Barr Says Ciprofloxacin Patent Challenge Creates Significant Consumer Benefit; Says Wall St. Journal Story Contains No New Information

Apr 02, 2001, 01:00 ET from Barr Laboratories, Inc.

    POMONA, N.Y., April 2 /PRNewswire/ -- Barr Laboratories, Inc. (NYSE:   BRL)
 today said that there is no new information contained in a story in the Wall
 Street Journal regarding the Company's settlement of its CIPRO(R)
 (ciprofloxacin hydrochloride) patent challenge.  Barr said that it continues
 to provide information to the Federal Trade Commission as requested.  The
 Company reiterated that the decision to settle the CIPRO challenge was
 pro-consumer and pro-competitive and Barr continues to work with the FTC to
 help them understand the benefits of this settlement.
     "Our decision to settle the patent challenge assures that consumers have
 access to a more affordable generic ciprofloxacin at least six months ahead of
 the patent expiry," said Bruce L. Downey, Barr's Chairman, and CEO.  "There
 was no assurance that Barr's patent challenge could have succeeded in the
 courts. This settlement represents a substantial savings on a product with
 current annual brand sales in excess of $900 million."  The patents protecting
 ciprofloxacin run through December 2003.
     "It is also important to note that our settlement of the ciprofloxacin
 patent challenge does not preclude any other pharmaceutical company from
 filing its own challenge to the product," Downey continued.  "In fact, another
 company, which had challenged the patents protecting ciprofloxacin, has lost
 at the District Court level."
     In January 1997, Barr and Bayer AG settled the pending litigation
 regarding Bayer's patents protecting CIPRO.  Under terms of the settlement,
 the parties entered into a Supply Agreement under which Bayer has the option
 to make payments to Barr or to provide Barr with quantities of ciprofloxacin
 that Barr could market pursuant to a license from Bayer.  Also as part of the
 settlement, Barr has the unconditional right to begin selling generic
 ciprofloxacin no later than six months prior to the expiration of the patent.
     The patent challenge process is a fundamental component of the 1984 Drug
 Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) that is
 designed to encourage generic companies to develop versions of brand products
 and challenge suspect patents years ahead of patent expiry.  The end result of
 a successful challenge is more affordable medicine for consumers, who would
 have paid higher prices for products improperly protected from marketplace
 competition by invalid patents.
     Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
 the development, manufacture and marketing of generic and proprietary
 pharmaceuticals.
 
     To the extent that any statements made in this release 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 timing and outcome of legal
 proceedings; the timing and outcome of discussions with the Securities and
 Exchange Commission (SEC); the difficulty of predicting the timing of U.S.
 Food and Drug Administration ("FDA") approvals; the difficulty in predicting
 the timing and outcome of FDA decisions on patent challenges; market and
 customer acceptance and demand for new pharmaceutical products; ability to
 market proprietary products; the impact of competitive products and pricing;
 timing and success of product development and launch; availability of raw
 materials; the regulatory environment; fluctuations in operating results; and,
 other risks detailed from time-to-time in the Company's filings with the
 Securities and Exchange Commission. 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.
    POMONA, N.Y., April 2 /PRNewswire/ -- Barr Laboratories, Inc. (NYSE:   BRL)
 today said that there is no new information contained in a story in the Wall
 Street Journal regarding the Company's settlement of its CIPRO(R)
 (ciprofloxacin hydrochloride) patent challenge.  Barr said that it continues
 to provide information to the Federal Trade Commission as requested.  The
 Company reiterated that the decision to settle the CIPRO challenge was
 pro-consumer and pro-competitive and Barr continues to work with the FTC to
 help them understand the benefits of this settlement.
     "Our decision to settle the patent challenge assures that consumers have
 access to a more affordable generic ciprofloxacin at least six months ahead of
 the patent expiry," said Bruce L. Downey, Barr's Chairman, and CEO.  "There
 was no assurance that Barr's patent challenge could have succeeded in the
 courts. This settlement represents a substantial savings on a product with
 current annual brand sales in excess of $900 million."  The patents protecting
 ciprofloxacin run through December 2003.
     "It is also important to note that our settlement of the ciprofloxacin
 patent challenge does not preclude any other pharmaceutical company from
 filing its own challenge to the product," Downey continued.  "In fact, another
 company, which had challenged the patents protecting ciprofloxacin, has lost
 at the District Court level."
     In January 1997, Barr and Bayer AG settled the pending litigation
 regarding Bayer's patents protecting CIPRO.  Under terms of the settlement,
 the parties entered into a Supply Agreement under which Bayer has the option
 to make payments to Barr or to provide Barr with quantities of ciprofloxacin
 that Barr could market pursuant to a license from Bayer.  Also as part of the
 settlement, Barr has the unconditional right to begin selling generic
 ciprofloxacin no later than six months prior to the expiration of the patent.
     The patent challenge process is a fundamental component of the 1984 Drug
 Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) that is
 designed to encourage generic companies to develop versions of brand products
 and challenge suspect patents years ahead of patent expiry.  The end result of
 a successful challenge is more affordable medicine for consumers, who would
 have paid higher prices for products improperly protected from marketplace
 competition by invalid patents.
     Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
 the development, manufacture and marketing of generic and proprietary
 pharmaceuticals.
 
     To the extent that any statements made in this release 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 timing and outcome of legal
 proceedings; the timing and outcome of discussions with the Securities and
 Exchange Commission (SEC); the difficulty of predicting the timing of U.S.
 Food and Drug Administration ("FDA") approvals; the difficulty in predicting
 the timing and outcome of FDA decisions on patent challenges; market and
 customer acceptance and demand for new pharmaceutical products; ability to
 market proprietary products; the impact of competitive products and pricing;
 timing and success of product development and launch; availability of raw
 materials; the regulatory environment; fluctuations in operating results; and,
 other risks detailed from time-to-time in the Company's filings with the
 Securities and Exchange Commission. 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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