Healthcare Industry News: tamoxifen
News Release - June 25, 2007
U.S. Supreme Court Denies Review of Tamoxifen Citrate Antitrust Lawsuits
Decision Ends the Litigation over tamoxifen SettlementWOODCLIFF LAKE, N.J., June 25 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that the United States Supreme Court has denied the plaintiffs' petitions for review of the Second Circuit's decision in Barr's favor in the tamoxifen Citrate antitrust lawsuits. The Court's ruling ends the antitrust litigation over the 1993 settlement of patent litigation between Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., and AstraZenca.
On November 2, 2005, a three-member panel of circuit judges of the Court of Appeals for the Second Circuit affirmed the May 2003 dismissal by U.S. District Judge I. Leo Glasser of all of the plaintiffs' claims against Barr and AstraZeneca in the case. The ruling affirmed that the patent litigation settlement agreement between Barr and AstraZeneca did not violate federal antitrust statutes or the antitrust and/or consumer protection statutes of various states.
"We have always believed that our patent challenge settlement related to tamoxifen Citrate was pro-consumer and pro-competitive, and this has now been definitively confirmed by the courts," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer.
In 1993, as a result of a patent challenge, Barr and AstraZeneca entered into an agreement that resulted in the distribution by Barr of a more affordable version of AstraZeneca's Nolvadex® (tamoxifen Citrate) treatment for breast cancer. That agreement expired in August 2002. AstraZeneca's pediatric exclusivity, which prevented generic competition, expired in February 2003. Barr launched its generic version of tamoxifen Citrate in February 2003. Approximately 30 class action complaints were filed by consumers and/or third party payors in state and federal courts against Barr and AstraZeneca arguing that the settlement insulated Barr and AstraZeneca from generic competition, and resulted in artificially inflated tamoxifen Citrate prices. All complaints were consolidated in the U.S. District Court for the Eastern District of New York. In May 2003, Judge Glasser issued an order in the case dismissing both the state and federal claims. The plaintiffs appealed Judge Glasser's order to U.S. Court of Appeals for the Second Circuit, which affirmed his order on November 2, 2005. On November 30, 2005, plaintiffs petitioned the Court for rehearing and rehearing en banc, which was denied on September 16, 2006. On December 13, 2006, the plaintiffs filed a petition for writ of certiorari with the United States Supreme Court to hear the case. Today, the United States Supreme Court denied that petition, definitively ending the litigation.
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 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.
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 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 Transition Report on Form 10-K/T for the six months ended December 31, 2006.
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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