Biofrontera AG

Biofrontera Initiates U.S. Commercial Launch of Ameluz® for Actinic Keratosis

Business news for the stock market

Leverkusen (pta043/18.10.2016/14:30) - -

- Commercial launch follows FDA approval in May 2016
- Rapidly onboarding experienced sales and marketing team with 4 regional sales managers and 13 representatives
- Well positioned to capture significant market share in PDT
- Launch VIP event at Fall Clinical Dermatology Conference

Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that it has initiated the U.S. commercial launch of its combination topical prescription drug Ameluz® and medical device BF-RhodoLED®, which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate actinic keratosis (AK) on the face and scalp.

Ameluz®, a topical prescription drug, 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. Typically, AK lesions occur on the face, scalp, lips, arms and hands, and when left untreated, AK lesions can develop into squamous cell carcinoma. 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 U.S. represents the largest photodynamic therapy market in the world, with approximately 58 million patients suffering from actinic keratosis. Photodynamic therapy in the U.S. is a well-established, accepted and reimbursed treatment option with a rapidly growing market share. Biofrontera is well positioned to enter the U.S. market, and is rapidly onboarding an experienced sales and marketing team, this year growing to 4 regional sales managers and 13 sales representatives who will drive early adoption with their strong prior experience in the PDT arena. The Company aims to expand its sales force to 5 regional sales managers and a total of 45 sales representatives by the end of 2017. The Company will initially target regions of the U.S. which have a high concentration of dermatology practices and build a strong foundation of support from key opinion leaders.