Lancet Meta-analysis Finds ANGIOMAX -bivalirudin- and Other Direct Thrombin Inhibitors are More Effective Than Heparin
Unique among its class, ANGIOMAX combines reduced ischemic and bleeding risk
CAMBRIDGE, Mass.--(BW HealthWire)--Jan. 30, 2002-- The Medicines Company (NASDAQ: MDCO - news) announced today that a major meta-analysis published by Dr. Yusuf et al. in the journal Lancet has found that direct thrombin inhibitors such as ANGIOMAX® (bivalirudin) are associated with a significantly reduced risk of death or myocardial infarction over the indirect thrombin inhibitor heparin (p=0.001, differences persisting at seven and 30 days). Additionally, the analysis concluded that of the direct thrombin inhibitors, only ANGIOMAX was associated with both a reduction in ischemic events and a reduced risk of major bleeding.
This overview, which was prospectively limited to randomized ACS and PCI trials involving a minimum of 200 patients, compared the outcomes of 11 trials studying six agents in 35,970 patients. In addition to looking at differences between direct thrombin inhibitors (hirudin, bivalirudin, argatroban, efegatran, and inogatran) and the indirect thrombin inhibitor heparin, the study evaluated the differences between bivalent direct thrombin inhibitors (hirudin and bivalirudin) and univalent inhibitors (argatroban, efegatran, and inogatran).
The paper stated, ``At the end of treatment, both hirudin and bivalirudin were associated with lower rates of myocardial infarction than was heparin, but the univalent inhibitors appeared to be associated with an increased risk of myocardial infarction.'' The authors went on to state, ``There seem to be important differences in the risk of major bleeding among individual direct thrombin inhibitors. Hirudin is associated with an increased risk of major bleeding, particularly in acute coronary syndromes without ST elevation, for which there was an almost two-fold excess in major bleeding. By contrast, bivalirudin was associated with a 50% reduction in bleeding risk, mainly in patients undergoing percutaneous coronary intervention, but also evident in those with ST-elevation acute coronary syndromes.''
``This ground-breaking paper spells out the unique profile of Angiomax as an effective foundation intravenous anticoagulant,'' said Clive Meanwell, M.D., Ph.D., Executive Chairman of The Medicines Company. ``The clear advantage of direct thrombin inhibitors over heparin is demonstrated with enormous statistical power and must now be regarded as scientifically robust. Even more exciting for us is the authors' recognition that ANGIOMAX is unique among direct thrombin inhibitors - leading to reductions in both thrombotic and bleeding complications compared to heparin.''
Dave Stack, President and Chief Executive Officer of The Medicines Company added, ``We are impressed with these data which strongly support our market positioning for ANGIOMAX as a replacement for heparin. We have known for some time that ANGIOMAX could be clearly differentiated from its key competitors and this paper clearly underscores our confidence in the brand's future.''
The Medicines Company was founded in 1996 to acquire, develop and commercialize selected pharmaceutical products in late stages of development and approved products. In December 2000, the Company received marketing approval from the U.S. Food and Drug Administration for ANGIOMAX for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing coronary balloon angioplasty. The Company began selling ANGIOMAX in the United States in January 2001. The Company expects ANGIOMAX to be the cornerstone product of a planned acute hospital franchise. The Company is also developing a second product, CTV-05, a proprietary biotherapeutic agent with a potentially broad range of applications in the treatment of gynecological and reproductive infections. Additional information about the company and its products can be found at www.themedicinescompany.com.
This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, ``believes,'' ``anticipates,'' ``plans,'' ``expects,'' ``intends,'' and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption ``Certain Factors that May Affect Future Results'' in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2001 and incorporated herein by reference. These risk factors include risks as to the commercial success of ANGIOMAX; how long the Company will be able to operate on its existing capital resources; whether the Company's products (other than ANGIOMAX for its approved indication) will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, whether and when, if at all, the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed; the Company's history of net losses; and the Company's dependence on third parties, including manufacturers, suppliers and collaborators. We do not assume any obligation to update any forward-looking statements.
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Contact:
The Medicines Company
Peyton Marshall
(617) 225-9099 |
