The Medicines Company Receives Paragraph IV Notifications
Published: Sep 04, 2009
PARSIPPANY, NJ--(Marketwire - September 04, 2009) - The Medicines Company (NASDAQ: MDCO) today announced that it has received Paragraph IV Certification notice letters from Teva Parenteral Medicines, Inc. (TPM) and Pliva Hrvatska, d.o.o. (Pliva) notifying the Company that TPM and Pliva have submitted Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA) for approval to market generic versions of Angiomax. The Certification notice letters relate to U.S. patent No. 7,582,727, the recently issued product patent.
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 also has two products in late stage development: cangrelor, an investigational antiplatelet agent, and oritavancin, a semi-synthetic lipoglycopeptide antibiotic. The Company's pipeline also includes a serine protease inhibitor, CU2010, in early-stage development. 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 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.
The Medicines Company
Phone: (973) 290-6000