SPRING VALLEY, N.Y., Sept. 13 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that it has acquired from Paddock Laboratories, Inc. all rights to the Abbreviated New Drug Application (ANDA) for testosterone gel 1%. Testosterone gel 1% is the generic version of AndroGel(R), which is marketed in the U.S. by Unimed Pharmaceuticals, Inc., a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc. Par subsequently entered into a settlement and license agreement with Solvay Pharmaceuticals that resolves patent litigation related to AndroGel, eliminating the inherent uncertainty and costs of litigation. The settlement and license agreement terminates all ongoing litigation involving Unimed Pharmaceuticals, Laboratories Besins Iscovesco and Paddock Laboratories, Inc. It also permits Par to launch its generic version of the product no later than February 28, 2016, assuring Par's ability to market a generic version well before the expiration of the patents at issue.
Par also entered into a separate extended-reach agreement with Solvay Pharmaceuticals that provides for Par's branded sales force to co-promote AndroGel for a period of six years. AndroGel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
"Par is very pleased to co-promote the most widely prescribed testosterone therapy in the U.S.," said John A. MacPhee, president, Branded Products Division. "This agreement provides Par with its third branded product to promote and we look forward to a very successful collaboration with Solvay Pharmaceuticals."
Purchase Agreement
Under the terms of its purchase agreement with Paddock, Par paid $6 million for all rights to Paddock's ANDA for testosterone gel 1%, including all intellectual property associated with the product. Paddock filed an ANDA with the U.S. Food and Drug Administration in May 2003 seeking marketing clearance for its generic version of AndroGel. In July 2003, Par entered into a licensing agreement with Paddock to market the product in the U.S.
Settlement and License Agreement
In accordance with the settlement and license agreement, pending patent litigation between Unimed, Laboratories Besins Iscovesco and Paddock in the United States District Court for the Northern District of Georgia, Atlanta Division has been dismissed. Solvay Pharmaceuticals will grant Par a non- exclusive license to market, sell and distribute a generic version of AndroGel beginning no later than February 26, 2016. This is more than four years prior to the expiration of U.S. Patent No. 6,503,894, which had been the subject of the litigation. As part of the settlement, Par admits that the patent is valid and enforceable and that Par infringes the patent.
Extended-Reach Agreement
Par also entered into an extended-reach agreement with Solvay Pharmaceuticals that provides for Par's branded sales force to co-promote AndroGel, as well as future versions of the product, for a period of six years. Par will commence pre-launch activities in the fourth quarter of 2006 and begin to co-promote AndroGel in the first quarter of 2007. As compensation for its marketing and sales efforts, Par will receive $10 million annually, paid quarterly, for the six-year period.
About Par
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced the appetite stimulant Megace(R) ES, its first branded pharmaceutical product. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 110 generic drugs. For press release and other company information, visit http://www.parpharm.com/.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
