Merck KGaA

Merck to Present Rebif® (interferon beta-1a) and Investigational Cladribine Tablets Data at AAN 2017

Darmstadt, Germany (ots/PRNewswire) -

- Breadth of data and activities underscore company's long-standing 
  commitment to enhancing care for people with MS  

Merck, a leading science and technology company, will present data at the American Academy of Neurology (AAN) 69th Annual Meeting, taking place from April 22-28, 2017, in Boston, Mass. Merck will present 15 abstracts on multiple sclerosis (MS), including studies evaluating Rebif® (interferon beta-1a) and investigational Cladribine Tablets, as well as analyses of complications and MS relapse rates during pregnancy and real-world data related to the impact of treatment adherence and patient costs.

(Logo: http://mma.prnewswire.com/media/492737/Merck_Logo.jpg )

"Rebif has a well-established safety profile supported by more than 20 years of accrued clinical trial and patient experience, and the information from the studies and analyses we are presenting at AAN deepens our understanding of this important RRMS therapy," said Dr. Kathleen Hawker, Vice President, Neurology and Immunology US, EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany.

The company will also present efficacy and safety data for Cladribine Tablets, an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes which may be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada or elsewhere. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of adult patients with RRMS.

"We have an unwavering focus on delivering innovation to patients in need, and our presentations this week at AAN, a leading neurology conference, further validate the promise of Cladribine Tablets as a potential RRMS treatment option," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck.

Attendees can learn more about our programs, pipeline and activities in neurology by visiting our medical booth #473. Booth activities include a $25,000 charitable donation presentation to Can DO MS on April 25 at 3 p.m., as well as "I'm Facing MS" simulation stations that will translate users' experiences with different MS impairments into artwork.

AAN Brain Health Fair

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada will have an exhibition at the AAN Brain Health Fair on April 21 from 10 a.m. - 4 p.m. ET, where attendees can gain first-hand experience about what it's like to have MS through virtual reality and other activities.

The following abstracts were accepted for presentation at the AAN 2017 Annual Meeting:



Rebif (interferon beta-1a) Presentations
Abstract/    
Presentation
Title                        Lead Author     Poster #     
Date/Time/Session

Cholecalciferol              W. Camu         004          April 
27, 2017, 4:06 p.m.
Supplementation in                                        Oral 
Presentation
Relapsing Multiple                                        Session
S44: MS Risk
Sclerosis Patients Treated                                Factors
and Modifications
with Subcutaneous
Interferon Beta-1a: A                                     
Randomized Controlled
Trial      

High Dose Cholecalciferol    R. Hupperts     005          April 
27, 2017, 4:18 p.m.
(Vitamin D3) Oil as Add-on                                Oral 
Presentation
Therapy in Subjects with                                  Session
S44: MS Risk
Relapsing-Remitting
Multiple Sclerosis
Receiving Subcutaneous
Interferon ss-1a
(scIFNbeta-1a)

Treatment with Interferon    M. Battaglini   340          April 
28, 2017, 4:00 - 
Reduces the Appearance of                                 5:30 
p.m.
Lesions in Clinically                                     Poster 
Session P6
Relevant White Matter (WM)
Tracts in Patients with
Clinically Isolated
Syndrome (CIS)                             

Effect of Early Versus       M. Freedman     358          April 
28, 2017, 4:00 -
Delayed Treatment (DT)                                    5:30 
p.m.                       
with Subcutaneous IFN                                     Poster 
Session P6
ss-1a (scIFNss-1a) on
Radiological Activity Free
(RAF) or Clinical Activity                                
Free (CAF) Status in                                      
Patients with Clinically
Isolated Syndrome (CIS): A
Post-hoc Analysis of
REFLEXION                                              

Clinical Efficacy of         F. Nelson       343          April 
28, 2017, 4:00 -
Interferon ss-1a                                          5:30 
p.m.
Subcutaneously Three Times                                Poster 
Session P6
Weekly According to
Baseline Radiological
Characteristics: Post Hoc                                 
Analyses of PRISMS Data                                   

Efficacy of Interferon       E. Williamson   329          April 
28, 2017, 4:00 -
ss-1a Subcutaneously Three                                5:30 
p.m.
Times Weekly According to                                 Poster 
Session P6
Baseline EDSS/Duration,
EDSS, and MSSS Sub-groups:
Post Hoc Analysis of
PRISMS Data            

Cladribine Tablets Presentations
Abstract/    
Presentation
Title                        Lead Author     Poster #     
Date/Time/Session

Cladribine Tablets in the    S. Cook         394          April 
27, 2017, 5:30 -
Treatment of Patients with                                7:00 
p.m.
Multiple Sclerosis (MS):                                  Poster 
Session P5
An Integrated Analysis of
Safety from the MS
Clinical Development
Program

Absolute Lymphocyte Count    P.              379          April 
27, 2017, 5:30 -
Recovery in Patients with    Soelberg-                    7:00 
p.m.
Relapsing-Remitting          Sorensen                     Poster 
Session P5
Multiple Sclerosis (RRMS)
Treated with Cladribine
Tablets 3.5 mg/kg in
CLARITY and CLARITY                                       
Extension                                           

Cladribine Tablets in the    G. Comi         349          April 
28, 2017, 4:00 -
ORACLE-MS Study Open-label                                5:30 
p.m.
Maintenance Period:                                       Poster 
Session P6  
Analysis of Efficacy in
Patients after Conversion
to Clinically Definite
Multiple Sclerosis (CDMS)                              

Defining High Disease        G. Giovannoni   351          April 
28, 2017, 4:00 -
Activity (HDA) in Patients                                5:30 
p.m.
with Relapsing Multiple                                   Poster 
Session P6
Sclerosis (RMS) Receiving
Placebo in the CLARITY                                    
Study                                                     

Durable Efficacy of          G. Giovannoni   353          April 
28, 2017, 4:00 -
Cladribine Tablets in                                     5:30 
p.m.
Patients with Multiple                                    Poster 
Session P6
Sclerosis: Analysis of
Relapse Rates and
Relapse-free Patients in
the CLARITY and CLARITY
Extension Studies          

Efficacy of Cladribine       G. Giovannoni   360          April 
28, 2017, 4:00 - 
Tablets 3.5 mg/kg in High                                 5:30 
p.m.
Disease Activity (HDA)                                    Poster 
Session P6
Subgroups of Patients with
Relapsing Multiple
Sclerosis (RMS) in the                                    
CLARITY Study            

Additional Company-Sponsored Presentations
Abstract/    
Presentation
Title                        Lead Author     Poster #     
Date/Time/Session

Multiple Sclerosis Relapse   A. Phillips     361          April 
23, 2017, 4:00 -
Rates, Before, During, and                                5:30 
p.m.
After Pregnancy: A US                                     Poster 
Session P1
Retrospective Claims                                      
Database Analysis                                         

Pregnancy Complications of   MK. Houtchens   110          April 
24, 2017, 8:30  
Women With and Without                                    a.m. - 
7:00 p.m.
Multiple Sclerosis in a                                   Poster 
Session P2
Large US Claims Database                                  

Does Patients' Experience    J. Smrtka       337          April 
25, 2017, 5:30 -                   
of Care Differ by Level of                                7:00 
p.m.
Adherence in Multiple                                     Poster 
Session P3
Sclerosis?                                     

About Cladribine Tablets

Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of relapsing remitting multiple sclerosis.

The clinical development program for Cladribine Tablets includes:

- CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its 
  extension: 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 and its two-year extension 
  designed to provide data on the long-term safety and efficacy of 
  extended administration of Cladribine Tablets for up to four years.
- 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).
- 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 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 Cladribine Tablets. The follow-up will consist of over 10,000 
  patient years of exposure in total, with follow-up in some patients
  exceeding eight years at completion. 

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. Cladribine Tablets is an investigational product and not approved for use in any indication 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.

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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.

 


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