Second Unique Formulation of Ondansetron in Portfolio
Woodcliff Lake, NJ, June 17, 2008 – Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), and MonoSol Rx 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 the thin film formulation of ondansetron from MonoSol Rx, a leader in oral thin film technology. Ondansetron thin film formulation is a new oral formulation in development for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
Based on the results of a recently completed pilot bio-equivalency study, MonoSol Rx is moving immediately to pivotal trials to enable application for drug approval in the U.S. Subject to favorable results, it is anticipated that Strativa could file an NDA with the appropriate regulatory authorities within the next twelve months.
Specific terms were not disclosed, but the agreement calls for milestone payments prior to commercial launch, payments for product supply, royalties and additional sales-based milestones on net sales of the product. Total milestone payments could be as high as $23.5 million.
Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.6 billion in 2007. Ondansetron was the prescription leader in the category in 2007, with 2.7 million scripts written.
John A. MacPhee, president of Strativa, said, “We are delighted to collaborate with MonoSol Rx and expand our pipeline of supportive care products.” Mr. MacPhee continued, “With two unique, yet complementary delivery systems of ondansetron in our portfolio, Zensana™ oral spray and the oral thin film, we are able to offer patients a better opportunity to find a product that meets their individual needs.”
A. Mark Schobel, president and CEO of MonoSol Rx, stated, “Strativa is uniquely positioned to market and sell our ondansetron thin film product and we are very excited about the collaboration,” Mr. Schobel continued, “Following approval, ondansetron would be one of the first prescription drugs to come to market utilizing thin film drug delivery technology.”
About Strativa
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
About MonoSol RX
MonoSol Rx is a drug delivery company specializing in proprietary, dissolving thin film pharmaceutical products. The Company’s thin film technology, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. The Company’s thin film formulations offer significant patient benefits, including convenience, taste, and potentially greater efficacy. MonoSol Rx’s strategy is to develop and partner innovative thin film strip products in the prescription, generic and OTC pharmaceutical markets and to establish a leadership position in thin film drug delivery technology through continued development of its drug delivery technology and intellectual property portfolio. For additional information, please visit www.monosolrx.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.
Contact:
Allison Wey
Senior Director
Investor Relations and Corporate Affairs
Par Pharmaceutical Companies, Inc.
(201) 802-4000
|
