Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine
April 17 2018 - 8:30AM
Business Wire
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, today announced that the company is beginning two Phase 3
studies of PCV-15 (V114), its investigational polyvalent conjugate
vaccine for the prevention of pneumococcal disease. The first study
(ClinicalTrials.gov, NCT03480763) will evaluate the safety,
tolerability and immunogenicity of PCV-15 followed by Pneumococcal
Vaccine Polyvalent one year later in healthy adult subjects 50
years of age or older. The second Phase 3 study
(ClinicalTrials.gov, NCT03480802) will evaluate the safety,
tolerability and immunogenicity of PCV-15 followed by Pneumococcal
Vaccine Polyvalent administered eight weeks later in adults
infected with human immunodeficiency virus (HIV).
The decision to move PCV-15 to Phase 3 is based on the findings
of Phase 1 and Phase 2 studies, the results of which are being
presented at the upcoming International Society on Pneumococci and
Pneumococcal Diseases (ISPPD), which begins on Sunday, April
15.
“Merck has been a pioneer in pneumococcal and infectious disease
prevention. We are building on this heritage with the development
program for PCV-15,” said Eliav Barr, M.D. senior vice president,
Merck Research Laboratories. “Based on our Phase 1 and 2 studies of
PCV-15 findings, we are initiating a comprehensive Phase 3 program
to further evaluate this investigational 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,
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).
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MerckMedia:Pamela Eisele, 267-305-3558orSkip Irvine,
267-305-0338orInvestors:Teri Loxam, 908-740-1986orMichael DeCarbo,
908-740-1807
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