3rd Sep 2014 15:19
LONDON (Alliance News) - Biofrontera AG said Wednesday that it had settled its legal issues with former supplier Biosynth AG amicably in an out-of-court agreement, and both parties have waived all mutual claims.
In August, the company had filed action for negative declaratory relief against Biosynth, as it refuted Biosynth's claim that Biofrontera terminated a mutual venture producing and marketing Biofrontera drug Ameluz.
At that time Biofrontera said it had terminated the supply agreement because Biosynth had not fulfilled standards set by the European Medicines Agency for a component of Ameluz.
Biosynth was the supplier of the active substance 5-aminolaevulinic acid hydrochloride for Biofrontera. This substance is a component of Ameluz, which has been approved in the EU for the treatment of superficial skin tumours.
However, as part of the approval process, the EMA defined certain quality standards for the component relating to Good Manufacturing Practice in its production. The EMA provided a time limit to implement the required manufacturing standard.
Biofrontera said that Biosynth has not fulfilled these standards, and could no longer produce the component at the quality required. As a result, Biofrontera had to seek out other suppliers.
On Wednesday Biofrontera said that Biosynth has claimed that the requirements from the EMA had been formally addressed to Biofrontera as applicant, and not to Biosynth. The requirements from the EMA made in the context of approval of Ameluz were not processed by Biosynth after the termination of the cooperation with Biofrontera, it said.
In Biosynth's opinion, the requirements concern the 5-aminolevulinic acid hydrochloride produced by Biosynth only insofar as it is used in Ameluz.
No mutual financial obligations for either of the two companies arise from the settlement, it said, and that the "past business relationship was terminated consensually."
As a result of this agreement, Biofrontera will now withdraw its filed action for negative declaratory relief against Biosynth.
Shares in Biofrontera are untraded Wednesday. It last traded at 208.00 pence.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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