The Medicines Co. says Angiomax monotherapy superior to dual drug treatment in coronary care

By Lisa Kerner

Erie, Pa., March 13 - The Medicines Co. said its Acuity trial of Angiomax (bivalirudin) met its objectives in favor of Angiomax in the treatment of acute coronary syndromes (ACS).

The results were presented at the American College of Cardiology Scientific Session, according to a company news release.

More than 13,800 patients participated at 448 clinical trial sites in 17 countries. Nycomed co-sponsored the trial in Europe, where more than 4,800 patients were enrolled.

The Acuity trial, consisting of three treatment arms, demonstrated that Angiomax and GP 2b/3a inhibitors can be combined safely, without any significant increase in either ischemic or bleeding complications compared to heparins plus GP 2b/3a inhibitor.

Angiomax alone is shown to be as effective as dual drug regimens and results in significantly less bleeding, officials said.

Acuity used a sequential analysis and met all levels of testing, including all six of the main pre-specified endpoints, the release stated.

"With Acuity complete and now presented, our belief that there are two major platforms for Angiomax growth ahead of us is bolstered significantly," president and chief executive officer John Kelley said in the release.

"We expect continued Angiomax growth in the cath lab in 2006 and anticipate a future platform in the emergency department."

Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. It is indicated in the United States for use as an anticoagulant with provisional GP 2b/3a inhibition in patients undergoing percutaneous coronary intervention.

The Medicines Co., based in Atlanta, develops products that improve acute hospital care.

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