WOODCLIFF LAKE, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that the Federal Trade Commission (FTC) has filed a lawsuit in Federal Court seeking injunctive relief to nullify the March 2004 agreement between Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., and Galen Holdings PLC (known since January 2005 as Warner Chilcott Holdings Company, Limited) regarding the Ovcon-35(R) oral contraceptive. The FTC suit asserts that the agreement, which permits Galen to launch a generic version of Ovcon-35(R) oral contraceptive under Barr’s Abbreviated New Drug Application (ANDA), constitutes an unfair method of competition in violation of Section 5 of the FTC Act. In bringing its lawsuit, the FTC is seeking to have Barr launch its own generic Ovcon-35(R) oral contraceptive. Twenty-one states and the District of Columbia have also filed a complaint in Federal Court challenging the agreement seeking injunctive relief and other equitable relief as well as civil penalties.
“We are disappointed with today’s announcement by the FTC. We continue to believe that the agreement with Galen is lawful and pro-competitive,” said Bruce L. Downey, Barr’s Chairman and CEO. “In fact, we voluntarily submitted a letter of intent outlining the terms of our arrangement with Galen to the FTC for review. At that time the FTC expressed no objection to this transaction and we finalized the agreement in 2004. We intend to vigorously defend the agreement.”
On March 24, 2004, Barr Laboratories and Galen signed an agreement under which Barr granted Galen an option to acquire an exclusive license under its ANDA for a generic version of Galen’s Ovcon-35(R), which was then pending at the U.S. Food & Drug Administration (FDA). Barr and Galen also entered into a contract manufacturing agreement requiring Barr to manufacture generic Ovcon- 35(R) for Galen. On April 23, 2004, Barr announced that it received approval from the FDA for its generic version of Ovcon-35(R) 21-day and 28-day Tablets oral contraceptive. Following the approval of Barr’s ANDA, Galen exercised its option, and under the terms of the agreement, was granted a five-year exclusive license to sell the product under Barr’s ANDA. At the end of the five-year term, Galen can extend the license on a non-exclusive basis for an additional five-year period.
Galen made a $1 million payment to Barr upon signing the option agreement in March 2004 and an additional $19 million in May 2004 when it exercised of the option. Barr has been amortizing the $19 million into Alliance, development and other revenue over a five-year term and has recognized approximately $6 million in revenue since the inception of the license agreement.
Ovcon-35(R) is a regimen of oral contraceptives that contains 0.4 mg of norethindrone and 0.035 mg of ethinyl estradiol and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
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.
Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, +1-201-930-3720 orccox@barrlabs.com
Web site: http://www.barrlabs.com//
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