Barr, Organon and Savient Finalize Mircette(R) Settlement and Acquisition
December 02 2005 - 2:30AM
PR Newswire (US)
WOODCLIFF LAKE, N.J., Dec. 2 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. ("Barr") (NYSE:BRL), Organon USA Inc. and
Organon (Ireland) Ltd. ("Organon"), business units of Akzo Nobel NV
(NASDAQ:AKZOY), and Savient Pharmaceuticals, Inc. ("Savient")
(NASDAQ:SVNTE) today announced that Barr and its subsidiaries have
finalized an agreement to acquire the exclusive rights to Organon's
Mircette(R) (Desogestrel/Ethinyl Estradiol) oral contraceptive
product. The agreement terminates the ongoing patent litigation
regarding Barr's generic version of Mircette(R), which the Company
markets under the trade name Kariva(R). On June 30, 2005, Barr and
Organon filed the Letter of Intent with the Federal Trade
Commission ("FTC") pursuant to the Hart Scott Rodino Antitrust
Improvements Act. On August 1, 2005, the FTC issued a second
request for information regarding the proposed transaction. On
November 16, 2005, the FTC's review period, which had been
voluntarily extended by Barr and Organon, expired without the FTC
having initiated any action to stop the acquisition. Barr's Duramed
Pharmaceuticals subsidiary will promote Mircette(R) to female
healthcare practitioners utilizing its recently expanded Specialty
Sales Force. Mircette(R) is indicated for the prevention of
pregnancy in women who elect to use oral contraceptives as a method
of contraception. Mircette(R) is available in a 28-tablet regimen
that represents a combination of desogestrel/ethinyl estradiol and
ethinyl estradiol. About Barr Barr Pharmaceuticals, Inc. is a
holding company, whose principal subsidiaries, Barr Laboratories,
Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and
market generic and proprietary pharmaceuticals. A
research-intensive pharmaceutical company, Barr currently
manufactures and markets more than 100 different dosage forms and
strengths of over 70 different generic pharmaceutical products,
including 22 oral contraceptive products, representing the largest
category of the Company's generic portfolio, and 17 proprietary
pharmaceutical products, largely concentrated in the female
healthcare arena. Forward-Looking Statements Except for the
historical information contained herein, the statements made in
this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking
statements can be identified by their use of words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates" and other words of
similar meaning. Because such statements inherently involve risks
and uncertainties that cannot be predicted or quantified, actual
results may differ materially from those expressed or implied by
such forward-looking statements depending upon a number of factors
affecting the Company's business. These factors include, among
others: 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 outcome of
litigation arising from challenging the validity or
non-infringement of patents covering our products; 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; our ability to complete
product development activities in the timeframes and for the costs
we expect; 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; 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 and products we
acquire and implementing our new enterprise resource planning
system; 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; changes in
generally accepted accounting principles; and other risks detailed
from time-to-time in our filings with the Securities and Exchange
Commission, including in our Annual Report on Form 10-K for the
fiscal year ended June 30, 2004. The forward-looking statements
contained in this press release speak only as of the date the
statement was made. The Company undertakes no obligation (nor does
it intend) to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except to the extent required under applicable law.
DATASOURCE: Barr Pharmaceuticals, Inc. CONTACT: Carol A. Cox of
Barr Pharmaceuticals, Inc., +1-201-930-3720, Web site:
http://www.barrlabs.com/ Company News On-Call:
http://www.prnewswire.com/comp/089750.html
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