- Settlement and License Agreement for Generic Versions of Nasacort(R) AQ
- Settlement and License Agreement with Aventis and Albany Molecular
Research, Inc. for Generic Versions of Allegra(R) D-12
- Settlement Agreement with Aventis and Albany Molecular Research, Inc.
Related to Generic Versions of Allegra(R) Tablets
MONTVALE, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc.
has entered into separate settlement agreements related to ongoing patent
challenges for Nasacort(R) AQ (triamcinolone acetonide) nasal spray,
Allegra(R) D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine
hydrochloride 120mg) extended-release tablets, and Allegra(R) (fexofenadine)
30mg, 60mg and 180mg tablets. As part of the settlements, the parties have
agreed to dismiss the underlying U.S. litigation related to the three patent
challenge cases.
"We are very pleased to have reached these three separate settlements,
bringing to a close the outstanding patent challenges in a manner that results
in the date certain launch of a generic version of Nasacort(R) AQ years prior
to the expiration of the applicable patents, and the launch of a generic
version of Allegra(R) D-12 in November of 2009," said Bruce L. Downey, Barr's
Chairman and CEO. "The agreement related to Allegra(R) resolves any ongoing
uncertainty about the possible impact of ongoing litigation for Barr and Teva
related to the launch of generic versions of Allegra(R) 30mg, 60mg and 180mg
tablets in September 2005. We believe that these agreements represent a
pro-consumer resolution to this ongoing litigation."
The individual agreements are subject to review by the Federal Trade
Commission (FTC) and state Attorneys General under an outstanding consent
decree and settlement entered into by a Sanofi-Aventis predecessor company,
and will not become effective for approximately 45 days. The parties may
prevent the agreements from becoming effective or terminate the agreements if
the FTC or state attorney generals raise objections that cannot be resolved by
the parties.
Nasacort(R) AQ Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with
Sanofi-Aventis US LLC and Aventis Pharmaceuticals Inc. to resolve the patent
litigation involving Barr's Triamcinolone Acetonide nasal spray, the generic
versions of Aventis Pharmaceuticals' Nasacort(R) AQ. Under this agreement,
Barr will have a license to launch a generic version of Nasacort(R) AQ as
early as June 15, 2011 if Barr's ANDA is approved on that date, or earlier in
certain circumstances. In addition, even if the Barr's ANDA is not approved,
Barr will have a license to launch a generic version of Nasacort(R) AQ,
supplied by Sanofi-Aventis, on December 1, 2013, or earlier, in certain
circumstances. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Barr developed its Triamcinolone Acetonide Nasal Spray product with
Perrigo Company (NASDAQ: PRGO; TASE) and, under the terms of a separate
agreement, will share in the costs and potential benefits with Perrigo.
Allegra(R) D-12 Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with
Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle
the outstanding patent litigation involving Barr's generic version of Aventis
Pharmaceuticals' Allegra(R) D-12 Hour (fexofenadine hydrochloride 60mg and
pseudoephedrine hydrochloride 120mg) extended-release tablets. Under the terms
of this agreement, Barr is permitted to launch a generic version of Aventis
Pharmaceuticals' Allegra(R) D-12 extended-release tablets on November 1, 2009,
and Barr has the right to acquire product from Sanofi-Aventis for commercial
launch. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Allegra(R) Tablets Settlement Agreement
Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. have signed an
agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research,
Inc. to settle the outstanding patent litigation involving Barr's and Teva's
generic version of Aventis Pharmaceuticals' Allegra(R) (fexofenadine) 30mg,
60mg and 180mg tablets, which Teva launched in September 2005 under a separate
agreement with Barr. Under the terms of this agreement, Barr and Teva will
each pay Aventis approximately $30 million to settle the patent litigation
with Aventis regarding Teva's fexofenadine 30mg, 60mg and 180mg tablets
product. In addition, Barr and Teva will pay Aventis a royalty on future U.S.
sales.
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 120 generic and 27
proprietary products in the U.S. and approximately 1,025 products globally
outside of the U.S. For more information, visit www.barrlabs.com.
Forward-Looking Statements
This communication contains "forward-looking statements" which represent
the current expectations and beliefs of management of Barr Pharmaceuticals,
Inc. (the "Company") concerning the proposed merger of the Company (the
"merger") with Boron Acquisition Corp., a wholly-owned subsidiary of Teva
Pharmaceutical Industries Ltd. (the "Teva") and other future events and their
potential effects on the Company. The statements, analyses, and other
information contained herein relating to the proposed merger, as well as other
statements including words such as "anticipate," "believe," "plan,"
"estimate," "expect," "intend," "will," "should," "may," and other similar
expressions, are "forward-looking statements" under the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are not
guarantees of future results and are subject to certain risks and
uncertainties that could cause actual results to differ materially from those
anticipated. Those factors include, without limitation: 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 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; 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; 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; the reactions of the Company's customers and
suppliers to the merger; and diversion of management time on merger-related
issues. These and other applicable risks, cautionary statements and factors
that could cause actual results to differ from the Company's forward-looking
statements are included in the Company's filings with the U.S. Securities and
Exchange Commission ("SEC"), specifically as described in the Company's annual
report on Form 10-K for the fiscal year ended December 31, 2007. The Company
undertakes no obligation to update or revise any forward-looking statements to
reflect subsequent events or circumstances.
Important Legal Information
In connection with the proposed merger, Teva has filed a registration
statement on Form F-4 containing a proxy statement/prospectus for shareholders
of the Company with the SEC, and the Company and Teva may be filing other
documents regarding the proposed transaction with the SEC as well. Before
making any voting or investment decision, investors are urged to read the
proxy statement/prospectus regarding the proposed transaction, as well as the
other documents referred to in the proxy statement/prospectus carefully in
their entirety when they become available because they will contain important
information about the proposed transaction. The definitive proxy
statement/prospectus has been mailed to the Company's shareholders.
Shareholders may obtain a free copy of the proxy statement/prospectus, as well
as other filings containing information about Teva and the Company, without
charge, at the SEC's Internet site (http://www.sec.gov). Copies of the proxy
statement/prospectus and the filings with the SEC that are incorporated by
reference in the proxy statement/prospectus can also be obtained, without
charge, by directing a request by mail or telephone to Barr Pharmaceuticals,
Inc., 225 Summit Avenue, Montvale, NJ, 07645 - Attention: Investor Relations.
The Company and its directors and officers may be deemed to be
participants in the solicitation of proxies from the Company's stockholders
with respect to the proposed merger. Information about the Company's directors
and executive officers and their ownership of the Company's common stock is
set forth in the Company's annual report on Form 10-K for the fiscal year
ended December 31, 2007 and the Company's proxy statement for the Company's
2008 Annual Meeting of Stockholders. Stockholders may obtain additional
information regarding the interests of the Company and its directors and
executive officers in the merger, which may be different than those of the
Company's stockholders generally, by reading the proxy statement and other
relevant documents regarding the proposed merger filed with the SEC.
NOTE TO EDITORS: Barr Pharmaceuticals, Inc. news releases are available
free of charge through PR Newswire's News On-Call site at
http://www.prnewswire.com/comp/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. All trademarks
referenced herein are the property of their respective owners.
CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
+1-201-930-3720
ccox@barrlabs.com
