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Theratechnologies appeals Health Canada’s decision on Egrifta

An ad for Egrifta in San Francisco’s Castro District.

Theratechnologies (Theratechnologies Stock Quote, Chart, News: TSX:TH) today announced it has filed a request for reconsideration of its recent rejection of Egrifta, its tesamorelin application proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy.

Theratechnologies had submitted the The NDS for Egrifta to Health Canada in June, 2011. It was was based on the results from two phase 3 clinical trials, which enrolled more than 800 patients, and followed a marketing approval for EGRIFTA by the U.S. Food and Drug Administration received in November, 2010.

The company, which already has a commercialization partner lined up for Egrifta, Actelion Pharmaceuticals Canada, says there are simply no other approved treatments for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy available in Canada.

Following the rejection of Egrifta, on March 4th, Byron Capital analyst Douglas Loe said the impact of Health Canada’s decision was minor.


Loe said he ascribes virtually no value to the Canadian HIV market, so the decision has no impact on his valuation of Theratechnologies. But the analyst says the decision is typical of the regulatory challenges Theratechnologies has had in other, more important markets. Loe says he expects that shares of the company, which have fallen from more than $2 to under thirty cents in the past year, will trade sideways until its regulatory status is resolved in Latin America and in Europe.

At press time, shares of Theratechnologies on the TSX were even at $.285.

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About The Author /

Cantech Letter founder and editor Nick Waddell has lived in five Canadian provinces and is proud of his country's often overlooked contributions to the world of science and technology. Waddell takes a regular shift on the Canadian media circuit, making appearances on CTV, CBC and BNN, and contributing to publications such as Canadian Business and Business Insider.
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