BioAlliance's buccal tab brings in the cash

BioAlliance's innovative muco-adhesive tablet for the treatment of oropharyngeal candidiasis (an opportunistic infection commonly contracted by immunocompromised patients) has drawn the attention of Par Pharmaceutical, with the two companies entering into an exclusive licensing agreement for commercialisation of the product in the US. Loramyc (miconazole) is formulated using the company's patented Lauriad drug delivery technology, and is currently in Phase III trials. According to BioAlliance, the product offers significant advantages over other oral antifungal treatments currently available. For example, the tablet sticks to the mucous membrane in the mouth and ensures prolonged release of the therapeutic agents solely at the site of infection without systemic passage. This also therefore means that the product only needs to be applied once daily - a significant plus point over other gel-based treatments that may require application four or five times a day. This simplified treatment routine should lead to improved patient compliance, and when coupled with trial results which revealed improved tolerability and efficacy and decreased systemic exposure to miconazole, would seem to suggest that the company's high hopes for the product are well-founded. Another major advantage of the drug delivery technique is that it could be instrumental in preventing resistance when placed as a first-line treatment before the use of systemic antifungals, of particular importance for immunocompromised patients. According to BioAlliance CEO Dominique Costantini, the product will be a major player in the antifungal market when it hits the shelves: "An IMS study estimated the worldwide market for Loramyc to be €350m,"​ she told in-PharmaTechnologist.com. "Loramyc is forecast to take 30 per cent of that market." ​ Enrolment for the Phase III trial of the drug in the US is due to be complete by the end of the year, with filing expected in 2008 and US approval anticipated in 2009. Loramyc was approved in France in October 2006, and the company plans to launch the product on the French market in September this year. Regulatory approval across Europe is expected through the Mutual Recognition Procedure, with the first marketing authorisations in some EU countries expected by the end of 2007 and market launches in 2008. This latest deal with Par Pharmaceutical will bring BioAlliance a $15m upfront payment, with milestones of up to $50m, including $20m upon US Food and Drug Administration (FDA) approval. A further $30m in milestone payments could come BioAlliance's way based on future sales and royalties. Back in March the company also announced a €29.5m deal with Dutch firm SpeBio, to establish a 50/50 joint venture to commercialise Loramyc across Europe (excluding France). With Europe accounting for approximately one third of the potential market for Loramyc and the US making up 50 per cent, the difference in market size is reflected in the financials of each deal. Loramyc is BioAlliance's very first product to be launched, although the company has two other products based on the same drug delivery technique in its pipeline. One is a treatment for labial herpes based on acyclovir and currently in clinical trials, and the company is also considering a fentanyl product for treatment of severe resistant cancer pain.