Dive Brief:
- Biofrontera, a biopharma company specializing in developing products to treat skin diseases, said Nov. 29 the European Commission extended EU approval for Ameluz (aminolevulinic acid hydrochloride), its drug for treating mild to moderate actinic keratosis on the face and scalp.
- The EU decision comes on the heels of Biofrontera's commercial launch of Ameluz, in combination with the the medical device BF-RhodoLED, in the U.S. last month.
- Biofrontera is working to expand its sales force, focusing on key regions in the U.S. with higher concentration of dermatology practices. The German-based company expects its sales force will be fully staffed by the end of 2017.
Dive Insight:
According to Biofrontera, Ameluz is the only photodynamic therapy drug approved for field-directed treatment of actinic keratosis. The company said its product's gel formulation allows enhanced skin penetration and rapid application.
Approval of the treatment is supported by three pivotal Phase 3 studies, which showed a complete patient response rate of 91%.
Biofrontera said the U.S. is the largest market globally for photodynamic therapy, with about 58 million patients suffering from actinic keratosis.
In October, company executives said Biofrontera is well positioned to enter the U.S. market and is "rapidly on-boarding an experienced sales and marketing team, this year growing to four regional sales managers and 13 sales representatives who will drive early adoption with their strong prior experience in the PDT arena."
Biofrontera plans to eventually expand its sales force to five regional sales managers and a total of 45 sales representatives.
In its third-quarter update call Nov. 30, Biofrontera said its subsidiary in the U.S. "is continuing to recruit experienced personnel in important functions, with the goal of developing a fully manned, highly effective sales organization by the end of 2017."