GENEVA, Switzerland,
October 11, 2010 /PRNewswire/ --
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has notified
the European Medicines Agency (EMA) of its intention to request a
re-examination of the opinion issued by the Committee for Medicinal
Products for Human Use (CHMP) in September regarding Cladribine
Tablets as a treatment for relapsing-remitting multiple sclerosis
(MS).
"We are committed to the potential of Cladribine Tablets to meet
an unmet medical need and to make this treatment option available
to patients who could benefit from it," said Elmar Schnee, President of Merck Serono. "We
will continue working closely with the CHMP to address the
committee's concerns and pursue a way forward."
In accordance with European regulations, applicants may appeal a
CHMP opinion provided they notify the EMA in writing of their
intention to appeal within 15 days of receipt of the opinion. The
applicant must provide to the agency with detailed grounds for a
re-examination of the opinion within 60 days after receipt of the
opinion.
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
approved in Russia in July 2010 and in Australia in September
2010.
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