Tuesday, April 16, 2024

Takeda Accelerates Access to its Dengue Vaccine Through ‘Make in India’ Manufacturing Partnership with Biological E.

  • New strategic partnership will scale-up manufacturing capacity to support global supply of dengue vaccine and expands Takeda’s footprint in vaccine manufacturing.
  • The strategic partnership will deliver potentially up to 50 million doses per year by 2030 to address global public health need.
  • Dengue is a global public health threat, and we are committed to helping reduce the burden of disease through ongoing efforts to expand our supply capacity for our dengue vaccine.

SINGAPORE, Feb. 27, 2024 /PRNewswire/ — Takeda (TSE:4502/NYSE:TAK) today announced a strategic partnership with Biological E. Limited, a leading vaccines and biologics company in India, to manufacture Takeda’s dengue vaccine, TAK-003. The partnership marks a crucial step in the fight against the global public health threat of dengue fever, aligning with the disease-specific target set by the World Health Organization (WHO) to achieve zero case-fatality rate due to dengue by 2030[i].

The partnership will substantially enhance manufacturing capabilities to ensure a sustainable global supply of the vaccine. Biological E will scale up its production capacity to potentially reach 50 million doses annually, accelerating Takeda’s efforts to manufacture 100 million doses annually within the decade.

Announcing the partnership at BioAsia 2024, a regional life sciences and healthcare forum organized by the Government of Telangana, Sri Anumula Revanth Reddy, the Hon’ble Chief Minister of Telangana said, “We are delighted that Hyderabad in Telangana will host the facility where the dengue vaccine, a result of the partnership between Takeda and Biological E., will be manufactured. The state of Telangana offers a conducive R&D and manufacturing environment with a focus on life sciences, particularly vaccines and biologics, and I am delighted that the dengue vaccine production in Hyderabad is aimed at accelerating its access in India and other endemic countries”. 

“Leveraging Takeda’s technological expertise and Biological E’s manufacturing capabilities will support greater accessibility and affordability of dengue vaccines, contributing to the nation’s healthcare resilience and future preparedness. We are happy to support this partnership among science, government and industry to drive and scale innovations for universal health coverage,” added Sri Duddilla Sridhar Babu, Hon’ble Minister of Industry & Commerce of Telangana.

“Takeda’s long-term goal for our dengue program has been to make TAK-003 broadly available to those at risk who may benefit from immunization. Within the last year, we’ve successfully launched in private markets, are now launching in some public programs, and working with partners to support a broader public health impact,” said Gary Dubin, M.D., President of the Global Vaccine Business Unit at Takeda. “We are proud to announce a strategic manufacturing partnership with Biological E. Limited, which has deep expertise in vaccine manufacturing and longstanding support of public health programs around the world. Together, we will help combat dengue on a global scale by significantly increasing manufacturing capacity for multi-dose vials of TAK-003 to drive sustainable access to the vaccine in more endemic countries.”

As the fastest-spreading mosquito-borne viral disease, about half of the world’s population is now at risk of dengue[ii]. In India and Southeast Asia, 1.3 billion people live in dengue-endemic areas, with Thailand, India, and Indonesia among some of the most highly endemic countries[iii]. The recent recommendations made by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommended Takeda’s dengue vaccine for introduction in settings with high dengue burden and high transmission intensity to maximize public health impact.

“This strategic partnership reaffirms our commitment to supplying vaccines to protect the health of people around the world and our efforts to strengthen partnerships in Asia. With vaccine approvals in Thailand, Indonesia, and recently in Malaysia, we are excited for a future where integrated protection against dengue can potentially improve the lives of countless people in India, Southeast Asia and beyond”, said Dion Warren, Head of India and Southeast Asia Multi-country Organisation, at Takeda.

Recently, The Lancet Global Health published long-term exploratory results from Takeda’s pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, demonstrating that TAK-003 showed continued protection against dengue fever through four and a half years (54 months) after vaccination. Currently, the vaccine has been approved in more than 30 countries, including the European Union[iv], the United Kingdom[v], Brazil[vi], Argentina[vii], Indonesia[viii], Thailand[ix] and Malaysia[x] for the prevention of dengue by any serotype. Moving forward, Takeda will continue to monitor the long-term data and continue with regulatory filings in more countries to address unmet public health needs.

Note to the Editor

These groundbreaking developments represent significant strides in the ongoing efforts to combat dengue fever globally. Takeda remains committed to developing a dengue vaccine that is safe for and protects those at risk of symptomatic dengue caused by any of the virus serotypes regardless of whether they have previously been exposed to dengue. Takeda continues to work closely with healthcare partners, governments, and communities to ensure the successful prevention of dengue per local guidelines.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

About TAK-003▼ (Dengue Tetravalent Vaccine [Live, Attenuated])

TAK-003 is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes.[xi]

TAK-003 is currently approved in more than 30 countries including the European Union, the United Kingdom, Brazil, Argentina, Indonesia, Thailand and Malaysia for the prevention of dengue disease. The vaccine should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule according to the approved dosing regimen and in accordance with local recommendations and age guidelines.[xii] 

Approval code: C-ANPROM/MY/DENV/0266

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.

[i] World Health Organization, Ending the neglect to attain the Sustainable Development Goals: A road map for neglected tropical diseases 2021–2030. Available at: https://www.who.int/publications/i/item/9789240010352. Accessed: February 2024.

[ii] World Health Organization, Dengue and Severe Dengue. Available at: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue#:~:text=About%20half%20of%20the%20world’s,urban%20and%20semi%2Durban%20areas. Accessed: February 2024.

[iii] World Health Organization, Dengue in South-East Asia. Available at: https://www.who.int/southeastasia/health-topics/dengue-and-severe-dengue. Accessed: February 2024.

[iv] European Medicines Agency, Qdenga. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/qdenga. Accessed: February 2024.

[v] Medicines and Healthcare products Regulatory Agency, Marketing authorisations granted 15 January to 31 January 2023. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1134336/Marketing_authorisations_granted_15_January_to_31_January_2023.pdf. Accessed February 2024.

[vi] Brazil’s ANVISA approves Takeda’s dengue vaccine Qdenga, Pharmceutical Technology, March 14, 2023. Available at: https://www.pharmaceutical-technology.com/news/brazil-takeda-dengue-vaccine/. Accessed: February 2024.

[vii] Regulator approves dengue vaccine in Argentina, Buenos Aries Herald, April 27, 2023. Available at : https://buenosairesherald.com/society/health/regulator-approves-dengue-vaccine-in-argentina. Accessed February 2024.

[viii] Takeda’s dengue vaccine approved in Indonesia for Use Regardless of Prior Dengue Exposure, August 22, 2022,. Available at: https://www.takeda.com/newsroom/newsreleases/2022/takedas-qdenga-dengue-tetravalent-vaccine-live-attenuated-approved-in-indonesia-for-use-regardless-of-prior-dengue-exposure/. Accessed February 2024.

[ix] Food and Drug Administration Ministry of Public Health, Thailand, May 8, 2023. Available at : https://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/pop-up_drug_ex.aspx?Newcode=U1DR2C1072660000411C. Accessed February 2024.

[x] Media Statement of National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Available at : https://www.npra.gov.my/easyarticles/images/shared/One-Stop%20Centre/Kenyataan-Media-KPK–keputusan-mesyuarat-PBKD-393—Zolgensma-dan-QDenga-v7-09022024.pdf. Accessed February 2024.

[xi] Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7: e2243.

[xii] Takeda. TAK-003 Summary of Product Characteristics. Accessed February 2024.

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