MONTVALE, N.J., Jan. 2 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories,
Inc., has initiated a challenge of the patent listed by Encysive
Pharmaceuticals in connection with its Argatroban(R) Injection (argatroban)
100mg/mL, 2.5mL vial. The Company believes that it is the first to file an
Abbreviated New Drug Application (ANDA) containing a paragraph IV
certification for Argatroban. Encysive Pharmaceuticals, Inc. is the holder
of the New Drug Application (NDA) for Argatroban, which is manufactured for
the U.S. market by GlaxoSmithKline for Encysive.
Barr filed its ANDA containing a paragraph IV certification for a
generic Argatroban product with the U.S. Food & Drug Administration (FDA)
in September 2007, and received notification of the application's
acceptance for filing in November 2007. Following receipt of the notice
from the FDA, Barr notified the New Drug Application (NDA) holder and
patent owner.
On December 28, 2007, Encysive Pharmaceuticals Inc. announced that
Mitsubishi Chemical Corporation, the patent holder for Argatroban
injections, Mitsubishi Tanabe Pharma Corporation, Encysive and
GlaxoSmithKline had filed suit in the U.S. District Court for the Southern
District of New York to prevent Barr from proceeding with the
commercialization of its product. This action formally initiates the patent
challenge process under the Hatch-Waxman Act.
Argatroban(R) Injection (argatroban) 100mg/mL, 2.5mL vial is indicated
as an anticoagulant for prophylaxis or treatment of thrombosis in patients
with heparin-induced thrombocytopenia, and as an anticoagulant in patients
with or at risk for heparin-induced thrombocytopenia undergoing
percutaneous coronary intervention (PCI). The product had sales of
approximately $111 million in the U.S., based on IMS sales data for the
twelve months ended October 2007.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 115 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements can be
identified by their use of words such as "expects," "plans," "projects,"
"will," "may," "anticipates," "believes," "should," "intends," "estimates"
and other words of similar meaning. Because such statements inherently
involve risks and uncertainties that cannot be predicted or quantified,
actual results may differ materially from those expressed or implied by
such forward-looking statements depending upon a number of factors
affecting the Company's business. These factors include, among others: the
difficulty in predicting the timing and outcome of legal proceedings,
including patent-related matters such as patent challenge settlements and
patent infringement cases; the outcome of litigation arising from
challenging the validity or non- infringement of patents covering our
products; the difficulty of predicting the timing of FDA approvals; court
and FDA decisions on exclusivity periods; the ability of competitors to
extend exclusivity periods for their products; our ability to complete
product development activities in the timeframes and for the costs we
expect; market and customer acceptance and demand for our pharmaceutical
products; our dependence on revenues from significant customers;
reimbursement policies of third party payors; our dependence on revenues
from significant products; the use of estimates in the preparation of our
financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to
launch new products in the timeframes we expect; the availability of raw
materials; the availability of any product we purchase and sell as a
distributor; the regulatory environment in the markets where we operate;
our exposure to product liability and other lawsuits and contingencies; the
increasing cost of insurance and the availability of product liability
insurance coverage; our timely and successful completion of strategic
initiatives, including integrating companies (such as PLIVA d.d.) and
products we acquire and implementing our new SAP enterprise resource
planning system; fluctuations in operating results, including the effects
on such results from spending for research and development, sales and
marketing activities and patent challenge activities; the inherent
uncertainty associated with financial projections; our expansion into
international markets through our PLIVA acquisition, and the resulting
currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly
increased debt obligations as a result of the PLIVA acquisition; changes in
generally accepted accounting principles; and other risks detailed in our
SEC filings, including in our Transition Report on Form 10-K/T for the six
months ended December 31, 2006.
The forward-looking statements contained in this press release speak
only as of the date the statement was made. The Company undertakes no
obligation (nor does it intend) to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise, except to the extent required under applicable law.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
http://www.prnewswire.com/comp/089750.html/
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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