WOODCLIFF LAKE, N.J., Sept. 25 /PRNewswire-FirstCall/ -- Barr
Laboratories, Inc. (NYSE: BRL) today announced that it has signed an amended
supply agreement with Bayer Pharmaceuticals Corporation (Bayer) that will
enable Barr to continue to distribute its alternative brand of ciprofloxacin
tablets and oral suspension products during any period of pediatric
exclusivity that may be granted to Bayer for its Cipro(R) (Ciprofloxacin HCl)
antibiotic. Bayer has previously indicated that it expects to receive
pediatric exclusivity for its Cipro product under rules established by the FDA
for companies who conduct requested studies on safety and efficacy in
pediatric patients. Bayer's pediatric exclusivity, if granted, would expire
on June 9, 2004.
In June 2003, Barr began marketing Ciprofloxacin Hydrochloride, pursuant
to a license that resulted from a 1997 settlement of a patent challenge.
Barr's distributed ciprofloxacin product competes in a market that had annual
sales of approximately $1.1 billion for the twelve months ending July 2003.
"We are pleased to have reached an agreement with Bayer that allows Barr
to continue to provide an alternative brand of ciprofloxacin products during
any period of pediatric exclusivity that may be granted to Bayer," said Bruce
L. Downey, Barr's Chairman and CEO.
In January 1997 Barr and Bayer signed a non-exclusive distribution
agreement that provided Barr with the right to begin distributing
ciprofloxacin products six months prior to the expiration of the patent
protecting Bayer's Cipro in December 2003. Currently Barr purchases
ciprofloxacin products that are manufactured under Bayer's New Drug
Application (NDA) for Cipro directly from Bayer and markets the ciprofloxacin
products under its own label.
Ciprofloxacin is an antibiotic used to treat various types of infections,
including urinary tract infections.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary
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; the ability of competitors 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 any 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," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar meaning. 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 statement. The Company undertakes no
obligation to publicly update any forward-looking statements.
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. Barr news releases and corporate
information are also available on Barr's website (www.barrlabs.com). For
complete indications, warnings and contraindications, contact Barr
Laboratories' Product Information Department at 1-800-Barr Lab. Cipro(R) is a
registered trademark of Bayer Pharmaceuticals Corporation.
Carol A. Cox
Barr Laboratories, Inc.