Barr Announces Agreements on Nasacort(R) AQ, Allegra(R) D-12 and Allegra(R) Patent Challenges
November 19 2008 - 1:30AM
PR Newswire (US)
- Settlement and License Agreement for Generic Versions of
Nasacort(R) AQ 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:PRGO) 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 http://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. DATASOURCE: Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox, Barr Pharmaceuticals, Inc., +1-201-930-3720,
Web Site: http://www.barrlabs.com/
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