Spring Valley, New York, April 7, 2004 — Par Pharmaceutical, Inc., the principal subsidiary of Pharmaceutical Resources, Inc. (NYSE:PRX), today announced that its marketing partner, Three Rivers Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration (FDA) for ribavirin 200 mg capsules. Ribavirin, a synthetic nucleoside analogue with antiviral activity, is indicated for the treatment of hepatitis C, a chronic condition suffered by approximately 4 million Americans. Ribavirin is currently marketed by Schering-Plough under the brand name Rebetol®. The U.S. market for ribavirin products exceeds $600 million annually. Following receipt of FDA approval, Par immediately began shipping ribavirin 200 mg capsules.
Three Rivers has been awarded 180 days of shared marketing exclusivity, commencing at launch, for being first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification. Under the terms of its agreement with Three Rivers, Par has exclusive marketing rights to sell Three Rivers' ribavirin product.
On July 16, 2003, the United States District Court for the Central District of California granted summary judgment of non-infringement regarding ribavirin to Three Rivers. The district court determined that the Three Rivers' product does not infringe any of three patents asserted by ICN Pharmaceuticals in the litigation. Earlier, Three Rivers reached a settlement of its patent litigation with Schering-Plough, so the district court decision resolved the remaining patent barriers to FDA approval of Three Rivers' ANDA.
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 more than 170 products representing various dosage strengths of 71 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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