Database closure in Biofrontera's phase III trial with BF-200 ALA
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Leverkusen, Germany - Biofrontera AG (DSE: B8F) announced, that thedata collection for its last pivotal phase III trial with BF-200 ALAhas been completed and the statistical analysis can now commence. Theaim of the study is to confirm the excellent efficacy ofBiofrontera's leading development candidate in the treatment ofactinic keratosis, a malignant tumor of the upper skin layer.BF-200 ALA gel is applied in combination with a red lightillumination, to remove keratotic lesions in a one-time treatmentwithout scar formation.In the now complete placebo controlled study comparing BF-200 ALAwith a competing product, a total of 571 patients were treated bysuch a photodynamic therapy. About 43% of the patients were treatedwith BF-200 ALA, and the same number with the comparator Metvix®. Inaddition, about 14% of the patients were treated with a placebo gel.The trial was performed with patients from 27 study centers inGermany, Austria and Switzerland under the clinical supervision ofDr. med. Thomas Dirschka.Following the closure of the database the results can bestatistically evaluated. The goal of the study is to demonstrate thatBF-200 ALA has the same or a better efficacy than the approved drugMetvix®.This phase III study completes the clinical development of BF-200ALA, such that Biofrontera expects to apply for drug registration inthe middle of 2010. The European agency EMEA has already approved theeligibility of BF-200 ALA for the centralized registration processdue to its high technical innovation.In the previous, already completed phase III trial comparing theefficacy of BF-200 ALA with a placebo treatment the excellentefficacy of the drug was impressively demonstrated. Up to 96% of thepatients could be completely cleared from all their actinickeratoses. The treatment led to a remarkable cosmetic result withoutleaving visible scars or pigmentation changes."The database closure has occurred within the time frame thatBiofrontera has anticipated. We now expect to obtain the results ofthe trial before the end of the year," commented Dr. ReinholdGahlmann, head of Biofrontera's development team.About Biofrontera AGBiofrontera AG is specialized in the development of pharmaceuticalproducts in the area of dermatology. The company is characterized bya broad, relatively close to the market product portfolio.Biofrontera is listed in the regulated market of the Düsseldorf stockexchange under the symbol B8F and the ISIN number DE0006046113.www.biofrontera.comThis press release contains forward-looking statements based on thecurrently held beliefs and assumptions of the management ofBiofrontera AG, which are expressed in good faith and, in theiropinion, reasonable. Forward-looking statements involve known andunknown risks, uncertainties and other factors, which may cause theassumptions expressed or implied in this press release to be faulty.Given these risks, uncertainties and other factors, recipients ofthis document are cautioned not to place undue reliance on theforward-looking statements. Biofrontera AG disclaims any obligationto update these forward-looking statements to reflect future eventsor developments.For further information please contact:Anke zur MühlenCorporate Communication+ 49 (0) 214 87632 22+ 49 (0) 214 87632 90a.zurmuehlen(at)biofrontera.comBiofrontera AGHemmelrather Weg 201D- 51377 Leverkusen, Germany --- 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: 25.11.2009 - 11:02 Uhr
Sprache: Deutsch
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