The Medicines Company got a big boost out of the news that its second attempt to make a great impression in a Phase III trial for its anticlotting drug cangrelor worked out as planned. More than three years ago the Parsippany, NJ-based biotech ($MDCO) had to suspend a Phase III study of the drug after concluding that it wasn't performing any better than Plavix. But a second take with a large patient population produced a positive result, with investigators claiming a top-line success in hitting the "primary composite efficacy endpoint" for a reduced risk of death, heart attack and stent thrombosis.
The developer now says it's preparing to take the data to the FDA and the EMA later this year in search of an approval. The actual data from the study, which enrolled 10,900 hospitalized patients, is being held back for a scientific meeting.
"The PHOENIX trial was designed with careful consideration of the prior studies to determine whether cangrelor is associated with improved ischemic outcomes compared with the usual treatment of oral clopidogrel [Plavix]," said Stanford investigator Dr. Robert A. Harrington in a press release. "We are grateful to the many investigators around the world who enabled rapid enrollment and the collection of high quality data. We are pleased that the trial delivered such clear results."
Jefferies' Biren Amin has estimated the drug could hit peak sales of $370 million if it can pass muster with regulators. And the turnaround cheered investors, who pushed shares up more than 12% after the news hit. The drug, an intravenous small molecule antiplatelet agent, is designed to thwart the kind of platelet accrual that can trigger blood clots.
"We believe that fast acting and rapidly reversible cangrelor may have an important role to play both in patients undergoing [percutaneous coronary intervention] and in patients who need to discontinue oral P2Y12 inhibitors prior to surgery," said Medicines Co. CEO Clive Meanwell in a release.
- here's the press release
- read the AP report
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