Investigational Cladribine Tablets Data Show Greater Treatment Effect in Relapsing MS Patients at a Higher Risk of Disease Progression - Seite 2

following the 10-day dosing period in treatment year 1, median
lymphocyte counts were reduced to a low of 1.00×10[9]/L. However, by
the end of treatment year 1 and 2, median lymphocyte counts had
recovered to within the normal range. In the 2-year CLARITY study,
the most commonly reported adverse event (AE) in patients treated
with Cladribine Tablets was lymphopenia. The incidence of infections
was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1%
and 99.0% respectively rated mild-to-moderate by investigators.

*Higher risk of disease progression and/or high disease activity
is defined as patients with >= 1 relapse during the year prior to
study entry while on DMD therapy AND >= 1 T1 Gd+ or >= 9 T2 lesions
plus patients with >= 2 relapses during the year prior to study
entry, regardless of prior use of DMD.

About Cladribine Tablets

Cladribine Tablets is an investigational short-course oral therapy
that is thought to selectively and periodically target lymphocytes
thought to be integral to the pathological process of MS. Cladribine
Tablets 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
Cladribine Tablets for the treatment of relapsing remitting multiple
sclerosis.

The clinical development program for Cladribine Tablets includes:

- CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its
extension: 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 and its two-year extension
designed to provide data on the long-term safety and efficacy of
extended administration of Cladribine Tablets for up to four years.
- ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III
placebo-controlled study 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).
- ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients
with Active Relapsing Disease) study: a Phase II placebo-controlled
study 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.
- PREMIERE (Prospective Observational Long-term Safety Registry of
Multiple Sclerosis Patients Who Have Participated in Cladribine