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Biofrontera AG: Actinic keratosis, most efficiently treated by Ameluz®, recognized as occupational disease

September 20, 2013 - London

Biofrontera AG /Biofrontera AG: Actinic keratosis, most efficiently treated by Ameluz®, recognized as occupational disease . Ad hoc announcement according to § 15 WpHG. Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

Leverkusen, Germany, 20 September 2013 - Biofrontera AG (DSE : B8F) announces that actinic keratosis, the disease for which Biofrontera's Ameluz® is approved in the EU, was classified as an occupational disease in Germany. This was the result of the "expert medical advisory board occupational diseases" at the Federal Ministry of Labor and Social Affairs, Germany.
Actinic keratoses are superficial skin tumors, which may develop into malignant squamous cell carcinomas. The scientific rational for the classification as an occupational disease was published in the 'Ministerialblatt' of the German federal government1. The medical advisory board concluded that an occupational UV exposure of 40 % above normal levels at the site of tumor formation argues for a mostly work-related cause. The acceptance as an occupational disease is contingent upon providing evidence for sufficient work-related outdoor activity, in general occurring in the following occupational groups: agriculture, forestry, fishing and marine, construction and crafts (such as roofers, carpenters, building labor, bricklayers, steel fitter, welder on bridges), road workers, garbage collectors, window cleaners, sports instructors, lifeguards, preschool teachers, mountain guides, and the like. In Germany, about two million people are employed in these occupational groups1. The statutory accident insurances are now required to create policies and forms for implementation.
As a consequence of the recognition of actinic keratosis as a work-related disease patients with multiple keratoses will now be reimbursed for the costs of treatment by the employer's mutual insurance association. Similar to private health insurances the medical services can then be paid for individually rather than by the flat fee per patient used in German public health insurances. Photodynamic therapy is a treatment option using a drug in combination with a red light illumination. Most public insurance companies remunerate the dermatologist's work in the procedure just by the flat fee. The recognition as an occupational disease is now providing access to this highly effective treatment option for patients with public health insurance.
Since the pivotal clinical studies for Ameluz® demonstrated the highest overall efficacy rates reported thus far, particularly when considering the long-term results2, Ameluz® will most likely benefit most from the classification of actinic keratosis as an occupational disease.
Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG, commented: "Actinic keratosis is frequently not taken seriously as precursor of a dangerous form of skin cancer. The recognition as an occupational disease illustrates the different appreciation by the medical expert's advisory board. Consequently, optimal efficacy rates should be the determining factor in selecting the appropriate therapy."

1 Gemeinsames Ministerialblatt, Herausgegeben vom Bundesministerium des Innern, 64. Jahrgang, Nr. 35, 12. August 2013, Page 669
2 Dirschka et al., British Journal of Dermatology (2013) 168, pp825-836

Biofrontera AG
Biofrontera aims at attending and treating the skin, recognizing the aesthetic needs of a person's visual reflection.
Biofrontera AG is listed on the regulated market of the Frankfurt stock exchange under the symbol B8F and the ISIN number DE0006046113.



This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the assumptions expressed or implied in this press release to be faulty. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on the forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments.


For further information please contact:

Anke zur Mühlen
Corporate Communication

+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90

Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany

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Source: Biofrontera AG via Thomson Reuters ONE



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