Healthcare Industry News:  buccal tablet 

Biopharmaceuticals Generics Litigation

 News Release - February 1, 2006

Barr Announces Agreements with Cephalon, Inc. Regarding Settlement of ACTIQ(R) and PROVIGIL(R) Patent Litigations

WOODCLIFF LAKE, N.J., Feb. 1 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Barr Laboratories, Inc., and Cephalon, Inc. have entered into agreements to settle its pending patent infringement disputes in the United States related to Cephalon's ACTIQ® (oral transmucosal fentanyl citrate) [C-II] and PROVIGIL® (modafinil) Tablets [C-IV] products.

"We are pleased that these agreements allow both parties to resolve pending patent litigation in a way that ensures that Barr can launch generic fentanyl at least 90 days prior to the expiration of any pediatric exclusivity period Cephalon might obtain on ACTIQ and can launch generic modafinil prior to patent expiry," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer.

Barr and Cephalon have entered into a Supplemental License Agreement related to ACTIQ, which supplements the license Cephalon previously granted Barr, pursuant to a Federal Trade Commission Order, in mid-2004. The existing license grants Barr a non-exclusive right to sell a generic version of ACTIQ effective on the earlier of final approval of Cephalon's fentanyl effervescent buccal tablet (FEBT) or February 3, 2007, if Cephalon receives a pediatric extension for ACTIQ (or September 5, 2006, if Cephalon does not receive the extension). The Supplemental License Agreement ensures that Barr will be allowed to enter the market no later than December 6, 2006 - two months earlier than the February 6, 2007 date.

The Supplemental License Agreement will go into effect only if the existing license is not otherwise effective on December 6, 2006 and will remain in effect until the existing license becomes effective. During the term of the Supplemental License, Barr will have an exclusive royalty-bearing right to market and sell a generic version of ACTIQ in the United States, and Cephalon will not market or sell, nor shall it license or authorize a third party to market or sell, a generic version of ACTIQ. The Supplemental License Agreement will cease to be effective when the existing license agreement becomes effective. After that date, Barr's rights will be controlled by the terms of the existing license.

In connection with the modafinil settlement, Cephalon will grant Barr a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States. Barr's license will become effective in October 2011, unless Cephalon obtains a pediatric extension for PROVIGIL which would permit entry by Barr in April 2012. An earlier entry by Barr may occur based upon the entry of another generic version of PROVIGIL.

Barr and Cephalon also agreed to a series of business arrangements related to modafinil. Specifically, Barr has agreed to grant to Cephalon a non- exclusive license, effective immediately, to certain of its worldwide intellectual property rights related to modafinil in exchange for an upfront payment.

The terms of the agreements are confidential, and are subject to review by the Federal Trade Commission. Financial terms were not disclosed.

The parties will promptly file a dismissal with the United States District Courts for the Districts of New Jersey and Delaware that will conclude pending litigation between the parties regarding PROVIGIL and ACTIQ, respectively.

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.

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.

Source: Barr Pharmaceuticals

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