Karl Note: Notice that this pain killer is classed as a "drug" but it mentions a "chemical carrier" to take the active ingredient in through the skin to bring pain relief. MSM, or Methyl Sulfonyl Methane does the same "carrying" function, but it is not a drug.
First Drug of Its Kind In Canada, says Dimethaid CEO
TORONTO, ON -- March 31, 2003 -- Specialty pharmaceutical developer, Dimethaid
Research Inc., (TSX: DMX) has received final Health Canada approval for Pennsaid®,
a topically applied, nonsteroidal anti- inflammatory drug (NSAID). The approval
gives physicians a new option for treating the pain, stiffness and physical
impairment that result from osteoarthritis (OA) of the knee.
"This is an historic achievement, the first drug of its kind in Canada," says
Rebecca Keeler, Dimethaid's president and CEO. "Pennsaid is the country's one
and only topical, prescription OA therapy, and Dimethaid is the first-ever
Canadian, public company to get regulatory approval for a drug it has conceived,
developed and manufactured on its own."
More than three million Canadians suffer from OA and because incidence of the
disease increases among seniors, both market size and sales volumes are expected
to rise as the population ages. According to IMS Health, the Canadian NSAID
market is worth an estimated $500 million. Datamonitor, another industry
intelligence source, projects that the worldwide market for arthritis products
will grow 4.8 percent annually, from its current $16.4 billion to $21 billion by
2008.
Dimethaid's new drug will be marketed as an alternative to oral NSAIDs, such as
ibuprofen and naproxen, which have been linked to serious side effects including
gastrointestinal bleeding, kidney and liver disease.
"We expect Pennsaid will be widely prescribed because it fills an obvious gap,"
says Dimethaid's medical director, Dr. Zev Shainhouse. "There are many patients
who don't need, don't want, or can't take oral NSAIDs."
A 1998 paper published in the Journal of Rheumatology reports that up to
30 percent of patients taking traditional NSAIDs develop persistent GI symptoms,
and more than 10 percent discontinue treatment. The Arthritis Society also
estimates that up to 1,900 Canadians die every year from complications related
to oral NSAID use.
Pennsaid has been designed to decrease the likelihood of serious side effects.
Based on Dimethaid's patented
technology, the treatment combines a chemical carrier with diclofenac sodium, a
proven anti-arthritic, and delivers active drug through the skin directly to the
site of disease. This more targeted approach introduces only negligible amounts
of NSAID into the bloodstream -- up to 150 times lower than levels reported for
comparable oral medication. Clinical trial data, reviewed by Health
Canada, has repeatedly demonstrated the product's ability to relieve symptoms
without provoking serious GI or other systemic side effects. Following Pennsaid
application, the most frequently reported adverse event has been a localized
patch of dry or irritated skin.
During the past year, Dimethaid medical sales representatives have been meeting
regularly with physicians, gathering information about the challenges of
managing osteoarthritis.
"The medical community has been waiting for this product," says Danny Dean,
director, national sales and marketing. "Patients clearly need better treatment
choices and with this approval, we expect to begin distribution to pharmacies
across Canada, shortly."
Pennsaid will be manufactured at Dimethaid's 26,000-sq-ft plant in Varennes,
Quebec. The facility has been licensed by Health Canada in recognition of
compliance with Good Manufacturing Practices (GMP).
About Dimethaid Research Inc.
Dimethaid Research Inc. is a publicly traded, Canadian, specialty pharmaceutical
company headquartered in Markham, Ontario, with manufacturing facilities in
Varennes, Quebec and Wanzleben, Germany. The company develops and commercializes
targeted therapeutic drugs designed to produce minimal side effects. Dimethaid's
two technology platforms focus on transcellular drug delivery and immune system
regulation. Products have potential applications in such areas as
osteoarthritis, onychomycosis and HIV/AIDS. For more information, please visit
http://www.dimethaid.com.
This release may contain forward-looking statements, subject to risks and
uncertainties beyond management's control. Actual results could differ
materially from those expressed here. Risk factors are discussed in the
Company's annual information form filed with the securities commissions in each
of the provinces of Canada. The Company undertakes no obligation to revise
forward-looking statements in light of future events.
SOURCE: Dimethaid Research Inc
There is a story of corruption behind this drug --
fully developed HERE.
Incidence
Personal and Economic Costs
Sources
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