Merck to Showcase New Data Across MS Portfolio at EAN 2019

Not intended for UK or U.S. based media

DARMSTADT, Germany, June 24, 2019 /PRNewswire/ --


-- Company to present 16 abstracts on MAVENCLAD® (cladribine tablets),
Rebif® (interferon beta-1a) and investigational evobrutinib at the 5(th
)Congress of the European Academy of Neurology
-- Presentations include new data on the long-term efficacy and safety of
MAVENCLAD(®), new safety data for Rebif(®) and the 48-week analysis
from the Phase 2 clinical study with evobrutinib
-- Merck-initiative MS in the 21(st) Century to present findings from
Patient Perceptions Initiative
Merck, a leading science and technology company, today announced that data from across its multiple sclerosis (MS) portfolio will be presented at the 5(th) Congress of the European Academy of Neurology (EAN), 29 June - 2 July 2019 in Oslo, Norway. Merck will present a total of 16 abstracts (12 posters and 4 presentations) on MAVENCLAD(®) (cladribine tablets), Rebif(®) (interferon beta-1a) and the investigational therapy evobrutinib (an oral, highly selective Bruton's Tyrosine Kinase [BTK] inhibitor). The company will also present findings from the Patient Perceptions Initiative by MS in the 21(st) Century.

"The wealth of new data that we are presenting at EAN 2019, from both our approved medicines and our pipeline in MS, highlight our commitment to making further advances for people living with this chronic disease," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck.

Key MAVENCLAD(® )data will include:


-- Post-hoc analysis of the CLARITY Extension study to examine the
long-term efficacy in high-disease activity patients treated with
cladribine tablets 3.5 mg/kg
-- Updated safety analysis of cladribine tablets 3.5 mg/kg in patients with
relapsing multiple sclerosis (RMS)
Key Rebif(®) data will include:


-- Results from the Nordic registry regarding the risk of spontaneous
abortion and ectopic pregnancy in patients using interferons
-- Results from the UK Multiple Sclerosis Risk Sharing Scheme on treatment
with subcutaneous interferon beta-1a
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
In addition, Merck will be presenting results from a global mapping study supported by the MS in the 21(st )Century initiative. The results will outline the availability of educational resources in MS across several themes including 'MS stages and progression'. The initiative, led by a steering group of international MS specialists, aims to gain insight into patient opinions on unmet needs in MS management.

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




MAVENCLAD

(R) (cladribine tablets)

---



Title

Lead Author

Poster

Presentation / Session

--- ---

NEDA-3 durability in
CLARITY Extension in
patients with relapsing
multiple sclerosis
receiving Cladribine
Tablets
Giovannoni G
EPO1244 Session: "MS and related disorders 3"



Date: Saturday, 29 June 2019



Time: 12:30 to 13:15



Location: Screen B12

--- ---

Variations of uric acid
levels and their clinical
correlates during
cladribine treatment
Moccia M
EPO2218 Session: "MS and related disorders 5"



Date: Sunday 30 June 2019



Time: 12:30 to 13:15



Location: Screen B11

--- ---

CLARITY Extension: Sustained
efficacy in relapsing
remitting multiple
sclerosis following switch
from Cladribine Tablets to
placebo in patients with
high disease activity at
baseline
Vermersch P
EPO3211 Session: "MS and related disorders 8"



Date: Monday, 01 July 2019



Time: 12:30 to 13:15



Location: Screen B11

--- ---

Rationale, design and
feasibility assessment of
the phase IV CLASSIC-MS
study evaluating long-term
efficacy outcomes for
patients with multiple
sclerosis treated with
Cladribine Tablets
Boyko A
POD026

Session: "Poster on Display
Date: Saturday 29 June-Monday 1 July



--- ---

Incidence and risk of any
malignancies in multiple
sclerosis (MS) from the
Netherlands (NL) and
Denmark (DK)
Kuiper J
EPO2202 Session: "MS and Related Disorders 4"



Date: Sunday 30 June 2019



Time: 12:30 to 13:15



Location: Screen B10

--- ---

Incidence and risk of
malignancies by type, in
multiple sclerosis (MS)
patients, compared from the
Netherlands (NL) and
Denmark (DK)
Nørgaard M
EPO2226 Session: "MS and related disorders 6"



Date: Sunday, 30 June 2019



Time: 12:30 -13:15



Location:
Screen B12

--- ---

Severity and frequency of
relapses in patients with
relapsing-remitting MS
treated with Cladribine
Tablets in CLARITY and
placebo in CLARITY
Extension
Schippling S
EPO3196 Session: "MS and related disorders 7"



Date: Monday, 01 July 2019



Time: 12:30 to 13:15



Location: Screen B10

--- ---

CLARITY/CLARITY Extension:
Lymphopenia rates are
consistent in patients with
and without high disease
activity at baseline
Cook S
POD049
Poster on Display
Date: Saturday 29 June-Monday 1 July

--- ---

Treatment of patients with
Multiple Sclerosis: An
updated safety analysis of
Cladribine Tablets
Cook S
POD050
Poster on Display
Date: Saturday 29 June-Monday 1 July

--- ---

Efficacy of Cladribine
Tablets 3.5 mg/kg in
Patients with Relapsing
Multiple Sclerosis
Giovannoni G
EPO1243 Session: "MS and related disorders 3"

Aged Above and Below 45 Years; CLARITY and CLARITY Extension

Date: Saturday, 29 June 2019



Time: 12:30 to 13:15



Location: Screen B12

--- ---



Evobrutinib

---

Bruton's Tyrosine Kinase
Inhibitor Evobrutinib
(M2951) in Patients with
Relapsing Multiple
Sclerosis: a Randomised,
Placebo-Controlled, Phase
2 Study
Montalban X Oral presentation -O1205 Session: "MS and related disorders"



Date: Saturday, 29 June 2019



Time: 17:30

--- ---



Rebif(R) (interferon beta-1a)

---

No increased risk of
spontaneous abortion and
ectopic pregnancy after
exposure to interferon-
beta prior to or during
pregnancy: Results from
register-based Nordic
study among women with MS
Juuti R
EPR2074

Session: ePresentation



Date: Sunday, June 30



Time: 13:30 to 14:15


Screen A6

--- ---

Subcutaneous Interferon
-1a: 10 years of the UK
Multiple Sclerosis Risk
Sharing Scheme
Harty G
EPR1089

Session: ePresentation



Date: Saturday 29 June



Time: 13:30 to 14:15


Screen A7

--- ---

A systematic review of
relapse rates in patients
with relapsing multiple
sclerosis during pregnancy
and breastfeeding
Sabidó M
EPO3194

Session: ePoster



Date: Monday 1 July



Time: 12:30 to 13:15


Screen B10

--- ---

Rapid reduction of lesion
accumulation in specific
white matter tracts as
assessed by lesion mapping
in RR-MS patients treated
with IFN beta-1a
De Stefano N
EPR1086

Session: ePresentation



Date: Saturday 29 June



Time: 13:30 to 14:15


Screen A7

--- ---

Dynamics of Pseudo-Atrophy
in RRMS Patients Treated
with Interferon beta-1a as
Assessed by Monthly Brain
MRI
De Stefano N
EPO1234

Session: ePoster



Date: Saturday 29 June



Time: 12:30 to 13:15


Screen B11

--- ---



MS in the 21st Century

---

A sub-analysis of global
mapping data on the
availability of online
educational resources for
multiple sclerosis patients
Vermersch P
EPO1148

Session: ePoster



Date: Saturday, 29 June 2019



Time: 12:30 to 13:15


Screen A5

--- ---


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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 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 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 selective 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 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 Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS 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.

The company`s 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.

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