Merck to Present Rebif® (interferon beta-1a) and Investigational Cladribine Tablets Data at AAN 2017
Freitag, 21.04.2017 15:45 von PR Newswire
PR Newswire
DARMSTADT, Germany, April 21, 2017
DARMSTADT, Germany, April 21, 2017 /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.
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"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™. 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 € 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.