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The Medicines Company and Oryx Pharmaceuticals Sign Agreement for Canadian Marketing Rights to Angiomax® (Bivalirudin), a Direct Thrombin Inhibitor for Coronary Angioplasty
Parsippany, NJ and Mississauga, Ontario (October 30, 2002) — The Medicines Company (NASDAQ: MDCO) and Oryx Pharmaceuticals Inc. have signed a marketing and promotion agreement under which Oryx will market Angiomax (bivalirudin) in Canada. Health Canada recently approved Angiomax for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA or "angioplasty").
Angiomax is a small-molecule, reversible, direct thrombin inhibitor that has been shown in clinical trials to reduce the incidence of death, myocardial infarction, and the need for revascularization in patients undergoing balloon angioplasty, as compared to heparin. In addition, Angiomax has been associated with a significant reduction in bleeding complications in this patient group. The benefits of Angiomax have been shown in these clinical trials to remain consistent in high-risk patients, unlike other agents that show reduced efficacy in high risk patients. Reductions in these complications not only provide improved patient care, but also the opportunity for cost-savings by reducing total hospital resource consumption associated with coronary angioplasty.
Dave Stack, President and CEO of The Medicines Company noted, "Licensing the marketing rights to Canada is consistent with our strategy to collaborate with partners ex-U.S. We are happy to have signed an agreement so quickly after regulatory approval with a partner that will focus on Angiomax. Canadian interventional cardiologists have been supportive of Angiomax, and we are eager to bring the product to the Canadian market."
Mr. Stack added that Angiomax is now covered by distribution arrangements in more than 60 countries outside the United States, and the product has been approved for use in the United States, New Zealand, Israel, and Canada.
Douglas Reynolds, the President of Oryx, said "We are pleased to add Angiomax to our portfolio of cardiovascular products, and we are excited about the launch of Angiomax in Canada in 2003."
Earlier this year Oryx launched Corvert®, an injectable antiarrhythmic for the rapid conversion of atrial fibrillation and atrial flutter to normal sinus rhythm, under an exclusive marketing and promotion agreement with Pharmacia Canada Inc.
Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing PTCA. Angiomax is intended for use with aspirin. The most common (greater than 10%) adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve specialized care. The Company's lead product, Angiomax (bivalirudin), has been approved in the United States and other countries for use as an anticoagulant in patients undergoing PTCA. 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 www.themedicinescompany.com.
About Oryx
Oryx Pharmaceuticals Inc is a Canadian specialty pharmaceutical company with offices in Mississauga, Ontario. Its mission is to serve the needs of Canadian health care professionals and patients through the licensing and commercialisation of unique pharmaceutical products. Oryx is focused in the therapeutic areas of cardiovascular disease, CNS and oncology. For further information, please consult www.oryxpharma.com.
This press release contains forward-looking statements of The Medicines Company 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 "Factors that May Affect Future Results" in The Medicines Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2002 and incorporated herein by reference. These important factors include risks as to the commercial success of Angiomax; how long The Medicines 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 Medicines Company's products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed; the Company's dependence on third parties, including manufacturers, suppliers and collaborators, such as Oryx Pharmaceuticals; the dependence of The Medicines Company's revenues on a limited number of wholesalers to which the Company sells Angiomax, and the fact that sales by such wholesalers to end-users may not be indicative of revenues of the Company. We do not assume any obligation to update any forward-looking statements.
Primary Contact Information:
Doug Reynolds
President
Oryx Pharmaceuticals Inc.
Tel. (866) 260-6291 (toll free) Ext. 6773
dougr@oryxpharma.ca
Michael Mitchell
Director of Corporate Communications
The Medicines Company
Tel.: (973) 656-1616
investor.relations@themedco.com