Biofrontera AG

Biofrontera Reports Financial Results and Business Update for Third Quarter and First Nine Months 2016 - Seite 3

After completion of the reporting period, the European Commission consented with an unlimited extension of the EU approval for Ameluz®. In the EU, approvals for new drugs are initially limited to five years, after which a thorough assessment of all then available efficacy and safety data is performed by the EMA before the approval gets an unlimited extension.

Clinical Developments
Biofrontera initiated its Phase III clinical trial of Ameluz® in June to evaluate its safety and efficacy in combination with daylight photodynamic therapy in comparison with Metvix® for the treatment of mild to moderate actinic keratosis. The multi-center study in the EU completed patient recruitment in September with a total of 52 patients across 8 sites, and is expected to be completed by the fourth quarter of 2016, with approval anticipated in 2017.
In addition to the daylight PDT trial, Biofrontera announced 12-month follow-up results of its Phase III trial evaluating Ameluz® for basal cell carcinoma. The analysis concluded that patients treated with Ameluz® PDT saw an overall lesion recurrence rate of 6.7% compared to 8.2% for those treated with comparator Metvix® at 12 months. Treatment with Ameluz® also resulted in an excellent cosmetic outcome at 12 months, with 68.3% of Ameluz® patients exhibiting improved aesthetic appearance compared to 65.5% of Metvix® treated patients.

International Commercialization
Biofrontera continues to progress in its efforts to expand the commercialization of Ameluz® and BF-RhodoLED®. The Swiss medical regulatory authority Swissmedic has granted approval in Switzerland, where reimbursement status has also been obtained. Biofrontera's partner Louis Widmer in Switzerland began commercialization of the products in April 2016.
The approval for Ameluz® in Israel was granted in April, Biofrontera's partner in Israel, Perrigo, is currently preparing the commercial launch of Ameluz®.

-Ends-

Enquiries, please contact: Biofrontera AG
Thomas Schaffer, Chief Financial Officer [phone]
[e-mail]

IR Germany: Brainwell Asset Solutions
Jürgen Benker [phone]
IR UK: Seton Services
Toni Vallen [phone]
IR and PR US: The Ruth Group
IR: Lee Roth / Tram Bui
PR: Kirsten Thomas
[phone] / 7035
[phone]

About Biofrontera

Biofrontera Group (FSE: B8F, ISIN DE0006046113) Biofrontera is a biopharmaceutical company specializing in the development, sale and distribution of drugs, medical devices and medical cosmetics for the care and treatment of skin diseases. Biofrontera's most important product is Ameluz®, a prescription drug which was initially approved and marketed in Europe and is now also approved in the US for the treatment of mild and moderate actinic keratosis, a precursor to squamous cell carcinoma, with photodynamic therapy (light therapy). Biofrontera is the first German pharmaceutical start-up company to obtain centralized EU and now US approval for a medical device/drug it has developed itself.