Cladribine Tablets Receives Positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis - Seite 2

registry, PREMIERE. The efficacy and safety results of these studies
allowed a full characterization of the benefit-to-risk profile of
Cladribine Tablets.

In patients with high disease activity, post hoc analyses of the
two-year Phase III CLARITY trial demonstrated that Cladribine Tablets
reduced the annualised relapse rate by 67% and the risk of 6-month
confirmed EDSS progression by 82% versus placebo. As demonstrated in
the Phase III CLARITY EXTENSION study no further Cladribine treatment
was required in Years 3 and 4. The comprehensive dataset has informed
the posology and monitoring requirements. The most important side
effects are lymphopenia, which can be severe and long-lasting, and
infections, including herpes zoster.

The CHMP's recommendation will be referred to the European
Commission which is expected to make a final decision on the
marketing authorisation application for Cladribine Tablets within 67
days from the CHMP opinion.

MAVENCLAD(TM) is the proprietary name submitted to EMA for the
investigational medicine Cladribine Tablets.

About MAVENCLAD[TM]

MAVENCLAD(TM) (cladribine tablets) is an investigational
short-course oral therapy that selectively and periodically targets
lymphocytes thought to be integral to the pathological process of MS.
MAVENCLAD is currently under clinical investigation and not yet
approved for the treatment for any use in the United States, Canada
and Europe. In July 2016, the European Medicines Agency (EMA)
accepted for review the Marketing Authorisation Application (MAA) of
MAVENCLAD(TM) for the treatment of relapsing remitting multiple
sclerosis.

The clinical development program for MAVENCLAD 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 MAVENCLAD as a monotherapy in patients
with RRMS.
- The CLARITY extension study: a four-year Phase III
placebo-controlled study following on from the CLARITY study,
designed to evaluate the safety and efficacy of MAVENCLAD over an
extended administration for four years.
- The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase
III placebo-controlled study designed to evaluate the efficacy and
safety of MAVENCLAD as a monotherapy in patients at risk of
developing MS (patients who have experienced a first clinical event
suggestive of MS).
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in
Patients With Active Relapsing Disease) study: a Phase II