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- European Medicines Agency to Conduct
First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine
Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the
EU-M4all (Previously Article 58) Procedure - Takeda Intends to Submit Regulatory Filings in
Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka
and Thailand During 2021 - TAK-003 is Being Studied for the Prevention of
Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60
OSAKA, JAPAN, and CAMBRIDGE, MASSACHUSETTS – Media
OutReach – 26 March 2021 – Takeda
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency (EMA) has
accepted the Company’s filing packages for its dengue vaccine candidate
(TAK-003) which is being investigated for the prevention of dengue due to any
dengue virus serotype in individuals ages four to 60. Takeda intends to submit
regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico,
Singapore, Sri Lanka and Thailand during 2021.
“Submission
of regulatory filings for our dengue vaccine candidate, TAK-003, marks an
important development for people who are living in or traveling to communities
burdened by the threat of dengue,” said Derek Wallace, VP, Dengue Global
Program Leader at Takeda. “Dengue outbreaks, which result in half a million
hospitalizations globally each year, can overwhelm communities and governments
because of the broad impact on the health care system. With limited options to
prevent the disease, there is a pressing need for widely available dengue
vaccines. Takeda is committed to working with regulatory authorities and
recommending bodies to support evaluation of our submissions and achieve access
for TAK-003.”
Takeda
is participating in the EMA’s first-ever parallel assessment of a medicinal
product for use in the European Union (EU), and through the EU-M4all
(previously Article 58) procedure for countries outside of the EU. Along with
the scientific opinion issued by the Committee for Medicinal Products for Human
Use (CHMP), national regulators in countries participating in the EU-M4all
procedure will conduct their own assessments to determine if national marketing
authorizations for TAK-003 are granted. Takeda is also seeking approval of
TAK-003 in dengue-endemic countries that are not participating in the EU-M4all
procedure.
Regulatory
submissions for TAK-003 include long-term safety and efficacy data through 36
months from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study
(TIDES) trial. Takeda intends
to present and publish details of the 36-month data at a scientific meeting and
in a peer-reviewed journal this year.
Takeda
also intends to submit regulatory filings in the United States, followed by
additional countries in Asia and Latin America.
EU-M4all[i]
EU-M4all (or
EU-Medicines for all) is a procedure designed to facilitate patient access to
essential medicines or vaccines intended to prevent or treat diseases of major
public health interest. Through the EU-M4all procedure (previously known as the
Article 58 procedure), the EMA, in cooperation with the World Health
Organization (WHO), can provide scientific opinion on medicines and vaccines
for public health priority diseases that are intended for markets outside of
the EU.
About
TAK-003
Takeda’s tetravalent
dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue
serotype 2 virus, which provides the genetic “backbone” for all four vaccine
viruses.[ii] Clinical Phase 2 data in children and adolescents showed that TAK-003 induced immune responses against all
four dengue serotypes, in both seropositive and seronegative participants,
which persisted through 48 months after vaccination, and the vaccine was found
to be generally safe and well tolerated.[iii] The pivotal Phase 3
TIDES trial met its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) at 12 months follow-up
and all secondary endpoints at 18 months follow-up for which there were a sufficient number of dengue cases, including VE
against hospitalized dengue and VE in baseline seropositive and baseline
seronegative individuals.[iv],[v] Efficacy varied by serotype. The
results demonstrated TAK-003 was generally well tolerated, and there have been
no important safety risks observed to date.
About the
Phase 3 TIDES (DEN-301) Trial
The double-blind,
randomized, placebo-controlled Phase 3 TIDES trial is evaluating the safety and
efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed
symptomatic dengue fever of any severity and due to any of the four dengue
virus serotypes in children and adolescents.[iv] The
TIDES trial is Takeda’s largest interventional clinical trial to date and
enrolled over 20,000 healthy children and adolescents ages four to 16 years
living in dengue-endemic areas. Study participants were randomly assigned to
receive either TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and
Day 90.[iv] The study is
comprised of five parts. Part 1 and the primary endpoint analysis evaluated
vaccine efficacy (VE) and safety through 15 months after the first dose (12
months after the second dose).[iv] Part 2 continued
for an additional six months to complete the assessment of the secondary
endpoints of VE by serotype, baseline serostatus and disease severity,
including VE against hospitalized dengue.[iv] Part 3 is evaluating
VE and long-term safety by following participants for an additional two and a
half to three years.[vi] Part 4 will
evaluate safety for 13 months following booster vaccination and Part 5 will
evaluate long-term safety for one year after completion of Part 4.[vi]
The trial is taking
place at sites in dengue-endemic areas in Latin America (Brazil, Colombia,
Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand
and Sri Lanka) where there are unmet needs in dengue prevention and where
severe dengue is a leading cause of serious illness and death among children.[iv] Baseline blood
samples were collected from all individuals participating in the trial to allow
for evaluation of safety and efficacy based on serostatus. Takeda and an
independent Data Monitoring Committee of experts are actively monitoring safety
on an ongoing basis.
About
Dengue
Dengue is the
fastest spreading mosquito-borne viral disease and was one of the WHO’s top 10
threats to global health in 2019.[vii],[viii] Dengue is mainly
spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus
mosquitoes. It is caused by any of four dengue virus serotypes, each of which
can cause dengue fever or severe dengue. The prevalence of individual serotypes
varies across different geographies, countries, regions, seasons and over time.[ix] Recovery from
infection by one serotype provides lifelong immunity against only that
serotype, and later exposure to any of the remaining serotypes is associated
with an increased risk of severe disease.
Dengue is pandemic
prone, and outbreaks are observed in tropical and sub-tropical areas and have
recently caused outbreaks in parts of the continental United States and Europe.[x],[xi] Approximately half
of the world now lives under the threat of dengue, which is estimated to cause
390 million infections and around 20,000 deaths globally each year.[x],[xi] The dengue virus
can infect people of all ages and is a leading cause of serious illness among
children in some countries in Latin America and Asia.[x]
Takeda’s
Commitment to Vaccines
Vaccines prevent 2
to 3 million deaths each year and have transformed global public health.[xiii] For the past 70
years, Takeda has supplied vaccines to protect the health of people in Japan.
Today, Takeda’s global vaccine business is applying innovation to tackle some
of the world’s most challenging infectious diseases, such as dengue, COVID-19,
Zika and norovirus. Takeda’s team brings an outstanding track record and a
wealth of knowledge in vaccine development, manufacturing and global access to
advance a pipeline of vaccines to address some of the world’s most pressing
public health needs. For more information, visit www.takedavaccines.com/.
Important Notice
For the purposes of this notice, “press
release” means this document, any oral presentation, any question and answer
session and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited (“Takeda”) regarding this release. This press
release (including any oral briefing and any question-and-answer in connection
with it) is not intended to, and does not constitute, represent or form part of
any offer, invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any securities
or the solicitation of any vote or approval in any jurisdiction. No shares or
other securities are being offered to the public by means of this press
release. No offering of securities shall be made in the United States except
pursuant to registration under the U.S. Securities Act of 1933, as amended, or
an exemption therefrom. This press release is being given (together with any
further information which may be provided to the recipient) on the condition
that it is for use by the recipient for information purposes only (and not for
the evaluation of any investment, acquisition, disposal or any other
transaction). Any failure to comply with these restrictions may constitute a
violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments
are separate entities. In this press release, “Takeda” is sometimes used for
convenience where references are made to Takeda and its subsidiaries in
general. Likewise, the words “we”, “us” and “our” are also used to refer to
subsidiaries in general or to those who work for them. These expressions are
also used where no useful purpose is served by identifying the particular
company or companies.
Forward-Looking Statements
This press release and any materials
distributed in connection with this press release may contain forward-looking
statements, beliefs or opinions regarding Takeda’s future business, future
position and results of operations, including estimates, forecasts, targets and
plans for Takeda. Without limitation, forward-looking statements often include
words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”,
“aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”
“anticipates”, “estimates”, “projects” or similar expressions or the negative
thereof. These forward-looking statements are based on assumptions about many
important factors, including the following, which could cause actual results to
differ materially from those expressed or implied by the forward-looking
statements: the economic circumstances surrounding Takeda’s global business,
including general economic conditions in Japan and the United States;
competitive pressures and developments; changes to applicable laws and
regulations, including global health care reforms; challenges inherent in new
product development, including uncertainty of clinical success and decisions of
regulatory authorities and the timing thereof; uncertainty of commercial
success for new and existing products; manufacturing difficulties or delays;
fluctuations in interest and currency exchange rates; claims or concerns
regarding the safety or efficacy of marketed products or product candidates;
the impact of health crises, like the novel coronavirus pandemic, on Takeda and
its customers and suppliers, including foreign governments in countries in
which Takeda operates, or on other facets of its business; the timing and
impact of post-merger integration efforts with acquired companies; the ability
to divest assets that are not core to Takeda’s operations and the timing of any
such divestment(s); and other factors identified in Takeda’s most recent Annual
Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities
and Exchange Commission, available on Takeda’s website at:
https://www.takeda.com/investors/ reports/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking statements
contained in this press release or any other forward-looking statements it may
make, except as required by law or stock exchange rule. Past performance is not
an indicator of future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate, forecast,
guarantee or projection of Takeda’s future results.
Medical information
This press release contains information
about products that may not be available in all countries, or may be available
under different trademarks, for different indications, in different dosages, or
in different strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs including
the ones under development.
References
[i] The European Medicines
Agency. Medicines for use outside the EU —
EU-M4all.
July 2020. Retrieved March 2021.
[ii] Huang CY-H, et al.
Genetic and phenotypic characterization of manufacturing seeds for tetravalent
dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.
[iii] Tricou, V, Sáez-Llorens X, et
al. Safety and immunogenicity of a
tetravalent dengue vaccine in children aged 2-17 years: a randomised,
placebo-controlled, phase 2 trial. Lancet. 2020. doi:10.1016/S0140-6736(20)30556-0.
[iv] Biswal S, et al.
Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. N
Engl J Med. 2019; 2019;381:2009-2019.
[v] Biswal S, et al.
Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a
randomized, placebo controlled, phase 3 trial. Lancet. 2020.
2020;395:1423-1433.
[vi] ClinicalTrials.Gov. Efficacy, Safety and Immunogenicity
of Takeda’s Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved March 2021.
[vii] World Health
Organization. Factsheet. Dengue and Severe Dengue. April 2019. Retrieved
February 2021.
[viii] World Health
Organization. Ten threats to global health in 2019. 2019. Retrieved February
2021.
[ix] Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.
[x] Knowlton K, et al. Mosquito-Borne Dengue Fever Threat
Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved February
2021.
[xi] Chan E, et al. Using web
search query data to monitor dengue epidemics: a new model for neglected
tropical disease surveillance. PLoS Negl Trop Dis. 2011;5:e1206.
[xii] Centers for Disease
Control and Prevention. About Dengue: What You Need to Know. May 2019. Retrieved
February 2021.
[xiii] UNICEF. Vaccination and Immunization Statistics. 2019. Retrieved February
2021.
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