(Reuters) - Theratechnologies Inc shares plummeted more than 60 percent on Friday after the Canadian drugmaker said its European partner, Ferrer Internacional SA, was withdrawing a marketing application for its lead drug for HIV patients.
The Spanish company’s decision to pull the European Medicines Agency application for tesamorelin, used to reduce excess abdominal fat in HIV-infected patients with lipodystrophy, was made after a health committee raised safety concerns.
The injectible drug is already approved by the U.S. Food and Drug Administration, according to the company’s website.
The Canadian drugmaker said it no longer expects to report a profit before interest, tax, depreciation and amortization (EBITDA) in 2013. It booked a net loss in the last fiscal year.
The Committee for Medicinal Products for Human Use in Europe cited potential concerns for long-term users and a lack of data on cardiovascular risks as the reason for its unfavorable view of the drug, Theratechnologies said in a statement.
Theratechnologies sank 61 percent to 75 Canadian cents on the Toronto Stock Exchange, making it the biggest decliner on the index in percentage terms.
Additional reporting by Aftab Ahmed in Bangalore; Editing by Frank McGurty