MONTVALE, N.J., May 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories,
Inc., has initiated a challenge of the patents listed by AstraZeneca LP in
connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg.
The Company believes that it is the first to file an Abbreviated New Drug
Application (ANDA) containing a paragraph IV certification for Entocort EC.
Barr filed its ANDA containing a paragraph IV certification for a
generic Entocort EC product with the U.S. Food & Drug Administration (FDA)
in January 2008. Following receipt of the notice from the FDA that Barr's
ANDA had been accepted for filing, Barr notified the New Drug Application
(NDA) and patent holder.
On May 22, 2008, AstraZeneca filed suit in the U.S. District Court for
the District of Delaware to prevent Barr from proceeding with the
commercialization of its product. This action formally initiates the patent
challenge process under the Hatch-Waxman Act.
Entocort EC (budesonide) had annual sales of approximately $125 million
in the U.S., based on IMS sales data for the twelve-month period ending
March 2008.
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 120 generic and
27 proprietary products in the U.S. and approximately 1,025 products
globally outside of the U.S. For more information, visit http://www.barrlabs.com.
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 and our forecasts; 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 Annual Report on Form 10-K for the year ended
December 31, 2007.
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 for Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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