PARSIPPANY, NJ, Sep 04, 2009 (MARKETWIRE via COMTEX) -- 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(R) (bivalirudin) in the
United States and other countries for use in patients undergoing
coronary angioplasty, and Cleviprex(R) (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.
Contact:
Robyn Brown
The Medicines Company
Phone: (973) 290-6000
investor.relations@themedco.com
SOURCE: The Medicines Company
mailto:investor.relations@themedco.com
