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44 | Merck Annual Report 2008
who received a higher total dose experienced a 55% reduction. We initiated ORACLE-MS,
a further Phase III trial, at the end of September. It will evaluate the efficacy of
cladribine in preventing conversion to definite multiple sclerosis in patients at risk of
developing multiple sclerosis. The Phase II study ONWARD, which is currently under-
way, is examining the safety and efficacy of cladribine as an add-on to treatment to
interferon beta, for example the new formulation of Rebif®.
Merck Serono is also developing atacicept for the treatment of multiple sclerosis.
In April 2008, we initiated a Phase II study to evaluate the efficacy of atacicept in
reducing central nervous system inflammation in patients with relapsing MS. In June,
an exploratory Phase II trial was started to evaluate the efficacy of atacicept in optic
neuritis. Inflammation of the optic nerve is a condition often experienced as an early
clinical manifestation by patients with multiple sclerosis.
Safinamide – a potential add-on treatment in Parkinson’s disease
Safinamide, an orally administered add-on treatment with a novel mechanism of
action, is also in late-stage clinical trials. Together with the Italian pharmaceutical
company Newron, we are developing safinamide for Parkinson’s disease. A Phase III
study to evaluate safinamide as an add-on treatment to levodopa in patients with
advanced Parkinson’s met its primary endpoint. The motor functioning of patients
with advanced Parkinson’s disease improved significantly. The ON times during
which motor function reaches its highest levels were extended by 1.3 hours. In a Phase
III study called MOTION, we are evaluating safinamide as an add-on therapy to dop-
amine agonist in early-stage disease.
Long-acting fertility hormone under development
Our research and development work in the therapeutic area of Fertility is aimed at
helping infertile couples to conceive a child, delivering products for every phase
of the reproductive cycle from ovulation to early pregnancy. With our innovative
treatments and technologies, we want to help couples increase their chances of a
successful pregnancy. In addition, it is our aim to continue making our products as
patient-friendly as possible.
For example, we are developing a long-acting recombinant follicle-stimulating hor-
mone (hyperglycosylated FSH), which would mean fewer injections for patients. We suc-
cessfully completed the Phase II program in assisted reproduction (ART) and are ready
to advance the compound to Phase III. Phase II studies to evaluate efficacy in inducing
ovulation are still underway.
We terminated the development of anastrozole, an aromotase inhibitor for ovulation
induction, in July 2008. Although Phase II dose finding studies were successfully com-
pleted, the substance did not show a promising profile to be advanced to Phase III when
compared to clomiphene citrate, the standard treatment.