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May 21, 2019 5:45 am ET

Acquisition Includes Novel Late-Stage Renal Cell Carcinoma Candidate, PT2977

KENILWORTH, N.J. & DALLAS–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
and Peloton Therapeutics, Inc. today announced that the companies have
entered into a definitive agreement under which Merck, through a
subsidiary, will acquire privately held Peloton, a clinical-stage
biopharmaceutical company focused on the development of novel small
molecule therapeutic candidates targeting hypoxia-inducible factor-2α
(HIF-2α) for the treatment of patients with cancer and other
non-oncology diseases. Peloton’s lead candidate is PT2977, a novel oral
HIF-2α inhibitor in late-stage development for renal cell carcinoma
(RCC).

“This acquisition exemplifies Merck’s strategy to pursue novel
therapeutic candidates based on exceptionally promising and innovative
research,” said Dr. Roger M. Perlmutter, president, Merck Research
Laboratories. “Peloton scientists have applied their unique expertise in
HIF-2α biology to develop PT2977, which has already shown intriguing
activity in the treatment of renal cell carcinoma. We look forward to
advancing this late-stage asset as part of our broad oncology R&D
program.”

Under terms of the agreement, Merck, through a subsidiary, will acquire
all outstanding shares of Peloton in exchange for an upfront payment of
$1.05 billion in cash. In addition, Peloton shareholders will be
eligible to receive a further $1.15 billion contingent upon successful
achievement of future regulatory and sales milestones for certain
candidates.

“Merck is recognized as a leader in cancer research and shares our
commitment to accelerating the development of candidates targeting
HIF-2α to help patients with advanced cancers and other diseases,” said
John A. Josey, Ph.D., Peloton’s Chief Executive Officer. “We are proud
to have advanced PT2977 to this stage of development and believe that
Merck is well suited to build upon the progress our company has made.”

The closing will be subject to certain conditions, including the
expiration of the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act and other customary conditions. The companies
anticipate the acquisition will close in the third quarter of 2019.

Merck was represented by Covington & Burling LLP as legal advisor and
Credit Suisse as financial advisor. Peloton was represented by Wilson
Sonsini Goodrich & Rosati as legal advisor and Centerview Partners as
financial advisor.

About PT2977

PT2977 is a potent, selective, investigational oral HIF-2α inhibitor
currently being evaluated in multiple clinical studies. Specifically,
PT2977 is being evaluated in a Phase 2 clinical trial in von
Hippel-Lindau (VHL) disease-associated RCC, a Phase 2 clinical trial in
combination with cabozantinib, a VEGFR-targeting agent, in metastatic
RCC, a Phase 1/2 dose-escalation and dose-expansion clinical trial in
patients with metastatic RCC, and an expansion arm of its Phase 1/2
clinical trial in glioblastoma multiforme (GBM). In cancer, HIF-2α is
aberrantly activated in these diseases as a result of the inactivity of
the VHL tumor suppressor. This inactivation of the VHL tumor suppressor
is observed in over 90% of clear cell RCC, the most common form of
kidney cancer. Results from a Phase 1/2 study of PT2977 demonstrated
favorable safety and early signs of anti-tumor activity as a monotherapy
for the treatment of patients with advanced or metastatic RCC.

About Peloton

Peloton Therapeutics, Inc. is a clinical-stage biopharmaceutical company
focused on translating novel scientific insights into first-in-class
medicines for patients with cancer and other debilitating or
life-threatening conditions. The company’s lead development program is
evaluating a small molecule inhibitor of HIF-2α, a transcription factor
implicated in the development and progression of clear cell RCC and a
variety of other disorders. HIF-2α was previously thought to be
intractable using small molecules.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology
medicines to help people with cancer worldwide. At Merck, the potential
to bring new hope to people with cancer drives our purpose and
supporting accessibility to our cancer medicines is our commitment. As
part of our focus on cancer, Merck is committed to exploring the
potential of immuno-oncology with one of the largest development
programs in the industry across more than 30 tumor types. We also
continue to strengthen our portfolio through strategic acquisitions and
are prioritizing the development of several promising oncology
candidates with the potential to improve the treatment of advanced
cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

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
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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 2018 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).

Merck

Media Contact:
Pam Eisele
(267) 305-3558

Investor Contacts:
Teri Loxam
(908) 740-1986

Michael DeCarbo
(908) 740-1807

Peloton

Media Contact:
Mike Beyer
(312) 961-2502

Investor Contact:
Alan Musso
(972) 629-4070