Spring Valley, New York, July 7, 2003 — Pharmaceutical Resources, Inc. (NYSE:PRX) announced today that through its subsidiary, Par Pharmaceutical, Inc., it has entered into a licensing agreement with developer Paddock Laboratories for testosterone gel 1%, the generic version of Unimed Pharmaceuticals' Androgel®. The product will be manufactured by Paddock and marketed by Par.
The ANDA, which was recently accepted by FDA, is believed to be the first ANDA filed with FDA with a paragraph IV notification potentially providing for 180 days of exclusivity. Based on FDA policy it is not possible at this time to know with certainty that the file does qualify for exclusivity. This information will not be known with certainty until after final approval by FDA.
Androgel®, with annual sales of approximately $225 million, is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Pharmaceutical Resources, Inc., a holding company, develops, manufactures, and distributes generic pharmaceuticals through its wholly owned subsidiary, Par Pharmaceutical. Through its FineTech unit, PRX also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. PRX currently manufactures and distributes over 170 products representing various dosage strengths of 63 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.
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