On Track to File NDA with FDA in Early to Mid-2009
WOODCLIFF LAKE, N.J., Dec. 2 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its development partner, MonoSol Rx, reported the successful completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron. The ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
Subject to final review of the data and discussions with the Food and Drug Administration (FDA), it is anticipated that Strativa and MonoSol Rx could file a New Drug Application (NDA) in early to mid 2009.
In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for the purchase of product supply and royalties on net sales. The successful achievement of all pivotal bioequivalence studies triggered a milestone payment to MonoSol Rx.
John A. MacPhee, president of Strativa, said, "Completion of the pivotal bioequivalence trials is a significant milestone in the development and commercialization process for our thin film ondansetron formulation. Working with MonoSol Rx we were able to demonstrate that the thin film formulation is bioequivalent to the FDA approved Zofran ODT(R) product in all human clinical trials."
Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.8 billion in 2007 at a prescription drug price. Ondansetron was a prescription leader in the category in 2007, with 2.7 million scripts written.
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa 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 commercialization 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 specialty pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films. PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that enable the funding of prescription product development programs that will generate long-term value.
The Company's commercialization strategy for all PharmFilm(R) products is to partner with the innovator or other specialty pharma or leading consumer products companies who have the core competency to sell-in and manage the sales and marketing of the products. For the Company's existing and future partners, PharmFilm(R) formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and ODTs.
Certain statements in this news 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 known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2007, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news 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 Companies, Inc.|
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