Loramyc®

The Loramyc® mucoadhesive gingival tablet is the first product developed and sold by BioAlliance Pharma.

Loramyc® is based on the Lauriad® technology, an oral delivery system allowing for a novel way of targeting the mucous membranes, releasing rapidly and on a continued basis a quantity of active pharmaceutical ingredient that impregnates the infected tissues, without systemic transfer. Loramyc® is the first anti-mycosis specialty to use this adhesive gingival technology.

The gingival tablet has been designed to remain in place in the oral cavity (in the canine fossa) where it gradually releases the active pharmaceutical ingredient. The gingival tablet disintegrates when release has ended. The tablet matrix, which gives the tablet its mucoadhesive properties, consists of a milk protein concentrate. This natural protein excipient gradually becomes hydrated and sticks to the proteins of the mucous surface, and then releases the active pharmaceutical ingredient on a prolonged basis. This excipient has been chosen for its long-lasting adhesive qualities, and it is moreover widely used in the food industry.

Miconazole Lauriad® (Loramyc®) is indicated for the treatment of oropharyngeal candidiasis in immune compromised patients. Oropharyngeal candidiasis is a fungal infection caused by candida which may develop in immune compromised patients, notably cancer patients being treated by chemotherapy or radiation therapy and HIV-infected patients). If left untreated in these fragile patients, oropharyngeal candidiasis may invade the esophagus or further progress to induce systemic complications.

BioAlliance Pharma has obtained its first marketing authorisation for Loramyc® in France in October 2006 and in 12 European countries at the end of 2007 via a European registration procedure (mutual recognition procedure). In 2009 marketing authorization has also been obtained in Korea (in February) and in Switzerland (in September).

The NDA (New Drug Application) file is under review by the FDA (Food and Drug Administration) and the marketing authorization in the United States is expected to be obtained in the first semester 2010.

Loramyc® is sold on the French market since September 2007 at a public price of € 71.55 per bottle of 14 tablets. It is entitled to a 65% reimbursement rate under the French public policy.

Loramyc® is also commercialized in the United Kingdom since May 2008 and in Germany since July 2008.