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July 31, 2015 7:10 am ET

Global Collaboration Enabled Vaccine to Move from First-in-Human Studies to Initial Phase 3 Results Within One Year

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (known as MSD outside the US and Canada) said today that its
investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have
100 percent efficacy in an analysis of interim data from a Phase 3 ring
vaccination trial in Guinea. Preliminary conclusions from this study,
which is continuing, were published on-line today in The Lancet.
The authors report that vaccine efficacy was 100 percent (95% confidence
interval: 74.7 – 100%; p=0.0036) following vaccination with a single
dose of the rVSV-ZEBOV vaccine. It appeared that all vaccinated
individuals were protected against Ebola virus infection within 6 to 10
days of vaccination.

To date, more than 4,000 participants have received the vaccine in this
innovative trial, called “Ebola ça suffit” or “Ebola, that’s enough.”
The trial was conducted by a team that included researchers from the
World Health Organization (WHO), the Norwegian Institute of Public
Health, the Health Ministry of Guinea and Médecins sans Frontières,
among others. The results from this continuing study, as well as other
studies already underway (see below) and additional studies to be
conducted, will be used to support worldwide regulatory submissions.

“Merck has an enduring commitment to develop vaccines and medicines that
address the world’s most devastating infectious diseases,” said Dr.
Roger M. Perlmutter, president of Merck Research Laboratories. “Building
on pioneering early work by the Public Health Agency of Canada and
NewLink Genetics Corporation, the extraordinary efforts of the team in
Guinea and other experts have yielded interim results that suggest a
potential role for our rVSV-ZEBOV vaccine in the fight against Ebola
disease.”

About the development of the rVSV-ZEBOV vaccine

The rVSV-ZEBOV vaccine was initially engineered with support from the
Public Health Agency of Canada and was licensed to NewLink Genetics
Corporation. To make the vaccine, the vesicular stomatitis virus was
weakened by removing one of its genes, which was then replaced with a
single Ebola virus gene that cannot cause disease by itself. Vaccinated
individuals have been shown to develop antibodies against the Ebola
virus, which could help protect against future infection. The
significance and durability of this immune response have not been
determined.

In late 2014, when the current Ebola outbreak was at its most severe,
Merck licensed rVSV-ZEBOV from NewLink Genetics, with the goal of
accelerating the assessment of this candidate vaccine. Since that time,
Merck has helped to enable a broad development program, including the
interim phase 3 efficacy results released today. To date, the rVSV-ZEBOV
vaccine has been administered to more than 9,000 people in phase 1, 2
and 3 clinical trials.

In addition to NewLink and the Public Health Agency of Canada, leading
global and national health organizations including the National
Institute of Allergy and Infectious Diseases (NIAID), the Walter Reed
Army Institute of Research (WRAIR), the Canadian Immunization Research
Network (CIRN) and the US Army Medical Research Institute of Infectious
Diseases (USAMRIID) have helped to conduct studies of the rVSV-ZEBOV
vaccine. Major funders for these studies included the US Department of
Defense’s (DoD) Defense Threat Reduction Agency (DTRA) and Joint Vaccine
Acquisition Program (JVAP), the US Department of Health and Human
Service’s Biomedical Advanced Research Development Authority (BARDA),
the National Institutes of Health (NIH) and the Wellcome Trust.

In addition to the phase 3 trial in Guinea described above, other
studies evaluating the rVSV-ZEBOV vaccine include the STRIVE (Sierra
Leone Trial to Introduce a Vaccine against Ebola) phase 3 study
currently being conducted by the Sierra Leone College of Medicine and
Allied Health Sciences (COMAHS), Sierra Leone Ministry of Health and
Sanitation and the US Centers for Disease Control and Prevention (CDC);
and the PREVAIL (Partnership for Research on Ebola Vaccines in Liberia)
phase 2 study being conducted by a Liberia-NIH partnership in Liberia.

Merck is responsible for research, development and manufacturing efforts
in support of the rVSV-ZEBOV vaccine. Merck has committed to work
closely with other stakeholders to accelerate the continued development,
production and, if licensed, distribution of the vaccine.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
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 healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States 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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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 2014 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).

Merck
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