Partnership Combines NGM’s Unique
Biology-focused Research Platform with Merck’s Late-stage Clinical
and Commercialization Strengths to Discover Medicines for
Serious Diseases
NGM Biopharmaceuticals, Inc., a privately-held
biotechnology company and Merck (NYSE:MRK), known as MSD outside
the United States and Canada, today announced they have entered
into a multi-year collaboration to research, discover, develop and
commercialize novel biologic therapies across a wide range of
therapeutic areas. This agreement will become effective upon the
expiration of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act.
“We are very pleased to establish this
alliance with Merck, which will be transformational for NGM,
providing us with the resources and flexibility to pursue our
ambitious research and development goals while preserving our
unique drug discovery culture,” said William J. Rieflin, Chief
Executive Officer of NGM. “We look forward to working with Merck to
generate a robust pipeline of therapies with the potential to make
a significant difference in the lives of patients.”
“NGM has developed a uniquely powerful
research program that has permitted identification of novel, and
quite consequential, pathways for metabolic regulation,” said Dr.
Roger M. Perlmutter, President of Merck Research Laboratories.
“Through this new collaboration, we hope to apply Merck’s
well-established translational capabilities to advance innovative
biologics that address the needs of patients suffering from
diabetes, metabolic dysregulation, and malignancy.”
The collaboration includes multiple drug
candidates currently in preclinical development at NGM, including
NP201, which is being evaluated for the treatment of diabetes,
obesity and nonalcoholic steatohepatitis (NASH). NGM will lead the
research and development of the existing preclinical candidates and
have the autonomy to identify and pursue other discovery stage
programs at its discretion. Merck will have the option to license
all resulting NGM programs following human proof of concept trials.
If Merck exercises this option, Merck will lead global product
development and commercialization for the resulting products, if
approved.
Under the terms of the agreement, Merck will
make an upfront payment to NGM of $94 million and will purchase a
15 percent equity stake in NGM for $106 million at a price per
share that represents a 20 percent premium to NGM’s most recent
financing. Merck will commit up to $250 million to fund all of
NGM’s efforts under the initial five-year term of the
collaboration, with the potential for additional funding if certain
conditions are met.
Prior to Merck initiating a Phase 3 study for
a licensed program, NGM may elect to either receive milestone and
royalty payments or, in certain cases, to co-fund development and
participate in a global cost and revenue share arrangement of up to
50 percent. The agreement also provides NGM with the option to
participate in the co-promotion of any co-funded program in the
United States. Merck will have the option to extend the research
agreement for two additional two-year terms.
“This collaboration brings together our
biology-driven research and development product platform with
Merck’s late-stage development and commercialization expertise,
while also enabling NGM to explore exciting new drug targets,”
commented Dr. Jin-Long Chen, Founder and Chief Scientific Officer
of NGM. “Both companies' commitment to scientific excellence and
willingness to creatively combine our strengths was key to
establishing this relationship."
NGM’s lead program, NGM282, currently in
clinical development for primary biliary cirrhosis (PBC) and NASH,
as well as programs that are the focus of NGM’s pre-existing
collaboration agreements, are not subject to the option under the
Merck collaboration.
NGM Conference Call Information
NGM will host a conference call and live audio
webcast today at 9:30 a.m. ET. To participate in the conference
call, please dial 1-877-930-8423 (domestic) or 1-253-642-1003
(international) and refer to conference ID 89756919. The live
webcast can be accessed via
http://edge.media-server.com/m/p/x7uj3857.
The archived webcast will be available on the
Company’s website, www.ngmbio.com, beginning approximately two
hours after the event.
About NGM Biopharmaceuticals
NGM Biopharmaceuticals is a private
biopharmaceutical company using a biology-centric approach to
create novel biologics for the treatment of a broad spectrum of
life-threatening diseases. NGM’s lead compound, NGM282, is in a
Phase 2b study for the treatment of PBC. NGM282 has received Orphan
Drug Designations in the U.S. and EU, and has been granted Fast
Track Designation for PBC by the U.S. Food and Drug Administration.
NGM has established collaborations with Merck, MedImmune, Daiichi
Sankyo and JDRF. NGM is financed by The Column Group, Prospect
Ventures, Rho Ventures, Tichenor Ventures, Topspin Ventures and
other leading investors around the world. For more information,
please visit www.ngmbio.com.
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, Facebook and
YouTube.
Merck Forward-Looking Statement
This news release 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
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 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; 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).
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MerckMedia Relations:Pamela Eisele, 267-305-3558orKim
Hamilton, 908-740-1863orInvestor Relations:Justin Holko,
908-740-1879orNGM BiopharmaceuticalsMedia Relations:Tony
Plohoros, 908-940-01356 Degreestplohoros@6degreespr.comorInvestor
Relations:Beth DelGiacco, 212-362-1200Stern Investor
Relationsbeth@sternir.com
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