To: john.d who wrote (5934 ) 11/28/2000 7:20:33 AM From: john.d Respond to of 14101 Interesting article in The Globe & Mail this morning. It suggests that we will have a decision from the Canadian regulators early next year and the FDA mid year. I am still of the mindset that we may see FDA approval by the Feb/Mar timeframe. Hope I'm right. John Dimethaid shares jump 18% after drug approved in U.K. Firm close to naming British partner to market Pennsaid in first quarter next year LEONARD ZEHR BIOTECHNOLOGY REPORTER Tuesday, November 28, 2000 Investors drove Dimethaid Research Inc. shares up 18 per cent yesterday after the company's Pennsaid lotion for osteoarthritis obtained marketing clearance from Britain's Medicines Control Agency. The stock, which hit a 52-week low of $3.50 last week on the Toronto Stock Exchange, climbed 80 cents to $5.30 yesterday after trading as high as $5.75 early in the session. Volume of 781,000 shares was more than seven times the daily trading average. "This first approval of Pennsaid in an important market is a significant milestone for Dimethaid," said president and chief executive officer Rebecca Keeler. "We are in the home stretch negotiating a marketing agreement in the U.K. and expect to announce very shortly who our partner is," she said, adding that the company plans to launch Pennsaid in the first quarter of next year. Markham, Ont.-based Dimethaid is currently producing Pennsaid at its plant in Quebec, which has the capacity to supply markets in North America and Europe. There are about seven million people in Britain suffering from osteoarthritis, a degenerative joint disease that is the most common type of arthritis. Treatment currently involves oral anti-inflammatory drugs, which can cause stomach ulcers and kidney failure. Ms. Keeler said anti-inflammatory drugs represent an annual market of over $600-million in Britain, of which topical treatments represent more than $75-million. "Our strategy will be to target the topicals first and then go after the oral market by promoting the safety and efficacy profile of Pennsaid as a first-line therapy for people suffering from gastrointestinal and kidney problems," she said. Dimethaid said it will use its British approval to seek marketing clearance for Pennsaid in other European Union countries, including Germany, France and Italy. Talks are continuing with potential distributors in each country, Ms. Keeler added. Dimethaid has already filed to sell Pennsaid in North America, and hopes to receive a decision from Canadian regulators early next year and from the U.S. Food and Drug Administration in midyear.