MONTVALE, N.J., Feb. 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories,
Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax(R)
(Alendronate Sodium) Tablets, 70 mg after receiving final approval from the
U.S. Food and Drug Administration (FDA).
The FDA approved the Company's application on February 6, 2008,
following the expiration of pediatric exclusivity associated with the
earliest to expire of the patents listed with the FDA for Fosamax, 70 mg
tablets. Barr obtained favorable resolutions with regard to the other
patents listed for this product. Barr is entitled to share 180 days of
marketing exclusivity for its 70 mg Alendronate Sodium product. This
exclusivity bars the entry of competition for this product against generic
competitors, other than an authorized generic and another company with
which Barr shares exclusivity.
"Barr is pleased to be able to provide people suffering from
osteoporosis and Paget's disease with a more affordable generic
alternative," said Bruce L. Downey, Barr's Chairman and Chief Executive
Officer. "This is particularly critical as our elderly population increases
and seeks to maintain their quality of life in their advanced years."
Barr's Alendronate Sodium product is indicated for the treatment and
prevention of osteoporosis in postmenopausal women; for the treatment to
increase bone mass in men with osteoporosis; for the treatment of
glucocorticoid-induced osteoporosis in men and women receiving
glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of
prednisone and who have low bone mineral density; and for the treatment of
Paget's disease of bone in men and women.
Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion
in the United States, based on IMS sales data for the 12 months ending
November 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. 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; 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/gh/cnoc/comp/089750.html/
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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