B8F.L Regulatory News (B8F)

Biofrontera AG

("Biofrontera" or the "Company")

New year-round treatment option for daylight-PDTfor use in dermatological practices

The IndoorLux® system simulates daylight-PDT under controlled conditions in dermatological practices and has now received European CE marking.

Murten/Leverkusen, 07 January 2016 - SwissRed AG, Murten, has, in collaboration with Biofrontera, received the European CE marking for its IndoorLux® illumination system for treatment of actinic keratoses. The clinical efficacy of the system was demonstrated using Biofrontera's PDT drug Ameluz®. Biofrontera and SwissRed® will now collaborate in marketing the IndoorLux® system. Ameluz® is already approved as a prescription drug in the European Union and Switzerland, and its market approval for the USA is anticipated mid-2016.

IndoorLux® provides the specific absorption spectrum of protoporphyrin IX and is an exposure system based on wide spectrum emitters in the orange/red bandwidth. The system mimics the generally painless daylight-PDT for the treatment of actinic keratoses. It allows year-round PDT treatment under controlled conditions in dermatological practices irrespective of weather conditions. The permanently installed illumination system allows for the treatment of several patients simultaneously.

In Europe almost one in ten people is affected by an early form of non-melanoma skin cancer. Approximately every other person over the age of 60 has actinic keratosis lesions on the face/scalp or other sun-exposed skin regions. Visibly damaged areas of skin are frequently accompanied by hidden nests of diseased skin cells. It has recently been found that quite inconspicuous nests of diseased skin cells progress more frequently to potentially fatal squamous cell carcinoma than clearly visible keratoses. To be on the safe side, dermatologists will therefore often treat large areas.

PDT is one of the most effective field therapies of actinic keratosis, but treating large areas of skin is often painful for the patient. The PDT procedure has thus been refined to provide the almost painless daylight-PDT. However, the dependency on seasonal temperature and weather conditions is disadvantageous for daylight-PDT in Europe.

The introduction of IndoorLux® by SwissRed AG delivers a standardised and permanently installed illumination system for use in dermatological practices that combines the advantages of daylight-PDT with controlled and constant light conditions.

"Our controlled PDT technology allows better medical care, at the same time minimising discomfort and morbidity," says Dr. Wilfried Priel, chairman of SwissRed AG.

Hermann Lübbert, CEO of Biofrontera AG commented: "IndoorLux® will provide dermatologists with a year-round platform to treat patients, thus providing a broader range of treatment options."

The CE certification allows SwissRed AG to market, install and service the Indoorlux® PDT illumination system across the European Union and Switzerland.

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