BioAlliance Pharma pursues development plan for Loramyc in Japan through partner Sosei

French orphan oncology and supportive care specialist BioAlliance Pharma (Euronext Paris: BIO) says its Japanese partner Sosei has initiated a Phase III clinical trial of Loramyc/Oravig (miconazole Lauriad) for the treatment of oropharyngeal candidiasis. This is the final step before registration of the drug by Japanese authorities.

In May 2011, BioAlliance Pharma signed a licensing agreement with Sosei (a wholly owned subsidiary of Sosei Group Corp (TSE Mothers Index: 4565) to conduct a development program and commercialization rights in Japan for Loramyc/Oravig muco-adhesive buccal tablets.

As traditionally required by the Japanese drug regulatory authorities, a complementary development plan driven by Sosei has been initiated to complete the registration dossier and meet Japanese regulatory requirements. Following the successful Phase I clinical trial finalized in July 2012, Sosei is now starting the final step of development with the Phase III open-label, randomised trial versus miconazole gel. This study is anticipated to last 12 to 18 months.