BioAlliance Pharma has gained marketing authorisation for its novel muco-adhesive antifungal tablet in the UK and Denmark, triggering a €2.5m payment and marching on with the drug's launch across Europe.
Approved in France in September 2007, Loramyc (miconazole) can now be introduced in the additional regions through the European Mutual Recognition Procedure. Gaining authorisation in the UK is a particular milestone for the French firm, as it triggers a €2.5m payment by the company's partner, SpePharm.
The innovative muco-adhesive tablet is intended for the treatment of oropharyngeal candidiasis (an opportunistic infection often contracted by immunocompromised patients), and is formulated using BioAlliance's patented Lauriad drug delivery technology.
According to the company, the Loramyc product offers significant advantages over other oral antifungal treatments currently available.
The tablet itself sticks to the mucous membranes of the mouth and ensures prolonged release of the therapeutic agents solely at the actual site of infection without systemic passage.
This carries the added advantage that the product only needs to be applied once daily, an improvement over other gel-based treatments that may need applications four or five times a day.
According to BioAlliance, the drug delivery technique could also help curb resistance when placed as a first-line treatment before the use of systemic antifungals, particularly important for immunocompromised patients.
The simplified treatment regime should lead to improved patient compliance, and when combined with trial results that reveal improved tolerability and efficacy and decreased systemic exposure to miconazole, it is not surprising that BioAlliance has attracted partners for both the US and European markets.
July saw the company sign a $65m exclusive licensing and commercialisation deal with Parr Pharmaceutical in the US, just a few months after landing a European partner in a €29.5m deal with Dutch firm SpePharm. The SpePharm agreement resulted in the establishment of a joint venture, SpeBio, launched in June to commercialise Loramyc across Europe (excluding France).
BioAlliance sees Loramyc a major player in the antifungals market as it becomes available over the course of the year. According to BioAlliance CEO, Dominique Constantini, the treatment is forecast to grab a 30 per cent slice of the €350m market.
Europe represents approximately one third of the potential market for the treatment, with the US representing a further 50 per cent; approval in the States is anticipated in 2009.
Loramyc is the first product to be launched by BioAlliance, though the company has two other products based on the Lauriad delivery technology currently in its pipeline. A near term follow-on acyclovir product for oral herpes is currently in clinical trials, and a fentanyl product for treatment of severe resistant cancer pain is likely to be the next candidate using the technology.