By Matthew Willett

When The Medicines Co. and Innovex Inc. agreed to a commercialization deal for the marketing of the antithrombin Angiomax, The Medicine Co.'s lead product, it was almost a foregone conclusion.

The two-year, milestone-bearing agreement with Innovex, a subsidiary of Research Triangle Park, N.C.-based Quintiles Transnational Corp., comes on the heels of the announcement of imminent approval for the antithrombin for use as an anticoagulant in patients undergoing coronary angioplasty.

Quintiles also is an investor in The Medicines Co. That made the deal a no-brainer, industry watchers such as ING Barings analyst Ruby Holder said.

Though financial terms of the deal were undisclosed, Holder said the deal is likely similar in scope to the 1999 Innovex agreement with CV Therapeutics Inc.

That deal called for Innovex to market CV Therapeutics' ranolazine, saving CV Therapeutics an estimated $110 million. The deal also included a $5 million up-front equity investment by Quintiles in CV Therapeutics and a $10 million milestone payment to CV Therapeutics upon commercialization.

Further, CV Therapeutics kept all rights to ranolazine, including the ability to log all revenues and keep 90 percent of those revenues, and the company has the option to take over the Innovex sales force after five years. (See BioWorld Today May 12, 1999.)

"I assume it will track fairly in line with the CV Therapeutics deal," Holder said. "For Quintiles there's the opportunity to obtain margins that are significantly higher than in a traditional fee-for-service-type arrangement, so it becomes a win-win situation for both sides."

TMC received an approvable letter for Angiomax in May. Final approval is contingent upon completion of conditions specified by the FDA, conditions the Medicine Co.'s Chief Financial Officer Peyton Marshall said the company has addressed.

"We have addressed many of the FDA's questions in a submission we've made to the FDA," Marshall told BioWorld Today. "We're looking forward to a possible approval in the not-too-distant future. We expect to be in a position, subject to approval, to launch the product [in 2001]."

Upon launch, the company expects to immediately go head-to-head with heparin, the lead therapeutic competitor for Angiomax.

"Our approvable letter is for use as an anticoagulant in patients undergoing coronary angioplasty," Marshall said. "There are something on the order of 680,000 percutaneous coronary intervention processes per year in the U.S."

Vice President of sales and marketing Tom Quinn called heparin relatively undefended.

"The drug of choice is heparin, and it has served patients and cardiologists well," Quinn said. "It has been around for a while and has limitations and drawbacks, so we see right out of the box a competition from heparin, and we'll go after it first. Heparin is one of those entities in the marketplace that's undefended, and that's where we see the main competition and our thrust right off the bat."

Beyond marketing Angiomax in its lead indication, the company has plans and trials to broaden the indication.

"We have a significant number of trials currently under way, including an acute myocardial infarction Phase III test slated to be complete sometime next year," Marshall said. "There's also clinical work under way for use of Angiomax in patients with heparin-induced thrombocytopenia, and we're planning to do clinical work in patients with acute coronary syndromes, unstable angina or non-Q-wave myocardial infarction, where we have Phase II data and we're looking to design a Phase III trial."

Marshall added TMC also has a study of Angiomax, called REPLACE, in angioplasty. "We view it as a product with a very interesting potential lead indication and the potential to grow in its use more broadly, particularly in acute hospital care," he said.