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Barr Confirms That Aventis and Albany Molecular Research, Inc. Are Seeking a Preliminary Injunction on Allegra(R) Tablets.

WOODCLIFF LAKE, N.J., Sept. 21 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Aventis Pharmaceuticals, Inc. along with Albany Molecular Research, Inc. have filed a motion for a preliminary injunction or expedited trial in the United States District Court for the District of New Jersey. The motion seeks to enjoin Barr and Teva Pharmaceutical Industries Ltd. from marketing their generic versions of Allegra(R) (Fexofenadine Hydrochloride) Tablets, 30 mg, 60 mg and 180 mg, or to expedite the trial in the case. The injunction also seeks to enjoin Ranbaxy Laboratories, Ltd. and Amino Chemicals, Ltd. from the commercial production of generic Fexofenadine raw material.

On September 6, 2005, Barr and Teva Pharmaceutical Industries Ltd. announced that they had entered into an agreement for the launch of Fexofenadine Hydrochloride, 30 mg, 60 mg and 180 mg Tablets, the generic version of Aventis Pharmaceuticals Allegra(R) tablets. Under the agreement, Barr had taken the regulatory steps necessary to permit Teva to obtain final U.S. Food and Drug Administration approval of Teva's Fexofenadine Hydrochloride Tablets and to sell the product within Barr's 180-day exclusivity. Teva launched the product and has been shipping product to customers since that time.

"We intend to vigorously oppose this effort to prevent the marketing of a more affordable generic Fexofenadine," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer.

Allegra (Fexofenadine Hydrochloride) is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Allegra tablets had annual sales of approximately $1.4 billion, based on IMS data for the twelve months ended July 2005.

Barr filed an ANDA for Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg, and 180 mg, in June 2001. Following receipt of notice of acceptance from FDA, Barr notified Aventis of its ANDA filing. Aventis filed suit in the United States District Court for the District of New Jersey seeking to prevent approval of Barr's ANDA until after the expiration of various patents, the last of which expires in 2017.

In July 2004, Barr announced that the U.S. District Court in New Jersey had granted summary judgment of non-infringement with respect to three patents in the Company's patent challenge litigation involving Allegra (Fexofenadine Hydrochloride). On April 1, 2005, the Company announced that the Court granted summary judgment of invalidity on an additional patent in the case.

The court has yet to rule on five patents related to the Allegra tablet and capsule products remaining in the litigation -- three method-of-use patents and two raw material patents. While no trial date has been set, Barr anticipates that the case may be ready for trial early in 2006.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

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 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; 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, 2004.

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,

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Publication:PR Newswire
Geographic Code:7ISRA
Date:Sep 21, 2005
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