By Matthew Willett

The Medicines Co. (TMC) received FDA approval for its thrombin-specific anticoagulant Angiomax for use in percutaneous transluminal coronary angioplasty (PTCA) procedures in patients with unstable angina.

The company plans to launch the therapeutic, its first to gain approval, in January, through a marketing agreement with Innovex Inc., its financial sibling through TMC investor and Innovex parent Quintiles Transnational, of Research Triangle Park, N.C. (See BioWorld Today, Dec. 8, 2000.)

That deal's terms were undisclosed, but Dave Stack, TMC's senior vice president of commercial sales, said the fee-for-service deal will give TMC access to Innovex's 52-person sales force, with TMC managing the force.

"Because we're able to outsource to the Innovex sales force we can do something like this without breaking the bank with fixed expenses," he said. TMC also is working to achieve European Union regulatory approval, he said.

TMC President and CEO Clive Meanwell said the company has always had faith in the drug and its imminent approval.

"The mode of action, the pharmacology and the clinical data set of this product have always been very consistent and, for us, convincing," he told BioWorld Today. "It's not a product that can be described in sound bites. Those that spend sufficient time looking at the data have been rewarded by the understanding that this product is a very significant step forward."

Angiomax was deemed approvable by the FDA in May. That came on the strength of double-blinded trials of the drug compared to heparin, the standard-of-care anticoagulant, in 4,312 patients undergoing angioplasty procedures for new-onset angina, accelerating episodes of angina or angina at rest. (See BioWorld Today, May 18, 2000.)

Funding for the first-quarter 2001 launch will come from the company's 6-million-share, $96 million IPO in August. After that offering the company had about $108.3 million in the bank. (See BioWorld Today, Aug. 9, 2000.)

TMC said there are about 680,000 percutaneous coronary intervention procedures performed in the U.S. annually.

Analyst Franklin Berger, of J.P. Morgan Securities Inc. in New York, said in a research note Monday that he estimated Angiomax sales to come in at $22 million in 2001. He put 2002 sales at $60 million and said the company should reach profitability in 2003.

Last week's approval marks the end of a turnaround from the drug's fate in its first incarnation. Shortly after its inception, Cambridge, Mass.-based TMC acquired Angiomax from Biogen Inc., of Cambridge, Mass., for $30 million. (See BioWorld Today, March 26, 1997.)

Hirulog, named then for its derivation from the anticoagulant leech enzyme hirudin, went straight to the FDA in spring 1998, but the FDA turned it down. (See BioWorld Today, Feb. 18, 1998; and Oct. 26, 1998.)

Since then, TMC has initiated clinical trials in further indications in addition to trials to support the drug's approval in PTCA.

"I think that if you look at any drug that finally reaches its right place, at some point in its development it encounters some snags," Meanwell said. "In a smaller company where perhaps most of the business revolves around a single asset, these typical development challenges can prove to be quite difficult to manage."

Despite early setbacks, he said TMC is aiming Angiomax at any indication heparin is used for currently. That market is estimated, he said, at about 5 million patients in the U.S.

A Phase III test of the drug in myocardial infarction is under way, and should be complete in 2001, and similar testing of Angiomax in patients with heparin-induced thrombocytopenia also is under way.

Further study of the drug in patients with other acute coronary syndromes - unstable angina and non-Q-wave myocardial infarction, specifically - are planned for 2001, and a study of Angiomax in angioplasty, called REPLACE, is in the works.

"That's a large opportunity and a large set of challenges for us to take on, and it'll keep us busy for a while," Meanwell said. "Beyond that, one can simply look at how heparin is used. We're in development of this product in any situation where heparin is used intravenously, particularly, and potentially everywhere heparin performance is somehow disappointing or limited." n