13th Nov 2014 11:09
LONDON (Alliance News) - Biofrontera AG Thursday posted a widened pretax loss in the first nine months of 2014 as costs rose ahead of the approval of its skin cancer drug Ameluz in the US.
The submission of the approval dossier for Ameluz in the US is scheduled for March 25, with the approval expected to be issued around one year later. Biofrontera said three clinical trials have been conducted in preparation for this submission.
The company posted a pretax loss of EUR8.0 million, widened from EUR6.0 million in the first nine months of 2013, as a 7% rise in revenue to EUR2.0 million was offset by a jump in operating costs.
Research and development costs rose to EUR3.1 million from EUR2.0 million due to work on extending its range of indications for basal cell carcinoma, and the preparation for the US approval of Ameluz. Sales and administrative costs rose to EUR5.6 million, compared with EUR3.8 million a year before, also related to the approval process in the US and the setting up of internal company infrastructure to meet the requirements of pharmaceutical companies.
Third quarter sales rose 54% on the year, but the company said revenue outside of Germany fell. For the first nine months, revenue from sales to foreign licensing partners fell to EUR523,000 from EUR798,000. Biofrontera said that at this stage it remains challenging to position Ameluz in hospitals whilst it is only approved for the treatment of actinic keratosis, but not basal cell carcinoma.
It expects sales to increase as approval is extended to include the treatment of basal cell carcinoma, and a phase III study to allow this is under-way. Biofrontera recruited 360 patients in Germany and the UK in February and May respectively.
The recruitment process is expected to be completed at the end of this year or the beginning of next year, which means that the expansion of the approval "can probably take place in early 2016," Biofrontera said. This process has been slower than expected, so Biofrontera has included a further 8 centres in Germany in the trial.
Shares in Biofrontera are untraded Thursday. It last traded at 235.00 pence.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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