Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents


January 30, 2019 6:45 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
today announced that V114, the company’s investigational 15-valent
pneumococcal conjugate vaccine, has received Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for the
prevention of invasive pneumococcal disease (IPD) caused by the vaccine
serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also
under development for the prevention of IPD in adults. Both indications
are currently being studied in Phase 3 clinical trials.

The Breakthrough Therapy Designation is an FDA program designed to
expedite the development and review of drugs intended for serious or
life-threatening conditions. To qualify for this designation,
preliminary clinical evidence must demonstrate that the drug may provide
substantial improvement over currently available therapy on at least one
clinically significant endpoint. The benefits of this Breakthrough
Therapy Designation include more intensive guidance from FDA on an
efficient drug development program, access to a scientific liaison to
help accelerate review time and eligibility for Accelerated Approval and
Priority Review if relevant criteria are met.

The FDA’s decision was informed in part by immunogenicity data from two
studies. Study 005 was a Phase 1/2, multicentre, randomized,
double-blind study to evaluate the safety, tolerability and
immunogenicity profiles of 4 different lots of a new formulation of V114
in healthy adults and infants. Study 008 was a proof of concept, Phase
2, pediatric trial to confirm the results from Study 005 in a larger
population of infants. In both studies, V114 induced an immune response
in infants for two disease-causing serotypes (22F and 33F) not contained
in the currently available 13-valent pneumococcal conjugate vaccine,
while demonstrating non-inferiority for the serotypes contained in both

“We are pleased with the data on V114 compiled to date, and we look
forward to working closely with the FDA on the subsequent development of
this investigational vaccine,” said Dr. Nicholas Kartsonis, senior vice
president and head of vaccine and infectious diseases clinical research
at Merck Research Laboratories. “The goal of our program in pediatric
patients remains focused on providing additional serotype coverage
versus currently available vaccines, while at the same time maintaining
a strong immune response across all serotypes in the vaccine.”

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,
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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
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 (

Pamela Eisele

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