BioWorld International Correspondent
PhotoCure ASA's efforts to obtain U.S. approval for its Metvix photodynamic therapy as a treatment for basal-cell carcinoma hit another roadblock last week, as FDA officials ruled that the clinical data submitted in its new drug application were insufficient for approval.
Oslo, Norway-based PhotoCure had submitted an amended NDA in June, following an unfavorable review of an earlier application by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee in September 2003. The negative decision is a significant reverse for the company, as it already has obtained marketing approval for Metvix photodynamic therapy (PDT) in basal-cell carcinoma in 26 European states, plus Australia and New Zealand. Moreover, the same therapy obtained FDA approval as a treatment for actinic keratosis (precancerous skin lesions) in July and will be marketed in the U.S. as Metvixia.
Although less prevalent than actinic keratosis, basal-cell carcinoma is a more lucrative indication. The U.S., PhotoCure said, gets about 1 million new cases every year, more than the combined total of all of the other countries in which the treatment is approved.
"I am surprised and disappointed by this decision by FDA. We strongly believe that the current scientific data support our application and we look forward to improving our documentation in collaboration with FDA," said CEO Vidar Hansson. The FDA is seeking additional Phase III trials, which, the company said, could take up to two years. The company now is weighing its options, along with marketing partner Galderma SA, of Lausanne, Switzerland.
"I don't think it's correct to make any comment until we have made a final decision," Hansson told BioWorld International.
The FDA's verdict has immediate financial implications for PhotoCure, as approval of Metvix PDT in basal-cell carcinoma would have triggered a €10 million (US$13.4 million) milestone payment from Galderma, adding to cash reserves that stood at NOK153.5 million (US$25.4 million) on Sept. 30.
Investors reacted by selling the stock Friday, in PhotoCure's heaviest trading day of the year on the Oslo Stock Exchange. A total of 495,500 shares changed hands, whereas the company's average daily trading volume had been just more than 30,000 shares for the preceding three months. At its close, the stock was down 16 percent at NOK39.90. The sell-off continued this week. It closed Tuesday at NOK36.50.
In other news, PhotoCure named its current chief operating officer, Kjetil Hestdal, successor to Hansson, who is retiring. Hestdal will take up his new post Jan. 1.