BioAlliance Pharma has attended the 49th Annual Interscience Conference
on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco to present results on miconazole
Lauriad® and anti-integrase inhibitor.
The results of a phase III study with miconazole Lauriad® mucoadhesive buccal tablets (MBT) that
demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic
infection of the mouth and throat, were subject to an oral presentation. This study is the largest study
conducted to date in OPC.
The randomized, double-blind, double-dummy study compared the efficacy and safety of once-daily
miconazole 50 mg MBT to clotrimazole 10 mg troche administered five times per day for treatment of
OPC for 14 days. The study was conducted in 577 HIV/AIDS patients in 40 sites in the United States,
Canada and South Africa. Results showed no significant differences between miconazole MBT and
clotrimazole troches in any of the clinical efficacy endpoints, including the primary endpoint of complete
resolution of signs and symptoms of OPC.
Results on two European phase III studies were also presented in two posters entitled: “Miconazole
Mucoadhesive Buccal Tablet for the Treatment of Oropharyngeal Candidiasis in Head and Neck Cancer
Patients” and “Evaluation of Miconazole MucoAdhesive Buccal Tablet: a novel once daily antifungal
treatment for Oropharyngeal Candidiasis”.
“With a fourth poster presented on our new integrase binding inhibitor acting in synergy with current
integrase inhibitor on HIV resistant strains, and with Loramyc® targeted on infection site also fighting
clinical resistance, BioAlliance confirms its expertise on treatment resistance issues”, said Pierre Attali,
Chief Medical Officer of BioAlliance Pharma.
“Based on this clinical phase III dossier, Strativa, the proprietary products division of Par Pharmaceutical
Companies, Inc. (NYSE: PRX), our exclusive U.S partner, could commercialize the product in the US, if
approved by the U.S. Food and Drug Administration (FDA), in the second half of 2010. While already
approved in 12 European countries under the trade name Loramyc®, miconazole MBT would be the first
miconazole oral local therapy available in the U.S., for the benefit of immunocompromised patients”, said
Dominique Costantini, President and CEO of BioAlliance Pharma.
OPC, also 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.