TIDMFARN
RNS Number : 3826W
Faron Pharmaceuticals Oy
18 August 2020
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Traumakine update
- EUR2.5 million loan guarantee from Finnvera to further expand
IV IFN beta-1a manufacturing process
- AGC Biologics selected as new commercial scale manufacturer
- COVID-19 trials continue to investigate Traumakine treatment
Company announcement, 18 August 2020 at 9.00 AM (EET)
Insider information
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 EUR2,500,000 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 EUR2,100,000, 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 slowed(1) , a condition which can
be life threatening for these virally-infected patients. Recent
findings show that seriously ill COVID-19 patients have compromised
interferon responses(2) .
In addition to the Solidarity trial, Faron continues to
investigate Traumakine in two other clinical trials, the ongoing
global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive
Platform Trial for Community-Acquired Pneumonia) trial, and the US
HIBISCUS (Human Interferon Beta In Severe CoronavirUS) trial.
- The global REMAP-CAP trial is evaluating Traumakine as a
potential treatment for community-acquired pneumonia, including in
COVID-19 patients, and is currently ongoing across more than 200
sites and 14 countries.
- As previously announced, HIBISCUS will be an
investigator-initiated study at Harvard Medical School's Beth
Israel Deaconess Medical Center (BIDMC), focused on intensive care
unit (ICU) patients with ARDS caused by a viral infection (e.g.
COVID-19, influenza). Commencement of the Phase II/III pivotal,
randomized, placebo-controlled study, remains subject to
finalisation of funding arrangements and regulatory approval. The
study will test Traumakine against both placebo and dexamethasone,
which is now a part of the standard of care in the US. Further
announcements will be made in due course.
Dr. Markku Jalkanen, Faron's CEO, said: "We are very pleased to
have secured additional resources that will enable us to progress
Traumakine manufacturing to support its potential future commercial
use. The science behind interferon (IFN) beta and its potential to
prevent multi-organ failure in severe COVID-19 patients is
compelling. Administering an IV formulation to strengthen the
body's own IFN beta production - its first line of defence against
viral infection - provides optimal exposure to the lung
vasculature, which is what we believe critically ill patients need.
We are proud to be supporting global research efforts against
COVID-19 and look forward to further data from these trials to
support the potential use of IV IFN beta-1a in the future."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
References
1. Interferon beta-1a for COVID-19: critical importance of the
administration route, Jalkanen et al., Critical Care (2020) 24:335
https://doi.org/10.1186/s13054-020-03048-5
2. Impaired type I interferon activity and inflammatory
responses in severe COVID-19 patients, J. Hadjadj et al., Science
10.1126/science.abc6027 (2020)
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson , Tony Rawlinson, Mark Rogers
Phone. +44 207 213 0880
Panmure Gordon (UK) Limited, Broker
Rupert Dearden
Phone: +44 207 886 2500
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Stern Investor Relations, Inc.
Julie Seidel
Phone: +(1)212 362 1200
Email: Julie.Seidel@sternir.com
About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including
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). 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
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identified by their use of terms and phrases such as "believe",
"could", "should", "expect", "hope", "seek", "envisage",
"estimate", "intend", "may", "plan", "potentially", "will" or the
negative of those, variations or comparable expressions, including
references to assumptions. These forward-looking statements are not
based on historical facts but rather on the Directors' current
expectations and assumptions regarding the Company's future growth,
results of operations, performance, future capital and other
expenditures (including the amount, nature and sources of funding
thereof), competitive advantages, business prospects and
opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on
information currently available to the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In particular, the early data from initial patients in
the MATINS trial may not be replicated in larger patient numbers
and the outcome of clinical trials may not be favourable or
clinical trials over and above those currently planned may be
required before the Company is able to apply for marketing approval
for a product. In addition, other factors which could cause actual
results to differ materially include the ability of the Company to
successfully licence its programmes within the anticipated
timeframe or at all, risks associated with vulnerability to general
economic and business conditions, competition, environmental and
other regulatory changes, actions by governmental authorities, the
availability of capital markets or other sources of funding,
reliance on key personnel, uninsured and underinsured losses and
other factors. Although any forward-looking statements contained in
this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that
actual results will be consistent with such forward looking
statements. Accordingly, readers are cautioned not to place
undue reliance on forward looking statements. Subject to any
continuing obligations under applicable law or any relevant AIM
Rule requirements, in providing this information the Company does
not undertake any obligation to publicly update or revise any of
the forward-looking statements or to advise of any change in
events, conditions or circumstances on which any such statement is
based.
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END
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