Pharmaceutical Industry discussion, review, analysis, news and information.

BioAlliance Pharma SA (EPA:BIO) has received marketing authorization for Loramyc® (miconazole Lauriad) from France's regulatory body, AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé). Loramyc® is the firm's first product, developed for the treatment of oropharyngeal candidiasis (OPC) in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV.

OPC, or commonly known as "thrush" is a fungal infectioncaused by a fungus called Candida, and is characterized by painless, white patches in the mouth, which may or may not be accompanied by pain and difficulty in swallowing. It occurs more frequently and more severely in people with weakened immune systems.

Loramyc is an oral bioadhesive buccal tablet containing miconazole developed to optimize local antifungal activity in the oropharyngeal cavity by ensuring an early and extended release of a dosage resulting in miconazole saliva concentrations greater than 1 µg/mL, the required minimum inhibitory concentration (MIC) level to treat OPC.

According to international data, the market for oropharyngeal candidiasis is approximately 350 million Euro, and Loramyc® is expected to obtain a 30 per cent market share. In the US, Loramyc® is currently undergoing a pivotal Phase III clinical trial.

More details from BioAlliance Pharma's press release (pdf file)