SOURCE: The Medicines Company

The Medicines Company

September 12, 2011 08:00 ET

The Medicines Company Launches 50mL Ready-to-Use Formulation of Argatroban Injection

PARSIPPANY, NJ--(Marketwire - Sep 12, 2011) - The Medicines Company (NASDAQ: MDCO) announced today the launch of a 50mL ready-to-use formulation of Argatroban injection, a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT), and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). Argatroban will be supplied in a pre-mixed ready-to-use, single use 50 mL vial. The Medicines Company expects the product to be available today, September 12, 2011.

"There should be 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. This smaller sized, pre-mixed formulation may offer a more efficient, economical delivery system, by allowing one step less for the pharmacy and nursing departments when preparing drugs."

"Thanks to the development work of our partners, Eagle Pharmaceuticals and SciDose, LLC, we can now bring this new 50 mL ready-to-use formulation to hospitals in the United States and expand our portfolio in the acute care marketplace. At a time of great pressure on patient quality outcomes and on containment of hospital costs, we anticipate creating meaningful value for our customers," said Clive Meanwell, M.D., Chairman and Chief Executive Officer of The Medicines Company.

"Argatroban is an important drug in the treatment of heparin-induced thrombocytopenia, including in patients with life-threatening thrombosis syndromes. Our U.S. engagement team is now working with hospitals, integrated health networks and group purchasing organizations to provide this 50 mL ready-to-use formulation as soon as possible for patients. Current Argatroban formulations available to hospital pharmacies include a concentrate formula that requires reconstitution to 250 mL and a package of two pre-mixed 125 mL vials. We believe that the Argatroban 50 mL formulation may minimize cost because it offers hospital pharmacists a smaller dosing unit which could potentially reduce medication waste," said Brent Furse, Senior Vice President and Chief Customer Officer.

The Medicines Company entered into a license agreement in September 2009 with Eagle Pharmaceuticals, Inc., a New Jersey based, specialty pharmaceutical company, to acquire marketing rights in the United States and Canada to Argatroban.

Important Argatroban Safety Information
Argatroban is contraindicated in patients with major bleeding and a history of hypersensitivity to Argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported. Hemorrhage at any site can occur (unexplained fall in hematocrit or blood pressure or other unexplained symptoms may indicate hemorrhage). Use with caution in patients at risk, including those receiving antiplatelet agents, thrombolytics, or other anticoagulants as it may increase the risk of hemorrhage. Argatroban should be used with extreme caution in disease states or other circumstances in which there is an increased risk of hemorrhage. Caution should be exercised when administering Argatroban to patients with hepatic impairment. Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI patients with clinically significant hepatic impairment. Anticoagulation effects associated with Argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the aPTT. Co-administration of Argatroban and warfarin results in a prolongation of PT and INR beyond that produced by warfarin alone. Overall major bleeding was reported in 5.3% of patients with HIT treated with Argatroban versus 6.7% of the historical controls in clinical trials. Major bleeding was reported in 1.8% of PCI patients with HIT treated with Argatroban versus 3.1% of the historical controls in clinical trials. In HIT patients, the most common non-hemorrhagic adverse reactions (greater than 5%) were dyspnea, hypotension, fever, diarrhea, sepsis and cardiac arrest. In HIT patients undergoing PCI, the most common non-hemorrhagic adverse reactions (greater than 5%) were chest pain, hypotension, back pain, nausea, vomiting and headache.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines 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, including the Company's preliminary revenue results, 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 extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, 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 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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