Barr Announces Agreements on Nasacort AQ, Allegra D-12 and Allegra Patent Challenges
- Settlement and License Agreement for Generic Versions of Nasacort(R) AQ
- Settlement and License Agreement with Aventis and Albany Molecular Research, Inc. for Generic Versions of Allegra(R) D-12
- Settlement Agreement with Aventis and Albany Molecular Research, Inc. Related to Generic Versions of Allegra(R) Tablets
MONTVALE, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc. has entered into separate settlement agreements related to ongoing patent challenges for Nasacort(R) AQ (triamcinolone acetonide) nasal spray, Allegra(R) D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra(R) (fexofenadine) 30mg, 60mg and 180mg tablets. As part of the settlements, the parties have agreed to dismiss the underlying U.S. litigation related to the three patent challenge cases.
"We are very pleased to have reached these three separate settlements, bringing to a close the outstanding patent challenges in a manner that results in the date certain launch of a generic version of Nasacort(R) AQ years prior to the expiration of the applicable patents, and the launch of a generic version of Allegra(R) D-12 in November of 2009," said Bruce L. Downey, Barr's Chairman and CEO. "The agreement related to Allegra(R) resolves any ongoing uncertainty about the possible impact of ongoing litigation for Barr and Teva related to the launch of generic versions of Allegra(R) 30mg, 60mg and 180mg tablets in September 2005. We believe that these agreements represent a pro-consumer resolution to this ongoing litigation."
The individual agreements are subject to review by the Federal Trade Commission (FTC) and state Attorneys General under an outstanding consent decree and settlement entered into by a Sanofi-Aventis predecessor company, and will not become effective for approximately 45 days. The parties may prevent the agreements from becoming effective or terminate the agreements if the FTC or state attorney generals raise objections that cannot be resolved by the parties.
Nasacort(R) AQ Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with Sanofi-Aventis US LLC and Aventis Pharmaceuticals Inc. to resolve the patent litigation involving Barr's Triamcinolone Acetonide nasal spray, the generic versions of Aventis Pharmaceuticals' Nasacort(R) AQ. Under this agreement, Barr will have a license to launch a generic version of Nasacort(R) AQ as early as June 15, 2011 if Barr's ANDA is approved on that date, or earlier in certain circumstances. In addition, even if the Barr's ANDA is not approved, Barr will have a license to launch a generic version of Nasacort(R) AQ, supplied by Sanofi-Aventis, on December 1, 2013, or earlier, in certain circumstances. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company (NASDAQ: PRGO; TASE) and, under the terms of a separate agreement, will share in the costs and potential benefits with Perrigo.
Allegra(R) D-12 Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's generic version of Aventis Pharmaceuticals' Allegra(R) D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets. Under the terms of this agreement, Barr is permitted to launch a generic version of Aventis Pharmaceuticals' Allegra(R) D-12 extended-release tablets on November 1, 2009, and Barr has the right to acquire product from Sanofi-Aventis for commercial launch. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Allegra(R) Tablets Settlement Agreement
Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. have signed an agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's and Teva's generic version of Aventis Pharmaceuticals' Allegra(R) (fexofenadine) 30mg, 60mg and 180mg tablets, which Teva launched in September 2005 under a separate agreement with Barr. Under the terms of this agreement, Barr and Teva will each pay Aventis approximately $30 million to settle the patent litigation with Aventis regarding Teva's fexofenadine 30mg, 60mg and 180mg tablets product. In addition, Barr and Teva will pay Aventis a royalty on future U.S. sales.
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.
Forward-Looking Statements
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 (the "merger") with Boron Acquisition Corp., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (the "Teva") 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, Teva has filed a registration statement on Form F-4 containing a proxy statement/prospectus for shareholders of the Company with the SEC, and the Company and Teva may be filing other documents regarding the proposed transaction with the SEC as well. Before making any voting or investment decision, investors are urged to read the proxy statement/prospectus regarding the proposed transaction, as well as the other documents referred to in the proxy statement/prospectus carefully in their entirety when they become available because they will contain important information about the proposed transaction. The definitive proxy statement/prospectus has been mailed to the Company's shareholders. Shareholders may obtain a free copy of the proxy statement/prospectus, as well as other filings containing information about Teva and the Company, without charge, at the SEC's Internet site (http://www.sec.gov). Copies of the proxy statement/prospectus and the filings with the SEC that are incorporated by reference in the proxy statement/prospectus can also be obtained, without charge, 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 filed with the SEC.
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