BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announces today the approval by the US FDA (Food and Drug Administration) of Oravig® (miconazole Lauriad®, known as Loramyc® in Europe) for the treatment of Oropharyngeal Candidiasis (OPC) in adults.
Oravig® is licensed to Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. and will be launched in the course of this second semester. The license agreement signed in July 2007 contemplates a $20 million milestone payment upon FDA approval, 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 US”, said Dominique Costantini, President and CEO of BioAlliance Pharma.
“With Oravig®, BioAlliance has developed an innovative local treatment for oral candida infection. We are very proud to now bring Oravig® to health care providers and patients in the US”, added John Mac Phee, Strativa President.
The NDA submission was based on the European file and on data from a large Phase III study (577 patients, 28 sites in the United States, Canada, and South Africa) comparing Oravig® (miconazole Lauriad®) to Mycelex® Troche (clotrimazole, the reference product in the USA) in the complete resolution of signs and symptoms of OPC.