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To: Johnny Canuck who wrote (42619)	9/10/2005 1:29:42 PM
From: Johnny Canuck	Read Replies (1) \| Respond to of 70587

Biovail stock leaps 24% on drug approval Tramadol ER painkiller taken only once a day Firm negotiating with potential marketing partner ABDUL LATHEEF CANADIAN PRESS Biovail Corp.'s shares jumped more than 24 per cent yesterday after the Canadian drug maker announced its once-a-day painkiller Tramadol ER had won final approval from the United States Food and Drug Administration, or FDA. The stock shot up $5.15, or 24 per cent, to close at $26.61on the Toronto Stock Exchange, eclipsing the 52-week high of $24.80. Biovail said its version of tramadol has been approved for the treatment of moderate to moderately severe chronic pain in once-daily 100-, 200- and 300-milligram dosage strengths. The approval clears the way for Biovail to bring the drug to the lucrative United States market, worth an estimated $13.5 billion a year. "The tramadol (currently) on the (U.S.) market is taken four to five times a day," said chief executive Douglas Squires. "This drug is taken once a day ... which is a huge difference." Squires also said Biovail is negotiating with a "significant partner" to market Tramadol ER and expects to conclude those talks quickly. Biovail said the drug, which doesn't have a trade name yet, should be launched commercially in early 2006. "This is an important milestone as it further demonstrates Biovail's technological and scientific capability in utilizing advanced drug-delivery technologies to add significant clinical benefits to medications," Squires said in an earlier statement. "The timing of the approval gives Biovail a significant competitive advantage, and allows us to further diversify our revenue base. The conditions of approval by the FDA for Tramadol ER support three years of exclusivity for the indication and doses approved." Rivals Labopharm Inc. of Laval, Que., and Cipher Pharmaceuticals Inc. of Mississauga are also developing their own versions of tramadol. Labopharm has received regulatory approval for its once-daily tramadol pain reliever in Europe, but has yet to complete clinical trials for U.S. submission. The company expects to file its new-drug application before the end of the year. But Merrill Lynch analyst Michael Pollard said the Biovail coup was not all that bad for Labopharm. "We do not view first-mover advantage as insurmountable, as the products are not identical and the market for tramadol is large (enough for multiple products) and growing," he said. In Toronto, Labopharm shares were under pressure on Biovail's victory, plunging $1.27, or 25.71 per cent, to $3.67. Cipher shares rose 1 cent to $2.21.