Biofrontera AG

Biofrontera Announces 12-Month Follow-Up Results of Phase III Trial Evaluating Ameluz® for BCC

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Leverkusen (pta019/20.10.2016/10:00) - Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced 12-month follow-up results from its Phase III clinical trial evaluating its combination topical prescription drug Ameluz® and medical device BF-RhodoLED® for the treatment of basal cell carcinoma (BCC). The analysis confirmed that photodynamic therapy (PDT) with Ameluz® had a lower lesion recurrence rate at 12 months compared to PDT with comparator Metvix®.

The 12-month follow-up results from the multi-national study in the European Union reported that patients treated with Ameluz® PDT saw an overall lesion recurrence rate of 6.7% compared to 8.2% for those treated with the comparator treatment, methyl aminolevulinate (MAL) PDT, marketed as Metvix®. The lower recurrence rate was confirmed by subgroup analysis. For the treatment of Superficial BCC, patients treated with Ameluz® saw a recurrence rate of 5.4%, compared to 7.9% for those treated with Metvix®. In Nodular BCC, Ameluz® had a recurrence rate of 9.1% versus 10.0% recurrence for Metvix®. Recurrence rates of BCC's on the head were 7.7% and 18.2% for Ameluz® and Metvix®, respectively. In BCC's of the trunk, Ameluz® and Metvix® had recurrence rates of 6.7% and 7.6%, respectively.

Treatment with Ameluz® also resulted in an excellent cosmetic outcome. In 60.0% of patients treated with Ameluz®, after 3 months skin aesthetic appearance was notably improved and rated by study physicians as good or very good, compared to only 48.6% of patients treated with Metvix®. After 1-year follow-up improvement of skin aesthetic appearance was still in favor of Ameluz®, rating 68.3% of Ameluz® treated patients and 65.5% of Metvix® treated patients with a good or very good skin aesthetic appearance, respectively.

"These very positive follow-up results demonstrate the long term clinical efficacy of Ameluz® in reducing the risk of recurring BCC alongside sustained skin rejuvenation effects," stated Prof. Hermann Lübbert, CEO of Biofrontera AG. "Ameluz® remains a superior photodynamic therapy treatment option for Actinic Keratosis and BCC, and these results will aid our ongoing EU application for the label extension to include basal cell carcinoma with expected approval by Q1 2017. The expansion of Ameluz® to BCC would significantly expand our market and revenue opportunity in the EU."