Cladribine Tablets Receives Positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis

Darmstadt, Germany (ots/PRNewswire) -

- Efficacy and safety data support positive benefit/risk
assessment from CHMP
- Cladribine Tablets is the first and only investigational medicinal
product to have shown a sustained 4 years of disease control
with a maximum of 20 days of oral treatment over 2 years in
clinical trials

Merck, a leading science and technology company, today announced
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion for
approval of Cladribine Tablets (proposed tradename MAVENCLAD[TM]) for
the treatment of relapsing forms of multiple sclerosis (RMS) in
patients with high disease activity.

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"The positive opinion from the CHMP is an extraordinary
development for Merck, affirming our belief in Cladribine Tablets as
a potential important treatment option for patients living with
multiple sclerosis," said Belén Garijo, CEO Healthcare and Member of
the Executive Board of Merck. "We now eagerly await the European
Commission decision, and the opportunity to make a difference in the
MS treatment paradigm. Our sincerest thanks to the entire MS
community for their unwavering support throughout the Cladribine
Tablets journey."

"We strongly believe in the therapeutic value of Cladribine
Tablets and the significant impact this investigational therapy may
have on the future of MS care," said Luciano Rossetti, Global Head
of R&D for the Biopharma business of Merck. "There are still
significant unmet needs for patients with MS, particularly those with
high disease activity. We look forward to our continued partnership
with the EMA, which has been an invaluable scientific advisor in
helping us advance the development of Cladribine Tablets."

The CHMP positive opinion is based on more than 10,000 patient
years of data with over 2,700 patients included in the clinical trial
program, and more than 10 years of observation in some patients. The
clinical development program included data from three Phase III
trials, CLARITY, CLARITY EXTENSION and ORACLE MS, the Phase II ONWARD
study and long-term follow-up data from the 8-year prospective