BioAlliance Pharma: FDA Accepts Drug Application For Miconazole Lauriad(R) (Loramyc(R)) To Treat Oropharyngeal Candidiasis

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Aug 2009 - 22:00 PDT

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BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad® (Loramyc®) Mucoadhesive Buccal Tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole Lauriad® 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® 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. This represents the largest study ever conducted in OPC.

"The NDA acceptance of miconazole Lauriad® represents a significant milestone for BioAlliance Pharma towards providing an innovative and effective option for OPC treatment to patients and healthcare providers in the USA," said Dominique Costantini, President and CEO of BioAlliance Pharma. If approved, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical, Inc. (NYSE: PRX), BioAlliance Pharma's partner for commercialization in the USA, could launch miconazole Lauriad® in the second half of 2010. This innovative product is protected in the USA by granted patents and patent applications in force until 2028.

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 Lauriad® was approved in 11 European countries and is currently being marketed in France under the trade name Loramyc®. While miconazole Lauriad® 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 Lauriad®. 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.

Source
BioAlliance Pharma

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