Biofrontera has filed for a Nasdaq IPO. The German company is seeking $22 million (€18 million) to support a clutch of clinical trials designed to expand use of Ameluz in types of skin cancer and other dermatological conditions.
Ameluz is a gel formulation of 5-aminolevulinic acid that is approved for use in the photodynamic treatment of actinic keratoses—potentially precancerous patches of rough skin—in the U.S. and Europe. Officials in Europe have also approved the use of the drug in forms of basal cell carcinoma. And Biofrontera is now working on clinical trials to support further expansion of the use of the product.
That is where the anticipated IPO haul comes in. Biofrontera plans to use some of the cash from the Nasdaq listing to trial its drug in patients with superficial basal cell carcinoma, Bowen’s disease—a form of squamous cell carcinoma—and actinic keratoses.
The trials involve the use of BF-RhodoLED, a lamp Biofrontera developed for use alongside Ameluz to enable photodynamic therapy. Illumination is critical to the process of treating patients with Ameluz. The process involves applying Ameluz to lesions and leaving it for several hours. Then, the gel is wiped away and the treatment area is bathed in red light.
Lamps other than BF-RhodoLED can be used in this process in Europe. But Biofrontera saw value in offering both the drug and device parts of the treatment, particularly as the lamp’s spectrum affects clearance rates. That led it to pick up a CE mark for the lamp in Europe in 2012—the year after regulators cleared Ameluz for sale—and to a U.S. approval that covers the use of Ameluz in combination with BF-RhodoLED.
That approval is one of the motivations for the IPO. Having secured the FDA nod in October 2016, Biofrontera now plans to grow its U.S. sales and marketing infrastructure.