Barr Confirms Patent Challenge of Amrix(R) Extended-Release Capsules, 15mg & 30mg
November 26 2008 - 12:20PM
PR Newswire (US)
MONTVALE, N.J., Nov. 26 /PRNewswire/ -- Barr Pharmaceuticals, Inc.
(NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories,
Inc., has initiated a challenge of the patent listed by Anesta in
connection with its Amrix(R) (cyclobenzaprine hydrochloride)
extended-release capsules, 15mg and 30mg. Barr filed its
Abbreviated New Drug Application (ANDA) containing a paragraph IV
certification for a generic version of Amrix with the U.S. Food
& Drug Administration (FDA), and following receipt of the
notice from the FDA that Barr's ANDA had been accepted for filing,
Barr notified the New Drug Application (NDA) holder and patent
owner. On November 26, 2008, Eurand, Inc., Cephalon, Inc., and
Anesta AG filed suit in the U.S. District Court for the District of
Delaware to prevent Barr from proceeding with the commercialization
of its product. This action formally initiates the patent challenge
process under the Hatch-Waxman Act. Amrix (cyclobenzaprine
hydrochloride) extended-release capsules, 15mg and 30mg had annual
sales of approximately $53 million in the U.S., based on IMS sales
data ending September 2008. 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; the occurrence of any event, change or other circumstance
that could give rise to the termination of the merger agreement;
the inability to complete the merger due to the failure to satisfy
customary conditions to the completion of the merger, including the
failure to receive required regulatory approvals and the 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
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. DATASOURCE:
Barr Pharmaceuticals, Inc. CONTACT: Carol A. Cox, +1-201-930-3720,
, for Barr Pharmaceuticals Web Site: http://www.barrlabs.com/
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