- 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 http://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.
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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