Healthcare Industry News:  schizophrenia 

Biopharmaceuticals FDA Generics

 News Release - November 9, 2006

Barr Receives Tentative Approval for a Generic Version of ZYPREXA(R) Zydis(R) Tablets, 5mg, 10mg, 15mg and 20mg

WOODCLIFF LAKE, N.J., Nov. 9 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA® Zydis® (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

The patent listed in the Orange Book for ZYPREXA Zydis expires on April 23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Barr's product.

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, formally initiating the patent challenge process under the Hatch-Waxman Act.

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 $246 million for the twelve months ended September 2006, based on IMS sales data.

A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.

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 Company markets more than 120 generic and 25 proprietary products in the U.S. and more than 550 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; 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 (including PLIVA d.d.) and products we acquire and implementing our new 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 the completion of the PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 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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