Merck 2008 Annual Report Download - page 50

MANAGEMENT REPORT OF THE MERCK GROUP 45
24 Responsibility
26 Merck shares
30 Pharmaceuticals business sector
50 Chemicals business sector
12 Overall economic situation
14 Economic development
of Merck
15 Financial position and results
of operations
60 Corporate and Other
61 Risk report
64 Report on expected developments
64 Subsequent events
New studies in systemic lupus erythematosus and rheumatoid arthritis
Our research and development activities in the Autoimmune and Inflammatory Diseases
therapeutic area focus on proteins that modulate important mechanisms in the develop-
ment of disease. The Merck Serono division is developing atacicept, a soluble fusion pro-
tein, for several indications including rheumatoid arthritis (RA). We completed patient
enrollment in our two largest Phase II studies in RA and started another Phase II study
in 2008. Data for the first two studies are expected in the second half of 2009.
Systemic lupus erythematosus (SLE), a chronic inflammatory disease where the
immune system attacks the body’s own tissues, is an area of high unmet medical need
that primarily affects women. A Phase II/III study with atacicept in patients with SLE
began in June. We discontinued one study of atacicept in lupus nephritis (LN), a par-
ticularly severe form of SLE affecting the kidneys, which was part of the ongoing SLE
development program. This Phase II/III study combined atacicept with other medica-
tions (mycophenolate mofetil and corticosteroids) and was discontinued because of the
occurrence of severe infections. These were thought to be the result of the underlying
significant disease activity coupled with the concomitant use of several immunosup-
pressive medications. We are currently analyzing the data and redesigning the develop-
ment plan for atacicept in lupus nephritis.
Thanks to its novel mechanism of action, fibroblast growth factor 18 (FGF 18) could
be the first treatment for osteoarthritis that stimulates the repair of articular cartilage
instead of simply treating the symptoms of this degenerative joint disease. A second
Phase I trial in osteoarthritis was initiated at the end of 2008. In July, Merck Serono
returned to the Swiss biotech company NovImmune the rights to develop and commer-
cialize the human monoclonal antibody anti-CD 3 (NI-0401).
Development projects on growth disorders and metabolic diseases
Our researchers are working on a number of development projects on selected growth dis-
orders and metabolic diseases in the therapeutic area of Endocrinology. The Merck Serono
division can build on its long-standing experience in these therapeutic indications.
Our U.S. subsidiary EMD Serono acquired the commercialization rights to tesamore-
lin, a growth hormone-releasing factor analogue with therapeutic potential in a variety
of anabolic and lipolytic indications. The compound is in the final stages of its second
Phase III clinical trial to assess the safety and efficacy when used to reduce excess
abdominal fat in HIV patients with lipodystrophy. The development of a high-dose
recombinant human growth hormone for the treatment of HIV-associated adipose redis-
tribution syndrome (HARS) was discontinued and an impairment loss was recognized
for the intangible assets capitalized to date.
In cooperation with the U.S. biopharmaceutical company Ambrx, we are studying the
long-acting growth hormone ARX-201 for the treatment of growth hormone deficiency.
In other projects we are working on the constant further development of our appli-
cation devices.
Focus on proteins that modu-
late important mechanisms in
the development of disease.