Faron Pharmaceuticals Oy Update on Traumakine drug substance manufacturing (4268O)
October 02 2019 - 2:00AM
UK Regulatory
TIDMFARN
RNS Number : 4268O
Faron Pharmaceuticals Oy
02 October 2019
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Update on Traumakine drug substance manufacturing
TURKU - FINLAND, 02 October 2019 - Faron Pharmaceuticals Oy
(AIM: FARN), the clinical stage biopharmaceutical company,
announces that further to the update provided in the H1 2019
interim results in relation to the active pharmaceutical ingredient
("API") manufacturing process for Traumakine, Rentschler Biopharma
SE ("Rentschler") has sent Faron a letter in which Rentschler
states that it terminates the agreement concerning the API
manufacturing. It is the Company's understanding that this relates
to the fact that significant upgrading of the API manufacturing
process would be required prior to MAA/BLA approval for
Traumakine.
The Company is exploring various options for future API
manufacturing. This termination has no impact on the currently
on-going clinical advice process with FDA/EMA, which focuses on the
structure of the next Traumakine clinical study.
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley (Corporate Finance)
James Stearns (Corporate Broking)
Phone: +44 207 886 2500
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline based on the
endothelial receptors involved in regulation of immune response, in
oncology and organ damage. Clevegen, its precision immunotherapy,
is a novel anti-Clever-1 antibody with the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. Currently in phase I/II clinical development as a
novel macrophage checkpoint immunotherapy for patients with
untreatable solid tumours, Clevegen has potential as a single-agent
therapy or in combination with other immune checkpoint molecules.
Traumakine, the Company's pipeline candidate to prevent vascular
leakage and organ failures, has completed a phase III clinical
trial in Acute Respiratory Distress Syndrome (ARDS) and progressing
in phase II trial for the Rupture of Abdominal Aorta Aneurysm
("RAAA"). Plans for its future development are being finalised to
avoid interfering steroid use together with Traumakine. Faron is
based in Turku, Finland. Further information is available at
www.faron.com
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END
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