- Barr Plans to Launch Generic Yasmin(R) on or before July 1, 2008
- Barr Plans to Launch Generic Yaz(R) on or before July 1, 2011
- Bayer to Continue Appeal of Yasmin(R) District Court Decision
MONTVALE, N.J., June 24 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that its wholly owned subsidiary, Barr
Laboratories, Inc. has entered into supply and licensing agreements with Bayer
for generic versions of Bayer's Yasmin(R) (drospirenone and ethinyl estradiol)
and Yaz(R) (drospirenone and ethinyl estradiol) oral contraceptive products.
Under terms of these agreements, Bayer will supply Barr with the generic
products for launch prior to the expiration of the patents protecting these
products and Barr will have sole responsibility to market, sell and distribute
the products in the U.S. under the Barr Laboratories label.
“We are very pleased to have reached these licensing agreements with Bayer
that permit Barr to launch our authorized generic versions of Yasmin and Yaz
to patients years before the patents protecting these products are due to
expire,” said Bruce L. Downey, Barr's Chairman and CEO. Although Bayer will
continue to appeal the March 3, 2008 decision by U.S. District Court for the
District of New Jersey that found the Yasmin patent invalid, these agreements
ensure that we will be able to continue selling our generic versions of Yasmin
and Yaz regardless of the outcome of that appeal.
Yasmin Supply and Licensing Agreement
Under the Yasmin agreement, Bayer will supply Barr with an authorized
generic version of Yasmin for launch on or before July 1, 2008 -- several
years earlier than the last-to-expire Bayer patent listed in the U.S. Food and
Drug Administration's Orange Book. Barr will pay Bayer an undisclosed supply
price for the product. Barr also has an additional undisclosed profit split
with Gedeon Richter, its development partner for generic Yasmin.
Yaz Supply and Licensing Agreement
Under a separate agreement, Bayer will supply Barr with an authorized
generic version of Yaz for launch on July 1, 2011, or earlier in certain
circumstances. Barr will pay Bayer an undisclosed supply price for the
product. Barr also has an additional undisclosed profit split with Gedeon
Richter, its development partner for generic Yaz.
Ongoing Yasmin Patent Litigation
On March 3, 2008 Barr announced that the U.S. District Court for the
District of New Jersey had ruled in favor of its subsidiary, Barr
Laboratories, Inc., in the challenge of the patent listed by Bayer's Yasmin
product. On April 1, 2008, Bayer appealed this ruling to the U.S. Court of
Appeals for the Federal Circuit. Under the licensing agreements, Barr will
continue to be able to sell generic versions of Yasmin and Yaz regardless of
the outcome of Bayer's appeal.
Yasmin provides an oral contraceptive regimen consisting of 21 active
tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol
and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in
women who elect to use an oral contraceptive. The product had annual U.S.
sales of approximately $575 million for the twelve months ended April 2008,
based on IMS sales data.
Yaz provides an oral contraceptive regimen consisting of 24 active tablets
each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4
inert tablets. Yaz is indicated for the prevention of pregnancy in women who
elect to use an oral contraceptive. The product had annual U.S. sales of
approximately $384 million for the twelve months ended April 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 www.barrlabs.com
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 and our forecasts; 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 and implementing our new SAP 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; 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; and other risks detailed in our SEC filings,
including in our Annual Report on Form 10-K for the year ended December 31,
2007.
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.
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http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate
information are also available on Barr's website (www.barrlabs.com). For
complete indications, warnings and contraindications, contact Barr
Laboratories' Product Information Department at 1-800-Barr Lab. All trademarks
referenced herein are the property of their respective owners.
CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
+1-201-930-3720
Carol.Cox@barrlabs.com
