LUXEMBOURG and NESS ZIONA,
Israel, June 19, 2017 /PRNewswire/ --
The European Investment Bank (EIB) and BiondVax
Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of
the Universal Flu Vaccine candidate M-001, announced that they have
entered into a €20 million (approximately $22 million) loan agreement. The event organized
to mark the collaboration and the granting of the loan occurs today
at the EIB Headquarters in Luxembourg, in presence of Mr. Ambroise Fayolle, EIB Vice-President responsible
for innovation, and Dr. Ron
Babecoff, CEO of BiondVax.
Flu viruses frequently and unpredictably mutate. Since it is
impossible to predict future mutations, current flu vaccines may
target strains that are not represented in the current wave of
influenza. Mainly due to vaccine-virus mismatch, current flu
vaccine effectiveness is on average only about 40%[1] in
the general population, and in elderly people as low as
9%.[2] In addition, current vaccines take
about four to six months to produce, and a new one must
be produced each year. So when a mismatch is identified at the
beginning of the flu season, there is insufficient time to make a
new vaccine for that specific season.
The World Health Organization (WHO) reports up to 500,000 annual
seasonal flu related deaths, mostly affecting people above 65 years
old.[3] Seasonal flu is the 8th leading cause
of death in the USA[4],
and it causes high social and economic burdens to patients, their
families, and health care providers.
BiondVax's M-001 vaccine candidate, consisting of nine widely
conserved flu epitopes, is designed to protect against current and
future, seasonal and pandemic flu strains. Clinical and
pre-clinical trials have shown that M-001 is safe and immunogenic
and that it has the capacity to enhance and broaden coverage of
current flu vaccines. M-001 has also shown potential to improve
upon current seasonal flu vaccines, and potential to serve as an
immediate effective response to new flu pandemic
strains.[5] The vaccine candidate has been
tested in a Phase IIb clinical trial in collaboration with
UNISEC,[6] which is funded by the EU under the 7th
Framework Programme for Research and Technological Development.
EIB support for the development of BiondVax's Universal Flu
Vaccine Candidate should be seen in the context of the Horizon
2020, the EU's Research Programme, in particular the EU Finance for
Innovators finance facility "InnovFin Infectious Diseases", which
offers bespoke products for financing high-risk projects in the
field of infectious diseases.
Carlos Moedas, European Commissioner for Research,
Science and Innovation said, "A healthier population is a major
priority for the EU, and preventing and treating the flu is
becoming more and more important with the ageing of the European
population. As the virus rapidly changes, we need to develop new
ways to combat the disease. This €20 million loan agreement will
help develop a more universal vaccine, effective in preventing a
range of different types of flu."
Mr. Othmar Karas, Member
of the European Parliament and EPP-Shadow Rapporteur for the
extension of the European Fund for Strategic Investments in the
Parliament's Committee on Economic and Monetary Affairs, commented,
"Joint investments in the future build strong bridges between
nations. It is a strength of Europe's innovation system to
cooperate with the best innovators in our neighbourhood. We
are glad to see today's announcement as an
important initiative for fostering innovation between the European
Union and our Mediterranean neighbours."
"Supporting innovation is a key priority for
the European Union's Bank", said EIB
Vice-President Mr. Ambroise
Fayolle. "This new financing shows our strong
willingness to create optimal conditions for this clinical research
and bring it to a successful conclusion. The EIB is proud to be
supporting BiondVax with regard to its high expertise and
pioneering research on such a universal flu vaccine. We hope that
this innovative financing will contribute to improve the prevention
of disease."
The technology behind BiondVax's universal flu vaccine candidate
was conceptualized in the lab of Professor Ruth Arnon at the Weizmann Institute of Science.
Weizmann Institute Vice-President for technology transfer Prof.
Mordechai Sheves noted,
"Yeda, the tech transfer arm of the Weizmann Institute of
Science, was delighted to learn that the European Union has found
merit in BiondVax, a company based on the pioneering work of Prof.
Ruth Arnon. The generous investment
by the European Union paves the way to tackling one of
today's most lethal infectious diseases, and is yet
another example of the outstanding basic research that typifies the
Weizmann Institute of Science."
Dr. Ron Babecoff, CEO of
BiondVax, commented, "We now have the resources to launch Phase
3 trials and set-up a mid-sized commercial manufacturing plant. The
EIB's funding is a monumental step forward for
BiondVax towards bringing M-001 to the market. We are proud and
honored that the EIB and the European Commission chose to
collaborate with BiondVax in the development of our universal flu
vaccine. Together with the support of Israel's Ministry of Economy, we
are closer than ever to accomplishing our mission of marketing the
first universal flu vaccine for the benefit of people
worldwide."
"It has been a pleasure working with the EIB team
towards this collaboration, and I wish to thank them for their
support and interest. We also greatly appreciate the assistance of
Mr. Holm Keller and his team at kENUP for facilitating this
financing," continued Babecoff.
The finance contract between BiondVax and the EIB has been
facilitated by kENUP, a civic society organization promoting
innovative industries in Europe.
kENUP Chairman Mr. Holm Keller noted that, "The
State of Israel's
substantive and smart investments in fundamental research are an
important catalyst for establishing globally leading industries in
Europe. We are proud to be a
liaison between the relevant European institutions and Israel's leading research
institutions."
Innovation and skills are key ingredients for ensuring
sustainable growth and creating high-value jobs. They play an
important part in driving long-term competitiveness. For this
reason, innovation and skills are a top priority for the EIB Group
with a total financing of €18.7 billion in 2016.
The EIB-BiondVax non-dilutive financing agreement will be
structured as a zero-percent fixed interest loan, available for up
to 36 months with a variable remuneration based on royalties of net
sales of M-001 following commercialization. Funds will be advanced
in three tranches. The tranches are available up to 12, 24, and 36
months following the date of the agreement, and are dependent on
achievement of certain specified milestones, with the ultimate
milestone including authorization to launch a Phase 3 trial. The
tranches are repayable five years after each drawdown. BiondVax
retains the option to repay the loan and repurchase the royalties
at any time.
General information on InnovFin - EU Finance
for Innovators
Under Horizon 2020, the EU Research and Innovation Framework
Programme for 2014-20, the European Commission and the European
Investment Bank Group (EIB and EIF) launched a new generation of
financial instruments and advisory services in 2014 to help
innovative firms access finance more easily. Up until 2020,
"InnovFin - EU Finance for Innovators" will offer a range of
bespoke products which will make available more than €24 billion
worth of finance in support of research and innovation (R&I)
products undertaken by small, medium-sized and large companies and
promoters of research infrastructure.
Backed by funds set aside under Horizon 2020 and by the EIB
Group, InnovFin financial products are used to support R&I
activities, which by their nature are riskier and harder to assess
than traditional investments, and therefore often face difficulties
in accessing finance. Firms and other entities located in EU Member
States and Horizon 2020 Associated Countries are eligible as final
beneficiaries These debt instruments are complemented by a series
of equity instruments managed by the EIF.
The facility for financing research into infectious diseases
enables a wide range of financial products to be offered, ranging
from standard debt instruments to risk sharing instruments,
amounting to between €7.5 million and €75 million, for researchers
working to develop innovative vaccines, medicines, or medical and
diagnostic equipment or new research infrastructure specialising in
infectious diseases. The final beneficiaries are project promoters
who have successfully negotiated the preclinical stage.
About the European Investment Bank (EIB)
The European Investment Bank (EIB) is the long-term lending
institution of the European Union owned by its Member States. It
makes long-term finance available for sound investment in order to
contribute towards EU policy goals. Further details are
available at: http://www.eib.org
Follow the EIB on Twitter @eib
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company
developing a universal flu vaccine. The vaccine is designed to
provide multi-season protection against most seasonal and pandemic
human influenza virus strains. BiondVax's proprietary technology
utilizes a unique combination of conserved and common peptides from
influenza virus proteins, activating both arms of the immune system
for a cross-protecting and long-lasting effect. BiondVax is traded
on NASDAQ: BVXV and TASE: BVXV. Please visit
http://www.biondvax.com.
About kENUP
kENUP promotes research based innovation for the public and
societal benefit. It facilitates the development of projects to
pursue market-leading positions for European innovation businesses.
kENUP is registered in the EU as a lawful purpose foundation.
BiondVax Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Litigation Reform Act of 1995. Words
such as "expect,"
"believe," "intend,"
"plan," "continue,"
"may," "will,"
"anticipate," and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements involve certain risks and uncertainties
reflect the management's current views with respect
to certain current and future events and are subject to various
risks, uncertainties and assumptions that could cause the results
to differ materially from those expected by the management of
BiondVax Pharmaceuticals Ltd. risks and uncertainties include, but
are not limited to, the receipt and timing of approved grant funds,
the risk that drug development involves a lengthy and expensive
process with uncertain outcome, the results of the Phase 2 & 3
trials, delays or obstacles in launching and/or successfully
completing our clinical trials, our ability to procure the funds
and permits and other governmental authorization for a commercial
size manufacturing plant, our ability to satisfy rigorous
regulatory requirements, the impact of the global economic
environment on the Company customer target base, the adequacy
of available cash resource and the ability to raise capital
when needed. More detailed information about the risks and
uncertainties affecting the Company is contained under the
heading "Risk Factors" in our Annual
Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities
and Exchange Commission, or SEC, which is available on the SEC's
website, http://www.sec.gov, and in the
Company's periodic filings with the SEC and the
Tel-Aviv Stock Exchange.
For further information, please contact:
EIB
Anne-Cécile Auguin
+352-43-79-83330 / mobile: +352-621-36-19-48
a.auguin@eib.org
Press Desk: +352-4379-21000 - press@eib.org
BiondVax
Joshua Phillipson
Business Development Manager
+972-8-930-2529 ext.5105
j.phillipson@biondvax.com
1. Center for Disease Control (CDC):
http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
2. World Health Organization (WHO):
http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
3. WHO: http://www.who.int/mediacentre/factsheets/fs211/en/
4. CDC: http://www.cdc.gov/nchs/fastats/deaths.htm
5. Back to the Future: Study Published in Vaccine Journal
Indicates BiondVax's Universal Flu Vaccine Candidate May Cover
Strains Which Don't Yet Exist:
http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/
6. http://cordis.europa.eu/project/rcn/110139_en.html
SOURCE BiondVax Pharmaceuticals Ltd.