POMONA, N.Y., Nov. 12 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today confirmed that it has filed an Abbreviated New Drug
Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Eli
Lily's Evista(R) 60mg Tablet (raloxifene hydrochloride). Barr's ANDA alleges
that the Orange Book listed patents for Evista are invalid or would not be
infringed by Barr's ANDA Product. Eli Lilly disclosed in its SEC form 10-Q
that Barr had filed an ANDA challenging the patents and that Lilly intends to
defend the patents.
Evista(R) is indicated for the treatment and prevention of osteoporosis in
postmenopausal women. Evista has current annual sales of approximately
$635 million.
Barr filed an ANDA for Raloxifene Hydrochloride 60 mg tablets with the
U.S. Food and Drug Administration (FDA) in June 2002, and notified Lilly of
the application's acceptance for filing in October 2002.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary
pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this
report contain information that is not historical, these statements are
essentially forward-looking. These statements are subject to risks and
uncertainties that cannot be predicted or quantified and, consequently, actual
results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include: the
difficulty in predicting the timing and outcome of legal proceedings,
including those relating to patent challenge settlements and patent
infringement cases; the difficulty of predicting the timing of U.S. Food and
Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity
periods; competitor's ability to extend exclusivity periods past initial
patent terms; market and customer acceptance and demand for our pharmaceutical
products; reimbursement policies of third party payors; our ability to market
our proprietary products; the successful integration of acquired businesses
and products into our operations; the use of estimates in the preparation of
our financial statements; the impact of competitive products and pricing; the
ability to develop and launch new products on a timely basis; the availability
of raw materials; availability of product we purchase and sell as a
distributor; the regulatory environment; fluctuations in operating results,
including spending for research and development, sales and marketing and
patent challenge activities; and, other risks detailed from time-to-time in
our filings with the Securities and Exchange Commission, or SEC.
Forward-looking statements can be identified by the use of words such as
"expects," "plans," "will," "believes," "estimates," "intends," "may" and
other words of similar meaning. Should known or unknown risks or uncertainties
materialize, or should our assumptions prove inaccurate, actual results could
vary materially from those anticipated. The Company undertakes no obligation
to publicly update any forward-looking statements.
SOURCE Barr Laboratories, Inc.
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Related links:
http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox of Barr Laboratories, Inc.,
+1-845-348-6808, or ccox@barrlabs.com
NOTE TO EDITORS: Barr Laboratories, Inc. news releases are
available free of charge through PR Newswire's News On-Call site
at http://www.prnewswire.com/corp/089750.html. For complete
indications, warnings and contraindications, contact Barr
Laboratories' Professional Services Department at 1-800-Barr Lab.
Evista(R) is a registered trademark of Eli Lilly.
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