The Medicines Company's Second Pivotal Efficacy Trial of Clevelox -Clevidipine- Meets Objectives; Clevelox ESCAPE-1 Trial Demonstrates Blood Pressure Lowering Effect

Business Wire, Dec 16, 2004

PARSIPPANY, N.J. -- The Medicines Company (Nasdaq:MDCO) today released primary results of the ESCAPE-1 clinical trial of Clevelox(TM) (clevidipine), an intravenous blood pressure control agent in Phase III development. ESCAPE-1 results met the pre-specified trial objectives. Cardiac surgery patients with high blood pressure treated with Clevelox achieved treatment success 92.5% of the time versus 17.3% in placebo (p less than 0.00001). Treatment success was measured by at least a 15% reduction in blood pressure.

ESCAPE-1 was conducted in patients before they underwent cardiac surgery (pre-operative). The successful close of the trial means that the efficacy portion of the Clevelox Phase III clinical trial program is complete. On November 11, 2004, The Medicines Company reported similar primary results of ESCAPE-2, its clinical trial of Clevelox conducted in patients after cardiac surgery (post-operative).

Mark Sumeray, MD, Vice President, Product Development for Clevelox, stated, "With a high level of statistical confidence, the ESCAPE data confirm that Clevelox is effective in the management of pre- and post-operative hypertension. Coupled with unique characteristics observed in previous trials - namely: fast-on, fast-off pressure response, highly selective arterial effect and clearance independent of the liver and kidneys - we expect that Clevelox will represent a novel intravenous agent for the perioperative management of blood pressure."

The Clevelox Phase III program is comprised of five clinical trials. The two completed ESCAPE studies evaluated Clevelox efficacy pre- and post operatively. Three trials, know as ECLIPSE, are evaluating Clevelox safety perioperatively (immediately before, during and after surgery) in approximately 1,500 patients. All three ECLIPSE studies are currently enrolling patients, with completion expected toward the middle of 2005. If ECLIPSE results meet their objectives, The Medicines Company plans on filing a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

Bob Weiland, Vice President and General Manager of The Medicines Company's Surgery Business Unit stated, "The Clevelox late-stage development program is proceeding as planned. The performance of Clevelox in clinical trials continues to impress, and we expect it to be a great fit for our acute hospital care franchise."

Both ESCAPE trials were placebo-controlled, doubled blind, randomized studies. The Medicines Company expects full data results from the ESCAPE program to be published and presented under scientific peer review.

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(R) (bivalirudin), an anticoagulant approved in the U.S. and other countries for use in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) procedures. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators.

Statements contained in this press release about the Company and its products 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," "plans," "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 the uncertainty of the results of our trials, whether the development and commercialization of our products may be terminated or delayed, whether the Company's products will advance in the clinical trials process, whether the Company's products will receive approvals from regulatory agencies, whether the Company will be able to acquire and develop additional product candidates, 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 Quarterly Report on Form 10-Q filed on November 5, 2004, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.