US FDA approves Strativa's Oravig, triggering a $20 million milestone for France's BioAlliance; Agency could put hold on GSK

US drugmaker Strativa Pharmaceuticals says that the Food and Drug Administration has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), or thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole - an antifungal medication - approved for this use in the USA.

Oravig, sold as Loramyc in Europe, was licensed to Strativa by France's BioAlliance Pharma in July 2007, and the US approval triggers a $20 million milestone to the French group, meaning the latter has received $35 million to date. Strativa, which is wholly-owned subsidiary of Par Pharmaceutical, said the drug will be launched in the third quarter of this year and noted that BioAlliance is eligible for additional sales milestones and royalties on sales of the product.

'This is a major achievement and the first time for a French biotech company to gain a US approval. BioAlliance expertise in development and registration at the international level is here properly recognized and rewarded. Following our commercial partnership agreement with Therabel Group for Europe (Loramyc and Setofilm), we are very confident in Strativa's commercialization ability to ensure Oravig success in the USA,' said Dominique Costantini, president and chief executive of BioAlliance.