BioWorld International Correspondent
PARIS - BioAlliance Pharma SA has created a wholly owned sales and marketing subsidiary, Laboratoires BioAlliance Pharma SAS, to prepare for the launch of Loramyc, its 50-mg formulation of miconazole as a once-a-day, bioadhesive, buccal tablet for the treatment of oropharyngeal candidiasis.
The company filed Loramyc for marketing authorization approval in Europe in September and expects the product to be approved as a first-line local treatment for oropharyngeal candidiasis before the end of this year.
Paris-based BioAlliance intends to launch the product in France in the first half of 2007, with a roll-out in other European countries as approvals are obtained under the mutual recognition procedure. Oropharyngeal candidiasis is an oral fungus commonly found in immuno-compromised patients suffering from diseases such as cancer, HIV and diabetes,
BioAlliance Pharma CEO Dominique Constantini, who also is president of Laboratoires BioAlliance Pharma, said the new subsidiary will allow the company to "operate as a vertically integrated specialty pharmaceutical organization."
Florence Dupré has been appointed vice president for sales and marketing of Laboratoires BioAlliance Pharma, having joined BioAlliance Pharma in that capacity in January. She is to recruit the company's initial sales force, which is due to be in place by the fall in order to prepare the product launch in France.
BioAlliance Pharma, which is developing therapeutics to overcome drug resistance in cancer, HIV and other infections, is due to embark on a pivotal Phase III trial of Loramyc in the U.S. this summer in conjunction with an American partner that will complete development and registration. The company hopes Loramyc will be on file in the U.S. in early 2008 and be approved before the end of that year.
Loramyc incorporates BioAlliance's Lauriad adhesive technology, which ensures early and prolonged release of therapeutic agents at the site of the disease. It is one of two proprietary drug delivery systems for BioAlliance, the other being its TransDrug nanoparticle technology for intracellular targeting.
BioAlliance Pharma in December completed an initial public offering on Eurolist Compartment C of the Euronext stock exchange in Paris, raising gross proceeds of some €30 million.