Barr Granted Rights to Generic of Cephalon's ACTIQ(R) Cancer Pain Treatments

Main Category: Cancer / Oncology
Article Date: 13 Aug 2004 - 11:00 PDT

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Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has entered into an agreement with Cephalon, Inc. that will provide the Company with a license to manufacture and market a generic version of Cephalon's ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] cancer pain management treatment.

The license will become effective on February 3, 2007, or earlier, depending on certain contingencies. The agreement also obligates Cephalon to supply Barr with a Cephalon-manufactured product for resale, if Barr cannot obtain U.S. Food & Drug Administration (FDA) approval of an Abbreviated New Drug Application (ANDA) product prior to the license's effective date. Under certain circumstances, the agreement also would provide Barr with the right to manufacture and market a generic version of Cephalon's proposed sugar-free formulation of ACTIQ.

"This agreement will enable Barr to launch a fentanyl product at least 30 days prior to the expiration of any pediatric exclusivity period Cephalon might obtain on ACTIQ," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "If Cephalon does not obtain pediatric exclusivity, the latest effective date of the license would be September 5, 2006. The license will be effective even earlier if CIMA/Cephalon obtains FDA approval of an OraVescent(R) fentanyl product prior to these dates."

The agreement was entered into pursuant to a U.S. Federal Trade Commission (FTC) consent agreement in connection with the proposed merger of CIMA and Cephalon, and is contingent upon final FTC approval and consummation of the merger.

ACTIQ is indicated for the treatment of breakthrough cancer pain in opioid tolerant patients and has current annual sales of approximately $319 million, based on IMS sales data for the twelve months ended June 2004.

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.

Forward-Looking Statements

This press release contains a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward- looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: 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 difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; 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; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products, which typically have lower margins, during any given period; 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 new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission.

CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
201-930-3720
ccox@barrlabs.com

Note to Editors: Barr Laboratories, Inc. news releases are available free of charge through PR Newswire's Company News On-Call at http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate information are also available on Barr's website (http://www.barrlabs.com ). For complete indications, warnings and contraindications, contact Barr Laboratories' Professional Services Department at 1-800-Barr Lab. All trademarks referenced herein are the property of their respective owners./

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Barr Pharmaceuticals, Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.