ROCKAWAY, N.J., Nov. 7 /PRNewswire/ -- Warner Chilcott Holdings III, Limited (the “Company”) today confirmed that the Federal Trade Commission and 21 States plus the District of Columbia have filed suit against the Company and certain of its subsidiaries alleging that a subsidiary of the Company entered into an anticompetitive agreement with Barr Pharmaceuticals (“Barr”) in 2004 involving one of its combined hormonal contraceptives, Ovcon(R) 35. The complaints, filed in the United States District Court for the District of Columbia, claim that the agreement constitutes unfair competition under Section 5 of the FTC Act and Section 1 of the Sherman Act and seek an injunction to remove the agreement’s exclusivity provision. Although the FTC is not seeking monetary remedies, the States and the District of Columbia are seeking monetary damages including civil penalties, other equitable relief and costs.
“We are disappointed by and disagree with the FTC’s decision to bring an action against our company. The agreement with Barr was examined by the FTC over two years ago as part of a Hart-Scott-Rodino review process and the FTC did not find it to be anticompetitive. It was not anticompetitive then and it is not anticompetitive now. Ovcon(R) 35 has less than a 2.5% share of the combined hormonal contraceptive market. The combined hormonal contraceptive marketplace has unique characteristics and is unlike other pharmaceutical markets the FTC has investigated and pursued in the past. Due to the heavy sampling of branded products in this marketplace, there has been no consumer harm resulting from our agreement with Barr.
“We are also dismayed by the States’ decision to join this action at the eleventh hour. Although we have been in discussions with the FTC about this transaction for over two years, we first learned of the States’ interest two weeks ago. Despite this recent turn of events, we continue to believe that our agreement with Barr is lawful and will vigorously defend it. Although it is impossible to predict with certainty the outcome of any litigation, the Company is confident in the merits of its defense and does not anticipate an unfavorable outcome. In any event, the Company does not believe that the outcome of this litigation will have a material adverse effect on the Company’s overall financial position although it could be material to future results of operations or cash flows in any one accounting period,” said Roger Boissonneault, the Company’s Chief Executive Officer and Director.
In March 2004, Warner Chilcott purchased an option to acquire a five-year exclusive license to an abbreviated new drug application owned by a unit of Barr for which the Company’s Ovcon(R) 35 oral contraceptive is the reference drug. In May 2004, the Company exercised this option. At that time, the Company entered into a finished product supply agreement under which Barr agreed to exclusively supply the Company with its requirements for finished Ovcon(R) product throughout the term of the license. Barr is now the Company’s sole source of supply for Ovcon(R) 35.
Warner Chilcott is a U.S. specialty pharmaceutical company focused on marketing, developing and manufacturing branded prescription pharmaceutical products in women’s healthcare and dermatology.
Read more on http://www.warnerchilcott.com.
Warner Chilcott’s Forward Looking Statements:
This press release contains forward-looking statements, including statements concerning our operations, our economic performance and financial condition, and our business plans and growth strategy and product development efforts. These statements 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. The words “may,” “might,” “will,” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” intend,” “outlook,” “believe” and other similar expressions are intended to identify forward- looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. For a discussion of these risk and uncertainties, see our quarterly reports to the holders of the 8-3/4% Senior Subordinated Notes due 2015 issued by the Company’s affiliate, Warner Chilcott Corporation. These documents and other information are available upon request at no cost, by sending a request by email to bkozinski@wcrx.com or by mail to 100 Enterprise Drive, Rockaway, New Jersey, 07866, Attention: Beth Kozinski.
Warner Chilcott
CONTACT: Paul Herendeen, Executive Vice President and Chief FinancialOfficer of Warner Chilcott, +1-973-442-3200, pherendeen@wcrx.com
Web site: http://www.warnerchilcott.com/
