Biofrontera Launches Ameluz for Actinic Keratosis

Biofrontera AG initiated the US commercial launch of its combination topical prescription drug Ameluz and medical device BF-RhodoLED, which has been FDA approved to treat mild to moderate actinic keratosis (AK) on the face and scalp.

Ameluz is used in combination with the medical device BF-RhodoLED for photodynamic therapy treatment (PDT). FDA approval of the combination treatment covers lesion-directed and field-directed treatment of AK. Field-directed treatment is recommended by dermatological guidelines due to the observation that early AKs are particularly prone to progression to squamous cell carcinoma. In addition, after field-directed treatment with Ameluz, patients benefit from the long-lasting skin rejuvenation effect demonstrated in Biofrontera's phase III trials.

"The commercial launch of Ameluz in the US represents a major milestone for Biofrontera, and we are pleased with the initial feedback from our experienced sales force," commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera. "We are well prepared to serve the rapidly growing PDT market as indicated by the accelerated activity at our production facility for the accompanying BF-RhodoLED lamps, many of which are in the process of being installed in dermatology offices across the U.S. Additionally we will host a VIP event at the Fall Clinical Dermatology Conference in Las Vegas later this week, to broadly announce the launch of Ameluz® to the US dermatology community."

In addition to the United States, Ameluz® is commercially available in 13 countries throughout the European Union, which recently expanded the label for Ameluz® to include field cancerization and the skin rejuvenation data.

The Fall Clinical Dermatology Conference is an annual meeting organized by the American Association of Dermatology (AAD). It is the second largest annual conference for US dermatologists and takes place in Las Vegas from October 20th to 23rd, 2016.