Merck Announces Settlement and License Agreement Resolving KEYTRUDA® (pembrolizumab) Patent Litigation
January 20 2017 - 4:01PM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada), and certain of its affiliates, today announced it agreed
to enter into a settlement and license agreement with Bristol-Myers
Squibb Company and Ono Pharmaceutical Co., Ltd., resolving the
worldwide patent infringement litigation related to the use of an
anti-PD-1 antibody for the treatment of cancer, such as KEYTRUDA®
(pembrolizumab).
Under the settlement and license agreement, the company will
make a one-time payment of $625 million to Bristol-Myers Squibb and
provide royalties on the worldwide sales of KEYTRUDA for a
non-exclusive license to market KEYTRUDA in any market in which it
is approved. For global net sales of KEYTRUDA, the company will pay
Bristol-Myers Squibb royalties as follows:
- 6.5 percent of net sales occurring from
Jan. 1, 2017 through and including Dec. 31, 2023; and
- 2.5 percent of net sales occurring Jan.
1, 2024 through and including Dec. 31, 2026.
The parties also agreed to dismiss all claims in the relevant
legal proceedings.
“Today’s announcement eliminates uncertainty and enables us to
continue to focus on KEYTRUDA, our immuno-oncology medicine, which
is already helping thousands of patients around the world and
becoming a foundation for the treatment of cancer through our
industry-leading clinical development program,” said Kenneth C.
Frazier, chairman and chief executive officer, Merck.
The $625 million payment will be recorded in the company’s
fourth-quarter and full-year 2016 results. This expense will be
excluded from Merck’s non-GAAP results.
About Merck
For more than a century, Merck has been a global health care
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 health care through far-reaching
policies, programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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.
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 2015
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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version on businesswire.com: http://www.businesswire.com/news/home/20170120005499/en/
MerckMedia:Pamela Eisele, 267-305-3558Claire Gillespie,
267-305-0932orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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