WOODCLIFF LAKE, N.J., Jan. 15 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX) and Alfacell Corporation (Nasdaq: ACEL) today announced that they have entered into an exclusive licensing agreement under which Strativa has acquired the commercialization rights in the United States and its territories to ONCONASE(R) (ranpirnase) from Alfacell. ONCONASE is in Phase III development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos. ONCONASE was previously granted orphan drug status as well as fast-track development status by the US Food and Drug Administration (FDA) for the treatment of malignant mesothelioma.
Under the terms of the agreement, Alfacell will receive an initial payment of $5 million in cash. Strativa will also make a payment to Alfacell of up to $30 million upon FDA approval of ONCONASE. In addition to royalties on sales, Alfacell may receive milestone payments on future sales. Alfacell will also retain the right to co-promote ONCONASE in the future.
ONCONASE is a first-in-class product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
John A. MacPhee, president of Strativa, said, "We are very excited to be partnering with Alfacell, an innovative biopharmaceutical company, to meet the treatment needs of mesothelioma patients. Adding ONCONASE to Strativa's product portfolio as our first oncology therapeutic advances our goal of becoming a leading specialty pharmaceutical company. We look forward to collaborating on future projects with Alfacell."
"From the beginning of our discussions, we were impressed with the capabilities, resources and commitment to success at Strativa," said Kuslima Shogen, Chairman and CEO at Alfacell. "These factors were critical for us in choosing the right partner for ONCONASE in the United States. We look forward to collaborating with Strativa as we develop ONCONASE in additional oncology indications, and are confident that this partnership will pave the way for future success for both companies."
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par's financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE(R), is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE(R) in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
Safe Harbor Statement 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, as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issues described in the Company's filings with the Securities and Exchange Commission (SEC), 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 the Company, 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 SEC, such as the Company's reports on Form 10-K, Form 10-Q and Form 8-K, and amendments thereto. Any forward-looking statements included in this press release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical, Inc.