MONTVALE, N.J., March 12 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary,
PLIVA - Lachema a.s., has received final approval from the U.S. Food and
Drug Administration (FDA) for its generic version of Bristol-Myers Squibb
Company's Taxol(R) (paclitaxel) Injection USP, 6mg/mL, packaged in
100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials. The Company plans to
launch its product shortly. Barr's U.S. generic injectable portfolio now
totals seven products.
Barr's product will compete in a market that had annual sales of
approximately $98 million for the twelve months ended January 2008, based
on IMS sales data.
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.
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; 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 (including PLIVA d.d.) and products we acquire and implementing
our new 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 the completion of the
PLIVA acquisition, and the resulting currency, governmental, regulatory and
other risks involved with international operations; our ability to service
our increased debt obligations as a result of the PLIVA acquisition;
changes in generally accepted accounting principles; and other risks
detailed from time-to-time in our filings with the Securities and Exchange
Commission, including in our Annual Report on Form 10-K for the calendar
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 of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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