Biofrontera publishes report on the third quarter of 2014 - Seite 3

The submission of the approval dossier in the US is scheduled for March 2015, after a combined analysis of all clinical results has been performed. The approval is expected to be issued around one year later.

The pre-NDA (new drug application) meeting, at which significant issues relating to the approval dossier were discussed again, took place shortly after the reporting date of this report, on 08 October 2014. Due to the few remaining outstanding questions following the FDA's examination of the documents submitted, this meeting was held as a conference call on the recommendation of the FDA. At this meeting, any remaining outstanding questions were also clarified.

Extension of indications to basal cell carcinoma

A recently published meta-analysis of all clinical trials already carried out for the treatment of actinic keratosis clearly showed that Ameluz^® is by far the most effective form of treatment for mild and moderate actinic keratosis on the face and scalp. Despite this, the lack of approval for the indication of basal cell carcinoma (BCC), for which there are several competing drugs, has proven to be a challenge  in the marketing of Ameluz^®.

Therefore, Biofrontera has begun the implementation of a phase 3 trial in order to have Ameluz^® European approval extended to include the treatment of BCC. BCCs are the most common invasive tumors to affect humans and account for approximately 80% of all invasive skin cancers in Caucasians. About 30% of all Caucasians develop at least one BCC in their lifetime, and cases are increasing rapidly worldwide due to increased exposure to UV light. Surgical removal is the most frequent treatment currently used in Germany but this can lead to clearly visible scarring, whereas treatment with photodynamic therapy (PDT), which is an alternative particularly in the treatment of thin, nonaggressive BCCs, is not only a highly effective treatment method, but also produces excellent cosmetic results.

The recruitment of the 360 planned patients began in Germany in early February and in the UK in May 2014. Because patient recruitment has been slower than expected, Biofrontera has included 8 further centers in Germany in the trial, which has increased the number of study centers involved to a total of 27. It is expected that the recruitment process will be completed at the end of this year or the beginning of next year, which will mean that the expansion of indications can probably take place in early 2016. The expansion of the European approval to include BCC will be of particular importance for sales development in European countries outside Germany.