Biofrontera AG

Pivotal Phase III Data Demonstrate Significant Efficacy and Excellent Safety for BF-200 ALA Treatment of Superficial Skin Cancer - Seite 2

Prof. Dr. Hermann Lübbert, PhD, CEO of Biofrontera AG, commented, "These results from our three Phase III trials evaluating BF-200 ALA in actinic keratosis are substantial as they demonstrate the clinical viability of our novel combination therapy system. Our photosensitizer agent BF-200 ALA utilizes a unique delivery method through nanoemulsion technology which constitutes a stabilized and penetration-enhancing formulation for use in PDT, making it one of the most effective treatment modalities for the removal AK lesions and BCC tumors."

Dr. Brian Berman, MD, PhD, Professor Emeritus, Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine and SBS Session Director and presenter of the oral presentation Futures Symposium: Innovations in Clinical and Aesthetic Dermatology, added, "Skin cancer remains the most diagnosed cancer in the U.S., and can often be fatal, requiring better treatment options and improved outcomes for patients. Innovations in the clinic like BF-200 ALA could offer an effective and safe treatment option. Data from the large 570-patient comparator study in particular demonstrated that BF-200 ALA reaches a significantly superior patient complete clearance rate in AK-treatment as compared to Metvix^® while the side-effect profile does not differ. Furthermore, the high therapeutic efficacy of BF-200 ALA becomes particularly evident when treating Olsen grade II lesions and lesions on the scalp."

 

References

1. Szeimies et al., 2010.

2. Dirschka et al., 2012.

3. Reinhold et al, submitted.

About South Beach Symposium

The South Beach Symposium has an audience of more than 550 attendees, with approximately 95% physicians in core specialties including Dermatology, Plastic Surgery, Ophthalmology and Facial Plastic Surgery. The Symposium features cutting edge educational sessions with non-overlapping CME tracks: the Masters of Pediatric Dermatology Symposium, the South Beach Clinical Dermatology Symposium, the South Beach Aesthetics Symposium and the Practice Management Symposium.

About Biofrontera

Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical company specialising in the development, sale and distribution of drugs and medical cosmetics for the care and treatment of skin diseases. Biofrontera's most important product is Ameluz®, a prescription drug which is approved in Europe for the treatment of mild and moderate actinic keratosis (superficial skin cancer) with photodynamic therapy (light therapy). Biofrontera is the first German pharmaceutical start-up company to obtain centralised approval for a drug it has developed itself. The company also plans for Ameluz® to be approved for basal cell carcinoma and is currently preparing for approval in other countries, especially in the largest pharmaceutical market in the world, the United States.