Barr Announces Withdrawal of Zyprexa Zydis Patent LitigationCompany Changes Application to a Paragraph III
WOODCLIFF LAKE, N.J., June 11, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced the dismissal of litigation related to its challenge of the patent protecting Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. Following the Federal Circuit's affirmance of a decision by the trial court in favor of Eli Lilly on this patent in a suit against Zenith Goldline Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. and Dr. Reddy's Labs, Ltd., the Company changed the patent certification for its Abbreviated New Drug Application (ANDA) that is currently pending at the U.S. Food & Drug Administration (FDA) for Olanzapine Orally Disintegrating Tablets from a paragraph IV to a paragraph III. The patent litigation dismissal is a result of the Company's change to a paragraph III certification.
The patent listed in the Orange Book for ZYPREXA Zydis expires on April 23, 2011 and the associated pediatric exclusivity expires on October 23, 2011. The Company anticipates receiving final FDA approval upon expiration of the patent, and any related exclusivities that may be sought and granted.
Barr filed its ANDA containing a paragraph IV certification for a generic ZYPREXA Zydis product with the FDA in August 2004, and received notification of the application's acceptance for filing in September 2004. Following receipt of the notice from the FDA, Barr notified Lilly Industries Limited, the patent owner, and Eli Lilly & Company, the New Drug Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and Eli Lilly & Company filed suit in U.S. District Court, Southern District of Indiana to prevent Barr from proceeding with the commercialization of its product. The FDA issued a tentative approval for Barr's ANDA for Olanzapine Orally Disintegrating Tablets in November 2006. The Company notified FDA of the change in its certification in April 2007 and the litigation between the Company and Lilly was subsequently dismissed.
ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder. The product had annual sales of approximately $252 million for the twelve months ended March 2007, 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 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.
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.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720, firstname.lastname@example.org
Web site: http://www.barrlabs.com/
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Ticker Symbol: (NYSE:BRL)
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Posted: June 2007