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OSAKA, JAPAN, and CAMBRIDGE, MASSACHUSETTS –\u00a0Media
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“Submission
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Takeda
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Regulatory
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Takeda
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EU-M4all[i]<\/sup><\/b><\/p>\n
EU-M4all (or
About
Takeda’s tetravalent
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About the
The double-blind,
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The trial is taking
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About
Dengue is the
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Dengue is pandemic
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Takeda’s
Vaccines prevent 2
\u00a0<\/p>\n Important Notice<\/b><\/p>\n
For the purposes of this notice, “press
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The companies in which Takeda directly and indirectly owns investments
Forward-Looking Statements<\/b><\/p>\n
This press release and any materials
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Medical information<\/b><\/p>\n
This press release contains information
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References<\/b><\/p>\n
[i]\u00a0<\/sup>The European Medicines
[ii]<\/sup>\u00a0Huang CY-H, et al.
[iii]\u00a0<\/sup>Tricou, V, S\u00e1ez-Llorens X, et
[iv]<\/sup>\u00a0Biswal S, et al.
[v]<\/sup>\u00a0Biswal S, et al.
[vi]<\/sup>\u00a0ClinicalTrials.Gov. Efficacy, Safety and Immunogenicity
[vii]<\/sup>\u00a0World Health
[viii]<\/sup>\u00a0World Health
[ix]<\/sup>\u00a0Guzman MG, et al.\u00a0Dengue: a continuing global threat<\/a>.\u00a0Nature Reviews Microbiology<\/i>. 2010;8:S7-S16.<\/p>\n
[x]<\/sup>\u00a0Knowlton K, et al.\u00a0Mosquito-Borne Dengue Fever Threat
[xi]<\/sup>\u00a0Chan E, et al. Using web
[xii]<\/sup>\u00a0Centers for Disease
[xiii]<\/sup>\u00a0UNICEF.\u00a0Vaccination and Immunization Statistics<\/a>. 2019. Retrieved February
\nOutReach<\/a>\u00a0– 26 March 2021 –\u00a0Takeda
\nPharmaceutical Company Limited<\/a> (TSE:4502\/NYSE:TAK<\/a>) (“Takeda”) today announced that the European Medicines Agency (EMA) has
\naccepted the Company’s filing packages for its dengue vaccine candidate
\n(TAK-003) which is being investigated for the prevention of dengue due to any
\ndengue virus serotype in individuals ages four to 60. Takeda intends to submit
\nregulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico,
\nSingapore, Sri Lanka and Thailand during 2021.<\/p>\n
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\nof regulatory filings for our dengue vaccine candidate, TAK-003, marks an
\nimportant development for people who are living in or traveling to communities
\nburdened by the threat of dengue,” said Derek Wallace, VP, Dengue Global
\nProgram Leader at Takeda. “Dengue outbreaks, which result in half a million
\nhospitalizations globally each year, can overwhelm communities and governments
\nbecause of the broad impact on the health care system. With limited options to
\nprevent the disease, there is a pressing need for widely available dengue
\nvaccines. Takeda is committed to working with regulatory authorities and
\nrecommending bodies to support evaluation of our submissions and achieve access
\nfor TAK-003.”<\/p>\n
\n
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\n
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\nis participating in the EMA’s first-ever parallel assessment of a medicinal
\nproduct for use in the European Union (EU), and through the EU-M4all
\n(previously Article 58) procedure for countries outside of the EU. Along with
\nthe scientific opinion issued by the Committee for Medicinal Products for Human
\nUse (CHMP), national regulators in countries participating in the EU-M4all
\nprocedure will conduct their own assessments to determine if national marketing
\nauthorizations for TAK-003 are granted. Takeda is also seeking approval of
\nTAK-003 in dengue-endemic countries that are not participating in the EU-M4all
\nprocedure.<\/p>\n
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\nsubmissions for TAK-003 include long-term safety and efficacy data through 36
\nmonths from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study
\n(TIDES)<\/a> trial. Takeda intends
\nto present and publish details of the 36-month data at a scientific meeting and
\nin a peer-reviewed journal this year.<\/p>\n
\n
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\nalso intends to submit regulatory filings in the United States, followed by
\nadditional countries in Asia and Latin America.<\/p>\n
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\nEU-Medicines for all) is a procedure designed to facilitate patient access to
\nessential medicines or vaccines intended to prevent or treat diseases of major
\npublic health interest. Through the EU-M4all procedure (previously known as the
\nArticle 58 procedure), the EMA, in cooperation with the World Health
\nOrganization (WHO), can provide scientific opinion on medicines and vaccines
\nfor public health priority diseases that are intended for markets outside of
\nthe EU.<\/p>\n
\n
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\nTAK-003<\/b><\/p>\n
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\ndengue vaccine candidate (TAK-003) is based on a live-attenuated dengue
\nserotype 2 virus, which provides the genetic “backbone” for all four vaccine
\nviruses.[ii]<\/sup> Clinical Phase 2<\/a> data in children and adolescents showed that TAK-003 induced immune responses<\/a> against all
\nfour dengue serotypes, in both seropositive and seronegative participants,
\nwhich persisted through 48 months after vaccination, and the vaccine was found
\nto be generally safe and well tolerated.[iii]<\/sup> The pivotal Phase 3
\nTIDES trial met its primary endpoint of overall vaccine efficacy<\/a> (VE) against virologically confirmed dengue (VCD) at 12 months follow-up
\nand all secondary endpoints at 18 months follow-up<\/a> for which there were a sufficient number of dengue cases, including VE
\nagainst hospitalized dengue and VE in baseline seropositive and baseline
\nseronegative individuals.[iv]<\/sup>,<\/sup>[v]<\/sup> Efficacy varied by serotype. The
\nresults demonstrated TAK-003 was generally well tolerated, and there have been
\nno important safety risks observed to date.<\/p>\n
\n
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\nPhase 3 TIDES (DEN-301) Trial<\/b><\/p>\n
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\nrandomized, placebo-controlled Phase 3 TIDES trial is evaluating the safety and
\nefficacy of two doses of TAK-003 in the prevention of laboratory-confirmed
\nsymptomatic dengue fever of any severity and due to any of the four dengue
\nvirus serotypes in children and adolescents.[iv]<\/sup> The
\nTIDES trial is Takeda’s largest interventional clinical trial to date and
\nenrolled over 20,000 healthy children and adolescents ages four to 16 years
\nliving in dengue-endemic areas. Study participants were randomly assigned to
\nreceive either TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and
\nDay 90.[iv]<\/sup> The study is
\ncomprised of five parts. Part 1 and the primary endpoint analysis evaluated
\nvaccine efficacy (VE) and safety through 15 months after the first dose (12
\nmonths after the second dose).[iv]<\/sup> Part 2 continued
\nfor an additional six months to complete the assessment of the secondary
\nendpoints of VE by serotype, baseline serostatus and disease severity,
\nincluding VE against hospitalized dengue.[iv]<\/sup> Part 3 is evaluating
\nVE and long-term safety by following participants for an additional two and a
\nhalf to three years.[vi]<\/sup> Part 4 will
\nevaluate safety for 13 months following booster vaccination and Part 5 will
\nevaluate long-term safety for one year after completion of Part 4.
\n
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\nplace at sites in dengue-endemic areas in Latin America (Brazil, Colombia,
\nPanama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand
\nand Sri Lanka) where there are unmet needs in dengue prevention and where
\nsevere dengue is a leading cause of serious illness and death among children.[iv]<\/sup> Baseline blood
\nsamples were collected from all individuals participating in the trial to allow
\nfor evaluation of safety and efficacy based on serostatus. Takeda and an
\nindependent Data Monitoring Committee of experts are actively monitoring safety
\non an ongoing basis.<\/p>\n
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\nDengue<\/b><\/p>\n
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\nfastest spreading mosquito-borne viral disease and was one of the WHO’s top 10
\nthreats to global health in 2019.[vii]<\/sup>,<\/sup>[viii]<\/sup> Dengue is mainly
\nspread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus
\nmosquitoes. It is caused by any of four dengue virus serotypes, each of which
\ncan cause dengue fever or severe dengue. The prevalence of individual serotypes
\nvaries across different geographies, countries, regions, seasons and over time.[ix]<\/sup> Recovery from
\ninfection by one serotype provides lifelong immunity against only that
\nserotype, and later exposure to any of the remaining serotypes is associated
\nwith an increased risk of severe disease.<\/p>\n
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\nprone, and outbreaks are observed in tropical and sub-tropical areas and have
\nrecently caused outbreaks in parts of the continental United States and Europe.[x]<\/sup>,<\/sup>[xi]<\/sup> Approximately half
\nof the world now lives under the threat of dengue, which is estimated to cause
\n390 million infections and around 20,000 deaths globally each year.
\ncan infect people of all ages and is a leading cause of serious illness among
\nchildren in some countries in Latin America and Asia.[x]<\/sup><\/a><\/p>\n
\n
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\n
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\nCommitment to Vaccines<\/b><\/p>\n
\n
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\nto 3 million deaths each year and have transformed global public health.[xiii]<\/sup> For the past 70
\nyears, Takeda has supplied vaccines to protect the health of people in Japan.
\nToday, Takeda’s global vaccine business is applying innovation to tackle some
\nof the world’s most challenging infectious diseases, such as dengue, COVID-19,
\nZika and norovirus. Takeda’s team brings an outstanding track record and a
\nwealth of knowledge in vaccine development, manufacturing and global access to
\nadvance a pipeline of vaccines to address some of the world’s most pressing
\npublic health needs. For more information, visit www.takedavaccines.com\/<\/a>.<\/p>\n
\n
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\n
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\nrelease” means this document, any oral presentation, any question and answer
\nsession and any written or oral material discussed or distributed by Takeda
\nPharmaceutical Company Limited (“Takeda”) regarding this release. This press
\nrelease (including any oral briefing and any question-and-answer in connection
\nwith it) is not intended to, and does not constitute, represent or form part of
\nany offer, invitation or solicitation of any offer to purchase, otherwise
\nacquire, subscribe for, exchange, sell or otherwise dispose of, any securities
\nor the solicitation of any vote or approval in any jurisdiction. No shares or
\nother securities are being offered to the public by means of this press
\nrelease. No offering of securities shall be made in the United States except
\npursuant to registration under the U.S. Securities Act of 1933, as amended, or
\nan exemption therefrom. This press release is being given (together with any
\nfurther information which may be provided to the recipient) on the condition
\nthat it is for use by the recipient for information purposes only (and not for
\nthe evaluation of any investment, acquisition, disposal or any other
\ntransaction). Any failure to comply with these restrictions may constitute a
\nviolation of applicable securities laws.<\/p>\n
\n
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\n
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\nare separate entities. In this press release, “Takeda” is sometimes used for
\nconvenience where references are made to Takeda and its subsidiaries in
\ngeneral. Likewise, the words “we”, “us” and “our” are also used to refer to
\nsubsidiaries in general or to those who work for them. These expressions are
\nalso used where no useful purpose is served by identifying the particular
\ncompany or companies.<\/p>\n
\n
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\n
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\ndistributed in connection with this press release may contain forward-looking
\nstatements, beliefs or opinions regarding Takeda’s future business, future
\nposition and results of operations, including estimates, forecasts, targets and
\nplans for Takeda. Without limitation, forward-looking statements often include
\nwords such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”,
\n“aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”
\n“anticipates”, “estimates”, “projects” or similar expressions or the negative
\nthereof. These forward-looking statements are based on assumptions about many
\nimportant factors, including the following, which could cause actual results to
\ndiffer materially from those expressed or implied by the forward-looking
\nstatements: the economic circumstances surrounding Takeda’s global business,
\nincluding general economic conditions in Japan and the United States;
\ncompetitive pressures and developments; changes to applicable laws and
\nregulations, including global health care reforms; challenges inherent in new
\nproduct development, including uncertainty of clinical success and decisions of
\nregulatory authorities and the timing thereof; uncertainty of commercial
\nsuccess for new and existing products; manufacturing difficulties or delays;
\nfluctuations in interest and currency exchange rates; claims or concerns
\nregarding the safety or efficacy of marketed products or product candidates;
\nthe impact of health crises, like the novel coronavirus pandemic, on Takeda and
\nits customers and suppliers, including foreign governments in countries in
\nwhich Takeda operates, or on other facets of its business; the timing and
\nimpact of post-merger integration efforts with acquired companies; the ability
\nto divest assets that are not core to Takeda’s operations and the timing of any
\nsuch divestment(s); and other factors identified in Takeda’s most recent Annual
\nReport on Form 20-F and Takeda’s other reports filed with the U.S. Securities
\nand Exchange Commission, available on Takeda’s website at:
\nhttps:\/\/www.takeda.com\/investors\/ reports\/sec-filings\/ or at www.sec.gov.
\nTakeda does not undertake to update any of the forward-looking statements
\ncontained in this press release or any other forward-looking statements it may
\nmake, except as required by law or stock exchange rule. Past performance is not
\nan indicator of future results and the results or statements of Takeda in this
\npress release may not be indicative of, and are not an estimate, forecast,
\nguarantee or projection of Takeda’s future results.<\/p>\n
\n
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\n
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\n
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\nabout products that may not be available in all countries, or may be available
\nunder different trademarks, for different indications, in different dosages, or
\nin different strengths. Nothing contained herein should be considered a
\nsolicitation, promotion or advertisement for any prescription drugs including
\nthe ones under development.<\/p>\n
\n
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\n
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\n
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\n
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\nAgency.\u00a0Medicines for use outside the EU \u2014
\nEU-M4all<\/a>.
\nJuly 2020. Retrieved March 2021.<\/p>\n
\n
<\/p>\n
\nGenetic and phenotypic characterization of manufacturing seeds for tetravalent
\ndengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.<\/p>\n
\n
<\/p>\n
\nal.\u00a0Safety and immunogenicity of a
\ntetravalent dengue vaccine in children aged 2-17 years: a randomised,
\nplacebo-controlled, phase 2 trial<\/a>.\u00a0Lancet.\u00a0<\/i>2020. doi:10.1016\/S0140-6736(20)30556-0.<\/p>\n
\n
<\/p>\n
\nEfficacy of a tetravalent dengue vaccine in healthy children and adolescents. N
\nEngl J Med. 2019;\u00a02019;381:2009-2019.<\/p>\n
\n
<\/p>\n
\nEfficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a
\nrandomized, placebo controlled, phase 3 trial. Lancet. 2020.
\n2020;395:1423-1433.<\/p>\n
\n
<\/p>\n
\nof Takeda’s Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES)<\/a>. Retrieved March 2021.<\/p>\n
\n
<\/p>\n
\nOrganization. Factsheet.\u00a0Dengue and Severe Dengue<\/a>. April 2019. Retrieved
\nFebruary 2021.<\/p>\n
\n
<\/p>\n
\nOrganization.\u00a0Ten threats to global health in 2019<\/a>. 2019. Retrieved February
\n2021.<\/p>\n
\n
<\/p>\n
\n
<\/p>\n
\nSpreading in the Americas<\/a>. The Natural Resources Defense Council (NRDC). 2009. Retrieved February
\n2021.<\/p>\n
\n
<\/p>\n
\nsearch query data to monitor dengue epidemics: a new model for neglected
\ntropical disease surveillance. PLoS Negl Trop Dis. 2011;5:e1206.<\/p>\n
\n
<\/p>\n
\nControl and Prevention.\u00a0About Dengue: What You Need to Know.<\/a>\u00a0May 2019. Retrieved
\nFebruary 2021.<\/p>\n
\n
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\n2021.<\/p>\n
\n
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