GENEVA, Switzerland,
November 26, 2010 /PRNewswire/ --
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food
and Drug Administration (FDA) has extended its review period for
Cladribine Tablets as a therapy for relapsing forms of multiple
sclerosis (MS) by three months to February
28, 2011.
The FDA granted Priority Review status for Cladribine Tablets in
July of 2010, reducing the standard 10-month review period to six
months, which was set to end on November 28,
2010. The FDA extended the review period to provide
additional time for a full review of additional information
provided under the new drug application (NDA).
"Merck Serono continues to work closely with the FDA during the
review process of the Cladribine Tablets new drug application,"
said Bernhard Kirschbaum, Merck
Serono's Head of Global Research and Development. "We will continue
working towards our goal of providing an oral disease-modifying
drug for the treatment of relapsing multiple sclerosis."
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.
Cladribine Tablets were approved in Russia in July
2010 and in Australia in
September 2010 as a treatment of
relapsing-remitting MS and are under regulatory review in other
countries.
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