Phase III results of Lauriad presented at the 49th Annual ICAAC

Sep 15 2009

BioAlliance Pharma has attended the 49^th 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.