Faron Pharmaceuticals signs US sublicence agreement

The AIM-traded firm said the agreement clarified its intellectual property position in the US ahead of any launch of ‘Traumakine’ for the treatment of capillary leak and systemic inflammatory response syndromes (SIRS), including acute respiratory distress syndrome (ARDS), subject to marketing approval from the US Food and Drug Administration (FDA).

Faron said it would pay a small signing fee, as well as single-digit standard market royalties from future sales of its intravenous IFN beta-1a, Traumakine, in the country.

The sublicence specifically covered a manufacturing patent valid only in the US, and added to Faron's existing patent portfolio for Traumakine, which included use and IV formulation patents, as well as market exclusivity in Europe as an orphan medicine.

“We continue to believe in Traumakine's potential as a much-needed new treatment for respiratory failure and organ protection,” said chief executive officer Dr Markku Jalkanen.

“Several recent publications have connected type 1 IFN with the severity of Covid-19 infections.

“Multiple associations have been drawn across the literature including deficiency of type 1 IFN, inborn errors of IFN-beta signalling, and the presence of auto-antibodies that neutralise the protective effect of type 1 IFN in viral infections.”

Dr Jalkanen said patients who did not have an early IFN response appeared to develop severe disease irrespective of the underlying reason for the deficiency.

“The continued further evidence supports the hypothesis that Covid-19 patients may become very ill because of an impaired interferon response.

“The administration of IFN is likely to benefit patients and relieve them from the hyper-inflammatory state that leads to severe disease.

“We believe intravenous administration of IFN-beta is the optimal route9 to compensate for this loss of first line viral defence and, in tandem induce CD73 a critical enzyme in organ protection during severe illness.”

At 0906 BST, shares in Faron Pharmaceuticals were down 0.15% at 332p.