- Biological E. Limited (BE) to Manufacture Up to 50 Million
Doses of QDENGA Per Year, Accelerating Takeda’s Ability to Deliver
100 Million Doses Per Year by 2030 At the Latest
- Addresses the Specific Need to Offer Multi-Dose Vials for
National Immunization Programs to Help Protect the Most Vulnerable
Populations
- Dengue Incidence Continues to Increase and Poses a Growing
Threat to Public Health Worldwide
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 infectiona, decreased
appetitec, irritabilityc, headache, somnolencec, myalgia, injection
site pain, injection site erythema, malaise, asthenia, fever.
Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitisb,
arthralgia, injection site swelling, injection site bruisinge,
injection site prurituse, 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.
______________________________ 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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Takeda Media Contacts: Japanese Media Maiko Miura
maiko.miura@takeda.com
U.S. and International Media Charlotte McCormack
charlotte.mccormack@takeda.com
Biological E. Limited Media Contact: K. Vijay
Amruth Raj Vijay.Kammari@biologicale.com +91 83740 77433
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