TIDMFARN
RNS Number : 6634P
Faron Pharmaceuticals Oy
04 September 2017
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Faron announces that US FDA proposes proceeding directly to BLA
submission for Traumakine(R) following completion of European and
Japanese Phase III studies
TURKU - FINLAND, 4 September 2017 - Faron Pharmaceuticals Ltd
("Faron") (LON: FARN), the clinical stage biopharmaceutical
company, today announces that the FDA has proposed that Faron can
proceed directly to Biologics License Application (BLA) submission
pending positive results from the two on-going Phase III trials
(INTEREST in Europe and MR11A8-2 in Japan) with the Company's
wholly-owned product, Traumakine(R) for the treatment of Acute
Respiratory Distress Syndrome (ARDS). In the letter received on 1
September 2017, the FDA proposed that, subject to the FDA being
satisfied with data from the trials, the BLA application for
Traumakine can be filed purely with data obtained from the ongoing
trials outside of the US. In the event of positive outcomes of the
ongoing trials this FDA feedback is therefore expected to shorten
the time for approval of Traumakine in US.
Commenting on the FDA's advice, Dr Markku Jalkanen, CEO of
Faron, said: "We welcome the news that the FDA have proposed that
we proceed directly to BLA submission for the US development of
Traumakine. This important feedback potentially speeds up the
regulatory approval process in the US and brings us one step closer
to delivering Traumakine to patients in the world's largest
pharmaceutical market. There is currently no approved
pharmaceutical treatment for ARDS and Traumakine has the potential
to address a significant unmet medical need in terms of mortality
and savings for society. We now eagerly await the outcome of our
ongoing Phase III trials and continue to build our presence in the
US."
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 characterised by widespread
capillary leakage and inflammation in the lungs, most often as a
result of pneumonia (e.g. following a pandemic influenza), sepsis,
or significant trauma with around 300,000+ annual cases in Europe
and US.
As the INTEREST Phase III study nears completion, Faron plans to
initiate an expanded access program for Traumakine to start once
the trial is closed to new patients. This will allow compassionate
use of Traumakine in eligible named patients at European ICU
hospitals, who may benefit from Traumakine treatment ahead of the
product's potential regulatory approval. The Company is also
considering providing this access to US ARDS patients.
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulation (EU) No. 596/2014. Upon the publication of this
announcement, this inside information is now considered to be in
the public domain.
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Philippa Gardner, 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
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson
Phone: +44 207213 0880
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, Nominated Broker
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
Glossary
BLA: a request for permission to introduce, or deliver for
introduction, a biologic product into US commerce.
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 focusing on acute
organ traumas, vascular damage and cancer immunotherapy. The
Company's lead candidate Traumakine, to prevent vascular leakage
and organ failures, is currently the only treatment for Acute
Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical
trials. There is currently no approved pharmaceutical treatment for
ARDS. An additional European Phase II Traumakine trial is underway
for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's
second candidate Clevegen is a ground breaking pre-clinical
anti-Clever-1 antibody. Clevegen has the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. This novel macrophage-directed immuno-oncology switch
called Tumour Immunity Enabling Technology ("TIET") may be used
alone or in combination with other immune checkpoint molecules for
the treatment of cancer patients. 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", "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 outcome of clinical trials
(including, but not limited to the Company's INTEREST trial) 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 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, 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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