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.