Merck to Present New Data on Mavenclad®, Rebif® and the Investigational Therapy Evobrutinib at the AAN Annual Meeting 2019

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

- 20 abstracts will be presented during the AAN Annual Meeting 2019 to demonstrate Merck's commitment and clinical development program in multiple sclerosis

DARMSTADT, Germany, April 30, 2019 /PRNewswire/ -- Merck, a leading science and technology company, today announced that data from across its multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology (AAN) 2019 Annual Meeting, 4-10 May 2019 in Philadelphia, United States. Merck will present a total of 20 abstracts (18 posters and two platform presentations), including data on MAVENCLAD(®) (cladribine tablets), the investigational therapy evobrutinib (an oral, selective Bruton's Tyrosine Kinase (BTK) inhibitor) and Rebif(®) (interferon beta-1a), as well as findings from the patient perceptions initiative by MS in the 21(st) Century.

"The wealth of data to be presented at AAN 2019 highlights our continued progress across our portfolio of marketed products and investigational agents in multiple sclerosis," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck. "We are very proud of our commitment to further the understanding of multiple sclerosis and enhance our clinical development program to meet the needs of patients."

Key MAVENCLAD(® )data will include:


-- Post-hoc analysis of the CLARITY Extension study to examine the
durability of no evidence of disease activity-3 (NEDA-3) in relapsing MS
(RMS) patients receiving cladribine tablets
-- Integrated analysis of pooled long-term safety data of cladribine
tablets in patients with MS collated from the CLARITY, CLARITY
Extension, ORACLE-MS studies and the PREMIERE registry
-- A new analysis of the speed of onset of the MRI effect is presented. At
3 months the effect on new inflammatory lesions was apparent in the
ORACLE-MS study. In the same study consistency in clinical outcomes was
observed across different patient subgroups defined by patient and
disease characteristics at baseline
-- Abstracts from the ORACLE-MS study describe the effect of cladribine
tablets on early MS
-- Results from studies investigating the biological effects of cladribine
tablets, including the effect on lymphocyte proliferation, and
endothelial responsiveness to tumour necrosis factor and its effect on
hematopoietic precursors and immune cells, to offer further insights on
the potential mode of action of cladribine tablets
Key evobrutinib data will include:


-- Results of analysis of the efficacy and safety of evobrutinib in
patients with RMS over 48 Weeks: a randomized, placebo-controlled, phase
2 study
Key Rebif(® )data will include:


-- Investigation from the European Interferon Beta (IFN ) pregnancy
registry and Nordic health study into the prevalence of pregnancy
outcomes in IFN -exposed women
-- Results from the IMPROVE study on the dynamics of pseudo-atrophy in RMS
patients treated with interferon beta-1a as assessed by monthly brain
MRI
In addition, Merck will be publishing new data from the MS in the 21(st )Century initiative comparing patient perceptions on MS management and care across Europe and North America. The initiative, led by a Steering Group of international MS specialists, aims to gain insight into patient opinions on unmet needs in MS management.

Merck will also be announcing the launch of a new, collaborative MS research network called 'MS-LINK' (Leadership and Innovation Network), an initiative that brings together a community of multiple sclerosis stakeholders to form a scientific foundation for sustainable transformation of MS care, with the shared goal of improving patient outcomes.

Below is a selection of abstracts that have been accepted for presentation at AAN 2019:




MAVENCLAD (cladribine tablets) data

---



Title Lead Author

Poster Presentation /Session

--- ---

Durability of NEDA-3 status
in patients with relapsing
multiple sclerosis receiving
cladribine tablets: CLARITY
Extension
Giovannoni G
P3.2-100 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

Cladribine tablets were
associated with rapid onset
of improvements in MRI
outcomes in the ORACLE-MS
trial
Scarberry S
P3.2-061 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

The effect of cladribine
tablets on delaying the time
to conversion to CDMS or
McDonald MS is consistent
across subgroups in the
ORACLE-MS study
Bowen J
P3.2-101 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

Untreated Patients with
Multiple Sclerosis:
Prevalence and
Characteristics in Denmark
and in the United States
Nørgaard M
P4.2-060 11:30 -18:30 ET, Wednesday 8 May

P4: MS Epidemiology, Co-Morbidities,
and Modifiable Risk Factors

--- ---

Updated safety analysis of
cladribine tablets in the
treatment of patients with
multiple sclerosis
Cook S
P4.2-046 11:30 -18:30 ET, Wednesday 8 May
P4: MS Therapeutics: MOA and Safety

--- ---

Gaps in treatment and
treatment discontinuation
among patients with multiple
sclerosis newly-initiating
once- or twice-daily oral
disease-modifying drugs
Nicholas J
P3.2-102 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

Lymphopenia rates in CLARITY/
CLARITY Extension are
consistent in patients with
or without high disease
activity at baseline
Cook S
P3.2-062 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

Meta-analysis of real-world
adherence and persistence of
maintenance once- or twice-
daily oral disease-
modifying drugs (dimethyl
fumarate, fingolimod, and
teriflunomide) in multiple
sclerosis
Nicholas J
P3.2-041 11:30 -18:30 ET, Tuesday 7 May

P3: MS Clinical Trials and Therapeutic
Research

--- ---

ADA genetic variants
influence central
inflammation and clinical
characteristics in MS:
implications for cladribine
treatment
Stampanoni Bassi M
P4.2-044 11:30 -18:30 ET, Wednesday 8 May
P4: MS Therapeutics: MOA and Safety

--- ---

Dissection of the distinct
susceptibility of
hematopoietic precursors and
immune cells to cladribine
Carlini F
P4.2-045 11:30 -18:30 ET, Wednesday 8 May
P4: MS Therapeutics: MOA and Safety

--- ---

Neuroblastoma cell line and
lymphocytes talk for
cladribine influenced
apoptosis and inflammation
pathways in Multiple
Sclerosis (MS): an "in
vitro" study
Ruggieri M
P2.2-095
11:30 - 18:30 ET, Monday 6 May

P2: MS Immunology and Basic Science

--- ---

Gene expression profiles of
proteins involved in
cladribine metabolism and
their possible correlation
with Epstein-Barr virus
variants
Mechelli R
P2.2-096
11:30 - 18:30 ET, Monday 6 May

P2: MS Immunology and Basic Science

--- ---



Evobrutinib data

---

Efficacy and Safety of the
Bruton's Tyrosine Kinase
Inhibitor Evobrutinib
(M2951) in Patients with
Relapsing Multiple Sclerosis
over 48 Weeks: a Randomized,
Placebo-Controlled, Phase 2
Study
Montalban X
Oral presentation
13:33 ET, Friday 10 May


S56: MS Trials and Treatment

--- ---

Inhibition of Bruton's
Tyrosine Kinase Prevents
Inflammatory Macrophage
Differentiation: A Potential
Role in Multiple Sclerosis
Alankus YB
P2.2-077
11:30 - 18:30 ET, Monday 6 May

P2: MS Immunology and Basic Science

--- ---

Inhibition of Bruton's
Tyrosine Kinase Selectively
Prevents Antigen-Activation
of B cells and Ameliorates
B-Cell-Mediated
Experimental Autoimmune
Encephalomyelitis
Torke S
P2.2-063
11:30 - 18:30 ET, Monday 6 May

P2: MS Immunology and Basic Science

--- ---



Rebif(R) (interferon beta-1a)

---

Pregnancy and Infant Outcomes
with Interferon Beta: Data
from the European Interferon
Beta Pregnancy Registry and
MS Preg study conducted in
Finland and Sweden
Hellwig K 450
13:44 ET, Thursday 9 May

S49: MS Epidemiology and Risk
Stratification

--- ---

Dynamics of Pseudo-Atrophy
in RRMS Patients Treated
with Interferon beta-1a as
Assessed by Monthly Brain
MRI
De Stefano N
P5.2-047 11:30 -18:30 ET, Thursday 9 May


P5: MS Neuroimaging

--- ---



MS in the 21st Century

---

Comparing patient perceptions
on multiple sclerosis
management and care - a sub-
analysis of geographic
differences
Williams M
P4.9-076 11:30 -18:30 ET, Wednesday 8 May

P4: Practice, Policy, and Ethics I

--- ---


All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About MAVENCLAD(®)

MAVENCLAD(®) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD(®) for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD(®) has since then been approved in more than 50 countries, including Canada and Australia and most recently in the U.S. in March 2019.

Visit www.MAVENCLAD.com [http://www.mavenclad.com/] for more information.

The clinical development program for cladribine tablets 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 cladribine tablets as a monotherapy in patients with RRMS.
-- The CLARITY extension study: a Phase III placebo-controlled study
following on from the CLARITY study, which evaluated the safety and
exploratory efficacy of cladribine tablets over two additional years
beyond the two-year CLARITY study, according to the treatment assignment
scheme for years 3 and 4.
-- 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
cladribine tablets 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 cladribine tablets 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) study: a long-term observational follow-up safety
registry of MS patients who participated in cladribine tablets clinical
studies.
In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is an oral, highly specific inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Rebif(®
)Rebif(®) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif(®) in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.

Rebif(®), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif(®) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.

Rebif(®) can be administrated with the RebiSmart(®) electronic auto-injection device (not approved in the US), or with the RebiDose(®) single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif(®) can also be administered with the autoinjector Rebiject II(®) or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif(®) in early multiple sclerosis. The extension of the indication of Rebif(®) has not been submitted in the United States.

Rebif(®) should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(®) with their doctors.

*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

Rebif(®) (interferon beta-1a) is approved in the United States for relapsing forms of MS.

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 Immunology
Merck has a long-standing legacy in immunology, with significant R&D and commercial experience in multiple sclerosis. Our robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

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 technologies 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.

(Logo: https://mma.prnewswire.com/media/842717/MERCK__Logo.jpg [https://mma.prnewswire.com/media/842717/MERCK__Logo.jpg])

Your Contact
tone-brauti.fritzen@merckgroup.com [mailto:tone-brauti.fritzen@merckgroup.com]
Phone: +49-151-1454-2694

PR Newswire

Dit persbericht is via ANP Pers Support naar internationale (vak en online) media gestuurd. Heb je nieuws voor buitenlandse journalisten? Bekijk dan onze mogelijkheden of neem contact met ons op.

Verstuur nu éénmalig een persbericht

Verstuur persberichten en beeldmateriaal naar redacties in binnen- en buitenland. Via het ANP-net, het internationale medianetwerk van PR Newswire of met een perslijst op maat.

Direct persbericht versturen
070 - 41 41 234