BUSINESS WIRE: PRESS RELEASE : Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir…

Please be aware of the WARNINGS AND ADVERSE REACTIONS LISTED BY MANUFACTURERS

  Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an
Investigational Oral Antiviral COVID-19 Medicine, Have Been Supplied to the
U.S. Government for Use in the United States

Merck Has Completed Manufacturing of 10 Million Courses of Therapy and Remains
on Track to Produce at Least 20 Million Courses in 2022 to Provide Widespread
Access to Molnupiravir Globally

Business Wire

KENILWORTH, N.J. & MIAMI -- February 8, 2022

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and
Ridgeback Biotherapeutics today announced that a total of approximately 3.1
million courses of molnupiravir, an investigational oral antiviral COVID-19
medicine, have been provided to the U.S. government for allocation across the
country. The U.S. Department of Health and Human Services (HHS) has created a
public website to help providers identify locations that have received
shipments of government-procured COVID-19 therapeutics available under
Emergency Use Authorization. In 2021, Merck entered a procurement agreement
with the U.S. government under which the company agreed to supply
approximately 3.1 million courses of molnupiravir to the U.S. government upon
Emergency Use Authorization or approval from the U.S. Food and Drug
Administration.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20220208005551/en/

“As we start 2022, more than 2,000 COVID-19 deaths are being reported in the
U.S. daily, which underscores the need for medicines including molnupiravir
that can be taken at home. In line with our commitment to accelerating access
to molnupiravir in the U.S., we have now supplied more than 3 million courses
to the U.S. government within approximately 7 weeks of receiving Emergency Use
Authorization from the U.S. Food and Drug Administration,” said Robert M.
Davis, chief executive officer and president, Merck. “I am grateful to our
colleagues who have worked tirelessly over the past year to accomplish this
goal and to the health care providers who remain on the front lines of caring
for patients with COVID-19.”

“We believe that molnupiravir will be a critical addition in helping curb the
impact of COVID-19 on patients and health care systems in the U.S.,
particularly with the medicine’s antiviral activity against many variants of
concern. We will continue to work with urgency to bring this important
medicine to appropriate patients as quickly as possible,” said Wendy Holman,
chief executive officer, Ridgeback Biotherapeutics.

In addition to the U.S. agreement, Merck has entered into advance purchase and
supply agreements for molnupiravir in more than 30 markets worldwide,
including Australia, Canada, Korea, Japan, Thailand, Ukraine and United
Kingdom, pending regulatory authorizations, and is currently in discussions
with additional governments. To date, Merck has shipped molnupiravir to more
than 25 countries; in countries where it is approved or authorized, patients
have begun to receive the medicine.

About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following
Regulatory Authorizations or Approvals

Global access has been a priority for Merck and Ridgeback since the inception
of their molnupiravir collaboration. The companies are committed to providing
timely access to molnupiravir globally through our comprehensive supply and
access approach, which includes investing at risk to produce millions of
courses of therapy; tiered pricing based on the ability of governments to
finance health care; entering into supply agreements with governments;
allocating up to 3 million courses of therapy for distribution through UNICEF
and the ACT Accelerator Therapeutics Partnership; and granting voluntary
licenses to generic manufacturers and to the Medicines Patent Pool to make
generic molnupiravir available in more than 100 low- and middle-income
countries following local regulatory authorizations or approvals.

Supply: In anticipation of the results from MOVe-OUT and the potential for
regulatory authorization or approval, Merck produced molnupiravir at risk,
manufacturing 10 million courses of treatment by the end of 2021, with at
least 20 million courses expected to be produced in 2022. To date, Merck has
shipped molnupiravir to over 25 markets, including approximately 3.1 million
patient courses supplied to the U.S. government; in countries where it is
approved or authorized, patients have begun to receive the medicine. To
supplement the supply from licensed generic manufacturers, Merck has entered
an agreement with UNICEF to allocate up to 3 million courses of therapy to
low- and middle-income countries through the first half of 2022.

Supply agreements: Merck entered into a procurement agreement with the U.S.
government under which the company has supplied approximately 3.1 million
courses of molnupiravir to the U.S. government, upon Emergency Use
Authorization or approval from the U.S. Food and Drug Administration. The
procurement of molnupiravir was supported in whole or in part with federal
funds from the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical Advanced
Research and Development Authority, in collaboration with the DOD Joint
Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND) under contract number W911QY21C0031.

The U.S. Department of Health and Human Services (HHS) has created a public
website to help providers locate dispensing sites that have received shipments
of government-procured COVID-19 therapeutics available under Emergency Use
Authorization. Merck has also entered into advance purchase and supply
agreements for molnupiravir with governments for over 30 markets worldwide,
including Australia, Canada, Korea, Japan, Thailand, Ukraine and United
Kingdom, pending regulatory authorizations, and is currently in discussions
with additional governments. Merck is implementing a tiered pricing approach
based on World Bank country income criteria to reflect countries’ relative
ability to finance their health response to the pandemic.

Voluntary licenses: As part of its commitment to widespread global access,
Merck previously announced that it has entered into a licensing agreement with
the Medicines Patent Pool to increase broad access for molnupiravir in low-
and middle-income countries. Additionally, Merck previously announced that the
company has entered into non-exclusive voluntary licensing agreements for
molnupiravir with established generic manufacturers to accelerate availability
of molnupiravir in more than 100 low- and middle-income countries following
approvals or emergency authorization by local regulatory agencies.

Merck continues to discuss additional measures and collaborations to
accelerate broad, global access to molnupiravir.

Authorized Use of Molnupiravir in the U.S.

The U.S. Food and Drug Administration (FDA) has issued an EUA for the
emergency use of the unapproved molnupiravir, a nucleoside analogue that
inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of
mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive
results of direct SARS-CoV-2 viral testing, and who are at high risk for
progression to severe COVID-19, including hospitalization or death, and for
whom alternative COVID-19 treatment options authorized by FDA are not
accessible or clinically appropriate. Molnupiravir is not FDA-approved for any
use including for use for the treatment of COVID-19. Prior to initiating
treatment with molnupiravir, carefully consider the known and potential risks
and benefits.

Molnupiravir is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use of
molnupiravir under section 564(b)(1) of the Federal, Food, Drug, and Cosmetic
Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or
revoked sooner.

Molnupiravir is not authorized for use in patients less than 18 years of age
or who are hospitalized due to COVID-19. Benefit of treatment with
molnupiravir has not been observed in subjects when treatment was initiated
after hospitalization due to COVID-19. Molnupiravir is not authorized for use
for longer than five consecutive days. Molnupiravir is not authorized for
pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
Molnupiravir may only be prescribed for an individual patient by physicians,
advanced practice registered nurses, and physician assistants that are
licensed or authorized under state law to prescribe drugs in the therapeutic
class to which molnupiravir belongs (i.e., anti-infectives).

Selected Safety Information for Molnupiravir

Contraindications

No contraindications have been identified based on the limited available data
on the emergency use of molnupiravir authorized under this EUA.

Warnings and Precautions

There are limited clinical data available for molnupiravir. Serious and
unexpected adverse events may occur that have not been previously reported
with molnupiravir use.

Molnupiravir is not recommended for use during pregnancy. Based on findings
from animal reproduction studies, molnupiravir may cause fetal harm when
administered to pregnant individuals. There are no available human data on the
use of molnupiravir in pregnant individuals to evaluate the risk of major
birth defects, miscarriage or adverse maternal or fetal outcomes.

Molnupiravir is authorized to be prescribed to a pregnant individual only
after the healthcare provider has determined that the benefits would outweigh
the risks for that individual patient. If the decision is made to use
molnupiravir during pregnancy, the prescribing healthcare provider must
document that the known and potential benefits and the potential risks of
using molnupiravir during pregnancy were communicated to the pregnant
individual.

There is a pregnancy surveillance program that monitors pregnancy outcomes in
individuals exposed to molnupiravir during pregnancy. The prescribing
healthcare provider must document that a pregnant individual was made aware of
Merck’s pregnancy surveillance program at 1-877-888-4231 or
pregnancyreporting.msd.com. If the pregnant individual agrees to participate
in the pregnancy surveillance program and allows the prescribing healthcare
provider to disclose patient specific information to Merck, the prescribing
healthcare provider must provide the patient’s name and contact information to
Merck. Pregnant individuals exposed to molnupiravir can also report the
exposure by contacting Merck at 1-877-888-4231 or pregnancyreporting.msd.com.

Advise individuals of childbearing potential of the potential risk to a fetus
and to use an effective method of contraception correctly and consistently
during treatment with molnupiravir and for 4 days after the final dose.

Prior to initiating treatment with molnupiravir, assess whether an individual
of childbearing potential is pregnant or not, if clinically indicated.

Molnupiravir is not authorized for use in patients less than 18 years of age
because it may affect bone and cartilage growth. The safety and efficacy of
molnupiravir have not been established in pediatric patients.

Adverse Reactions

The most common adverse reactions occurring in ≥1% of subjects in the
molnupiravir treatment group in the Phase 3 double-blind MOVe-OUT study were
diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and
dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade
2 (moderate).

Serious adverse events occurred in 7% of subjects receiving molnupiravir and
10% receiving placebo; most serious adverse events were COVID-19 related.
Adverse events leading to death occurred in 2 (<1%) of the subjects receiving
molnupiravir and 12 (2%) of subjects receiving placebo.

Drug Interactions

No drug interactions have been identified based on the limited available data
on the emergency use of molnupiravir. No clinical drug-drug interaction trials
of molnupiravir with concomitant medications, including other treatments for
mild to moderate COVID-19, have been conducted.

Pregnancy/Breastfeeding

There are no data on the presence of molnupiravir or its metabolites in human
milk. It is unknown whether molnupiravir has an effect on the breastfed infant
or effects on milk production. Based on the potential for adverse reactions in
the infant from molnupiravir, breastfeeding is not recommended during
treatment with molnupiravir and for 4 days after the final dose. A lactating
individual may consider interrupting breastfeeding and may consider pumping
and discarding breast milk during treatment and for 4 days after the last dose
of molnupiravir.

Males of Reproductive Potential

Nonclinical studies to fully assess the potential for molnupiravir to affect
offspring of treated males have not been completed. Advise sexually active
individuals with partners of childbearing potential to use a reliable method
of contraception correctly and consistently during treatment and for at least
3 months after last dose of molnupiravir. The risk beyond three months after
the last dose of molnupiravir is unknown.

Required Reporting for Serious Adverse Events and Medication Errors

The prescribing healthcare provider and/or the provider’s designee are/is
responsible for mandatory reporting of all serious adverse events and
medication errors potentially related to molnupiravir within 7 calendar days
from the healthcare provider’s awareness of the event.

Submit adverse event and medication error reports, using FDA Form 3500, to FDA
MedWatch using one of the following methods:

* Complete and submit the report online: www.fda.gov/medwatch/report.htm
* Complete and submit a postage-paid FDA Form 3500
(https://www.fda.gov/media/76299/download) and return by:

* Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
* Fax to 1-800-FDA-0178

* Call 1-800-FDA-1088 to request a reporting form

In addition, please provide a copy of all FDA MedWatch forms to:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ
USA by:
Fax: 215-616-5677
E-mail: dpoc.usa@merck.com

About Molnupiravir

Molnupiravir (MK-4482) is an investigational, orally administered nucleoside
analog that inhibits the replication of SARS-CoV-2, the causative agent of
COVID-19.

Merck and Ridgeback’s “orange COVID-19 pill” is a Swedish Orange opaque
capsule with the Merck corporate logo and “82” printed in white ink, available
in certain markets outside of the U.S. as LAGEVRIO^®.

Results from the Phase 3 MOVe-OUT study demonstrated the efficacy benefit of
molnupiravir treatment was generally consistent across patients infected with
SARS-CoV-2 variants of concern, Delta, Gamma and Mu. Preclinical data has
shown that molnupiravir has antiviral activity against the newly identified
variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated against
Omicron in clinical studies.

Molnupiravir was invented at Emory University. Drug Innovation Ventures at
Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug
candidates for viral diseases of global concern, advanced molnupiravir through
IND submission. Emory/DRIVE received some research funding from the U.S.
Department of Defense and the U.S. National Institutes of Health. Molnupiravir
is being developed by Merck in collaboration with Ridgeback Biotherapeutics.
Ridgeback received an upfront payment from Merck and also is eligible to
receive contingent payments dependent upon the achievement of certain
developmental and regulatory approval milestones. Any profits from the
collaboration will be split between the partners equally. Since licensed by
Ridgeback, all funds used for the development of molnupiravir have been
provided by Merck and Ridgeback.

Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized,
placebo-controlled, double-blind, multi-site study of non-hospitalized adult
patients with symptomatic, laboratory-confirmed mild to moderate COVID-19 and
at least one risk factor associated with poor disease outcomes. The Phase 3
portion of the MOVe-OUT trial was conducted globally in more than 170 sites in
locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France,
Germany, Guatemala, Israel, Italy, Mexico, Philippines, Poland, Russia, South
Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United
States. For further information about the MOVe-OUT trial, please visit
clinicaltrials.gov. Molnupiravir is also being evaluated for post-exposure
prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind,
placebo-controlled Phase 3 study evaluating the efficacy and safety of
molnupiravir in preventing the spread of COVID-19 within households. For more
information, please visit http://merckcovidresearch.com.

Please visit the Merck media library for molnupiravir images and b-roll.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a
biotechnology company focused on emerging infectious diseases. Ridgeback
markets Ebanga™ for the treatment of Ebola and has a late-stage development
pipeline which includes molnupiravir for the treatment of COVID-19. The team
at Ridgeback is dedicated to developing life-saving and life-changing
solutions for patients and diseases that need champions as well as providing
global access to these medicines. In line with Ridgeback’s mission for
equitable global access, all Ridgeback services and treatment for Ebola
patients in Africa are delivered free of charge.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada,
has been inventing for life, bringing forward medicines and vaccines for many
of the world’s most challenging diseases in pursuit of our mission to save and
improve lives. We demonstrate our commitment to patients and population health
by increasing access to health care through far-reaching policies, programs
and partnerships. Today, Merck continues to be at the forefront of research to
prevent and treat diseases that threaten people and animals – including
cancer, infectious diseases such as HIV and Ebola, and emerging animal
diseases – as we aspire to be the premier research-intensive biopharmaceutical
company in the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, 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.
There can be no guarantees with respect to pipeline candidates that the
candidates 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 the global outbreak of
novel coronavirus disease (COVID-19); 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 2020
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).

Please see the Molnupiravir FDA Letter of Authorization at
https://www.merck.com/eua/Merck-EUA-letter.pdf, Fact Sheet for Healthcare
Providers, including Mandatory Requirements for Administration of Molnupiravir
under Emergency Use Authorization, at
https://www.merck.com/eua/molnupiravir-hcp-fact-sheet.pdf and Fact Sheet for
Patients and Caregivers at
https://www.merck.com/eua/molnupiravir-patient-fact-sheet-english.pdf.

View source version on businesswire.com:
https://www.businesswire.com/news/home/20220208005551/en/

Contact:

Media:

Melissa Moody
(215) 407-3536

Courtney Ronaldo
(908) 442-5695

Investor:

Peter Dannenbaum
(908) 740-1037

Damini Chokshi
(908) 740-1807