Takeda and Biological E. Limited Collaborate to Accelerate Access to Dengue Vaccine in Endemic Areas

Takeda (TSE:4502/NYSE:TAK) and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA^®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments in endemic countries by 2030 at the latest to support National Immunization Programs. MDVs offer economic and logistical advantages for National Immunization Programs by minimizing packaging and storage expenses, while also reducing medical and environmental waste. BE will ramp up to a manufacturing capacity of up to 50 million doses a year, accelerating Takeda’s efforts to manufacture 100 million doses a year within the decade. The partnership will build upon existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany and Takeda’s long-term partnership with IDT Biologika GmbH.

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“Takeda's long-term goal for our dengue program has been to make QDENGA 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 QDENGA to drive sustainable access to the vaccine in more endemic countries."

Dengue fever is among the most common mosquito-borne viral diseases worldwide, with global incidence rates increasing 30-fold over the last 50 years due to urbanization, travel and climate change.^1,2 Dengue is currently endemic in more than 100 countries and causes an estimated 390 million infections each year.³ The Americas, South-East Asia and Western Pacific regions are the most seriously affected, with Asia alone representing ~70% of the global burden of disease.³

“We are proud to collaborate with Takeda in the production of their groundbreaking Dengue Tetravalent Vaccine, QDENGA, in multi-dose vials,” affirmed Ms. Mahima Datla, managing director at Biological E. Limited. “Takeda’s commitment to patient-focused, value-based research and development aligns extremely well with our dedication to advancing healthcare. We are fortunate to have created an institute that attracts such strong global partners for complex vaccines and underscores our shared mission of shaping a healthier future for all. With Takeda’s esteemed history and global presence, we are honored to advance our vision of delivering highly innovative medicines and transformative care worldwide.”

QDENGA is currently available for children and adults in the private market in countries in Europe, Indonesia and Thailand, and in private and some public programs in Argentina and Brazil. TAK-003 is not approved for use in India.

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 Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved Generic Injectables in its portfolio. Recently, BE has received Emergency Use Listing (EUL) from the WHO for CORBEVAX^®, the COVID-19 vaccine.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit www.biologicale.com and follow us on Facebook, LinkedIn and Twitter.

About QDENGA^® ▼ (Dengue Tetravalent Vaccine [Live, Attenuated])

QDENGA ^® (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 help protect against any of these serotypes.

In the European Union (EU) Member States, QDENGA is indicated for the prevention of dengue disease in individuals from four years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen.

The indications for use of QDENGA may vary in different countries/regions. The use of QDENGA should be in accordance with local recommendations.

Important Safety Information

Please consult the Summary of Product Characteristics (SmPC) before prescribing.

Guidance for use: QDENGA should be administered by subcutaneous injection preferably in the upper arm in the region of deltoid. QDENGA must not be injected intravascularly, intradermally or intramuscularly. Vaccination should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in a deferral of vaccination. Vaccination should be preceded by a review of the individual’s medical history (especially with regards to previous vaccination and possible hypersensitivity reactions which occurred after vaccination). Appropriate medical treatment and supervision must always be readily available in the event of a rare anaphylactic reaction following administration of the vaccine. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. A protective immune response with QDENGA may not be elicited in all vaccinees against all serotypes of dengue virus and may decline over time. It is currently unknown whether a lack of protection could result in an increased severity of dengue. It is recommended to continue personal protection measures against mosquito bites after vaccination. Individuals should seek medical care if they develop dengue symptoms or dengue warning signs.

Contraindications: Hypersensitivity to the active substances or excipients listed, or to previous QDENGA dose. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. Pregnant and breast-feeding women.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 of the SmPC for how to report adverse reactions.

Adverse Reactions: Most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common: (≥1/10 of subjects): upper respiratory tract infection^a, decreased appetite^c, irritability^c, headache, somnolence^c, myalgia, injection site pain, injection site erythema, malaise, asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitis^b, arthralgia, injection site swelling, injection site bruising^e, injection site pruritus^e, influenza like illness. ^aIncludes upper respiratory tract infection and viral upper respiratory tract infection. ^bIncludes pharyngotonsillitis and tonsillitis. ^cCollected in children below 6 years of age in clinical studies. ^dIncludes rash, viral rash, rash maculopapular, and rash pruritic. ^eReported in adults in clinical studies. Refer to the SmPC for details on full side effect profile and interactions.

For full prescribing information, please see the Summary of Product Characteristics (SmPC) for QDENGA ^® ▼.

Please consult with your local regulatory agency for any approved labeling in your country.

The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.

About Dengue

Dengue is a mosquito-borne viral disease that spreads rapidly around the world and was one of the WHO’s top 10 threats to global health in 2019.^3,4 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes.³ It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.⁵ The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.⁶ 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.^3,7

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/sec-filings-and-security-reports/ 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.

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¹ Ebi KL, Nealon J. Dengue in a changing climate. Environmental Research. 2016;151:115-123. doi:10.1016/j.envres.2016.07.026.
² Messina, J.P., Brady, O.J., Golding, N. et al. The current and future global distribution and population at risk of dengue. Nat Microbiol 4, 1508–1515 (2019). https://doi.org/10.1038/s41564-019-0476-8.
³ World Health Organization. Dengue and Severe Dengue. World Health Organization. https://www.who.int/en/news-room/fact-sheets/detail/dengue-and-severe-dengue. Published March 17, 2023.
⁴ World Health Organization (WHO). Ten threats to global health in 2019. Retrieved July 2023.
⁵ CDC. About Dengue: What You Need to Know. Published April 13, 2023.
⁶ Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.
⁷ Reich, et al. Interactions between serotypes of dengue highlight epidemiological impact of cross-immunity. J R Soc Interface 10: 20130414. http://dx.doi.org/10.1098/rsif.2013.0414.

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Contact information

Takeda Media Contacts:
Japanese Media
Maiko Miura
maiko.miura@takeda.com

U .S. and International Media
Charlotte McCormack
charlotte.mccormack@takeda.com

B iological E. Limited Media Contact:
K. Vijay Amruth Raj
Vijay.Kammari@biologicale.com
+91 83740 77433