GENEVA, Switzerland,
July 28, 2010 /PRNewswire/ -- Merck
Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food
and Drug Administration (FDA) has accepted for filing the New Drug
Application (NDA) for Cladribine Tablets as a therapy for relapsing
forms of multiple sclerosis (MS).
The application also has been granted a Priority Review
designation by the FDA, which means the review period for the NDA
is reduced. The goal for completing a Priority Review is six months
instead of the standard 10 months. Priority Review is applied to
drugs that have the potential to provide significant advances in
treatment. A decision by the FDA is expected in Q4 2010.
"This is a critical milestone on the path to potential approval
for short course therapy with Cladribine Tablets, moving us one
step closer to meeting an unmet need as an oral, disease-modifying
drug available for relapsing MS," said Fereydoun Firouz, President and CEO of EMD
Serono, Inc., the US affiliate of Merck KGaA, Darmstadt,
Germany. "Our commitment to people
living with MS is to transform the way they approach their therapy
options, and Priority Review for short-course therapy with
Cladribine Tablets means we are moving closer to delivering on this
promise. We look forward to working with the FDA throughout the
regulatory process."
The NDA is supported by results from the CLARITY 1 study, a
two-year, randomized, double-blind, placebo-controlled Phase III
trial of Cladribine Tablets in people with relapsing-remitting MS.
The CLARITY study results were published in The New England Journal
of Medicine 2 in February 2010.
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 multiple
sclerosis (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 forms of 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 initiated global filings for Cladribine Tablets in mid-2009
and, to date has submitted regulatory applications for Cladribine
Tablets covering about 40 countries. Cladribine Tablets was granted
its first marketing approval in July
2010, in Russia.
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.
- The PREMIERE (PRospective observational long-term safEty
registry of Multiple sclerosis patIEnts who have participated in
CladRibinE clinical trials) registry: an eight-year observational
safety registry of patients who have participated in Cladribine Tablets
clinical trials, designed to support the evaluation of the long-term
safety of Cladribine Tablets in MS.
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
40,000 (including Merck Millipore) 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