thin, flexible, clear patch that should be applied to the
abdomen, hip or buttock twice weekly. The active ingredient in OXYTROL(R) is
oxybutynin, a medication widely accepted and prescribed in oral formulation
for the past 25 years. The OXYTROL(R) transdermal delivery system delivers
3.9 milligrams per day of oxybutynin consistently and continuously through
the skin into the bloodstream, bypassing initial metabolism in the liver and
the gastrointestinal tract that occurs with oral medications, providing
relief of overactive bladder symptoms for up to four days. Clinical trials
involving approximately 1,000 subjects at more than 50 U.S. centers
demonstrated that Watson's OXYTROL(R) product, with its unique transdermal
delivery system, provides effective control of overactive bladder symptoms
over a three to four day period. Data also shows that OXYTROL(R) is well
tolerated, with an anticholinergic side effect profile, including dry mouth,
constipation and dizziness, not significantly different from placebo.
About Paladin Labs
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing innovative
pharmaceutical products for the Canadian market. With this strategy, a
focused national sales team and proven marketing expertise, Paladin has
evolved into one of Canada's leading specialty pharmaceutical companies.
Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB.
For more information about Paladin, please visit the Company's Web site at
www.paladinlabs.com.
This news release may contain forward-looking statements or predictions.
These statements represent our judgement as of this date and are subject to
risks and uncertainties that could cause actual results or events to differ
materially from those expressed in such forward-looking statements.
Potential risks and uncertainties include, without limitation, those
associated with product development, clinical trials, future revenues and
profitability, and obtaining marketing approval and other factors that are
discussed in the Management Discussion and Analysis published in the
Company's annual report.
For further information: Samira Sakhia, Chief Financial Officer, Paladin
Labs Inc., (514) 340-5067, info@paladin-labs.com; Bruce Wigle, Investor
Relations, The Equicom Group Inc., (416) 815-0700 ext. 228, bwigle@equicomgroup.com