Biofrontera delivers excellent results from the Phase III study for field therapy of actinic keratosis for publication

Biofrontera AG / Biofrontera delivers excellent results from the Phase III study for field therapy of actinic keratosis for publication . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Excellent clearance rates with 90.9% of patients cleared from all actinic keratoses

Details of skin quality assessment illustrate strong skin rejuvenation effect

Leverkusen, 06 May 2015 - Biofrontera AG (AIM/FSE: B8F), the biopharmaceutical company focussing on sun induced skin cancer, has prepared a scientific publication about the results of the multi-centre, placebo-controlled phase III study for field therapy of actinic keratosis using the combination of Biofrontera's prescription drug Ameluz^® and PDT-lamp BF-RhodoLED^®. Field therapy involves treating entire fields on the face or scalp covered with mild to moderate actinic keratosis with photodynamic treatment (PDT) with an entire tube of Ameluz^® in combination with Biofrontera's PDT-lamp BF-RhodoLED^®. Preliminary results of the phase III trial were first published in October 2014 and comprise a key component of the clinical program executed for the approval of Ameluz^® in the US.

With 90.9% of all patients fully cleared from all actinic keratoses, the combination of Ameluz^® and BF-RhodoLED^® provided excellent efficacy. After a maximum of two treatments clearance of the non-hyperkeratotic Olsen Grade I lesions¹ reached 99.1%, that of the moderately hyperkeratotic Olsen Grade II lesions 91.7%. Completely eliminating all Olsen Grade I lesions is of particular importance since up to 63.8% of all squamous cell carcinomas originate from the less suspicious Olsen Grade I lesions².

The cosmetic outcome of the treatment was assessed by the clinical investigators without taking the removal of the keratotic lesions into consideration. All tested parameters improved significantly during the treatment. The number of patients left without skin roughness, dryness, and scaliness increased from 14.8% to 63% after Ameluz^® treatment. Patients without hyperpigmentation or hypopigmentation increased from 40.7% to 57.4% and 53.7% to 70.4%, respectively. Mottled pigmentation, including both hyper- and hypopigmentation within the treatment area, decreased from 48.1% of the patients to 29.6% of the patients, respectively. Before treatment, 22.2% of the patients displayed mild scarring, which after treatment was reduced to 14.8% of the patients. Atrophic skin tissue was apparent in 31.5% of the patients before, and in 16.7% of the patients after treatment.