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March 1, 2018 7:00 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that data from studies of Merck’s robust HIV pipeline,
including doravirine, a late-stage investigational non-nucleoside
reverse transcriptase inhibitor (NNRTI), and MK-8591, an investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI), a
“first of its kind” mechanism to enter clinical trials, are scheduled to
be presented at the Conference on Retroviruses and Opportunistic
Infections (CROI 2018). In addition, Merck scientists will present data
from experiments investigating the mechanisms of formation and
maintenance of HIV reservoirs and the impact of HIV persistence in the
gut on immune recovery during antiretroviral therapy. CROI
2018 is taking place in Boston, Massachusetts, from March 4-7, 2018.

“Merck’s commitment to HIV has never wavered, and we are very excited
about the progress being made in our labs today to both better
understand HIV and to bring forward the next generation of potential
treatments,” said Dr. George Hanna, associate vice president, clinical
research, Merck Research Laboratories.

Presentations include Week 48 subgroup analysis from the pivotal Phase 3
DRIVE-AHEAD trial evaluating the efficacy and safety of doravirine
(DOR), lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a
once-daily fixed-dose combination single tablet as a complete regimen
(DOR/3TC/TDF) for the treatment of HIV-1 infection in treatment-naïve
adults. In addition, results from a Phase 1 study evaluating MK-8591, an
investigational nucleoside reverse transcriptase translocation inhibitor
(NRTTI) that potentially inhibits HIV reverse transcriptase through
multiple mechanisms will be presented in a late breaking abstract
session.

Merck Abstracts at CROI 2018:

• Abstract # 491: Similar Efficacy and Safety by Subgroup in
  DRIVE-AHEAD: DOR/3TC/TDF versus EFV/FTC/TDF
  • Chloe Orkin
  • Poster presentation, Monday, March 5, 2:30 – 4:00 PM, Poster
    Hall D
• Abstract # 89LB: Low Dose MK-8591 Protects Rhesus Macaques Against
  Rectal SHIV Infection
  • Martin Markowitz
  • Late-breaker oral presentation, Tuesday, March 6, 11:45 AM,
    Ballroom B
• Abstract # 26: Multiple Daily Doses of MK-8591 as Low as 0.25 mg
  Are Expected to Suppress HIV
  • Randolph P. Matthews
  • Oral presentation, Monday, March 5, 11:00 AM, Auditorium
• Abstract # 158: CD32+ CD4+ T Cells Are HIV Transcriptionally Active
  Rather Than a Resting Reservoir
  • Mohamed Abdel-Mohsen
  • Oral presentation, Wednesday, March 7, 5:45 PM, Ballroom A
• Abstract # 730: Validation of a Chronic Kidney Disease Risk Score
  in HIV+ Patients in the US
  • Anthony Mills
  • Poster presentation, Tuesday, March 6, 2:30 – 4:00 PM, Poster
    Hall D
• Abstract # 316: A Bispecific Approach for Targeting Negative
  Checkpoint Receptors in HIV-1 Latency
  • Daniel Gorman
  • Poster presentation, Tuesday, March 6, 2:30 – 4:00 PM, Poster
    Hall A
• Abstract # 383: Higher Rectal p24 Levels Correlate with Poor CD4
  Recovery in Treated HIV Infection
  • Bonnie J. Howell
  • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
    Hall A
• Abstract # 376: IL-10 Signaling Is a Key Mechanism of SIV
  Persistence in ART-Treated Rhesus Macaques
  • Maria Pino
  • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
    Hall A
• Abstract # 393: Blinded Evaluation of Ultrasensitive Assays of HIV
  in Plasma
  • Sheila M. Keating
  • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
    Hall A

About Doravirine

Doravirine (MK-1439, DOR) is an investigational NNRTI being evaluated by
Merck for the treatment of HIV-1 infection. DOR is being evaluated in
several ongoing clinical trials both as a once-daily single-entity
tablet in combination with other antiretroviral agents in a tailored
regimen, and as a once-daily fixed-dose combination (DOR/3TC/TDF) in a
complete single tablet regimen. Phase 3 trials include DRIVE-FORWARD, a
trial comparing DOR to once-daily ritonavir-boosted darunavir (DRV+r),
each administered in combination with emtricitabine (FTC)/TDF or
abacavir (ABC)/3TC, in treatment-naïve adults; DRIVE-AHEAD, a trial
comparing DOR/3TC/TDF to efavirenz (EFV)/FTC/TDF in treatment-naïve
adults; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in
HIV-1 infected adults who are currently virologically suppressed on
another antiretroviral regimen. Other ongoing Phase 2 clinical trials
include an evaluation of DOR/3TC/TDF in treatment-naïve adults with
transmitted resistance to NNRTIs and in people switching from EFV due to
intolerability.

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted
for review two New Drug Applications (NDAs) for DOR for the treatment of
HIV-1 infection in treatment-naïve adults. The submission includes a
once-daily single-entity tablet in combination with other antiretroviral
agents in a tailored regimen, and a once-daily fixed-dose combination
(DOR/3TC/TDF) in a complete single tablet regimen. The FDA has set a
target action date of October 23, 2018, for both applications.

About MK-8591

MK-8591 is Merck’s investigational nucleoside reverse transcriptase
translocation inhibitor (NRTTI) currently being evaluated in clinical
trials for the treatment of HIV infection. Preclinical evidence
indicates that MK-8591 inhibits HIV reverse transcriptase through
multiple mechanisms that are different from any approved anti-HIV
medicines, including traditional nucleoside reverse transcriptase
inhibitors (NRTIs). MK-8591 is being evaluated in a 3-part Phase 2b
dose-ranging trial, DRIVE2SIMPLIFY, a study of MK-8591 in combination
with doravirine.

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 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).

Merck
Media Contacts:
Pamela Eisele, 267-305-3558
or
Carmen de Gourville, 267-305-4195
or
Investor Contacts:
Teri Loxam, 908-740-1986
or
Michael DeCarbo, 908-740-1807