Washington Editor

Millennium Pharmaceuticals Inc. and GlaxoSmithKline plc entered a commercialization alliance in which GSK will exclusively market Integrilin, an acute coronary syndrome drug, in Europe.

Neither company would discuss details surrounding the financial arrangements. However, Millennium, a Cambridge, Mass.-based firm, said it will receive license fees, milestone payments and royalties from GSK on European sales upon the achievement of certain objectives.

The agreement is the result of Millennium acquiring European rights from its partner, Schering-Plough Corp., which maintains its partnership with Millennium in all other parts of the world, including the U.S. Schering-Plough will continue to pay Millennium royalties on Integrilin sales outside the U.S. and Europe

In 2003, worldwide sales for the drug reached $305.8 million, a Millennium spokesperson told BioWorld Today. The company expects Integrilin to hit a worldwide peak of $500 million annually.

GSK, of London, will commence commercialization of Integrilin on the approved transfer of marketing authorizations, anticipated by December.

Schering-Plough, of Kenilworth, N.J., will continue to promote and sell Integrilin in Europe until the deal is closed.

Millennium officials would not discuss financial arrangements associated with the Schering-Plough part of the agreement. A company spokesperson did confirm that Millennium had been "aggressively seeking a new partner for Europe to fully maximize the potential of Integrilin."

David Mawdsley, GSK's director of corporate media relations in London, told BioWorld Today GSK believes Integrilin complements its other products for managing critical health care.

"[Integrilin] is a good opportunity, particularly given its successful performance in the U.S.," he said. "It also strengthens our cardiovascular critical-care portfolio."

GSK has established a European critical-care business unit, which will optimize Integrilin sales throughout Europe by leveraging its 180-person sales force, the company said.

Integrilin (eptifibatide) Injection is in a class of blood-clot inhibitors known as glycoprotein (GP) IIb-IIIa inhibitors. Launched in Europe in 1999 and in the U.S. in 1998, Integrilin treats patients with unstable angina and non-ST-segment elevation myocardial infarction.

It also is indicated in the U.S. for the treatment of patients at time of percutaneous coronary intervention, including patients undergoing intracoronary stenting.

The drug works by breaking apart and preventing blood clots by blocking the GP IIb-IIIa receptors expressed on the platelet surface. Integrilin prevents myocardial infarction in patients presenting with unstable angina and non-Q-wave myocardial infarction.

Integrilin also helps prevent further clot formation and growth, reducing existing coronary obstruction. The effects of the drug are specific to platelets, avoiding interference with other normal cardiovascular processes, and the effects can be reversed upon Integrilin discontinuation when no longer needed, Millennium said.

In early June, Millennium and Schering-Plough initiated a multicenter Phase IIIb trial to evaluate the benefit of Integrilin administered early to high-risk patients experiencing non-ST-segment elevation acute coronary syndrome. The trial will evaluate the benefit of Integrilin compared to placebo in reducing death and other adverse cardiac events, including heart attack, within 96 hours and up to 30 days following randomization. It will enroll 10,500 patients at 500 sites worldwide.

Millennium's stock (NASDAQ:MLNM) was up 55 cents Wednesday to close at $14.22.

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