MONTVALE, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) announced today that its Barr Laboratories subsidiary has
signed a Settlement Agreement and a License Agreement with Boehringer
Ingelheim to resolve the patent litigation involving Boehringer Ingelheim's
Mirapex(R) product. Separately, Barr Laboratories entered into a Settlement
Agreement and a Supply Agreement to resolve the patent litigation regarding
Boehringer Ingelheim's Aggrenox(R) product and Duramed Pharmaceuticals, a
subsidiary of Barr Pharmaceuticals, entered into a Co-Promotion Agreement
with Boehringer Ingelheim relating to Aggrenox(R).
"The agreements announced today equitably resolve our patent litigation
regarding these two products in a way that benefits consumers and Barr's
shareholders," said Bruce L. Downey, Barr's Chairman and Chief Executive
Officer. "In addition, the co-promotion agreement creates significant
opportunities for both Barr and Boehringer Ingelheim, adding a new product
to Duramed's promotional portfolio and providing Boehringer Ingelheim with
unique access to physicians in the women's health care area, through the
Duramed sales force."
Mirapex(R) Settlement Agreement and License Agreement
Under these agreements, Barr Laboratories is permitted to launch its
generic version of Mirapex commencing no later than January 1, 2010,
approximately 10 months earlier than the expiration of the Boehringer
Ingelheim patent at issue in the patent challenge litigation. Upon launch,
Barr would pay Boehringer Ingelheim an undisclosed royalty amount.
Aggrenox(R) Settlement Agreement and Supply Agreement
Under these agreements, Barr Laboratories is permitted to launch an
authorized generic version of Aggrenox(R) commencing no later than July 1,
2015, approximately 18 months earlier than the last-to-expire Boehringer
Ingelheim patent listed in the U.S. Food and Drug Administration's (FDA's)
Orange Book. Upon launch, Barr would pay Boehringer Ingelheim an
undisclosed royalty amount.
Aggrenox(R) Co-Promotion Agreement
Under this agreement, Duramed Pharmaceuticals is required to co-promote
Aggrenox to obstetricians, gynecologists and other practitioners with a
focus on women's healthcare in the United States using its Specialty Sales
Force. Under the terms of the agreement, Boehringer Ingelheim will train
the 93- person Duramed Specialty Sales Force, which will begin promoting
Aggrenox in March 2009. Under terms of the agreement, Boehringer Ingelheim
will pay Duramed undisclosed royalties based on net sales of Aggrenox.
The settlements and the related agreements are conditional upon entry
of a proposed order dismissing the underlying litigation in the respective
patent challenge cases.
Mirapex (pramipexole dihydrochloride) had annualized sales of
approximately $389 million for the twelve months ended May 2008, based on
IMS sales data.
Aggrenox (aspirin/extended-release dipyridamole) had annualized sales
of approximately $331 million for the twelve months ended May 2008, based
on IMS sales data.
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 with Boron Acquisition Corp., a wholly-owned subsidiary of Teva
Pharmaceutical Industries Ltd. (the "merger") 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, the Company will prepare a
proxy statement to be filed with the SEC. When completed, a definitive
proxy statement and a form of proxy will be mailed to the stockholders of
the Company. Before making any voting decision, the Company's stockholders
are urged to read the proxy statement regarding the merger carefully and in
its entirety because it will contain important information about the
proposed merger. The Company's stockholders will be able to obtain, without
charge, a copy of the proxy statement (when available) and other relevant
documents filed with the SEC from the SEC's website at http://www.sec.gov.
The Company's stockholders will also be able to obtain, without charge, a
copy of the proxy statement and other relevant documents (when available)
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, when
filed with the SEC.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
http://www.prnewswire.com/comp/089750.html /
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, Carol.Cox@barrlabs.com
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