Faron Pharmaceuticals, the clinical stage biopharmaceutical company, is pleased to announce that its patent application to protect the intravenous use of interferon-beta (IFN-beta) in a novel formulation has been accepted by the Finnish patent office.
The allowed claims cover single intravenous dose of IFN-beta at the range of 2–15 µg in a formulation that allows a precise dosing of IFN-beta.
This formulation is being used in both ongoing pivotal Traumakine trials in Europe and Japan for acute respiratory distress syndrome (ARDS) and will be the drug for which Faron is targeting approval in various territories for the treatment of ARDS and other vascular dysfunctions.
ARDS is a severe orphan disease with a reported mortality rate of approximately 30–45%, for which there is currently no approved pharmacological treatment.
It is characterized by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (following a pandemic influenza), sepsis, or significant trauma. An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine showed a decline in the odds of all-cause mortality at day 28 of 81%.
Faron has developed the first intravenous formulation of IFN-beta to enable treatment of vascular leakage in lungs and other central organs. The allowed claims cover this use but are not limited to ARDS.
Dr Markku Jalkanen, CEO of Faron, said: “We are delighted that the patent claims for the intravenous use of IFN-beta in vascular dysfunctions have been accepted as they enable us to build a strong global proprietary position for Traumakine. We have already granted patents for INF-beta in ischemic conditions in many countries, and these additional claims significantly extend protection for Traumakine as a drug to treat life threatening conditions like acute lung injuries up to 2036-37.”
“Faron plans to file application to the US patent office with same scope of protection. Furthermore, in spring 2017, we will file the international PCT to initiate the patenting process in other countries too,” he added.