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Labopharms once-daily pain killer tramadol approved for sale in Canada



June 18, 2007

Ross Marowits

Drug developer Labopharm Inc. (TSX:DDS) received some welcome relief of its own after Health Canada approved the sale of its once-daily painkiller tramadol despite ongoing concerns of U.S. regulators.

The health agency's therapeutic products directorate approved 100-milligram, 200-mg and 300-mg tablets of its formulation of tramadol for the management of moderate pain in adults who require treatment for several days or more, the Laval, Que.-based company said Monday.

"We're excited," Labopharm CEO James Howard-Tripp said in an interview.

"It's very positive for us. Canada is a smaller market than the U.S., but it's still a very important market. It's one of the G8, it's a very serious regulatory body, so it's nice to get approval from that perspective."

Labopharm's once-daily tramadol now has been approved in 27 countries and a broad European launch is underway.

The formulation is based on the company's Contramid technology, which provides a dual delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range.

Studies have shown that tramadol provides relief from both acute and chronic pain conditions, including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain.

Half of its use is for osteoarthritis and low back pain.

It also avoids potentially serious side-effects such as gastrointestinal bleeding and cardiovascular issues of non-steroidal anti-inflammatory drugs (NSAIDs) such as Vioxx and Celebrex.

However, the U.S. Food and Drug Administration has raised approval concerns for distribution into the important American market.

The same regulatory package was sent to Health Canada and its U.S. counterpart, leaving company officials confused about the different results.

"We're going to meet with the agency in a while and I think once we've met with them hopefully we can establish a path forward," Howard-Tripp said.






"The U.S. market is typically 50 per cent of the global sales so you really want it if you can get it."

The drug is not recommended for very mild pain or migraines. As a weak opiad, it can cause constipation, nausea and dizziness. Although it can be addictive in theory, that hasn't been the practical experience, he said.

Howard-Tripp said there's a gap in the $800 million Canadian prescription pain drug market for a product like tramadol.

Competition comes principally from Tylenol 3, Percocet and Biovail Corp.'s (NYSE:BVF) Ultram.

Labopharm hopes to have it for sale by the end of the year after selecting a yet unnamed group that will market and sell it in Canada.

No sales price has been announced for Canada, but they typically sell for C$0.86 to C$1.44 in Europe, where the prevalence of generics tend to depress drug prices.

Analyst Claude Camire of Paradigm Capital Inc. said Health Canada's blessing is positive but Canadian sales are projected to be between $5 million and $10 million by 2009.

"We're already using a lot of generics so it leaves a small opportunity out there for Labopharm to market their drugs," he said in an interview.

"I think it's positive but I think everybody is waiting for the U.S. approval, probably by the second part of '08."

He said the potential global annual market for tramadol is US$1.7 billion, US$750 million in the United States and US$60-$70 million in Canada.

With serious concerns subsequently arising from drugs like Vioxx and Celebrex, Camire said the FDA is being extra cautious.

"It will be approved at some point in time, there's no doubt."

Labopharm has faced unusual problems since, 95 per cent of drugs are approved during a second application, he said.

The pills will be produced by the same company that manufactures for the European market.

Health Canada approval caused Labopharm shares to surge by 6.23 per cent or 17 cents to $3.24 on the Toronto market Monday. Over the last year, shares have traded between $2.80 and $8.85.

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