Faron Pharmaceuticals Ltd("Faron" or the
"Company")
Faron announces that US FDA proposes
proceeding directly to BLA submission for Traumakine®
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®
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 LtdDr Markku Jalkanen, Chief
Executive Officerinvestor.relations@faron.com
Consilium Strategic CommunicationsMary-Jane Elliott,
Chris Welsh, Philippa Gardner, Lindsey NevillePhone: +44 (0)20 3709
5700E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)Chris BrinzeyPhone: 01 339 970
2843E-Mail: chris.brinzey@westwicke.com
Cairn Financial Advisers LLP, Nominated AdviserEmma Earl,
Tony RawlinsonPhone: +44 207213 0880
Panmure Gordon (UK) Limited, Joint
BrokerFreddy Crossley, Duncan Monteith (Corporate Finance)Tom
Salvesen (Corporate Broking)Phone: +44 207 886 2500
Whitman Howard Limited, Nominated BrokerRanald
McGregor-Smith, Francis NorthPhone: +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.
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