MAVENCLAD® (Cladribine Tablets) Approved As The First Short-Course Oral Treatment for Relapsing Remitting Multiple Sclerosis in Switzerland - Seite 2

remitting multiple sclerosis by Swissmedic in Switzerland is good
news because it extends the range of options for this group of MS
patients with an oral treatment with proven, long-lasting effect."

In patients with high disease activity, post hoc analyses of the
two-year Phase III CLARITY trial2,[8] demonstrated that MAVENCLAD®
reduced the annualized relapse rate by 67% and the risk of 6-month
confirmed Expanded Disability Status Scale (EDSS) progression by 82%
versus placebo. As demonstrated in the Phase III CLARITY EXTENSION
study, no further MAVENCLAD® treatment was required in Years 3 and
4.[9] MAVENCLAD® has a well-characterized safety profile, with up to
ten years of observation in some patients and no reported cases of
progressive multifocal leukoencephalopathy (PML) in MS. The most
clinically relevant adverse reactions were lymphopenia and herpes
zoster. Lymphocyte counts must be assessed before, and during,
treatment with MAVENCLAD®. MAVENCLAD® is contraindicated in certain
groups including immunocompromised patients and pregnant women.

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About MAVENCLAD®

MAVENCLAD® is a short-course oral therapy that selectively and
periodically targets lymphocytes thought to be integral to the
pathological process of relapsing MS (RMS). In August 2017, the
European Commission (EC) granted marketing authorization for
MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis
(RMS) in the 28 countries of the European Union (EU) in addition to
Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been
approved in more than 50 countries, including Canada and Australia.
MAVENCLAD® is currently under clinical investigation and not yet
approved for the treatment for any use in the United States.

Visit www.MAVENCLAD.com for more information.

The clinical development program for cladribine tablets includes:

- The CLARITY (Cladribine Tablets Treating MS Orally) study: a
two-year Phase III placebo-controlled study designed to evaluate
the efficacy and safety of cladribine tablets as a monotherapy in
patients with RRMS.
- The CLARITY extension study: a Phase III placebo-controlled study
following on from the CLARITY study, which evaluated the safety and
exploratory efficacy of cladribine tablets over two additional
years beyond the two-year CLARITY study, according to the treatment