Healthcare Industry News: bivalirudin
News Release - April 4, 2006
The Medicines Company Commences Patient Enrollment in Pivotal Phase III Clinical Trial of CangrelorNovel Intravenous Antiplatelet Agent Described in March Issue of American Heart Journal
PARSIPPANY, N.J.--(HSMN NewsFeed)--April 4, 2006--The Medicines Company (NASDAQ: MDCO ) today announced that the first patients have been enrolled in pivotal Phase III clinical trials evaluating cangrelor, a fast-acting, reversible, intravenous (IV) antiplatelet agent for preventing platelet activation and aggregation during the clotting process. If the trials are successfully completed and cangrelor receives regulatory clearance, the Company believes cangrelor will be the first IV platelet inhibitor to market that binds directly to the P2Y12 receptor, a clinically validated target to treat or prevent arterial thrombosis in patients undergoing percutaneous coronary intervention (PCI).
The Phase III program is comprised of two multinational trials to evaluate cangrelor's effectiveness and safety in preventing ischemic events in patients who require PCI. The first trial to enroll is called CHAMPION PCI and has a planned enrollment estimated at 9,000 patients. The second trial, expected to begin in late 2006, is called CHAMPION PLATFORM and has planned enrollment estimated at 4,000 patients. The trials' co-primary investigators are Deepak Bhatt, MD of The Cleveland Clinic Foundation and Robert Harrington, MD of the Duke Clinical Research Institute.
The first CHAMPION PCI patient was enrolled by investigator Charles Pollack, MD, Chairman, Department of Emergency Medicine, at Pennsylvania Hospital. Dr. Pollack stated, "Current antiplatelet therapies have limitations when used in patients with an acute presentation in the hospital setting. If the unique attributes cangrelor has previously demonstrated are confirmed, I believe cangrelor will be an important new therapeutic agent that will reshape the way we manage acute coronary thrombosis."
Phase II cangrelor clinical trial results were published in the most recent (March) issue of the American Heart Journal. In the discussion section, the publication describes cangrelor as "a rapidly acting, selective and specific antagonist of platelet aggregation via direct binding to the P2Y12 receptor." The authors also described the potential of cangrelor in, "...treatment of acute coronary syndromes such as those targeted for an early invasive strategy, in need of urgent percutaneous or emergent surgical revascularization, or in the case of vascular trauma."
The Medicines Company expects the entire Phase III clinical trial patient enrollment to be completed in 18 to 24 months. "The initiation of this pivotal program advances our development pipeline, which will be an important driver of future growth," said John Kelley, President and Chief Operating Officer of The Medicines Company. "We believe cangrelor will be a centerpiece in our acute hospital care product franchise and we expect to aggressively move this late-stage development program."
About The Medicines Company: The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin) in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and cangrelor that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed on March 15, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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