BioWorld International Correspondent

Norwegian cancer therapy firm PhotoCure ASA submitted a new drug application to the FDA for Metvix Photodynamic Therapy in the treatment of nodular and superficial basal cell carcinoma (BCC).

The same regimen has already gained an FDA approvable letter for treatment of actinic keratosis, or premalignant skin lesions, although it has not yet been launched in the U.S. It is approved for marketing in both indications in most European countries and New Zealand.

The Oslo-based company's NDA submission comprises data from a series of pivotal Phase III trials that involved 340 patients and a total of 498 BCC lesions. "We have actually six Phase III clinical studies - one in the U.S., two in Australia and the rest in Europe on BCC," PhotoCure CEO Vidar Hansson told BioWorld International.

PhotoCure has not publicly disclosed its U.S. Phase III data, but this time last year it reported on studies involving 200 patients following 12 months of observation. In patients with superficial BCC, which generally occurs as multiple lesions, often on the trunk, it observed an 8 percent recurrence rate with Metvix PDT compared to a 16 percent recurrence rate for cryotherapy. In patients with nodular BCC, which generally develops as a solitary lesion on the face or nose, it observed a 5 percent recurrence rate for Metvix PDT, as compared with 0 percent for surgery. The company claimed a superior cosmetic outcome for Metvix PDT as compared to standard therapy.

Metvix PDT comprises a two-step treatment process in which a topical cream is applied to the lesion and allowed to stand for several hours. During this period, its active ingredient, methylaminolevulinate, is converted into a photosensitizer and accumulates selectively within the cancerous cells. Illumination with red light for 10 minutes excites the photosensitizer, resulting in the production of cytotoxic single-oxygen molecules, which destroy the cells.

Galderma SA, the dermatology pharmaceutical firm jointly owned by Nestlé SA, of Vevey, Switzerland, and L'Oréal Group, of Clichy, France, has marketing rights to Metvix PDT outside of the Nordic region. So far, it has launched the product only in Germany, while PhotoCure already is marketing it throughout its home territories.

Hansson said the product is aimed at a large market. "I think that a good guess for BCC in the U.S. is an incidence of 1 million new patients in one year," he said. But developing that market will be a gradual process. "When you are going to take this market from surgeons and give it to other kinds of doctors, it's quite normal to consider a five- to seven-year time frame to maximum sales, or even longer," he said.