Merck KGaA recently filed a marketing application with the European Medicines Agency (EMA) in its endeavor to expand the label of Rebif, its multiple sclerosis (MS) therapy. The company is seeking approval for Rebif to treat patients who have experienced a single demyelinating event (an early symptom of the disease) and who stand a high risk of developing MS.
Merck KGaA’s application was supported by data from the REFLEX study, which met the primary endpoint of delaying the time to conversion to McDonald MS (2005) – a criterion for the diagnosis of MS. The study evaluated patients who suffered from a demyelinating event such as optic neuritis, myelopathy or brainstem syndrome and had magnetic resonance imaging brain scans consistent with early signs of MS.
Rebif is currently available worldwide as a treatment for the relapsing versions of MS. The drug primarily faces competition from Biogen Idec’s (BIIB - Free Report) , Tysabri and Avonex and Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone.
Enrollment Completed in a Late-stage Study
Merck KGaA, along with its partner Newron Pharmaceuticals S.p.A., also reported the completion of patient enrollment in a late-stage study (MOTION) of safinamide. The study will evaluate the efficacy and safety of safinamide (50 mg and 100 mg once daily) in patients suffering from early-stage Parkinson’s disease. Safinamide will be evaluated as add-on therapy to a stable dose of a single dopamine agonist and compared with dopamine agonist monotherapy.
We note that the MOTION study is a part of the clinical development program of safinamide, which comprises of studies 015, 016, 017 and 018. These studies have already been completed, while another study, SETTLE, is currently underway. This clinical program is designed to evaluate safinamide as an add-on therapy to dopamine agonist therapy in patients with early Parkinson’s disease and also as an add-on to levodopa therapy in patients suffering from advanced Parkinson’s disease.
According to the partnership agreement between Merck KGaA and Newron Pharma, Merck KGaA has the worldwide development, manufacturing and commercialization rights to safinamide as a treatment for Parkinson’s disease, Alzheimer’s disease and other therapeutic applications.