Healthcare Industry News: estradiol
News Release - June 24, 2008
Barr and Bayer Sign Supply and Licensing Agreements for Launch of Generic Yasmin(R) and Yaz(R) Oral ContraceptivesBarr 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 (HSMN NewsFeed) -- 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® (drospirenone and ethinyl estradiol) and Yaz® (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
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
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