Saint-Herblain (France), Sao Paulo, (Brazil), May 5,
2020 – Valneva SE (“Valneva” or “the Company”), a
specialty vaccine company, and Instituto Butantan, producer of
immunobiologic products, today announced the signing of a binding
term sheet for the development, manufacturing and marketing of
Valneva’s single-shot chikungunya vaccine, VLA1553, in Low and
Middle Income Countries (LMICs). The collaboration falls within the
framework of the $23.4 million in funding Valneva received from the
Coalition for Epidemic Preparedness Innovations (CEPI) in July
20191. The definitive agreements are expected to be finalized in
the next six months.
After the signing of the definitive agreements,
Valneva will transfer its chikungunya vaccine technology to
Instituto Butantan, who will develop, manufacture and commercialize
the vaccine in LMICs. In addition, Instituto Butantan will provide
certain clinical and Phase 4 observational studies that Valneva
will use to meet regulatory requirements. The agreement will
include small upfront and technology transfer milestones.
Valneva held its End of Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) in February 2020 and is now
preparing to initiate Phase 3 clinical studies in the U.S. later
this year.
Thomas Lingelbach, Chief Executive
Officer of Valneva, commented, “Although millions of
people have been affected by chikungunya, there is currently no
vaccine and no effective treatment available against this
debilitating disease. We look forward to working with Instituto
Butantan to help address this current public health crisis and
speed up the development of a chikungunya vaccine in LMICs, which
are high outbreak areas."
Dr. Dimas Covas, Director of Instituto
Butantan added, “The burden of chikungunya virus disease
resides not only in the two million deaths worldwide since 2005,
but also in the chronification of its symptoms, which constitutes a
long term public health problem. By tackling the challenge of
developing, manufacturing and marketing Valneva's chikungunya
vaccine, Instituto Butantan will further strengthen its commitment
to improving public health in low and middle income countries.”
About Chikungunya Chikungunya
is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Clinical symptoms include acute onset of fever, debilitating joint
and muscle pain, headache, nausea and rash, potentially developing
into long-term, serious health impairments. Chikungunya virus
causes clinical illness in 72-92% of infected humans around 4 to 7
days after an infected mosquito bite. Complications resulting from
the disease include visual, neurological, heart and
gastrointestinal manifestations; fatalities have been reported
(case fatality rates of 0.1% to 4.9% from epidemics)2 in elderly
patients at higher risk. Chikungunya outbreaks have been reported
in Asia, Africa, the Americas and recently (2017) in Europe. As of
2017, there have been more than one million reported cases in the
Americas3 and the economic impact is considered to be
significant (e.g., 2014 Colombia outbreak: $73.6 million4). The
medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to further spread geographically.
There are no preventive vaccines or effective treatments available
and, as such, chikungunya is considered to be a major public health
threat.
About Valneva’s vaccine candidate
VLA1553VLA1553 is a monovalent, single dose,
live-attenuated vaccine candidate for protection against
chikungunya. It was granted Fast Track designation by the U.S. Food
and Drug Administration (FDA) in December 20185.The vaccine
candidate is designed for prophylactic, active, single-dose
immunization against chikungunya in humans over one year old. The
vaccine targets long-lasting protection and an anticipated safety
profile similar to licensed vaccines for active immunization in
adults and children. The target population segments are travelers,
military personnel and individuals at risk living in endemic
regions. The global market for vaccines against chikungunya is
estimated to exceed $500 million annually6, including a traveler
vaccine market potential of ~$250 million. VLA1553 is based on an
infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a major
part of the gene encoding the non-structural replicase complex
protein nsP3, aiming for protection against various chikungunya
virus outbreak phylogroups and strains7.
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including unique vaccines against Lyme disease and
chikungunya. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the U.S. with over 500 employees. For
more information, visit www.valneva.com and follow the company on
LinkedIn.
About Instituto
ButantanInstituto Butantan is the main producer of
immunobiological products and vaccines in Brazil. Instituto
Butantan carries out scientific missions domestically and abroad
through the Pan American Health Organization, the World Health
Organization, UNICEF and the United Nations. The Institute
collaborates with other agencies of the São Paulo State Secretariat
of Health and the Brazilian Ministry of Health for the improvement
of overall health in Brazil. It acts in partnership with various
universities and entities such as the Bill & Melinda Gates
Foundation for the achievement of its institutional objectives. For
more information please visit the Institute website at
www.butantan.gov.br or contact the press office at (+55 11)
2627-9606 / 9428 or email to imprensa@butantan.gov.br
About CEPICEPI is an innovative
partnership between public, private, philanthropic, and civil
organisations, launched at the World Economic Forum at Davos in
2017, to develop vaccines to stop future epidemics. CEPI’s priority
diseases include Ebola virus, Lassa virus, Middle East Respiratory
Syndrome coronavirus, Nipah virus, Rift Valley Fever and
Chikungunya virus. CEPI also invests in platform technologies that
can be used for rapid vaccine and immunoprophylactic development
against unknown pathogens (i.e., Disease X).
CEPI has moved with great urgency and in
coordination with WHO in response to the emergence of COVID-19.
CEPI has initiated 9 partnerships to develop vaccines against the
novel coronavirus. The programmes leverage rapid response platforms
already supported by CEPI as well as new partnerships. The aim is
to advance COVID-19 vaccine candidates into clinical testing as
quickly as possible.
CEPI’s commitment to accessAs
COVID-19 demonstrates, infectious diseases utterly ignore political
borders. We cannot prevent or stop a global infectious disease
threat without equitable access to globally fair allocation of
vaccines. CEPI is wholly committed to equitable access. This
commitment drives every aspect of our work. CEPI’s support for
equitable access is key to our success as a global health
organisation. Equitable access to epidemic vaccines—in the context
of an outbreak—means that appropriate vaccines are first available
to populations when and where they are needed to end an outbreak or
curtail an epidemic, regardless of ability to pay.
Learn more
at http://www.cepi.net. Follow us
at @CEPIvaccines.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineGlobal Head of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. In addition, even if the actual results or development
of Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be indicative of their in the future. In some
cases, you can identify forward-looking statements by words such as
"could," "should," "may," "expects," "anticipates," "believes,"
"intends," "estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. In light of these risks and uncertainties, there can be
no assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release, and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
1 CEPI awards up to US$23.4 million to Valneva for late-stage
development of a single-dose chikungunya vaccine
2 WHO, PAHO3 PAHO/WHO data: Number of reported cases of
Chikungunya Fever in the Americas – EW 51 (December 22, 2017)4
Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg
109:793-802.5 Valneva Awarded FDA Fast Track Designation for
Chikungunya vaccine candidate6 Company estimate supported by an
independent market study7 Hallengärd et al. 2013, J. Virology
88:2858-2866.
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