By Charles Craig
Medicines Co., a Massachusetts start-up firm whose drug-making strategy revolves around licensing in candidates in late-stage development, selected for its first acquisition Biogen Inc.'s anti coagulant, Hirulog, which failed three years ago in Phase III trials for preventing cardiac complications associated with angioplasty.
Biogen, of Cambridge, Mass., will receive up to $30 million, including up-front licensing fees and milestone payments, from Medicines, also of Cambridge. Biogen will be paid royalties on a marketed product, but further breakdown of the financial terms was not provided by either company.
Biogen officials said they have commitments from Medicines for an undisclosed portion of the $30 million in addition to the up-front cash.
Aside from handing over data related to development of Hirulog, Biogen will not be involved in continued development of the thrombin inhibitor. Hirulog was derived from hirudin, a natural anti-coagulating enzyme secreted by leeches, and was under development as a substitute for heparin.
"Where Hirulog is concerned," said Clive Meanwell, president and CEO of privately held Medicines, "there is a sense of it being a fallen angel. Clearly we knew that. We went into an evaluation with skepticism and came out of it with a different viewpoint."
Meanwell said his company will meet with the FDA and regulatory officials in Europe to determine how to proceed with development.
He said published data from Biogen's angioplasty trials suggest Hirulog is "as effective as heparin and, in a stratified subgroup of patients, it was more effective."
Overall, Meanwell added, Hirulog's safety performance bested heparin with reduced incidences of bleeding.
He also noted Biogen's Phase II/III results of Hirulog, released in March 1996, for acute heart attacks showed the drug achieved a statistically significant improvement over heparin in opening blood vessels. The heart attack study was ongoing when Biogen discontinued development of Hirulog in November 1994.
Not all data from the heart attack trials have been released, Meanwell said. Complete findings will be published, "but we may be party to information that has not been available to the public," he added. "We are confident of our ability to develop Hirulog."
After the failed Phase III study for angioplasty, Biogen ended its Hirulog program to focus resources on its multiple sclerosis drug, Avonex, which is interferon beta-1a. Avonex became Biogen's first marketed product in 1996.
Biogen's stock (NASDAQ:BGEN) closed Tuesday at $42.75, up $0.50.
Medicines Co., which has 10 employees, was founded in 1996 with funding from Medical Portfolio Management Capital LP (MPM), a Cambridge, Mass., health care investment and acquisition firm, and E.M. Warburg Pincus Ltd., a New York venture capital group.
Meanwell, former senior vice president of development and operations at F. Hoffmann-La Roche AG, was a partner in MPM prior to starting Medicines. Hoffmann-La Roche is part of Roche Holding Ltd., of Basel, Switzerland.
Meanwell's new company, he said, will seek drug candidates developed by biotechnology and pharmaceutical companies that do not intend to take the products to market because they do not offer large enough financial returns.
For clinical development activities, Medicines forged a relationship with Quintiles Transnational Corp., a contract research organization headquartered in Research Triangle Park, N.C.
Meanwell likened Medicines' business model to that used by movie companies. "You acquire an asset," he said. "In our case it's a drug — for a movie it's a script — and configure the appropriate resources around it."
He listed Vanguard Medica Group plc, of Guilford, U.K., Interneuron Pharmaceuticals Inc., of Lexington, Mass., and Intercardia Inc., of Research Triangle Park, as firms with a similar strategy of licensing in drugs for development. *