UK biopharma Faron Pharmaceuticals Oy (LON:FARN) has established a second manufacturing site for its lead drug candidate, Traumakine.
A facility in Ilsensburg, Germany – run by contract manufacturing organisation, Lyocontract – will complement the primary site currently operated by Rentschler Biopharma.
The two facilities will support Faron’s commercial preparations for Traumakine should the pivotal INTEREST phase III acute respiratory distress syndrome (ARDS) trial return positive results later this year.
Lyocontact – which has already produced several successful test batches – is able to produce 120,000 vials of the drug in a single production batch, which is the equivalent to roughly 20,000 courses of treatment.
By the middle of next year, Faron expects to have 100,000 courses ready for distribution, assuming that Traumakine is granted the necessary regulatory approvals.
“We are very pleased to secure additional manufacturing for Traumakine drug product FP-1201-lyo as we continue to prepare for commercialization,” said chief executive Markku Jalkanen.
“This will enable us to provide Traumakine supply for early access programmes as well as for later market demand in the event of product approval.”
ARDS is a little-known condition that can affect people of any age and usually develops as a complication of an existing serious illness such as flu, pneumonia, sepsis or even severe trauma.
It is so serious that the mortality rate is between 30-45% and there is no recognised pharmaceutical treatment.
Faron has repurposed beta interferon (a drug normally used to slow the progression of multiple sclerosis) to tackle the life-threatening illness with remarkable results.