WOODCLIFF LAKE, N.J., June 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Janssen Pharmaceutica Products, L.P. and Synaptech filed suit against its subsidiary, Barr Laboratories, Inc., in the District Court of Delaware, relating to the patents protecting Razadyne(R) (Galantamine Hydrobromide), 4 mg, 8 mg and 12 mg Tablets, formerly Reminyl(R). This suit officially initiates the patent challenge process under the Hatch-Waxman Act.
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. Barr received notification from the FDA of the application's acceptance for filing in April 2005. Following receipt of notice from FDA, Barr notified Janssen, the New Drug Application (NDA) holder, and Synaptech, the patent owner, of Barr's challenge to the patents protecting Razadyne.
In its Form 10-Q filed with the Securities and Exchange Commission on May 10, 2005, Janssen, a subsidiary of Johnson & Johnson, announced that it had received Paragraph IV certifications for Razadyne from six other generic pharmaceutical companies relating to the patents protecting Razadyne 4 mg, 8 mg and 12 mg Tablets from generic competition. Janssen indicated they are in the process of evaluating these certifications.
Razadyne, formerly Reminyl, is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
Razadyne had annual sales of approximately $247 million for the twelve months ending April 2005, according to IMS sales data.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
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.
Barr Pharmaceuticals, Inc.