Merck Serono Notified EMA of its Intention to Appeal CHMP Opinion on Cladribine Tablets in MS

By Merck Serono, PRNE
Sunday, October 10, 2010

Merck Serono is Committed to the Potential of Cladribine Tablets to Meet an unmet Medical Need as an oral, Short-Course, Disease-Modifying Drug for Multiple Sclerosis

GENEVA, Switzerland, October 11, 2010 - 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

"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

The clinical development program for Cladribine Tablets

    - 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

    - 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
and Canada, EMD Serono operates through separately incorporated

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.

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