FDA Accepts Drug Application For Miconazole Lauriad(R) To Treat Oropharyngeal Candidiasis

Main Category: Ear, Nose and Throat
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 20 Aug 2009 - 2:00 PDT

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Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), 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 submission was based primarily on data from a Phase III study demonstrating noninferiority to Mycelex((R)) Troche (clotrimazole) in the complete resolution of signs and symptoms of OPC. 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.

"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.

OPC, familiarly known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.

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

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.

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.

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, 2008, 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