GENEVA, June 8, 2010 /PRNewswire/ -- Merck Serono, a
division of Merck KGaA, Darmstadt, Germany, announced the submission of a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for Cladribine Tablets as a therapy for reducing relapses in
people with relapsing forms of multiple sclerosis (MS). The company
received a refuse to file letter from the FDA for the Cladribine
Tablets NDA in November 2009.
Regulatory filings for Cladribine Tablets are currently under
review in a number of other locations including the European
Union.
About Cladribine Tablets
Merck Serono's proprietary 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.
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 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.
- 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 more than 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