Thursday, February 29, 2024
Takeda ( TSE:4502/NYSE:TAK ) and Biological E. Limited (BE), a leading vaccines and pharmaceuticals company based in India, announced today a strategic partnership to accelerate access to QDENGA ® ▼ (tetravalent dengue vaccine [live, attenuated]) multidose vials (MDVs) (TAK-003). These doses will finally be made available for acquisition by governments in endemic countries by 2030 at the latest to support National Immunization Programs. MDVs offer economic and logistical advantages to immunization programs by minimizing packaging and storage expenses while reducing medical and environmental waste. BE aims to increase production capacity to up to 50 million doses per year, accelerating Takeda's efforts to manufacture 100 million doses per year within a decade. The partnership will build on the vaccine's existing manufacturing capacity at Takeda's facility in Singen, Germany, and Takeda's long-term partnership with IDT Biologika GmbH.
“Takeda’s long-term goal for our dengue program has been to make QDENGA widely available to those at risk who can benefit from immunization. Last year, we successfully launched the vaccine in private markets, and now we plan to launch in some public programs and work with partners to support broader public health impact," said Gary Dubin, MD, president of the Global Vaccines 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 long-standing support of public health programs around the world. Together, we will help combat dengue on a global scale by significantly increasing production capacity for multi-dose vials of QDENGA to promote sustainable access to the vaccine in more endemic countries."
Dengue is among the most common mosquito-borne viral diseases worldwide, with global incidence rates increasing 30-fold over the past 50 years due to urbanization, travel and climate change. 1,2 Dengue is currently endemic in more than 100 countries and causes approximately 390 million infections each year. 3 The Americas, Southeast Asia, and Western Pacific regions are most severely affected, with Asia alone accounting for about 70% of the global disease burden. 3
“We are proud to collaborate with Takeda in the production of its innovative tetravalent dengue vaccine, QDENGA, in multi-dose vials,” said Mahima Datla, Managing Director at Biological E. Limited. “Takeda’s commitment to patient-centered, value-based research and development aligns perfectly well with our dedication to advancing healthcare. We are fortunate to have created an institute that attracts such strong global partners to produce complex vaccines and that highlights our shared mission to shape a healthier future for all. With Takeda’s esteemed history and global presence, we are honored to advance our vision of providing highly innovative medicines and transformative care around the world.”
QDENGA is currently available to children and adults in the private market in European countries, Indonesia and Thailand, and in private programs 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. Our goal is to discover and deliver life-changing treatments across 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 based 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 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 pharmaceutical and biological company founded in 1953, is the first private sector biologics company in India and the first pharmaceutical company in the south of the country. BE develops, manufactures and supplies vaccines and medicines. 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 vaccines pre-qualified by the WHO and 10 generic injectables approved by the USFDA in its portfolio. Recently, BE 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 the development of specialty injectable products for global markets as a means of sustainably manufacturing APIs and the development of new vaccines for the global market.
For more details, visit www.biologicale.com and follow us on Facebook , LinkedIn and Twitter .
About QDENGA ® ▼ (tetravalent dengue vaccine [live, attenuated])
QDENGA ® (TAK-003) is a dengue vaccine that is based on the live attenuated dengue virus serotype 2, which provides the genetic “skeleton” for the four dengue virus serotypes, and which is designed to protect against any one of these serotypes
In the Member States of the European Union (EU), QDENGA is indicated for the prevention of dengue in individuals over the age of four, and must be administered subcutaneously at a dose of 0.5 mL in a two-dose schedule (0 and 3 months ), in accordance with the approved dosage regimen.
Indications for use of QDENGA may vary in different countries/regions. The use of QDENGA must be in accordance with local recommendations.
Important safety information
Consult the Summary of Product Characteristics (SmPC) before prescribing.
Guidance for use: QDENGA should be administered by subcutaneous injection, preferably in the upper part of the arm, in the deltoid region. QDENGA should not be injected intravascularly, intradermally or intramuscularly. Vaccination should be postponed in individuals who have a severe acute febrile illness. The presence of a mild infection, such as a cold, should not result in postponing vaccination. Vaccination should be preceded by a review of the individual's medical history (especially in relation to previous vaccination and possible hypersensitivity reactions that occurred after vaccination). In case of a rare anaphylactic reaction following vaccine administration, appropriate medical treatment and supervision should always be available. 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 to take all precautions to avoid injuries from fainting. It is possible that no protective immune response will be produced with QDENGA in everyone vaccinated against all serotypes of the dengue virus and it may decrease over time. It is currently unknown whether a lack of protection can result in an increase in the severity of dengue fever. It is recommended to continue personal protective measures against mosquito bites after vaccination. People should seek medical attention if they develop dengue symptoms or warning signs of dengue fever.
Contraindications: hypersensitivity to the active substances or excipients mentioned, or to the previous dose of QDENGA. People 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 two weeks or more) within the previous four weeks to vaccination. People with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. Pregnant and lactating women.
▼ This medicine is subject to additional monitoring. This will allow you to quickly identify new security information. It is necessary for healthcare professionals to report any adverse reactions. See Section 4.8 of the SmPC for how to report adverse reactions. .
Adverse reactions: the most frequently reported reactions in people aged 4 to 60 years: pain at the injection site (50%), headache (35%), myalgia (31%), erythema at the injection site (27%), malaise (24%), asthenia (20%) and fever (11%). Very common: (≥1/10 of individuals): upper respiratory tract infection c , decreased appetite c , irritability c , headache, drowsiness c , myalgia, injection site pain, injection site erythema, malaise being, asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitis , arthralgia, injection site swelling, injection site bruising , injection site pruritus , flu-like illness. a Includes upper respiratory tract infection and viral upper respiratory tract infection. b Includes pharyngotonsillitis and tonsillitis. c Collected from children under 6 years of age in clinical studies. d Includes rash, viral rash, maculopapular rash, and pruritic rash. and Reported in adults in clinical studies. Please see the SmPC for details on the full side effect profile and interactions.
For complete prescribing information, see the Summary of Product Characteristics (SmPC) for QDENGA ® ▼.
Consult your local regulatory agency for any labeling approved in your country.
The drug information contained herein is intended to disclose corporate information. Nothing contained herein should be considered a solicitation, promotion or indication of any prescription drug, including those currently in 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 transmitted primarily by Aedes aegypti mosquitoes and, to a lesser extent, by mosquitoes Aedes albopictus . 3 It is caused by any of the four serotypes of the dengue virus, each of which can cause dengue fever or severe dengue fever. 5 The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time. 6 Recovery from infection with one serotype provides lifelong immunity against that serotype only, and subsequent exposure to any of the remaining serotypes is associated with an increased risk of severe disease. 3.7
Important warning
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Forward-looking statements
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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 strengths or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs, including those in development.
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 fever. 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 on 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 on April 13, 2023.
6 Guzman MG, et al. Dengue: an ongoing global threat. Nature analyzes microbiology. 2010;8:S7-S16.
7 Reich, et al. Interactions between dengue serotypes highlight the epidemiological impact of cross-immunity. JR Soc Interface 10: 20130414. http://dx.doi.org/10.1098/rsif.2013.0414 .
The original language text of this announcement is the official authorized version. Translations are provided as a facility only and must refer to the text in the original language, which is the only version of the text that has legal effect.
Contacts
Takeda Media Contacts:
Japanese Media
Maiko Miura
maiko.miura@takeda.com
US Media 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
Source: businesswire.com
