Press Releases

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Leverkusen, Germany - Biofrontera AG (DSE: B8F) today announced that the treatment and clinical evaluation of all patients in a pivotal phase III study with BF-200 ALA has been completed. The study compares the efficacy of Biofrontera's most advanced development product BF-200 ALA in actinic keratosis with that of a placebo treatment.

Since the patients could be recruited more rapidly than anticipated (compare press release of April 2, 2008), Biofrontera expects the results of the study in Q4, 2008. As defined in the study protocol 120 patients were included, of whom 114 completed the treatment and all subsequent examinations in accordance with the protocol. The remaining patients must be excluded from the evaluation due to other diseases or protocol deviations. Two thirds of the study participants were treated with BF-200 ALA, one third with placebo. The completed patient reports will now be evaluated by the clinical research organization appointed by Biofrontera and, if required, inconsistencies in the documentation or the realization of the study protocol will be discussed with the study centers. Only after answering all such questions can the final assessment of the study results be initiated. Patients will be re-examined 6 and 12 months after the last PDT treatment. Since the results of this observation phase will only be used as supplementary information, this period is not a formal part of the study and does not have to be completed before the study can be evaluated.

Biofrontera's product candidate BF-200 ALA combines the nanoemulsion BF-200, developed and patented by Biofrontera, with the active ingredient 5-aminolevulinic acid (ALA). The latter active ingredient is used in the photodynamic therapy of precancerous and cancerous skin lesions.

Actinic Keratosis Actinic keratosis primarily develops in skin regions exposed to the sun e.g. face, head and hands. Taking up the form of individual, small skin alterations, actinic keratosis is classified as an early skin cancer, which develops into malignant squamous cell carcinoma in approximately 10% of the cases. Actinic keratosis is the third most common reason for visiting a dermatologist. In Europe approximately 5 million new cases of actinic keratosis are reported each year.

About Biofrontera AG Biofrontera AG is specialized in the development of pharmaceutical products in the area of dermatology. The company is characterized by a broad, relatively close to the market product portfolio. Biofrontera is listed in the regulated market of the Düsseldorf 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.

For further information please contact:

Anke zur Mühlen Corporate Communication

+ 49 (0) 214 87632 22 + 49 (0) 214 87632 90 a.zurmuehlen@biofrontera.com

Biofrontera AG Hemmelrather Weg 201 D- 51377 Leverkusen, Germany

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Biofrontera AG Hemmelrather Weg 201 Leverkusen Germany

WKN: 604611; ISIN: DE0006046113; Listed: Freiverkehr in Börse Berlin, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart, Freiverkehr in Frankfurter Wertpapierbörse, Geregelter Markt in Börse Düsseldorf;

Biofrontera AG

http://www.biofrontera.com/

ISIN: DE0006046113

Stock Identifier: XQTX.B8F