ANDA Filing with Paragraph IV Certification May Offer Co-Exclusive Marketing Rights
Spring Valley, New York, July 08, 2002 Par Pharmaceutical, Inc., a subsidiary of Pharmaceutical Resources, Inc., (“PRI”) (NYSE:PRX), today announced that it has entered into an agreement with Three Rivers Pharmaceuticals to market and distribute 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. Schering-Plough currently markets ribavirin under the brand name Rebetol®. Rebetol® achieved U.S. sales of approximately $300 million in 2001.
Three Rivers filed an ANDA with a paragraph IV certification with the U.S. Food and Drug Administration (FDA) in August 2001 and is currently in litigation with the patent holders. According to current FDA practice, Par believes it may be entitled to exclusively market the generic product ribavirin for up to 180 days, during which time only one other generic company could be approved to market the drug. If successful, Par could introduce ribavirin in the 2003-2004 timeframe.
Under the terms of the agreement, Three Rivers will supply the product to Par and be responsible for managing the regulatory approval process and ongoing patent litigation. Upon receipt of final marketing clearance, Par will have the exclusive right to sell the product in the non-hospital markets.
“Our collaboration with Three Rivers is yet another demonstration of our proven ability to bring products into our new product pipeline that have high barriers to competitive entry and the opportunity for periods of generic market exclusivity,” said Scott Tarriff, president and chief executive officer of Par Pharmaceutical. “We have successfully launched five first-to-file products and have a strong pipeline of products which have potential for the remainder of 2002 through 2005. Our goal is to maintain the momentum we’ve established in the marketplace by continuing to provide important drug therapies to clinicians and their patients.”
PRI, a holding company, develops, manufactures, and distributes generic pharmaceuticals through its wholly owned subsidiary, Par Pharmaceutical. Through its FineTech unit, PRI also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. PRI currently manufactures and distributes over 139 products representing various dosage strengths of 58 drugs. For press release and other Company information, visit our website at 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, including those concerning management’s expectations with respect to future events or future financial performance. Any such statements that refer to PRI’s anticipated future results, product performance, release date of future products, or other non-historical facts are forward-looking and reflect PRI’s current perspective of existing trends and information. These statements involve risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the uncertainty associated with complex litigation, including the eventual outcome and litigation costs and expenses incurred along the way, the success of PRI’s product development activities, and the timeliness with which regulatory authorizations and product introductions may be achieved, market acceptance of PRI’s products, the availability of raw materials on commercially reasonable terms, successful compliance with extensive, costly, complex, and evolving governmental regulations and restrictions, exposure to product liability, and other risks and uncertainties detailed in PRI’s filings with the Securities and Exchange Commission, such as the Company’s Form 10-K, Form 10-Q, and Form 8-K reports.