Mavenclad (Cladribine Tablets) Receives First Approval in Latin America

Darmstadt, Germany (ots/PRNewswire) -

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

- First oral short-course treatment for highly active relapsing
multiple sclerosis (RMS) now approved in Argentina
- Mavenclad has shown sustained clinical efficacy for up to 4 years
with a maximum of 20 days of oral treatment over 2 years

Merck, a leading science and technology company, today announced
that the Argentinian Administration of Medicines, Food and Medical
Technology (ANMAT), has approved the registration of MAVENCLAD®
(cladribine tablets) for the treatment of adult patients with highly
active relapsing multiple sclerosis (MS) as defined by clinical or
imaging features. This marks the first approval for MAVENCLAD® in
Latin America and following local regulatory processes, the product
is expected to be available in the coming months.

(Logo: http://mma.prnewswire.com/media/472778/Merck_Logo.jpg )

"Having a new MS treatment approved in Argentina is very
motivating," said Dr. Jorge Correale M.D., the Head of
Neuroimmunology and Demyelinating Diseases at the Institute for
Neurological Research Dr. Raúl Carrea. "Mavenclad allows the
patient's immune system to go through a selective immune
reconstitution, similar to a reset, and the treatment mechanism is
simple because it does not require frequent administration or
monitoring."

MAVENCLAD® is the first oral short-course treatment to provide
efficacy across key measures of disease activity in patients with
highly active relapsing MS, including disability progression,
annualized relapse rate and magnetic resonance imaging (MRI)
activity. The approval of MAVENCLAD® is based on more than 10,000
patient years of data with over 2,700 patients included in the
clinical trial program,[1] and up to 10 years of observation in some
patients. The clinical development program included data from three
Phase III trials, CLARITY,[2],[3] CLARITY EXTENSION[4] and ORACLE
MS,[5] the Phase II ONWARD study;[6] and long-term follow-up data
from the 8-year prospective registry, PREMIERE.[7] The efficacy and
safety results of these studies allowed for a full characterization
of the benefit-to-risk profile of MAVENCLAD®.

"We are pleased the Argentinian Administration of Medicines, Food
and Medical Technology has approved Mavenclad," said Rehan Verjee,
Chief Marketing and Strategy Officer at the Biopharma business of
Merck. "Our goal is to ensure fast access to patients who may benefit
from this innovative therapy and we will be working with payers on
obtaining reimbursement as a next step."

MAVENCLAD® is a selective immune reconstitution therapy[8],[9]
which simplifies treatment administration by giving patients just 2
short annual courses of tablets with a maximum of 20 days of
treatment over 2 years providing a lasting treatment benefit up to 4
years. MAVENCLAD® works by selectively targeting B & T lymphocytes
followed by a distinct pattern of lymphocyte reconstitution, without
continuous suppression of the immune system.[10]

In patients with high disease activity, post hoc analyses of the
two-year Phase III CLARITY trial[3],[4] demonstrated that MAVENCLAD®
reduced the annualized relapse rate by 67% and the risk of 6-month
confirmed expanded disability status scale (EDSS) progression by 82%
versus placebo. As demonstrated in the Phase III CLARITY EXTENSION[4]
study, no further MAVENCLAD® treatment was required in Years 3 and 4.
The comprehensive dataset has informed the posology and monitoring
requirements. The most clinically relevant adverse reactions were
lymphopenia and herpes zoster. Lymphocyte counts must be assessed
before, and during, treatment with MAVENCLAD®. MAVENCLAD® is
contraindicated in certain groups including immunocompromised
patients and pregnant women.

The approval for MAVENCLAD® in Argentina follows marketing
authorizations in the EU, Canada, Australia and Israel. Merck plans
additional filings for regulatory approval in other countries,
including the United States.

About MAVENCLAD®

MAVENCLAD® (cladribine tablets) is approved in the 28 countries of
the European Union (EU) in addition to Norway, Liechtenstein,
Iceland, Isreal and Argentina for the treatment of highly active
relapsing multiple sclerosis (RMS). MAVENCLAD® is approved in Canada
and Australia for the treatment of relapsing-remitting multiple
sclerosis (RRMS). MAVENCLAD® is a short-course oral therapy that
selectively targets lymphocytes thought to be integral to the
pathological process of relapsing MS (RMS). MAVENCLAD® is currently
under clinical investigation and not yet approved for the treatment
for any use in the United States.

The clinical development program for MAVENCLAD® includes:

- The CLARITY (Cladribine Tablets Treating MS Orally) study: a
two-year Phase III placebo-controlled study designed to evaluate
the efficacy and safety of MAVENCLAD® as a monotherapy in patients
with RRMS.
- The CLARITY extension study: a two-year Phase III
placebo-controlled study following on from the CLARITY study,
designed to evaluate the safety and efficacy of MAVENCLAD® over an
extended administration for four years.
- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase
III placebo-controlled study designed to evaluate the efficacy and
safety of MAVENCLAD® as a monotherapy in patients at risk of
developing MS (patients who have experienced a first clinical event
suggestive of MS).
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in
Patients With Active Relapsing Disease) study: a Phase II
placebo-controlled study designed primarily to evaluate the safety
and tolerability of adding MAVENCLAD® treatment to patients with
relapsing forms of MS, who have experienced breakthrough disease
while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of
Multiple Sclerosis Patients Who Have Participated in Cladribine
Clinical Studies) study: interim long-term follow-up data from the
prospective registry, PREMIERE, to evaluate the safety and efficacy
of MAVENCLAD®

The clinical development program of MAVENCLAD® in MS comprises
more than 10,000 patient years of data with over 2,700 patients
included in the clinical trial program, and more than 10 years of
observation in some patients.

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.

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About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Around 50,000 employees work
to further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2016, Merck
generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States
and Canada, where the company operates as EMD Serono, MilliporeSigma
and EMD Performance Materials.

1. Merck data on file

2. Giovannoni G, Comi G, Cook S et al. A Placebo-Controlled Trial of
1O Oral Cladribine for Relapsing Multiple Sclerosis. 2010 New England
Journal of Medicine 362:416-426

3. Giovannoni G et al. Sustained disease-activity-free status in
patients with relapsing-remitting multiple sclerosis treated with
cladribine tablets in the CLARITY study: a post-hoc and subgroup
analysis Lancet Neurol 2011; 10:329-337

4. EU Clinical Trials Register. A Phase IIIb, Double-Blind,
Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to
Evaluate the Safety and Tolerability of Oral Cladribine in Subjects
with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial
25643 (CLARITY). Available at https://www.clinicaltrialsregister.eu/c
tr-search/trial/2007-000381-20/results . Last accessed August 2017

5. Leist T, Comi G, Cree B et al. Effect of oral cladribine on time
to conversion to clinically definite multiple sclerosis in patients
with a first demyelinating event (ORACLE MS): a phase 3 randomised
trial. Lancet Neurol 2014; 13: 257-67

6. EU Clinical Trials Register. A phase II, multicenter, randomized,
double-blind, placebo-controlled, safety, tolerability and efficacy
study of add-on Cladribine tablet therapy with Rebif New Formulation
in Multiple Sclerosis Subjects with Active Disease. Available at http
s://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003366-33/res
ults . Last accessed August 2017

7. Schreiner T, Miravalle A,. Current and Emerging Therapies for the
Treatment of Multiple Sclerosis: Focus on Cladribine. Journal of
Central Nervous System Disease. 2012; 4: 1-14

8. Giovannoni G. Personalized medicine in multiple sclerosis. 2017
Neurodegenerative Disease Management; 7 (6s) 13-17

9. Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple
Sclerosis. Neurotherapeutics. November 2017; DOI
10.1007/s13311-017-0573-4

10. MAVENCLAD(TM) Product Monograph. November 2017

ots Originaltext: Merck KGaA
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Original-Content von: Merck KGaA, übermittelt durch news aktuell