Files NDA for Ondansetron Orally Dissolving Film Strip
BioAlliance to Resubmit Loramyc(R) NDA
WOODCLIFF LAKE, N.J., April 9 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today provides an update on two of its pipeline products.
Ondansetron Orally Dissolving Film Strip
On April 7, 2009, Strativa submitted a New Drug Application (NDA) for its new orally dissolving film strips (ODFS) formulation of ondansetron to the U.S. Food and Drug Administration (FDA). Strativa is seeking approval of ondansetron ODFS in 8 mg and 4 mg strengths for the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of post-operative nausea and vomiting.
A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to Zofran ODT(R) 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions.
The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.
In June 2008, Strativa acquired the commercialization rights in the United States and its territories to ondansetron ODFS from MonoSol Rx. To date, Strativa has paid MonoSol Rx a total of $3.5 million for the completion of certain milestones.
Loramyc(R) (miconazole Lauriad) for the treatment of oropharyngeal candidiasis (OPC)
After preliminary review, the FDA has informed BioAlliance Pharma, Strativa's development partner, that the agency did not accept its NDA for Loramyc(R) (miconazole) mucoadhesive buccal tablet (MBT) based on the lack of an imprint code on the tablet. Loramyc was approved in the European Union in 2007 and is currently marketed in several EU territories. The EU does not require an imprint code while the U.S. requires an imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of a debossed tablet and will soon after resubmit the Loramyc application.
About Strativa Pharmaceuticals
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 BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The Company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.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 new and currently marketed drugs. The Company's leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on 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 fund 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, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For 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 orally disintegrating tablets (ODTs).
Safe Harbor Statement
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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