FDA Accepts Drug Application for Miconazole Lauriad® (Loramyc®) to Treat Oropharyngeal Candidiasis

BioAlliance Pharma SA (Euronext 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
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