Merck 2008 Annual Report Download - page 48

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MANAGEMENT REPORT OF THE MERCK GROUP 43
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
Merck Serono is currently evaluating the investigational integrin inhibitor cilengitide
in glioblastoma – the most aggressive form of brain tumor – and in head and neck
cancer. Cilengitide is thought to suppress the new formation of blood vessels (angio-
genesis) and cut off the tumor from the blood supply. In addition, it is believed to
target tumor cells directly. Following Phase II data, cilengitide is now being studied
in a global Phase III trial (CENTRIC) to evaluate its efficacy in patients with newly
diagnosed glioblastoma. All patients enrolled in the study are carriers of a specific
chemical modification in a certain section of their DNA (methylated MGMT promoter).
A further Phase II trial (ADVANTAGE) is evaluating the novel combination of cilen-
gitide and Erbitux® in squamous cell carcinoma of the head and neck. In addition, we
entered into a worldwide alliance with Lpath, Inc. of the United States to develop and
commercialize sonepcizumab (ASONEP™), a Phase I monoclonal antibody currently
being evaluated for the treatment of various cancer types.
Progress with the further development of Rebif®
Our development projects in Neurodegenerative Diseases are focused on innovative
therapeutic options for multiple sclerosis (MS) and Parkinson’s disease – two areas
with high unmet medical needs. The Merck Serono division wants to expand the range
of approved indications for the successful MS treatment Rebif® based on the outcome
of clinical trials. One of the aims is to enable more patients in the early stages of the
disease to benefit from treatment with Rebif®. In September, we completed the enroll-
ment of more than 500 patients for the REFLEX trial, one of the most important studies
on the further development of Rebif®. This 24-month Phase III registration study will
examine the efficacy of the new formulation of Rebif® in clinically isolated syndrome.
In this new indication, the study participants have so far only experienced MS-like
attacks, but have not yet been diagnosed with clinically defined MS. The aim of the
study is to investigate the therapeutic value of Rebif® prior to the outbreak of MS in
these patients.
Initial results of the ongoing Phase IIb IMPROVE study after 16 weeks of treatment
show that the primary endpoint has been met, confirming the therapeutic effect of the
new formulation of Rebif® in MS patients. The number of active lesions in the brain
as measured by magnetic resonance imaging was significantly lower than in patients
treated with the new formulation of Rebif® compared with those receiving placebo in
the control group.
Oral MS treatment – a new therapeutic option in development
With cladribine tablets, Merck Serono is developing a drug that – once approved –
would represent the first therapeutic option for oral treatment of relapsing MS. Patients
would only need to take this proprietary oral formulation of a nucleoside analogue a
few times a year for a period of four to five days in a single daily dose, making treat-
ment considerably more comfortable and improving the prospects for compliance. The
U.S. Food and Drug Administration has given cladribine tablets fast-track designation.
The safety and efficacy of cladribine tablets as an MS monotherapy in two dosage
strengths were tested in a two-year Phase III registration study called CLARITY. This
study, which involved more than 1,300 patients, was completed at the end of 2008.
According to the results of the trial, which met the primary endpoint, the relapse
rate was significantly reduced. Patients who received a lower total dose experienced
a 58% relative reduction in annualized relapse rates versus placebo while patients
Studies are investigating
whether Rebif® can be used
in early-stage disease.
Cladribine tablets have
fast-track designation from
the FDA.