21st Aug 2014 07:07
LONDON (Alliance News) - Biofrontera AG said Thursday it has filed action for negative declaratory relief against its former supplier Biosynth AG, which has been claiming that Biofrontera terminated a mutual venture over the production and marketing of its drug Ameluz.
Biofrontera refutes this, saying that it had only terminated a supply agreement. It believes that Biosynth making its claims in order to trigger "material financial concessions".
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.
It said that these other suppliers are certified to manufacture the component according to the standards, and it had transitioned quickly and "without supply problems."
Biosynth has since claimed that a mutual venture exists between the two companies regarding the production and marketing of Ameluz.
Before making this claim, Biosynth had previously raised damage claims of around EUR600,000. However no law suit has been filed on this claim, Biofrontera said.
Biofrontera said the risks from the claims are considered low, so it has made no reserve provisions. The company does not expect the dispute to hit its revenues and financial results, it said.
Biofrontera shares were up 4.3% at 232.00 pence at the open Thursday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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