Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced ...
June 30 2014 - 6:00AM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the European Medicines Agency (EMA) has
accepted for review a Marketing Authorization Application (MAA) for
pembrolizumab (MK-3475), the company’s investigational anti-PD-1
antibody, for the treatment of advanced melanoma. If approved by
the European Commission (EC), pembrolizumab has the potential to be
the first anti-PD-1 therapy in Europe. Additional regulatory
filings in other countries outside of Europe are planned by the end
of 2014.
“With the five-year survival rate for patients with advanced
melanoma at less than 20 percent, there remains a need to offer
patients additional options,” said Dr. Roy Baynes, senior vice
president, clinical development, Merck Research Laboratories. “We
are pleased to have regulatory applications under review in the
United States and Europe as we work toward bringing pembrolizumab
to patients around the world.”
About Advanced Melanoma
Melanoma is the most serious form of skin cancer and is the 19th
most common cause of cancer death in Europe. In 2012, there were an
estimated 22,200 deaths from malignant melanoma in Europe. There
were an estimated 232,000 new cases of melanoma diagnosed worldwide
in 2012.
About Pembrolizumab
Pembrolizumab (MK-3475) is an investigational, selective,
humanized, monoclonal anti-PD-1 antibody designed to reactivate
anti-tumor immunity. Pembrolizumab exerts dual ligand blockade of
the PD-1 pathway by inhibiting the interaction of PD-1 on T cells
with its ligands PD-L1 and PD-L2.
Today, pembrolizumab is being evaluated across more than 30
types of cancers, as monotherapy and in combination. It is
anticipated that by the end of 2014, the pembrolizumab development
program will grow to more than 24 clinical trials, enrolling an
estimated 6,000 patients at nearly 300 clinical trial sites
worldwide. For information about Merck’s oncology clinical studies,
please visit http://www.merck.com/clinical-trials/index.html.
The Biologics License Application (BLA) for pembrolizumab is
under priority review with the U.S. Food and Drug Administration
(FDA) for the treatment of patients with advanced melanoma
previously-treated with ipilimumab; the PDUFA date is October 28,
2014. Pembrolizumab has been granted FDA’s Breakthrough Therapy
designation for advanced melanoma. If approved by the FDA,
pembrolizumab has the potential to be the first anti-PD-1 therapy
approved within the United States.
About Merck Oncology
At Merck Oncology, our goal is to translate breakthrough science
into biomedical innovations to help people with cancer worldwide.
Harnessing immune mechanisms to fight cancer is the priority focus
of our oncology research and development program. The Company is
advancing a pipeline of immunotherapy candidates and combination
regimens. Cancer is one of the world's most urgent unmet medical
needs. Helping to empower people to fight cancer is our passion.
For information about Merck’s commitment to Oncology visit the
Oncology Information Center at
http://www.mercknewsroom.com/oncology-infocenter.
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 consumer care 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, Facebook and
YouTube.
Forward-Looking Statement
This news release 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 Merck’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; Merck’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 Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck 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 Merck’s 2013 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).
Media:Steve Cragle, 973-432-4781Claire Mulhear,
908-423-7425orInvestors:Joseph Romanelli, 908-423-5185Justin Holko,
908-423-5088
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