Merck Receives European Medicines Agency Acceptance for Review of Marketing Authorization Application for Cladribine Tablets

Darmstadt, Germany (ots/PRNewswire) -

Merck, a leading science and technology company, today announced
that the European Medicines Agency (EMA) has accepted for review the
Marketing Authorization Application (MAA) of the investigational
product Cladribine Tablets for the treatment of relapsing-remitting
multiple sclerosis (MS).

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"Our submission of the Marketing Authorization Application for
Cladribine Tablets demonstrates Merck's continued commitment to
fighting the devastating disease of multiple sclerosis," said Luciano
Rossetti, Head of Global R&D for the Biopharma business of Merck.
"Although there are multiple therapies available for
relapsing-remitting MS, there is still a significant unmet medical
need with a focus on efficacy, dosing, durability and safety. We
believe that Cladribine Tablets, if approved, would have a
first-of-its-kind dosing regimen and serve as an important
therapeutic option for patients with relapsing-remitting MS."

The MAA submission includes data from three Phase III studies,
CLARITY, CLARITY EXTENSION and ORACLE MS, and the Phase II ONWARD
study. In these trials, Cladribine Tablets showed significantly
reduced relapse rates, risk of disability progression and development
of new MS lesions, as detected by MRI, versus placebo in patients
with relapsing-remitting MS.[1],[2],[3],[4],[5] Together with interim
long-term follow-up data from the prospective registry, PREMIERE, the
new MAA also includes follow-up consisting of over 10,000 patient
years of exposure in total, with follow-up in some patients exceeding
eight years.[6]

References

1. A Placebo-Controlled Trial of Oral Cladribine for Relapsing
Multiple Sclerosis. New England Journal of Medicine.
http://www.nejm.org/doi/full/10.1056/NEJMoa0902533 Accessed May 5,
2016.
2. Safety and Efficacy of Oral Cladribine in Patients with
Relapsing-Remitting Multiple Sclerosis: Results from the 96 Week
Phase IIIb Extension Trial to the CLARITY Study (P07.119).
Neurology. http://www.neurology.org/content/80/7_Supplement/P07.11
9.short?sid=f809adbd-a031-410b-97ad-fe26ccbee454 Accessed May 5,
2016.
3. Effect of Oral Cladribine on Time to Conversion to Clinically
Definite Multiple Sclerosis in Patients with a First Demyelinating
Event (ORACLE MS): A Phase 3 Randomised Trial. Lancet Neurology.
http://www.ncbi.nlm.nih.gov/pubmed/24502830 Accessed May 5, 2016.
4. A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta)
Therapy in Multiple Sclerosis (MS) Subjects With Active Disease
(ONWARD). Clinical Trials. https://clinicaltrials.gov/ct2/show/NCT