Merck 2010 Annual Report Download - page 65

Study 016. The data from Study 018 also confirm the safety profile of safinamide. With SETTLE,
a further Phase III clinical trial is underway in this indication. In the MOTION study, a Phase III
clinical trial, we are evaluating safinamide as an add-on therapy to a dopamine agonist in early
Parkinson’s disease.

The objective of fertility research and development work at Merck Serono is to help infertile
couples at every stage of the reproductive cycle – from follicular development to early preg-
nancy – to realize their dream of having a child. The innovative drugs and application devices
must offer patients maximum ease of use and increase the probability of a pregnancy. In this
way, we want to further expand our leading position in the treatment of infertility. Our ongoing
research efforts are focused on drugs, technologies and support services that will improve the
success rate of in vitro fertilization (IVF) procedures, and thus ultimately increase the take-
home baby rate.

In the field of autoimmune and inflammatory diseases, we shifted our focus to rheumatological
diseases and consequently renamed this therapeutic area. Our research and development work
is centered on molecules that modulate the key pathogenic mechanisms of these diseases. We
are developing the recombinant protein atacicept for the treatment of systemic lupus erythe-
matosus (SLE), an inflammatory rheumatological disease. This innovative compound blocks the
two immunomodulatory factors APRIL and BLyS. They are important for the survival and the
proliferation of lymphocytes that trigger an abnormal immune reaction against the patient’s
own normal tissues. SLE is a chronic autoimmune disease that mainly affects women and is an
area of great unmet medical need. We are currently conducting a Phase II/III clinical trial with
atacicept in SLE. Lupus nephritis (LN) is a particularly severe form of SLE involving the kidneys.
We are currently adapting the clinical development plan for atacicept in this indication after
having discontinued a Phase II / III study in 2008.
Thanks to its novel mechanism of action, fibroblast growth factor 18 (FGF 18) could be the first
disease-modifying treatment for osteoarthritis and the repair of cartilage damage following
injury. In the laboratory, FGF 18 has been shown to stimulate the regeneration of defective
articular cartilage. FGF 18 may support the healing of degenerative joint disease. We success-
fully completed a Phase I trial of patients with osteoarthritis of the knee joint. A further clinical
trial in osteoarthritis is still in progress. We are investigating the efficacy of FGF 18 in the
treatment of knee cartilage defects in a Phase II trial that we initiated in 2010.

The aim of our research and development efforts in endocrinology is to offer patients with
growth disorders and metabolic diseases new therapeutic options or improved versions of
established products based on our own development work or cooperation with partners. The
most recent examples include Egrifta™ (tesamorelin for injection) for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy, as well as the development of
a liquid formulation of Saizen ® for injection.
Phase II study of FGF 18 started
in a new indication, the treatment
of knee cartilage defects
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