Biofrontera and Allergan sign marketing and distribution agreement for Ameluz® in Spain

29 maart 2012 Biofrontera AG / Biofrontera and Allergan sign marketing and distribution agreement for Ameluz® in Spain . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Leverkusen, Germany - Biofrontera Pharma GmbH and Allergan announce they have signed an agreement whereby Allergan will obtain exclusive rights to market and distribute Biofrontera's new prescription product, Ameluz(®) (5-aminolevulinic acid) in Spain. In December 2011, the European Commission approved Ameluz(®) for the treatment of actinic keratosis in the European Union. Actinic keratosis is a superficial skin cancer, affecting the upper skin layer (the epidermis). These tumours result from damage caused by UV-light and are therefore frequent in countries where people commonly expose their skin to the sun, such as Spain. In return for exclusive marketing rights in Spain, Biofrontera receives an immediate upfront payment of €1.1 million plus an undisclosed percentage of all net revenues of Ameluz(® )generated by Allergan. Biofrontera will remain responsible for the regulatory approval, manufacturing and quality control of the product while Allergan will be responsible for all aspects of commercialization in Spain. Both companies will work together on pharmacovigilance (drug safety). Prof. Hermann Lübbert, CEO of Biofrontera, comments on the agreement: "Since the introduction of Ameluz(®) onto the German market, we have received positive feedback by the dermatologists and their patients due to its superior clinical efficacy and its advantages particularly in the treatment of larger areas. We hope to achieve a similarly positive reception in other countries. Working with experienced and motivated local representatives will be essential to making Ameluz® an international success. Allergan has repeatedly proven its excellence in the marketing of innovative pharmaceuticals, and we are convinced that they are the ideal partner for making Ameluz(®) a success in Spain." -- ENDS -- Background Ameluz® (developed as BF-200 ALA gel) was approved by the European Commission for the treatment of actinic keratosis in December 2011. The product is a photosensitizing agent used in photodynamic therapy (PDT). The registration was based on two phase III clinical trials involving more than 693 patients suffering from four to eight independent actinic keratosis lesions. These studies demonstrated that PDT using Ameluz® and narrow spectrum LED light sources lead to the complete removal of all actinic keratosis lesions at 12 weeks after the last PDT in 85% and 87% of patients(1). The treatment can be repeated after three months if residual lesions remain. In a direct head to head comparison against a cream containing 16% methyl-aminolevulinate (MAL), 85% of the patients were totally cleared from all lesions with Ameluz® while the MAL cream cleared only 68% of the patients when LED light sources were used(1). As with any PDT, the most common side effects occurred at the site of application and included irritation, erythema, pain, pruritis and odema(1). Other treatment options have lower clinical efficacy, longer-lasting side effects and many result in visible scars or pigmentation changes(2). Actinic keratosis is mostly seen in fair-skinned people on skin areas that have had long-term sun exposure(3). The condition affects about 10% of the entire Caucasian population world-wide(4). About 5-20% of patients with actinic keratosis lesions develop malignant and potentially fatal squamous cell carcinomas(5). About Biofrontera Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The Biofrontera group aims at attending and treating the skin, recognizing the aesthetic needs of a person's visual reflection. Biofrontera is listed at the regulated market of the Düsseldorf stock exchange under the symbol B8F and the ISIN number DE0006046113. www.biofrontera.com 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. References 1.) Ameluz® Summary of Product Characteristics; www.ema.europa.eu 2.) Lawrence, N., Cox, S. E., Cockerell, C. J., Freeman, R. G., & Cruz, P. D. Jr., 1995, Arch.Dermatol, 131, 176-181. Lebwohl, M., Dinehart, S., Whiting, D., Lee, P. K., Tawfik, N., Jorizzo, J., Lee, J. H., & Fox, T. L., 2004, J Am.Acad.Dermatol, 50, 714-721. Stockfleth, E. & Kerl, H., 2006, Eur. J. Dermatol. 16, 599-606. 3.) Salasche SJ., 2000, Am Acad Dermatol, 42, 4-7. 4.) Frost, C. A. & Green, A. C., 1994, Br J Dermatol, 131, 455-464. Memon, A. A., Tomenson, J. A., Bothwell, J., & Friedmann, P. S., 2000, Br J Dermatol, 142, 1154-1159. 5.) Braathan LR, Szeimes RM, Basset-Seguin N et al., 2007 J Am Acad Dermatol, 56, 125-143. For further information please contact: Anke zur Mühlen Director PR/IR + 49 214 87632 0 + 49 214 87632 90 a.zurmuehlen@biofrontera.com Biofrontera AG Hemmelrather Weg 201 D- 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#1598259]