Biofrontera discusses approval of Ameluz® in the US with the FDA

23 juli 2012 Biofrontera AG / Biofrontera discusses approval of Ameluz® in the US with the FDA . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Leverkusen, 23 July 2012 - Biofrontera AG (DSE: B8F) was involved in a consultation with the American medication approval authority, the FDA (Food and Drug Administration), to discuss the approval of Ameluz(®) in the United States. Ameluz(®) was approved by the European Medicines Agency (EMA) in December 2011 as a first-line therapy for the treatment of mild and moderate actinic keratosis on the face and scalp(1). Biofrontera has now submitted to the FDA the documentation that led to approval in Europe and discussed its validity for the US. Whilst clinical comparison with a representative competitive medicine, which is compulsory in Europe - in a Phase III study Biofrontera clearly demonstrated superiority in the overall clearance rate compared with rival product Metvix(®1,2 )- is not required to gain approval in the US, the FDA places greater value on other aspects. As a result, Biofrontera was advised to expand on the existing data to include the fact that at the maximum dosage the active ingredient 5-aminolevulinic acid (ALA) is not absorbed into the bloodstream. It was also discussed whether a more detailed investigation is needed to analyse the potential of Ameluz(®) to cause skin irritation and contact allergies. No evidence of this has been found in extensive trials in animals and clinical studies performed to date. In addition, the fact that ALA is a substance that is produced naturally in every cell of the body was not considered sufficient, since during therapy ALA is highly concentrated in the affected area of skin. Although it is unlikely that Ameluz(®) has allergenic potential, a concern in this regard could be based on results using preparations containing methyl-ALA, which caused allergies in about one third of the patients upon repeated exposure(3). The FDA has not explicitly requested further clinical studies on efficacy. Whether the patients included in the existing European clinical studies are sufficient to adequately cover the ethnic origin of the population in the US is a matter that has been left open. People of Asian origin and descendants of South American tribes can also develop actinic keratosis, even if this occurs less frequently than in fair-skinned Caucasians. The FDA is expected to only answer this conclusively during the approval process. The FDA has not made any binding statement with regard to the approval of Biofrontera's PDT lamp, BF-RhodoLED. The American authority may consider approval of the lamp in combination with Ameluz(®) based solely on data from cell culture experiments and physical measurements. 'As anticipated not all of our questions were answered conclusively in our meeting with the FDA, but we have obtained clarification on several important aspects. Overall, the FDA assessed the presented data package positively. The proposed studies do not require the great investment in time and expenditure that were required for the European Phase III studies and can be implemented quickly. We continue to assume that we will be able to apply for approval in the USA in 2013,' said Professor Hermann Lübbert, CEO of Biofrontera AG. Background Ameluz(®) was approved across Europe in December 2011 as a medication for the first-line treatment of mild and moderate actinic keratosis on the face and the scalp. The product is used as a photosensitiser in the still relatively new area of photodynamic therapy (PDT)(1). Actinic keratosis is particularly seen in fair-skinned people who have been exposed to the sun for a long time(4). The condition affects about 10% of the entire Caucasian population worldwide(5). 5-20% of patients with actinic keratosis develop malignant and potentially life-threatening squamous cell carcinomas(6). About Biofrontera AG Biofrontera aims at attending and treating the skin, recognizing the aesthetic needs of a person's visual reflection. Biofrontera is listed in the regulated market of the Düsseldorf stock exchange under the symbol B8F and the ISIN DE0006046113. www.biofrontera.com References 1.) Ameluz(®) Produktinformation; www.ema.europa.eu 2.) Dirschka T et al., 2012, Br J Dermatol. 166:137-46 3.) Korshøj S et al., 2009, Contact Dermatitis 60:320-324 4.) Salasche SJ, 2000, Am Acad Dermatol. 42, 4-7. 5.) Frost, CA & Green, AC, 1994, Br J Dermatol. 131, 455-464. Memon, AA, Tomenson, JA, Bothwell, J & Friedmann, PS, 2000, Br J Dermatol. 142, 1154-1159. 6.) Braathan LR, Szeimes RM, Basset-Seguin N et al., 2007, J Am Acad Dermatol. 56, 125-143. For further information: Anke zur Mühlen Director PR/IR +49 (0)214 876 32 22 +49 (0)214 876 32 90 a.zurmuehlen@biofrontera.com Biofrontera AG Hemmelrather Weg 201 51377 Leverkusen Germany This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Biofrontera AG via Thomson Reuters ONE [HUG#1628641]