FDA Accepts Par Pharmaceutical Companies, Inc. Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis

WOODCLIFF LAKE, N.J., Aug. 19 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.

"The NDA acceptance of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals as this would be the first oral miconazole therapy available in the U.S. and would provide healthcare providers with a new option for treating OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "We believe miconazole MBT's delivery system and once-daily dosing schedule will offer an effective, convenient alternative to currently available local therapies, which require several doses per day to treat OPC." Strativa could launch miconazole MBT in the second half of 2010, if approved.

Miconazole MBT was approved in 11 countries and is currently being marketed in several EU territories including France, Germany and the UK under the trade name Loramyc((R)). While miconazole MBT would be the first miconazole treatment available in oral form in the U.S., other dosage forms of miconazole have been marketed around the world. Under a licensing agreement with BioAlliance Pharma SA, Strativa is the exclusive U.S. distributor of BioAlliance's miconazole MBT. Upon FDA approval of the product, Strativa will pay BioAlliance $20 million, as well as a royalty on future net sales. BioAlliance may also be entitled to milestone payments if net sales achieve specified targets.

About Strativa Pharmaceuticals

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.

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