The Medicines Company Announces Completion of Enrollment of Part One of the REPLACE Program.

Business & Health Editors

CAMBRIDGE, Mass.--(BW HealthWire)--Feb. 26, 2001

The Medicines Company (Nasdaq: MDCO) announced today it reached the enrollment target of one thousand patients in part one of the REPLACE program. Patients were recruited at 75 sites faster than planned into the Phase 3b randomized trial examining ANGIOMAX(R) (bivalirudin), The Medicines Company's lead product, in patients undergoing angioplasty.

"We are pleased with the progress of the REPLACE program and the successful enrollment under the leadership of the Cleveland Clinic," commented Clive Meanwell, M.D., Ph.D., President and Chief Executive Officer of The Medicines Company.

Transition to the second part of the REPLACE program will begin with evaluation of the data from part one. The second part of the program will randomize approximately 6,000 patients who are referred for angioplasty. The program, coordinated by the Cleveland Clinic Cardiovascular Coordinating Center (C5), is one of the largest electronic-data-capture trials.

The Medicines Company was founded in 1996 by a team of experienced pharmaceutical executives to acquire, develop and commercialize selected pharmaceutical products in late stages of development. The Company expects ANGIOMAX to be the cornerstone product of an acute hospital franchise we plan to build. The Company is developing ANGIOMAX for additional potential applications for use in the treatment of ischemic heart disease. ANGIOMAX is being examined in patients presenting with acute myocardial infarction in the Phase 3 HERO-2 trial and in patients undergoing angioplasty with HIT or HITTS in a Phase 3 trial. The Company is also focused on specialty anti-infectives and is 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. CTV-05 is currently being studied in a double-blind placebo controlled Phase 2 trial examining the safety and effectiveness of the compound as an adjunct to antibiotic therapy in the treatment of bacterial vaginosis.

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 "Risk Factors" in the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on February 23, 2001 and incorporated herein by reference. These risk factors include risks as to the commercial success of ANGIOMAX(R) (bivalirudin), 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 how long the Company will be able to operate on its existing capital resources; and the Company's dependence on third parties, including manufacturers, suppliers and sales agents.