WOODCLIFF LAKE, N.J., May 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Duramed Pharmaceuticals, Inc. has received a Non-Final Rejection notice from the Patent and Trademark Office (PTO) regarding its application for reissue of U.S. Patent 5,898,032 (‘032) relating to its SEASONALE(R) extended-cycle oral contraceptive. A Non-Final Rejection affords the Company with three months to respond to the issues raised by the PTO. The PTO then would have additional time to review the Company’s response and decide whether the application for reissue of the patent should be allowed. While the Company said that it had not had the opportunity to review the correspondence from the PTO, it noted that it would be unlikely, given the timing, that the patent in question could be reissued prior to the September 5, 2006 expiration of Duramed’s regulatory exclusivity on SEASONALE.
“While we are disappointed in the determination by the PTO, we intend to fully review all options available to protect our patentable invention, and will respond to the Non-Final Rejection as quickly as possible,” said Bruce L. Downey, Barr’s Chairman and CEO.
Barr filed its application seeking reissue of the ‘032 patent with the PTO in July 2004. The ‘032 patent remains in effect and continues to be listed in the U.S. Food and Drug Administration’s (FDA) Orange Book while the PTO evaluates Duramed’s application for reissue.
In June 2004 the Company announced that it received notification that Watson Laboratories, Inc. had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering SEASONALE is invalid, unenforceable or would not be infringed by Watson’s generic product. Barr did not initiate patent infringement litigation with respect to Watson’s ANDA. Watson’s generic version of SEASONALE will be eligible for final FDA approval following expiration of Duramed’s New Product Exclusivity in September 2006.
Conference Call/Webcast
Barr will host a conference call at 9:00 AM Eastern time on Friday, May 12, 2006 to discuss the Non-Final Rejection notice related to SEASONALE. The number to call from within the United States is (800) 230-1059, and participants from outside the United States should call (612) 332-0107. A replay of the conference call will be available from 12:00 Noon Eastern time on May 12th through 11:59 PM Eastern time on May 15th, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 829570.
About Barr Pharmaceuticals, Inc.
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. The Company is the leading marketer and manufacturer of oral contraceptive products in the United States, based on industry data. The Company currently markets 22 generic oral contraceptive products under its Barr Laboratories, Inc. label and five proprietary (branded) oral contraceptive products under the Duramed Pharmaceuticals, Inc. label.
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.
Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, +1-201-930-3720,ccox@barrlabs.com
Web site: http://www.barrlabs.com/
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