Health Canada Approves Pennsaid (Diclofenac) Osteoarthritis Treatment

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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.

Source

Incidence

In Canada, more than 4 million people have some type of arthritis ¹
In the United States, over 40 million people have some type of arthritis²
One in ten are estimated to have osteoarthritis¹
Twenty million Americans suffer from osteoarthirits²
One of the three most commonly reported chronic conditions in Canada¹
21.1% of women suffer from arthritis while 15.7% of men have the disease¹
The likelihood of incidence increases with age¹
5% of those between 16 and 44 report having the disease
21% of those between 45 and 64 report having the disease
38% of those over 65 report having the disease
Nearly 50% of Americans over 65 years of age have some form of arthritis²
At any time, approximately one-third of all US adults are affected by objective joint pain, swelling, or limitation of motion³
By 2020, it is estimated that 60 million Americans, or 20% of the population, will have some form of arthrits²

Personal and Economic Costs

Estimated to have cost the Canadian economy $5 Billion in 1996¹
$1.1B in direct cots and $3.9B in indirect costs
Estimated to have cost the American economy $65 Billion annually²
$15B in direct costs and $50B in indirect costs
Arthritis and other rheumatic conditions have an annual economic impact on the United States roughly equivalent to a moderate recession, with an aggregate cost of about 1.1% of the gross national product⁴
One in three prescriptions written in Canada are for treatments for arthritis (29 million prescriptions in 1992)¹
Arthritis is the second most common reason for purchasing non-prescription (or over-the-counter) drugs¹
Arthritis is the most common cause of long-term disability in both Canada and the United States^1,2
Arthritis is one of the most frequent reasons for consulting a physician1
Each year, 39 million Americans visit a physician because of their arthritis²
Up to 30% of chronic NSAID users will develop gastroduodenal ulceration⁵
The relative risk of a gastrointestinal (GI)-provoked hospitalization was more than five times greater in patients taking NSAIDs than in non-NSAID-treated patients, with an excess hospitalization rate of 1.3% per annum6
Adverse events associated with the use of NSAIDs are reported more frequently to the Food and Drug Administration than are those associated with any other group of drugs⁷
An estimated that 1,900 Canadians die every year from NSAID induced ulcers (more than multiple vehicle accidents, fires and gunshot wounds combined)¹
Conservative calculations for the United States estimate that approximately 107,000 patients are hospitalized annually for NSAID-related GI complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone (more than from asthma, cervical cancer or melanoma). ^2,8,9

Sources

Canadian Arthritis Society

Centers for Disease Control and Prevention

Lawrence, RC, et. al., Arthritis & Rheumatism, Vol. 41, No. 5, May 1998, pp 778-799

Yelin, Edward H. Ph.D., Professor (Adjunct) of Medicine and Health Policy, University of California, San Francisco

Blower, AL, Scand. Journal of Rheumatology Supplement, 1996; 105: 13-24

Fries, J, Scand Journal of Rheumatology Supplement 1996;102:3-8

Loeb DS, Ahlquist DA, Talley NJ, Mayo Clinical Procedure, 1992 Apr;67(4):354-64

Business Week, Feb. 16, 1998, p. 71-72

Singh, Gurkirpal, "Recent Considerations in Nonsteroidal Anti-Inflammatory Drug Gastropathy," American Journal of Medicine, pp. 31S-38S, Volume 105 (1B), July 27, 1998.

This page last updated on September 16, 1999

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