ALLEGAN, Mich., Oct. 25 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that its Perrigo Israel Pharmaceuticals Ltd. (formerly Agis Industries (1983) Ltd.) subsidiary is challenging the patent submitted to the U.S. Food and Drug Administration (FDA) in connection with Connetics Corporation’s Olux (clobetasol propionate) Foam 0.05%. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Olux Foam (0.05%).
Olux is a topical corticosteroid indicated for the short-term treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatosis of the scalp. Olux sales are estimated at approximately $70 million for the past twelve months.
Perrigo filed its ANDA for clobetasol propionate foam (0.05%) containing a paragraph IV certification with the FDA in June 2005, and received notification of the application’s acceptance for filing in August 2005. Following receipt of the notice from FDA, Perrigo notified Connetics Corporation, the New Drug Application (NDA) holder, and Connetics Australia Pty Ltd., the patent owner. On October 19, 2005, Connetics filed suit in the U.S. District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
About Paragraph IV Drug Product Applications
Under the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of one or more patents the brand has advised the FDA covers its commercial product if it challenges one or more of these patents. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA containing such a challenge has the exclusive right to market the generic drug for 180 days if the challenge is successful.
To begin the FDA approval process, the generic applicant must: 1) certify in its ANDA that the patent in question is invalid, unenforceable or not infringed by the generic product (known as “paragraph IV certification”); and 2) notify the NDA and patent holder of the submission of the ANDA. If the NDA or patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA cannot approve the ANDA for 30 months, unless, before that time the patent expires or is judged to be invalid or not infringed. This 30-month postponement allows the NDA or patent holder time to assert its patent rights in court before a generic competitor is permitted to enter.
The Perrigo Company is a leading global healthcare supplier and the world’s largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, drug, mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico and Germany. Visit Perrigo on the Internet (http://www.perrigo.com ).
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. Please see the “Cautionary Note Regarding Forward-Looking Statements” on pages 33 - 41 of the Company’s Form 10-K for the year ended June 25, 2005 for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Perrigo Company
CONTACT: Ernest J. Schenk, Manager, Investor Relations and Communicationof Perrigo Company, +1-269-673-9212, or E-mail: eschenk@perrigo.com
Web site: http://www.perrigo.com/
