Merck KGaA

Merck to Present Data on Mavenclad® and Rebif® in Relapsing Forms of Multiple Sclerosis at EAN

Darmstadt, Germany (ots/PRNewswire) -

- 14 abstracts  to be presented, further characterizing the 
  complementary profiles of Mavenclad  (cladribine tablets)and  Rebif
  (interferon beta-1a)    

Merck, a leading science and technology company, will present data from its neurology and immunology portfolio at the 4th Congress of the European Academy of Neurology (EAN), taking place from June 16-19, in Lisbon, Portugal. Merck will present a total of 14 abstracts in the area of relapsing multiple sclerosis (RMS), including a post-hoc analysis of the Phase III CLARITY study, investigating whether the beneficial clinical and magnetic resonance imaging (MRI) effects of MAVENCLAD® are consistent in older (>50 years) and younger (<=50) adult patients with relapsing remitting MS (RRMS). Data presented at the congress will also provide further insights into the benefit-risk profile of MAVENCLAD® in patients with relapsing MS with high disease activity, using Multi-Criteria Decision Analysis, an EMA-recommended methodology used to indirectly compare the benefit-risk profile between treatments. A separate post hoc analysis of patients in the ONWARD study evaluates the efficacy of MAVENCLAD® as add-on to interferon beta-1a in patients with secondary progressive MS (SPMS) with relapses, compared to patients with RRMS from the same study.

Additionally, data presentations on Rebif® (interferon beta-1a) include analysis of MRI in MS (MAGNIMS) score[1] to predict long-term clinical disease activity (CDA)-free status and disability progression following treatment with Rebif®.

In line with Merck's MS Inside Out campaign aiming to better understand patients with MS, results of the Merck-sponsored 'MS in the 21st Century International Unmet Needs Survey' show that MS patients have substantially different perceptions of the current unmet needs in MS compared to healthcare professionals (HCPs). Identification and understanding of these differences could lead to an improved dialogue between HCPs and patients, which is integral to finding appropriate individualised treatment approaches for each patient.

Attendees can learn more about Merck's programs, pipeline and activities in neurology and immunology by visiting the company`s medical booth A07

The following abstracts have been accepted for presentation at EAN Congress 2018:


MAVENCLAD(R) (Cladribine Tablets) Presentations

Presentation
Title                       Authors             Abstract No.    
Date/Time/Session


Infections during    
periods of grade 3 or
4 lymphopenia in                                        
patients taking          Cook S, Leist T,                      
cladribine tablets 3.5   Comi G, Montalban                     
mg/kg: data from an      X, Sylvester E,                        
ePoster
integrated safety        Hicking C, Dangond                     
16-18 Jun 2018
analysis                 F                        748           
Time:12:30-14:15       

Effects of cladribine
tablets on CD4+ T cell                                         
subsets in the           Stuve O,                              
ORACLE-MS study:         Soelberg-Sorensen
Results from an          P, Leist T, Hyvert                     
ePoster
analysis of lymphocyte   Y, Damian D,                           
16-18 Jun 2018
surface markers          Boschert U               762           
Time:12:30-14:15

Innate Immune Cell                                             
Counts in Patients
with
Relapsing-Remitting                   
Multiple Sclerosis                                             
(RRMS) Treated with      Soelberg-Sorensen
Cladribine Tablets 3.5   P, Dangond F,                          
ePresentation
mg/kg in CLARITY and     Hicking C,                             
16-18 Jun 2018
CLARITY Extension        Giovannoni G             749           
Time:12:30-14:15

Cladribine tablets
produce selective and
discontinuous                                                  
reduction of B and T
lymphocytes and
natural killer cells     Stuve O,
in patients with early   Soelberg-Sorensen                     
and relapsing multiple   P, Giovannoni G,
sclerosis (ORACLE-MS,    Leist T, Hyvert Y,                     
ePresentation
CLARITY and CLARITY      Damian D, Boschert                     
16-18 Jun 2018
Extension)               U                        746           
Time:12:30-14:15

An analysis of
malignancy risk in the
clinical development
programme of             Galazka A, Nolting                    
cladribine tablets in    A, Cook S, Leist T,
patients with            Comi G, Montalban                      
ePoster
relapsing multiple       X, Hicking C,                          
16-18 Jun 2018
sclerosis (RMS)          Dangond F                757           
Time:12:30-14:15

Pregnancy outcomes
during the clinical
development programme
of cladribine in         Galazka A, Nolting                    
multiple sclerosis       A, Cook S, Leist T,
(MS): an integrated      Comi G, Montalban                      
ePresentation
analysis of safety for   X, Hicking C,                          
16-18 Jun 2018
all exposed patients     Dangond F                765           
Time:12:30-14:15

A benefit-risk
assessment of                                                  
cladribine tablets
using Multi-Criteria
Decision Analysis for    Vermersch P,
patients with            Martinelli V,                        
relapsing multiple       Pfleger C,
sclerosis                Rieckmann P,                           
ePoster
demonstrating high       Galazka A, Dangond                     
16-18 Jun 2018
disease activity         F, Phillips L            759           
Time:12:30-14:15

Efficacy of cladribine
tablets 3.5 mg/kg
added to
interferon-beta in                                             
patients with
secondary progressive
multiple sclerosis
(SPMS) or                                                      
relapsing-remitting      Montalban X, Cohen
multiple sclerosis       B, Leist T, Moses                      
ePresentation
(RRMS): a post-hoc       H, Hicking C,                          
16-18 Jun 2018
analysis from ONWARD     Dangond F                766           
Time:12:30-14:15

A pooled analysis of
the efficacy of                                                
cladribine tablets 3.5
mg/kg in patients with
EDSS greater than or
equal to3.5 or less                                            
than or equal to3.0 at   Giovannoni G,
baseline in the          Montalban X,                           
ePresentation
CLARITY and ONWARD       Hicking C, Dangond                     
16-18 Jun 2018
studies                  F                        747           
Time:12:30-14:15
Efficacy of cladribine                                         
tablets 3.5 mg/kg in
patients with highly
active relapsing
multiple sclerosis                                             
(RMS): Pooled analysis
of the double-blind      Giovannoni G,                          
ePresentation
cohort from CLARITY      Montalban X, Damian                    
16-18 Jun 2018
and ONWARD               D, Dangond F             1345          
Time:12:30-14:15

Efficacy of cladribine                                         
tablets 3.5 mg/kg in
patients less than or    Giovannoni G,
equal to50 and >50       Rammohan K, Cook S,
years of age with        Comi G, Rieckmann                     
relapsing-remitting      P,
multiple sclerosis       Soelberg-Sørensen                      
ePresentation
(RRMS): a post hoc       P, Vermersch P,                        
16-18 Jun 2018
analysis from CLARITY    Dangond F, Damian D      1341          
Time:12:30-14:15

Rebif(R) (interferon beta-1a) Presentations

Disease activity as
assessed by the                                                
MAGNIMS score predicts
long-term clinical
disease activity free
status and disability    Sormani MP,                           
progression in           Freedman MS,
patients treated with    Aldridge J,                            
ePresentation
subcutaneous             Marhardt K, De                         
16-18 Jun 2018
interferon beta-1a       Stefano N                743           
Time:12:30-14:15

Evolution of new
lesions and its          Vrenken H, de Vos
temporal patterns in     ML, Battaglini M,
patients with            Nagtegaal GJ, de                      
clinically isolated      Almeida Teixeira
syndrome treated with    BC, Marhardt K, De                     
ePresentation
subcutaneous             Stefano N, Barkhof                     
16-18 Jun 2018
interferon beta-1a       F                        444           
Time:12:30-14:15

Additional Merck-sponsored Presentations

Patient involvement in
treatment
decision-making: a
sub-analysis of the
'MS in the 21st
Century international    Rieckmann P,
unmet needs survey'      Langdon D on behalf                   
comparing patient and    of MS in the 21st
healthcare               Century Steering
professional             Group, and Contango
perspectives             EV                       1340          
Poster on Display 

1. Magnetic Resonance Imaging in MS

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About MAVENCLAD®

MAVENCLAD® (cladribine tablets) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of multiple sclerosis (MS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of MS (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® is now available in over 10 countries in Europe, plus Australia, Argentina and the United Arab Emirates. MAVENCLAD® is not yet approved for any use in the United States.

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 up to 10 years of observation in some patients. These clinical trials include the Phase III CLARITY, CLARITY extension and ORACLE MS trials, the Phase II ONWARD trial and the PREMIERE Long-term Safety Registry.

EU Indication

MAVENCLAD® (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.

Important EU Safety Information

Contraindications:

MAVENCLAD® is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance <60 mL/min), and those who are pregnant and breast-feeding. MAVENCLAD® is also contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy.

Special warnings and precautions for use:

The most clinically relevant adverse reactions were lymphopenia and herpes zoster.

Haematology

Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have been observed in clinical studies, although these parameters usually remain within normal limits.

Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile

Lymphocyte counts must be determined

- before initiating MAVENCLAD® in year 1,
- before initiating MAVENCLAD® in year 2,
- 2 and 6 months after start of treatment in each treatment year. If 
  the lymphocyte count is below 500 cells/mm³, it should be actively 
  monitored until values increase again. 

Infections

Cladribine can reduce the body's immune defence and may increase the likelihood of infections. HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine.

The incidence of herpes zoster was increased in patients on cladribine. If lymphocyte counts drop below 200 cells/mm³, anti-herpes prophylaxis according to local standard practice should be considered during the time of grade 4 lymphopenia. Interruption or delay of MAVENCLAD® may be considered until proper resolution of the infection.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.

In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported. However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD® (usually within 3 months).

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. RebiSmart®, an electronic device for self-injection of Rebif®, is also not approved in the United States.

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 is a leading science and technology company in healthcare, life science and performance materials. More than 53,000 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 2017, Merck generated sales of EUR 15.3 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.

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