WOODCLIFF LAKE, N.J., July 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Janssen Pharmaceutica N.V., Janssen, L.P., Ortho-McNeil Neurologics, Inc. and Synaptech, Inc. (“Plaintiff”) filed suit against it and its subsidiary, Barr Laboratories, Inc., relating to the patent protecting Razadyne(R) ER (Galantamine Hydrobromide Extended-Release Capsules), 8 mg, 16 mg and 24 mg. The Company indicated it believes it is the first to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for the product.
Barr filed an ANDA with the FDA for Janssen’s Razadyne ER (Galantamine Hydrobromide Extended-Release Capsules), 8 mg, 16 mg and 24 mg in March 2006. Barr received notification from the FDA of the application’s acceptance for filing in April 2006. Following receipt of notice from FDA, Barr notified Janssen Pharmaceutica, N.V., the New Drug Application holder, and Synaptech, the patent owner, of Barr’s challenge to the patent protecting Razadyne(R) ER. Plaintiffs filed suit against Barr in the District Court of New Jersey. This suit officially initiates the patent challenge process under the Hatch-Waxman Act.
Razadyne ER is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
Razadyne ER had annual sales of approximately $54 million for the twelve months ending May 2006, according to IMS sales data. Razadyne ER was launched in May 2005.
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, 2005.
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.
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Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720, orccox@barrlabs.com
Web site: http://www.barrlabs.com//
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