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Efficacy of Cladribine Tablets and Advantages of Early Treatment with Rebif® at
the 2016 ECTRIMS Congress
presentations and nine posters include new analyses on investigational
Cladribine Tablets
assess the safety, tolerability and effectiveness of Rebif®
unmet needs among patients with MS and real-word issues
Sclerosis Innovation (GMSI) award recipients will share in €1 million
DARMSTADT,
Germany, September 12, 2016 –Merck, a leading
science and technology company, today announced key symposia and more than 30
presentations of clinical data on Cladribine Tablets, an investigational, oral,
small molecule for the treatment of relapsing-remitting multiple sclerosis
(RRMS), and Rebif® (interferon beta-1a), the company’s high-dose,
high-frequency interferon beta for relapsing forms of multiple sclerosis (MS),
are scheduled for the 32nd Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 14-17, 2016, in London.
“Merck
is committed to advancing patient care and offering therapeutic options that
help address unmet medical needs for people with MS, with a focus on efficacy,
dosing, durability and safety,” said Luciano
Rossetti, Global Head of Research & Development for Merck’s
biopharma business. “We look forward to sharing additional data on Rebif®
and Cladribine Tablets with the scientific community at this year’s ECTRIMS
Congress.”
Oral
presentations include a comparison of the CLARITY and the CLARITY EXTENSION
studies, which sought to examine the duration of clinical outcome response to
Cladribine Tablets, and results of the SOLAR study, which examined the effects
of adding high-dose cholecalciferol (vitamin D3) to Rebif® therapy
for patients with RRMS. Poster presentations will report on clinical and
magnetic resonance imaging outcomes in patients treated with Cladribine Tablets
or Rebif® and patient-reported outcomes in patients being treated
with Rebif®. Several health economics outcomes research
presentations will highlight key issues facing people with MS, including
pregnancy outcomes.
In addition
to data presentations, a Merck-sponsored satellite symposium, “Reimagining
the MS Treatment Journey,” will take place Wednesday,
September 14, 18:45-19:45 BST in Hall A at
the ExCel. The panel session will feature distinguished experts in MS who will
debate whether unmet needs in MS care remain, consider what an ideal MS therapy
might look like, and review current and potential future therapies.
On Thursday, September 15, Merck will hold its fourth annual
Grant for Multiple Sclerosis Innovations (GMSI) Awards symposium. Up to €1
million will be awarded to one or more researchers to support work that aims to
improve the understanding of MS for the ultimate benefit of patients. The
symposium will take place in the South Gallery 19 at the ExCel from 19:30-20:30 BST.
For more
information about the data to be presented, please review the ECTRIMS website.
Also, visit Merck’s booth at this year’s
Congress to learn more about the company’s programs and commitment to advancing
MS care.
About
Cladribine Tablets
Cladribine
Tablets is an oral small molecule prodrug that selectively and periodically
targets lymphocytes thought to be integral to the pathological process of MS.
Cladribine Tablets is currently under clinical investigation and not approved
for any use in the United States, Canada and Europe.
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.
All Merck
Press Releases are distributed by e-mail at the same time they become available
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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 2015, Merck generated sales of € 12.85 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, Darmstadt, Germany 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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