Biofrontera AG

Pivotal Phase III Data Demonstrate Significant Efficacy and Excellent Safety for BF-200 ALA Treatment of Superficial Skin Cancer

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Results Outlined in Poster and during Two Oral Presentations at 14^th Annual South Beach Symposium

LEVERKUSEN, Germany, February 11, 2016 - Biofrontera AG (FSE: B8F), the specialist for sun-induced skin cancer, presents data from three pivotal Phase III trials for its lead drug candidate BF-200 ALA at the 14th Annual South Beach Symposium. The studies demonstrate very high efficacy, positive safety and excellent aesthetic outcomes that is activated using photodynamic therapy (PDT) for the topical treatment of actinic keratosis (AK), a superficial skin cancer caused by sun damage.

The results are being presented in a poster (Poster #118) on display February 11-14 and will be highlighted during two oral presentations on Friday, February 12 by two members of Biofrontera's Scientific Advisory Board at the 14^th Annual South Beach Symposium, being held February 11-14, 2016 at the Fontainebleau Hotel in Miami Beach, Florida.

Two of the studies formed the basis for marketing authorization approval of BF-200 ALA as first-line treatment of mild to moderate actinic keratosis on the face and scalp by the European Medicines Agency in December 2011. The third study was performed to strengthen the New Drug Application submitted to the U.S. Food and Drug Administration in July 2015. Filing of the application was accepted in September, since when the FDA undertakes its substantive review. No review issue was reported by the FDA following their mid-term review meeting.

In the three Phase III trials conducted in centers in Germany, Switzerland and Austria, a total of 779 patients with 4 to 8 mild to moderate AK lesions were randomized, with all three studies using red light PDT with LED illumination sources at approximately 635 nanometers (nm).

• A 122-patient Phase III study demonstrated excellent efficacy of BF-200 ALA compared to placebo with a patient complete clearance rate of 87%, compared to placebo response of 13%.¹
• A 571-patient Phase III study showed significantly improved patient clearance rates for BF-200 ALA (85%) compared to those of placebo (13%) and methylaminolevulinate (MAL) (68%), which is marketed as Metvix(TM) and was the current standard of care topical photosensitizing agent used in PDT. A 1-year follow-up showed slightly lower recurrence rates for BF-200 ALA compared to MAL, and PDT side effects were not enhanced using BF-200 ALA.²
• An 86-patient Phase III study used a field directed approach (the entire tube of BF-200 ALA was applied to a field of cancerized skin) and compared efficacy and cosmetic outcome of BF-200 ALA with placebo, finding that 91% percent of the patients completely cleared after a maximum of two treatments with BF-200 ALA, compared to only 22% complete clearance with placebo. With BF-200 ALA treatment, clearance was sustained over one year of follow-up in 63.3% of the patients. Several cosmetic parameters were followed during follow-up and found to continuously improve, for the first time proving the strong skin rejuvenation of PDT in a controlled pivotal trial.³

In addition to the three phase III studies on AK, results of a Phase III study of BF-200 ALA for the treatment of non-aggressive basal cell carcinoma (BCC) showed high clearance rates of all superficial and nodular BCCs in more than 93.4% of the patients.