RE: Rns18 Aug 2020 08:05
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on manufacturing plans for Traumakine, its investigational intravenous (IV) interferon (IFN) beta-1a, and the continuing clinical investigations in COVID-19 patients.
Commercial scale manufacturing
The Company has received a guarantee from Finnvera Oyj ("Finnvera") for a €2,500,000 loan ("Loan") which will be provided by Danske Bank A/S Finland Branch. The Loan is for a period of 7 years with Loan repayment only commencing after 2 years and is subject to certain financial covenants. Interest cost equates to approximately 4.1% per annum over Euribor. The Loan funds will be used to further expand the use of a new cell line planned to be established using the previously received Business Finland loan of €2,100,000, announced on 15 June 2020, and which will be used in the future commercial scale production of Faron's IV IFN beta-1a.
Finnvera is a specialised financing company owned by the State of Finland and it is the official Export Credit Agency (ECA) of Finland. For more information see: https://www.finnvera.fi/eng/finnvera/finnvera-in-brief.
Faron also announces today that AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), has been selected as the new manufacturing house for the commercial scale production of the Company's IV IFN beta-1a. As announced on 5 May 2020, AGC Biologics is also the commercial scale manufacturer of bexmarilimab, Faron's wholly-owned novel precision cancer immunotherapy (Clevegen). Faron has been very satisfied with AGC Biologics' work since that time.
"We are very happy to expand our partnership with Faron. Our priority has always been to serve our customers with a commitment to continuous innovation, aided by building strong, long term collaborative relationships," said AGC Biologics' CEO Patricio Massera.
Clinical investigations in COVID-19
Traumakine continues to be investigated as a potential COVID-19 treatment in global trials, including the World Health Organization's (WHO) Solidarity trial. In July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit. This leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion. IFN beta-1a had previously been included in a treatment arm testing it in combination with lopinavir/ritonavir. IFN beta-1a now remains as a monotherapy.
Traumakine is used in the trial's severe patients for whom it is critical to rapidly provide high serum concentrations of IFN beta-1a and to maximise levels of the drug in the lung vasculature where peripheral circulation is slowed1, a condition which can be life threatening for these virally-infected patients. Rece
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