Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and Instituto Butantan, Sao Paulo, Brazil, a non-profit
producer of immunobiologic products for Brazil today announced a
collaboration agreement to develop vaccines to protect against
dengue virus disease, the mosquito-borne infection. Instituto
Butantan and Merck have licensed certain rights from National
Institute of Allergy and Infectious Diseases (NIAID), part of the
United States National Institutes of Health (NIH), for the
development of live attenuated tetravalent vaccines (LATV).
Instituto Butantan’s dengue vaccine candidate, TV003, is currently
being evaluated in a large Phase 3 study in Brazil.
“By sharing data from our ongoing vaccine development programs,
Instituto Butantan and Merck are better positioned to achieve our
goal of reducing the significant human and economic toll of dengue
virus in Brazil and around the world,” said Dr. Dimas Covas,
director, Instituto Butantan. “We look forward to collaborating
with Merck, an established global leader in vaccine
development.”
Under the agreement, Merck and Instituto Butantan have agreed to
collaborate to share clinical data and other learnings from their
respective dengue vaccine development programs, both derived from
licensed materials from the NIAID. Instituto Butantan will receive
a $26 million upfront payment from Merck and is eligible to receive
up to $75 million for the achievement of certain milestones related
to the development and commercialization of Merck’s investigational
vaccine as well as potential royalties on sales. Instituto Butantan
will retain responsibility for the manufacturing and
commercialization of their investigational vaccine, TV003, in
Brazil.
“This agreement recognizes the tremendous progress that
scientists and clinicians at the Instituto Butantan have made in
developing their investigational dengue virus vaccine,” said Dr.
Roger M. Perlmutter, president, Merck Research Laboratories.
“Through our new collaboration, we together have made a commitment
to help protect people around the world who are at risk of
developing dengue virus disease.”
The agreement builds upon a productive long-term collaboration
between MSD Brazil and Instituto Butantan, initiated in 2012, for
human papillomavirus (HPV) and Hepatitis-A vaccine products.
About dengue fever
Dengue fever is a mosquito-borne disease that occurs in tropical
and subtropical areas of the world. Mild dengue fever is
characterized by a high fever, rash, and muscle and joint pain. A
severe form of dengue fever, (dengue hemorrhagic fever) can cause
severe bleeding, a sudden drop in blood pressure and death. The
World Health Organization has estimated that up to 400 million
dengue infections occur annually, resulting in 500,000
hospitalizations.
About the dengue LATV candidate
Scientists in the Laboratory of Infectious Diseases at the NIAID
of the NIH engineered a candidate live attenuated tetravalent
vaccine against the dengue virus. NIAID then supported the
development of the candidate vaccine through a series of clinical
trials.
Instituto Butantan is sponsoring a placebo-controlled, double
blind, multi-center Phase 3 trial evaluating a single dose of LATV
produced at the institute in Sao Paulo. The Phase 3 trial aims to
enroll almost 17,000 healthy people aged 2 to 59 years in 15
cities. All participants will be monitored for five years through a
combination of in-person visits to the health clinic and telephone
or text communications from the investigators. The goal of the
trial is to determine the efficacy of the vaccine for preventing
dengue, and importantly to provide additional information about its
safety. The principal investigator is Dr. Esper Kallas, for the
University of Sao Paolo.
Additional information about the trial is available at
https://clinicaltrials.gov using the identifier NCT02406729.
About Instituto Butantan
Instituto Butantan is the main producer of immunobiological
products and vaccines in Brazil. Instituto Butantan carries out
scientific missions domestically and abroad through the Pan
American Health Organization, the World Health Organization, UNICEF
and the United Nations. The Institute collaborates with other
agencies of the São Paulo State Secretariat of Health and the
Brazilian Ministry of Health for the improvement of overall health
in Brazil. It acts in partnership with various universities and
entities such as the Bill & Melinda Gates Foundation for the
achievement of its institutional objectives. For more information
please visit the Institute website at www.butantan.gov.br or
contact the press office at (+55 11) 2627-9606 / 9428 or
email to imprensa@butantan.gov.br
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us
on Twitter, Facebook, Instagram, YouTube
and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2017
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181212005533/en/
Media Contacts:Pamela Eisele267-305-3558orSkip
Irvine267-305-0338orInvestor Contacts:Teri
Loxam908-740-1986orMichael DeCarbo908-740-1807
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024