While we're on the subject of regulatory priorities, Canadian discovered arthritis drugs (albeit, by a major multi-national drug company) and COX-II inhibitors I received this yesterday
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Attention News/Health Care/Social Issues Editors:
Fast-Track Review Granted to Canadian-Discovered Arthritis Drug
KIRKLAND, Québec, April 15 /CNW/ - Rofecoxib, a Canadian-discovered drug for the treatment of arthritis, is currently under a fast-track review process by Health Canada, a Merck Frosst Canada & Co. spokesperson said today. Dr. Robert Young, Vice-president, Medicinal Chemistry, indicated that rofecoxib, a once-a-day COX-II (cyclooxygenase) specific inhibitor - a new class of medication - could be a major advance in the treatment of arthritis.
''This is an exciting development since rofecoxib was discovered and developed at our Merck Frosst Centre for Therapeutic Research in Kirkland, Québec,'' said Dr. Young. ''This is where all of our worldwide research on this new class of anti-inflammatory drugs is concentrated,'' he added. Dr. Young indicated that Merck Frosst Canada & Co. has completed clinical studies on rofecoxib for the treatment of osteoarthritis and for the relief of pain, and that additional studies are also underway for the treatment of rheumatoid arthritis.
Clinical studies to date demonstrate that rofecoxib is as effective in relieving pain and inflammation as the maximum doses of non-steroidal anti-inflammatory drugs (NSAIDs), without the gastrointestinal side effects. NSAIDS such as aspirin, diclofenac and ibuprofen are currently the most common medications used to relieve pain and inflammation due to arthritis. However, they can lead to serious GI side effects. Peptic ulcers, which may result in bleeding and/or perforation, are among the more serious complications.
New Class in More than a Decade
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There are two types of cyclooxygenase in the body. Cyclooxigenase-I (COX-I) produces prostaglandins that are believed to be responsible, among other things, for the protection of the stomach lining. Cyclooxygenase-II (COX-II) produces prostaglandins believed to be responsible for pain and inflammation.
NSAIDs act by inhibiting both COX-II and COX-I which can cause serious gastrointestinal side effects such as ulcers, stomach perforations and bleeds. COX-II specific inhibitors work by inhibiting the role of COX-II on pain and inflammation without inhibiting COX-I which protects gastrointestinal lining. As a COX-II specific inhibitor, rofecoxib's once daily dosing is expected to enhance compliance among patients with osteoarthritis while improving their quality of life.
A Common Condition
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Arthritis is a chronic, inflammatory disease affecting more than four million Canadians. As one of Canada's top three chronic conditions, arthritis is the most common cause of long-term disability in the country accounting for more than 25 per cent of all long-term disability cases(1).
Osteoarthritis is the most common form of arthritis affecting one in ten Canadians(2). Osteoarthritis is a degenerative joint disease characterized by the deterioration of joint cartilage and adjacent bones.
Merck Frosst Canada & Co. is based in Kirkland, Québec and is Canada's leading research-based pharmaceutical company. The company markets an extensive line of cardiovascular products for high blood pressure, elevated cholesterol and heart failure as well as a broad range of vaccines. Merck Frosst is also a recognized leader in the treatment of asthma, osteoporosis, HIV/AIDS, glaucoma, prostate disease, male pattern hair loss and other diseases.
The company employs more than 1,400 people of which approximately 300 of the world's leading scientific personnel work in Medical Research and at the Merck Frosst Centre for Therapeutic Research, the largest biomedical research facility in Canada. In 1998, the Company invested more than $94 million in research and development.
1.2. Source: The Arthritis Society
-0- 04/15/1999
For further information: Christian Blouin, Manager, Public Affairs, Merck Frosst Canada inc., (514) 428-3939; Roch Landriault, NATIONAL PharmaCom, (514) 843-2345
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