Theratech 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 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 Theratech 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.