SOURCE: The Medicines Company

The Medicines Company

September 29, 2009 17:00 ET

The Medicines Company Licenses Innovative New Formulation of Argatroban; Gains Strategic Complement to Angiomax Franchise and Potential Near Term Revenue Opportunity

PARSIPPANY, NJ--(Marketwire - September 29, 2009) - The Medicines Company (NASDAQ: MDCO) today announced that it has entered into a license agreement with Eagle Pharmaceuticals, Inc. (Eagle) under which The Medicines Company will have rights in the United States and Canada to a ready-to-use formulation of Argatroban, which is currently under review by the U.S. Food and Drug Administration (FDA).

"The Medicines Company is pleased to announce our agreement with Eagle," said Clive Meanwell, M.D., Chairman and Chief Executive Officer of The Medicines Company. "Argatroban is a valuable therapeutic option for critical care patients, with U.S. sales in the currently marketed formulation of about $140 million in 2008. We believe we can capture a portion of that market by providing this innovative formulation, which has the potential to address the needs of our customers by providing an economically favorable product in an indication for which Angiomax is not approved."

Argatroban, currently marketed in a concentrated formulation, is approved as an anticoagulant for prophylaxis or treatment of thrombosis in patients with or at risk for heparin-induced thrombocytopenia (HIT), and for patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

"When available, there should be absolutely no delay in switching to this product," said John Fanikos, M.B.A., R.Ph., Assistant Director of Pharmacy, Brigham and Women's Hospital, Assistant Professor of Clinical Pharmacy, Northeastern University, Massachusetts College of Pharmacy. "Argatroban is an important drug, and we use a lot of it. This pre-mixed formulation will be a more efficient, economical delivery system, with one step less for the pharmacy and nursing departments, reducing the risk of mistakes when preparing drugs."

Formed in 2007, Eagle Pharmaceuticals is a specialty pharmaceutical company focused on developing specialty injectable products that tend to have some unique aspect or barrier to entry. Under the terms of the license agreement, The Medicines Company will pay $5 million in cash up front and make a $2 million equity investment in Eagle. Combined with a previous equity investment in Eagle, The Medicines Company will own less than 10% of Eagle on a fully diluted basis. Additional approval and commercialization milestones and royalties could follow.

"This transaction can provide top line revenues to fuel near and mid term growth and expand our portfolio of critical care products. This late stage product opportunity has the potential for near-term revenue as soon as mid-2010. We believe the deal terms reflect a balanced investment that minimizes risk for The Medicines Company," said Glenn Sblendorio, Executive Vice President & Chief Financial Officer.

About The Medicines Company

The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company's website is www.themedicinescompany.com.

Statements contained in this press release about The Medicines Company 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 we are able to obtain or maintain patent protection for the intellectual property relating to the Company's products, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers 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 Quarterly Report on Form 10-Q filed on August 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

Contact Information