CHESHIRE, Conn. (AFX) - Alexion Pharmaceuticals Inc. said Wednesday a late-stage study it had previously trimmed down because of negative results failed to meet its primary endpoint.
The drug, called pexelizumab, was being tested for its effectiveness in reducing heart attacks or deaths in moderate-to-high risk patients following heart bypass surgery.
In February, the company said it was trimming the Phase 3 clinical trial by moving on with fewer patients. Initially, the trial consisted of more than 10,000 people at 300 U.S. and international locations. That was trimmed down to between 5,000 and 6,000 patients.
The goal of the study, or the primary endpoint, was to reduce mortality at 30 days following heart bypass surgery. In the initial trial, the company said 15.2 percent of the patients taking the drug died or had a heart attack following surgery, compared with 16.3 percent who took placebo.
'Our view is that we were best off to invest less and bring it to an earlier conclusion,' said Chief Executive Dr. Leonard Bell in an interview late Wednesday.
He said the company is focusing on other drugs in its pipeline, which include eculizumab, aimed at treating a rare form of anemia called paroxysmal nocturnal hemoglobinuria. The company has estimated that between 8,000 and 10,000 people in North America and Western Europe have the disease.
The drug candidate has already received a patent in Japan and is awaiting approval from the U.S. Food and Drug Administration. The company has already set up a subsidiary in Paris in preparation for the developing and marketing the drug in Europe.
'That's an exciting opportunity for us,' Leonard said of the treatment. 'Our focus is entirely on eculizumab.'
Shares of Alexion rose 27 cents to close at $35.03 on the Nasdaq, then gave up 48 cents, to $34.55 in aftermarket trading on the INET.
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