BioWorld International Correspondent

PARIS - BioAlliance Pharma SA received marketing approval for Loramyc in France for oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV.

Loramyc is a 50-mg, once-a-day topical formulation of miconazole incorporating BioAlliance's Lauriad adhesive technology, which allows early and prolonged release of therapeutic agents at the site of disease. The approval was granted by the French Health Products Safety Agency and will be the basis for a European mutual recognition procedure.

Describing it as "another major milestone" for BioAlliance, the CEO of the Paris-based company, Dominique Costantini, said the next step would be to negotiate pricing with the French authorities and to prepare for a 2007 launch in France.

After that, BioAlliance plans to commercialize Loramyc in other European countries. In addition, it is carrying out a pivotal Phase III trial of Loramyc in the U.S., where the company hopes to file for approval in 2008.

The company pointed out that the market for oropharyngeal candidiasis is worth an estimated €350 million (US$438.9 million) a year, and it expects Loramyc to capture 30 percent of that at peak.

BioAlliance focuses on therapeutics to treat drug resistance in cancer, HIV and severe and opportunistic infections. Lauriad is one of two drug delivery technologies it has developed, the other being Transdrug, a proprietary nanotechnology that allows intracellular drug targeting for optimal efficacy and tolerability.

The company's first product incorporating the technology, doxorubicin Transdrug, recently completed a Phase I/II trial in primary liver cancer. That drug, which is injected directly into the liver via a catheter inserted in the hepatic artery, has been granted orphan drug status by the EMEA in Europe and the FDA in the U.S. for hepatocellular carcinoma, the most fatal form of liver cancer for which no approved treatment exists.