FDA Approves MAVENCLAD® (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis

- MAVENCLAD is the first oral MS treatment to provide two years of
proven efficacy with a maximum of 20 days of treatment

- MAVENCLAD's unique mechanism may provide an important new option
for patients with ongoing active disease

- MAVENCLAD demonstrated significant efficacy across key measures
of disease activity

- Approval is based on clinical program consisting of more
than9,500 patient years of cladribine data and up to 8 years of time
on study

Darmstadt, Germany (ots/PRNewswire) -

Not intended for U.S. or U.K. based media

Merck, a leading science and technology company, today announced
that the U.S. Food and Drug Administration (FDA) has approved
MAVENCLAD® (cladribine) tablets for the treatment of adults with
relapsing-remitting disease (RRMS) and active secondary progressive
disease (SPMS). MAVENCLAD is the first and only FDA approved
treatment for RRMS and active SPMS that provides two years of proven
efficacy with a maximum of 20 days of oral treatment, during a
two-year period.

Because of its safety profile, use of MAVENCLAD is generally
recommended for patients who have had an inadequate response to, or
are unable to tolerate, an alternate drug indicated for the treatment
of multiple sclerosis (MS), and MAVENCLAD is not recommended for use
in patients for Clinically Isolated Syndrome (CIS). The MAVENCLAD
label includes a boxed warning for potential risk of malignancy, and
the risk of teratogenicity. The label appropriately defines the
relevant associated contraindications.

"Multiple sclerosis is the leading cause of non-traumatic
disability in young and middle-aged adults," said Belén Garijo, CEO
Healthcare and Member of the Executive Board of Merck. "We feel
privileged to introduce MAVENCLAD into clinical practice in the
United States. MAVENCLAD opens a new way to treat MS-a treatment that
requires a maximum of 20 days of oral therapy to deliver two years of
efficacy to a patient. This approval is a testimony to our
long-standing commitment to people living with MS."

"As an investigator in the clinical trial program, I am pleased
MAVENCLAD will now be available to patients in the US. With short
treatment courses with pills taken for no more than 10 days in a year
and no injections or infusions, MAVENCLAD is an efficacious new
treatment option for MS," said Thomas Leist, M.D., PhD, Director,
Comprehensive Multiple Sclerosis Center at Jefferson University
Hospitals, Philadelphia, USA. "Nearly 1 million individuals are
afflicted with MS in the US alone according to a recent National MS
Society sponsored study. MAVENCLAD is a welcome new oral treatment
option for this heterogenous and often unpredictable disease."

Eighty-five percent of people living with MS are initially
diagnosed with RRMS, characterized by attacks of new or increasing
neurological symptoms. Most people with RRMS will eventually
transition to a secondary progressive course in which there is a
progressive worsening of neurologic function over time.1 SPMS can be
further characterized at different points as either active (with
relapses and/or evidence of new MRI activity) or not active.

"The FDA approval of MAVENCLAD is excellent news for people living
with RRMS and active SPMS. MAVENCLAD offers a new and effective
option for some of those patients with an oral dosing schedule unlike
any other treatment currently available," said June Halper, CEO of
the Consortium of MS Centers. "People living with MS should have the
ability to work with their clinician to choose a treatment with a
dosing schedule that supports their lifestyle. CMSC congratulates
Merck for their dedication to bring MAVENCLAD to the US as the first
short-course oral treatment option for the community."

In the clinical trial program, 1,976 patients received therapy for
a total of 9,509 patient years, of which the mean time on study
including follow-up was approximately 4.8 years and 24% of the
follow-up was for eight years. MAVENCLAD demonstrated clinical
efficacy across key measures of disease activity, such as annualized
relapse rate, disability progression, and magnetic resonance imaging
(MRI) activity:

- Patients experienced a 58% relative reduction in the annualized
relapse rate with MAVENCLAD compared to placebo (0.14 vs 0.33,
p<0.001).
- 81% of patients were free of relapses after two years of
short-course oral treatment with MAVENCLAD, compared to 63% of
patients who received placebo (p<0.05).
- Patients treated with MAVENCLAD had a 33% reduction in risk of
3-month confirmed disability progression as measured by Expanded
Disability Status Scale (EDSS) compared to placebo (p<0.05).
- Patients taking MAVENCLAD experienced a lower median number of
T1-weighted gadolinium-enhanced brain lesions and new or enlarging
T2 brain lesions compared to patients with placebo (0 vs 0.33 and 0
vs 0.67) p<0.001).

The most common (> 20%) adverse reactions reported in the pivotal
phase III study, CLARITY were upper respiratory tract infection,
headache, and lymphopenia. Serious adverse reactions reported in the
clinical program included malignancies (0.27 events per 100
patient-years) in MAVENCLAD treatment arms, compared to placebo
patients (0.13 events per 100 patient-years), and herpes zoster
infections (2.0% vs. 0.2%) and oral herpes (2.6% vs. 1.2%).

Following the administration of two treatment courses, additional
courses of MAVENCLAD are not to be administered. Re-treatment with
MAVENCLAD during years three and four may further increase the risk
of malignancy. The safety and efficacy of reinitiating MAVENCLAD more
than two years after completing two treatment courses has not been
studied.

Merck is committed to helping support patients prescribed
MAVENCLAD. Over the course of 16 years, Merck`s comprehensive patient
support program in the U.S., MS LifeLines®, has had over four million
touchpoints with patients, care partners, health care professionals,
and other stakeholders to support our goal of providing one-on-one
assistance to U.S. patients prescribed a Merck MS therapy. MS
LifeLines® is now expanding to help patients prescribed MAVENCLAD and
offers personalized patient support, including assistance with
navigating insurance questions and additional resources that may be
able to assist patients who are uninsured or underinsured.

The U.S. approval of MAVENCLAD follows its approval in over 50
countries, including the European Union in August 2017.

For more information on MAVENCLAD, and prescribing information
(https://www.mavenclad.com/en/prescribing-information) including the
boxed WARNINGS, visit www.MAVENCLAD.com.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
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1. National MS Society. Secondary progressive MS (SPMS). https
://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progres
sive-MS. Accessed March 2019.

About MAVENCLAD® (cladribine) Tablets (10 mg)

MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA)
on March 29th, 2019, is the first short-course oral therapy for the
treatment of relapsing forms of multiple sclerosis (RMS). MAVENCLAD
is not recommended for use in patients with clinically isolated
syndrome (CIS) because of the risk of malignancy. Patients should
follow healthcare provider instructions including cancer screening,
contraception, and blood tests. The approved dose of MAVENCLAD is 3.5
mg per kg body weight over two years, administered as one treatment
course of 1.75 mg per kg per year, each consisting of two treatment
weeks. The mechanism by which cladribine exerts its therapeutic
effects in patients with multiple sclerosis has not been fully
elucidated but is thought to involve cytotoxic effects on B and T
lymphocytes through impairment of DNA synthesis, resulting in
depletion of lymphocytes. MAVENCLAD causes a dose dependent reduction
in lymphocyte counts followed by recovery.

Because cladribine is cytotoxic, special handling and disposal
instructions should be followed.

MAVENCLAD has been approved in over 50 countries, including the
European Union (EU), Canada, Australia and Switzerland, for various
relapsing MS indications.

Visit www.MAVENCLAD.com for more information.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of
the central nervous system and is the most common, non-traumatic,
disabling neurological disease in young adults. It is estimated that
approximately 2.3 million people have MS worldwide. While symptoms
can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common.

Merck in Multiple Sclerosis

Merck has a long-standing legacy in neurology and immunology, with
significant R&D and commercial experience in multiple sclerosis (MS).
Merck's current portfolio includes two products for the treatment of
relapsing MS, with a robust pipeline focusing on discovering new
therapies that have the potential to modulate key pathogenic
mechanisms in MS. Merck aims to improve the lives of those living
with MS, by addressing areas of unmet medical needs.

About Merck

Merck, a leading science and technology company, operates across
healthcare, life science and performance materials. Around 52,000
employees work to make a positive difference to millions of people's
lives every day by creating more joyful and sustainable ways to live.
From advancing gene editing and discovering unique ways to treat the
most challenging diseases to enabling the intelligence of devices -
the company is everywhere. In 2018, Merck generated sales of EUR 14.8
billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been
key to Merck's technological and scientific advances. This is how
Merck has thrived since its founding in 1668. The founding family
remains the majority owner of the publicly listed company. Merck
holds the global rights to the Merck name and brand. The only
exceptions are the United States and Canada, where the business
sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma
in life science, and EMD Performance Materials. For more information
about Merck visit www.merckgroup.com.

Friederike Segeberg: +49-151-1454-6328

Investor Relations: +49-6151-72-3321

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