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Barr Announces Favorable Ruling in Razadyne Patent Challenge
Thursday, August 28, 2008
Montvale, NJ -- Barr Pharmaceuticals, Inc. today announced that the U.S. District Court for the District of Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of U.S. Patent No. 4,663,318 ("the '318 patent") listed by Ortho McNeil Janssen in connection with Janssen's Razadyne (galantamine hydrobromide), 4mg, 8mg and 12mg tablets. The Court's decision will effectively end the 30-month stay with respect to Barr's generic Razadyne tablets and Barr's generic Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules.
In her ruling, District Court Judge Robinson found that the '318 patent is invalid for lack of enablement. Judge Robinson also denied Janssen's request for a Temporary Restraining Order which would have prevented Barr from marketing its product.
"We are very pleased with the Court's decision invalidating the patent on Razadyne and we intend to launch our generic Razadyne product immediately following receipt of final FDA approval, which we expect imminently," said Christine Mundkur, CEO of Barr Laboratories, Inc. "We also are evaluating our options regarding a launch of our generic version of Razadyne ER," Mundkur continued.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005, the first day that an ANDA containing a Paragraph IV certification could be submitted based on the expiration of the New Chemical Entity (NCE) exclusivity on the product. Following receipt of notification from the FDA of the application's acceptance for filing, Barr notified the New Drug Application (NDA) holder and patent owner of Barr's challenge to the patents protecting Razadyne. On June 15, 2005, Barr announced that Janssen had filed suit in the District Court for the District of Delaware, and the trial occurred in May 2007.
Janssen announced in its Form 10-Q filed with the U.S. Securities & Exchange Commission on May 10, 2005 that it had received Paragraph IV certifications for Razadyne tablets from six other generic pharmaceutical companies relating to the patents protecting Razadyne.
Barr also has a pending ANDA for Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. In its ANDA for that product, Barr certified that the '318 patent was invalid, unenforceable or not infringed. Barr subsequently amended its application to certify that an additional patent, U.S. Patent No. 7,160,559 ("the '559 patent"), which was not listed at the time Barr's original ANDA was filed, was invalid, unenforceable or not infringed. Janssen sued Barr in the District Court for the District of New Jersey on June 30, 2006. Pursuant to an Order in the case, Judge Robinson's decision in the District of Delaware will be given effect in the Razadyne ER litigation. Janssen continues to assert in the Razadyne ER litigation that Barr's generic Razadyne ER product infringes the '559 patent, which is scheduled to expire on December 20, 2019. Barr believes that, because the '559 patent was not listed at the time Barr's original application was filed, the decision with respect to the '318 patent will end the 30-month stay with respect to the generic Razadyne ER product.
Razadyne tablets had annual sales of approximately $102 million for the twelve months ending June 2008, according to IMS sales data.
Razadyne ER capsules had annual sales of approximately $112 million for the twelve months ending June 2008, according to 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.
This communication contains "forward-looking statements" which represent the current expectations and beliefs of management of Barr Pharmaceuticals, Inc. (the "Company") concerning the proposed merger of the Company with Boron Acquisition Corp., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (the "merger") and other future events and their potential effects on the Company. The statements, analyses, and other information contained herein relating to the proposed merger, as well as other statements including words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "will," "should," "may," and other similar expressions, are "forward-looking statements" under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future results and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. Those factors include, without limitation: 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 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; 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; 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; the reactions of the Company's customers and suppliers to the merger; and diversion of management time on merger-related issues. These and other applicable risks, cautionary statements and factors that could cause actual results to differ from the Company's forward-looking statements are included in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), specifically as described in the Company's annual report on Form 10-K for the fiscal year ended December 31, 2007. The Company undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.
Important Legal Information
In connection with the proposed merger, the Company will prepare a proxy statement to be filed with the SEC. When completed, a definitive proxy statement and a form of proxy will be mailed to the stockholders of the Company. Before making any voting decision, the Company's stockholders are urged to read the proxy statement regarding the merger carefully and in its entirety because it will contain important information about the proposed merger. The Company's stockholders will be able to obtain, without charge, a copy of the proxy statement (when available) and other relevant documents filed with the SEC from the SEC's website at http://www.sec.gov. The Company's stockholders will also be able to obtain, without charge, a copy of the proxy statement and other relevant documents (when available) by directing a request by mail or telephone to Barr Pharmaceuticals, Inc., 225 Summit Avenue, Montvale, NJ, 07645 -- Attention: Investor Relations
The Company and its directors and officers may be deemed to be participants in the solicitation of proxies from the Company's stockholders with respect to the proposed merger. Information about the Company's directors and executive officers and their ownership of the Company's common stock is set forth in the Company's annual report on Form 10-K for the fiscal year ended December 31, 2007 and the Company's proxy statement for the Company's 2008 Annual Meeting of Stockholders. Stockholders may obtain additional information regarding the interests of the Company and its directors and executive officers in the merger, which may be different than those of the Company's stockholders generally, by reading the proxy statement and other relevant documents regarding the proposed merger, when filed with the SEC.
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