GENEVA, July 12, 2010 /PRNewswire/ --
- First Approval Ever of an Oral Disease-modifying Therapy for Multiple
Sclerosis
- Cladribine Tablets Will be Marketed in Russia Under the Trade Name
Movectro(R)
- Russian Launch Expected Early 2011
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian
Federal Service on Surveillance in Healthcare and Social
Development has become the first government agency to grant
marketing approval to Cladribine Tablets for the treatment of
relapsing-remitting multiple sclerosis (MS). Cladribine Tablets
will be available in Russia under
the trade name Movectro(R).
"This approval for Cladribine Tablets means that people with
relapsing-remitting multiple sclerosis in Russia will benefit soon from this effective
oral treatment", said Elmar Schnee,
President of Merck Serono. "This is an important milestone
reinforcing Merck Serono's leadership position and ongoing
commitment to fight against the devastating disease of multiple
sclerosis. We expect other regulatory approvals in the near
future."
Merck Serono initiated its global filings in mid-2009 and, to
date has submitted regulatory applications for Cladribine Tablets
in about 40 countries.
"The availability of Cladribine Tablets in Russia will represent a key milestone for
people with multiple sclerosis as this is the first approval of an
orally-administered disease-modifying therapy for
relapsing-remitting multiple sclerosis", said Professor
Alexey Boyko, Department of
Neurology and Neurosurgery at the Russian State Medical University,
Moscow. "This approval is an
important step toward optimizing medical care in multiple
sclerosis."
"The approval of Cladribine Tablets will transform the way
Russian patients with relapsing-remitting multiple sclerosis and
physicians approach therapy options", said Professor Gavin Giovannoni, Blizard Institute of Cell and
Molecular Science, Barts and The London School of Medicine and
Dentistry, London, United Kingdom,
and principal investigator of the CLARITY study. "I hope that this
new therapeutic option will also be available soon for people
living with multiple sclerosis in other countries."
Merck Serono will now apply for the listing of Cladribine
Tablets within the Russian State Federal drug reimbursement
program. The Company expects to launch Movectro(R) in Russia in early 2011
Russian registration was supported by the results from the
CLARITY(1) study, the largest placebo-controlled Phase III clinical
trial in relapsing-remitting MS completed to date. A total of 1,326
patients with relapsing-remitting MS were randomized at 155 centers
in 32 countries, including 23 centers in Russia. The CLARITY study results, recently
published in The New England Journal of Medicine(2), show that
short-course treatment with Cladribine Tablets significantly
reduced relapse rates (the primary endpoint), the risk of
disability progression (a key secondary endpoint), and MRI measures
of disease activity (other key secondary endpoints) at 96 weeks.
Adverse events that were more frequent in the Cladribine Tablets
groups included lymphopenia and herpes zoster.
1 CLARITY: CLAdRIbine Tablets Treating MS OrallY
2 Giovannoni G et al. A Placebo-Controlled Trial of Oral
Cladribine for Relapsing Multiple Sclerosis; N Engl J Med 362:416,
February 4, 2010
About the CLARITY study design
The CLARITY study was a two-year (96-week), randomized,
double-blind, placebo-controlled, international trial. It
randomized 1,326 patients with relapsing-remitting MS according to
the revised McDonald criteria. Study participants were randomized
to one of three different treatment groups consisting of two
different dose regimens of Cladribine Tablets or matching placebo
tablets (1:1:1 ratio). Cladribine Tablets were given in two (3.5
mg/kg total dose) or four (5.25 mg/kg total dose) treatment courses
in the first year, with each course consisting of once daily
administration for four to five consecutive days (depending on
patient weight), which means study patients took Cladribine Tablets
for 8 to 20 days during the year. In the second year, two treatment
courses were administered to all patient groups, meaning that
patients took Cladribine Tablets for 8 to 10 days during the
year.
The primary endpoint of the CLARITY study was the relapse rate
over 96 weeks. Secondary endpoints included MRI endpoints,
proportion of subjects relapse-free and disability progression at
96 weeks.
About Cladribine Tablets
Merck Serono's oral formulation of cladribine (Cladribine
Tablets) is an investigational treatment for patients with
relapsing-remitting multiple sclerosis (MS). Cladribine is a small
molecule that may interfere with the behavior and the proliferation
of certain white blood cells, particularly lymphocytes, which are
thought to be involved in the pathological process of MS. Merck
Serono has applied for marketing approval of Cladribine Tablets in
the European Union, the United
States and other regions.
The clinical development program for Cladribine Tablets
includes:
- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study
and its extension: a two-year Phase III placebo-controlled trial designed to
evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in
patients with relapsing-remitting MS and the CLARITY EXTENSION two-year Phase
III study designed to provide data on the long-term safety and efficacy of
extended administration of Cladribine Tablets for up to four years.
- The ORACLE MS (ORAl CLadribine in Early MS) study: a
two-year Phase III placebo-controlled trial 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). This trial was announced in September 2008.
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a
in Patients With Active Relapsing Disease) study: a Phase II
placebo-controlled trial 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. This trial was announced in January
2007.
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 two 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.
About Merck Serono
Merck Serono is the division for innovative prescription
pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical
company. Headquartered in Geneva,
Switzerland, Merck Serono discovers, develops, manufactures
and markets innovative small molecules and biopharmaceuticals to
help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately
incorporated affiliates.
Merck Serono has leading brands serving patients with cancer
(Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon
beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and
metabolic disorders (Saizen(R) and Serostim(R), somatropin),
(Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic
diseases (Glucophage(R), metformin), (Concor(R), bisoprolol),
(Euthyrox(R), levothyroxine). Not all products are available in all
markets.
With an annual R&D expenditure of more than EUR 1 billion, Merck Serono is committed to
growing its business in specialist-focused therapeutic areas
including neurodegenerative diseases, oncology, fertility and
endocrinology, as well as new areas potentially arising out of
research and development in autoimmune and inflammatory
diseases.
About Merck
Merck is a global pharmaceutical and chemical company with total
revenues of EUR 7.7 billion in 2009,
a history that began in 1668, and a future shaped by approximately
33,600 employees in 64 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating
activities come under the umbrella of Merck KGaA, in which the
Merck family holds an approximately 70% interest and free
shareholders own the remaining approximately 30%. In 1917 the U.S.
subsidiary Merck & Co. was expropriated and has been an
independent company ever since.
For more information, please visit http://www.merckserono.com or
http://www.merck.de