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Health Canada Approves Pennsaid (Diclofenac) Osteoarthritis Treatment

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

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