Ad hoc: Biofrontera AG: Phase III data of BF-200 ALA demonstrate superiority against Metvix®
(Thomson Reuters ONE) - Biofrontera AG / Misc. matters / Ad hoc: Phase III data of BF-200 ALA demonstrate superiority against Metvix® Ad hoc announcement according to §15 WpHG processed and transmitted by Hugin. The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------Leverkusen, Germany, 02 December 2009 - Biofrontera (DSE: B8F)announces that the company has today been informed about preliminaryresults of the final pivotal phase III trial with its leading drugcandidate BF-200 ALA.The results show with high statistical significance that 78% of thepatients were totally cleared from all actinic keratoses aftertreatment with BF-200 ALA, while comparator Metvix® showed totalclearance in only 64% of the patients. A total clearance rate of 17%was measured in the placebo group. In spite of the higher efficacy ofBF-200 ALA the incidence of side-effects was not increased comparedto Metvix®.The first, already completed phase III trial has shown that the lightsource has an immense effect on the efficacy of the treatment.Several different light sources were also tested in the currentstudy, but the individual results have not been analyzed thus far.Therefore, the detailed analysis is expected to show substantiallybetter clearance rates with the best light source."Results were obtained earlier than expected due to the outstandingdata management of the responsible clinical research organizationAccovion GmbH. The statistically significant superiority of BF-200ALA over Metvix® exceeds the original goals of the study," commentedProf. Hermann Lübbert, Biofrontera's CEO.In the treatment, superficial tumors were covered with one of the twodrugs, followed by an illumination with red light for a few minutes.The treatment was repeated in those cases where residual keratoseswere still present three months after the treatment. Treatmentsuccess was monitored another three months later.570 patients were included in this phase III trial performed withphotodynamic therapy of actinic keratoses. The study, which wasongoing since 2008, compared the efficacy of BF-200 ALA with that ofMetvix®. Additionally placebo-controlled, this comparator study isthe final pivotal trial required for the Marketing AuthorizationApplication (MAA) of BF-200 ALA, which will be filed after obtainingthe last stability data in the next summer.Telephone conferenceOn Thursday, December 3, at 10 a.m. CET Biofrontera will hold atelephone conference, in which the Biofrontera management will informabout the results of the phase III trial in more detail and answerquestions.The dial-in numbers for the telephone conference will be: +49 (0)699897 2623 (from Europe) or +44(0)20 7138 0844 (from UK).Please dial in 10 minutes before the conference starts to warrant atimely beginning.About BF-200 ALABF-200 ALA is a gel applied within photodynamic therapy for thetreatment of actinic keratosis, a superficial, malignant skin cancer.The gel combines Biofrontera's proprietary nanoemulsion BF-200 withthe active ingredient 5-aminolevulinic acid (ALA). The photodynamictherapy consists of a one-time application of BF-200 ALA, followedwith some time-delay by a brief illumination with red light.Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen, GermanyISIN: DE0006046113, WKN: 604611Contact:Anke zur MühlenBiofrontera AGTel.: +49 (0214) 87 63 222Fax.: +49 (0214) 87 63 290E-mail: a.zurmuehlen(at)biofrontera.com --- End of Message ---Biofrontera AGHemmelrather Weg 201 Leverkusen GermanyWKN: 604611; ISIN: DE0006046113; Listed: Freiverkehr in Börse Berlin, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart, Open Market (Freiverkehr) in Frankfurter Wertpapierbörse, Regulierter Markt in Börse Düsseldorf;
Datum: 02.12.2009 - 15:56 Uhr
Sprache: Deutsch
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