Strativa Pharmaceuticals Announces Phase III Results For Loramyc To Treat Oropharyngeal Candidiasis
Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. recently announced that its development partner, BioAlliance Pharma reported preliminary, top-line results for a Phase III study of Loramyc (miconazole Lauriad) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC).
Top line data show that Loramyc achieved its primary endpoint of noninferiority to Mycelex Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC (complete clinical cure). The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa. All secondary endpoints were also met. Loramyc, which is approved in Europe and currently being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing of the active ingredient at the site of infection. In July 2007, Par Pharmaceutical, Inc. entered into an exclusive licensing agreement under which Par received commercialization rights in the U.S. to BioAlliance Pharma's Loramyc(miconazole Lauriad). In return for the commercialization rights to Loramyc, Par paid BioAlliance an initial payment of $15M, which Par incurred as a research and development (R&D) expense in 2007. Upon FDA approval of the product, Par will also pay BioAlliance $20M. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.
John MacPhee, president of Strativa Pharmaceuticals, said, "We are pleased with the results of this trial. There is a significant need for this innovative treatment option for patients suffering with OPC and their healthcare providers." Mr. MacPhee continued, "Subject to a favorable review of the full study results and discussions with the FDA, an NDA could be filed in the 2nd half of 2008."
About Strativa
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 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 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.
SOURCE: Strativa Pharmaceuticals