Barr Confirms Patent Challenge of Oxytrol(R)
24 Octubre 2008 - 11:46AM
PR Newswire (US)
MONTVALE, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE:BRL) today confirmed that its
subsidiary, Barr Laboratories, Inc., has initiated a challenge of
the patents listed by Watson Laboratories, Inc. in connection with
its Oxytrol(R) (oxybutynin transdermal system). The Company
believes it is the first to file an Abbreviated New Drug
Application (ANDA) with the U.S. Food & Drug Administration
(FDA) for the product. Barr filed its ANDA containing a paragraph
IV certification for a generic version of Oxytrol with the 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) and patent holder. On October 23, 2008, Watson 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. Oxytrol (oxybutynin transdermal system) had
annual sales of approximately $39 million in the U.S., based on IMS
sales data ending August 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; 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, 201-930-3720, Web Site:
http://www.barrlabs.com/ Company News On-Call:
http://www.prnewswire.com/comp/089750.html
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