WOODCLIFF LAKE, N.J., May 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Janssen Pharmaceutica Products, L.P.'s Razadyne(R) (Galantamine Hydrobromide), 4mg, 8mg and 12mg Tablets.
A tentative approval reflects FDA’s preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen’s Razadyne (Galantamine Hydrobromide), 4mg, 8mg and 12mg 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 June 2005, Janssen and Synaptech filed suit against Barr Laboratories in the District Court of Delaware to formally initiate the patent challenge process under the Hatch-Waxman Act. Trial is set for May 21, 2007. The 30- month stay for the case expires in August 2008.
Razadyne is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. The product had annual sales of approximately $140 million for the twelve months ending March 2007, 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 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.
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 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 and implementing our new SAP 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; 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; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.
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.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,ccox@barrlabs.com
Web site: http://www.barrlabs.com/
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