BioWorld International Correspondent

PARIS - BioAlliance Pharma SA set up a new subsidiary called SpeBio to sell and distribute Loramyc in Europe.

SpeBio is a joint subsidiary between Paris-based BioAlliance and Spepharm Holding BV, of Amsterdam, the Netherlands, with which BioAlliance signed an agreement in March providing for the creation of a 50:50 joint venture to market Loramyc in all European Union countries except France, where BioAlliance has set up its own sales force.

Under that agreement, BioAlliance is due to receive a total of €29.5 million (US$39.4 million) from Spepharm for distribution rights to Loramyc in Europe. Spepharm has paid €8 million to date, consisting of an investment of €5 million in the acquisition of BioAlliance shares and an up-front payment of €3 million for the licenses granted by BioAlliance (which are valued at €24.5 million altogether).

The balance of €21.5 million that Spepharm is due to pay BioAlliance is linked to the regulatory approvals for Loramyc in two major European countries and to sales of the product in the territory covered by the joint venture.

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 the disease. It received marketing approval in France last October for the treatment of oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV.

The approval was granted by the French Health Products Safety Agency, and a European mutual recognition procedure is under way. According to BioAlliance Pharma's CEO, Dominique Costantini, "the setting-up of SpeBio means we will be ready for the launch of Loramyc once the mutual recognition procedure is completed." The product is due to be launched in France before the end of this year.