BioWorld International Correspondent
PARIS - BioAlliance Pharma SA has launched its first product, Loramyc, in France. Loramyc is a once-a-day topical formulation of miconazole that incorporates BioAlliance's Lauriad adhesive technology.
The product received marketing approval from the French Health Products Safety Agency in October 2006 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. A European mutual recognition procedure is under way.
According to Paris-based BioAlliance Pharma, Loramyc is an optimized antifungal treatment with the same level of activity as systemic therapies but with the added advantage that it specifically targets the mouth and the oropharynx.
Dominique Costantini, president and CEO of BioAlliance Pharma, welcomed the fact that the French authorities had granted it "a manufacturer's price reflecting the innovation inherent in Loramyc."
The price of a daily dose is set at €4 (US$5.53), representing a manufacturer's price of €56 and a patient's price of €70 for a box of 14 tablets, which BioAlliance says is "at the upper end of analysts' forecasts."
To support the launch of Loramyc, BioAlliance, which has been listed on the Eurolist market of the Euronext Paris stock exchange since completing an IPO in December 2005, raised €40 million in July in a private placement with 32 international institutions.
BioAlliance has established its own sales force to market Loramyc in France, but in other European Union countries, the product will be marketed by SpeBio, a 50:50 joint venture that BioAlliance formed in March with Spepharm Holding B.V., of Amsterdam, the Netherlands.
BioAlliance is due to receive a total of €29.5 million from Spepharm for distribution rights to Loramyc.
Although Loramyc probably will not be launched in the U.S. until 2009, BioAlliance signed an exclusive licensing agreement in July with Par Pharmaceutical, of Wooodcliff Lake, N.J., for the commercialization of Loramyc in the U.S.
The deal is worth $65 million, and the French company received an initial payment of $15 million. Par is to pay BioAlliance $20 million upon FDA approval of Loramyc, expected in 2008, as well as possible milestones and royalties on sales.
At the same time as launching Loramyc, BioAlliance announced its financial results for the first half of 2007, which showed an increased net loss of €8.76 million, compared with €5 million in the same period of 2006. According to the company, this outcome "reflects a mature portfolio, with three products in Phase III."
In addition to conducting a pivotal Phase III trial of Loramyc in the U.S., BioAlliance is carrying out a Phase II/III trial of its doxorubicin Transdrug in Europe in the indication of primary liver cancer, as well as a Phase III trial of acyclovir Lauriad for the treatment of oral herpes in four European countries plus Australia.
The company plans to file the product for marketing approval in Europe in the first half of 2009.