WOODCLIFF LAKE, N.J., Aug 15, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr
Laboratories, Inc., has initiated a challenge of the patent listed by Warner
Chilcott (US), Inc. in connection with Warner Chilcott's Femcon(R) FE
(norethindrone and ethinyl estradiol) chewable oral contraceptive. The Company
believes that it is the first to file an Abbreviated New Drug Application
(ANDA) containing a paragraph IV certification for Femcon FE.
Barr filed its ANDA containing a paragraph IV certification for a generic
Femcon FE product with the U.S. Food & Drug Administration (FDA) in April
2007, and received notification of the application's acceptance for filing in
August 2007. Following receipt of the notice from the FDA, Barr notified
Warner Chilcott, the New Drug Application (NDA) holder and patent owner.
On August 15, 2007, Warner Chilcott announced it had received a Paragraph
IV certification notice for a generic version of its Femcon FE oral
contraceptive from Barr Laboratories, Inc. Warner Chilcott indicated that it
is evaluating the paragraph IV certification notice.
Femcon FE is indicated for the prevention of pregnancy in women who elect
to use this product as a method of contraceptive. The product had sales of
approximately $16 million since it was launched in the U.S. in December 2006,
based on IMS sales data ending June 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.
Carol A. Cox
Barr Pharmaceuticals, Inc.
+1-201-930-3720
ccox@barrlabs.com
