SPRING VALLEY, N.Y., Oct. 20 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its marketing partner, Three Rivers Pharmaceuticals, has been granted tentative approval by the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ribavirin 200 mg, 400 mg and 600 mg tablets. Ribavirin, a synthetic nucleoside analogue with antiviral activity, is used in combination with peginterferon alfa-2a for the treatment of hepatitis C. Ribavirin tablets are currently marketed by Roche Pharmaceuticals under the brand name Copegus(R). Annual U.S. sales of the product are approximately $200 million.
Par expects final approval of ribavirin tablets following the expiration of Copegus’ exclusivity on December 3, 2005. Under the terms of its agreement with Three Rivers, Par will co-market Three Rivers’ ribavirin tablets and the companies will split profits from the sales of the product.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace(R) ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 prescription 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.
Par Pharmaceutical Companies, Inc.
CONTACT: Stephen J. Mock or Cecelia C. Heer, both of Par PharmaceuticalCompanies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
