Merck and Instituto Butantan Announce Collaboration Agreement to Develop Vaccines to Protect Against Dengue Infections

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December 12, 2018 10:30 am EST

KENILWORTH, N.J.–(BUSINESS WIRE)–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

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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
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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
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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
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and other protections for innovative products; and the exposure to
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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).



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