DETROIT, March 31 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). This product has been added to Caraco’s Paragraph IV marketing agreement with Sun Pharma that was signed on January 29, 2008. Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Ethyol(R), and being the first-to-file an ANDA with a Paragraph IV certification, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology, Inc. concerning this product in the U.S. District Court for the District of Maryland.
Amifostine is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. This new product is bioequivalent to Ethyol(R), a registered trademark of MedImmune Oncology, Inc. Ethyol(R) had U.S. sales of approximately $80 million for the 12-month period ended December 31, 2007, according to IMS Data.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation’s filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
CONTACT: Daniel Movens, +1-313-871-8400, Aaron Miles, +1-313-556-4150,
both of Caraco Pharmaceutical Laboratories, Ltd.
Web site: http://www.caraco.com//
