CHMP Recommends Merck KGaA's Rebif

Merck KGaA (MKGAF) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Rebif for the treatment of patients with early signs of multiple sclerosis (MS). On approval, the drug can be used in patients who have experienced a single demyelinating event, and are at high risk of converting to MS.

Merck KGaA had submitted the European application for the extended indication of Rebif in June 2011. The 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.

We note that Rebif is already marketed worldwide as a treatment for relapsing forms of MS. Apart from Rebif, other MS treatments available in the market include Biogen Idec’s (BIIB - Analyst Report) Tysabri and Avonex and Teva Pharmaceuticals’ (TEVA - Analyst Report) Copaxone.

We view the positive recommendation by the CHMP as a major boost for the company and believe that it would add to the drug’s sales, which climbed 8.4% during the third quarter of fiscal 2011. Moreover, we are of the view that this development will help strengthen Merck KGaA’s MS portfolio, which recently saw an addition with the acquisition of the exclusive worldwide development and commercialization rights to Peptimmune Inc.’s PI-2301. The candidate has completed early-stage studies in MS and is about to enter mid-stage trials.

We currently have a Zacks #3 Rank (short-term Hold rating) on Merck KGaA.

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