Zacks_Analysts' Blog : Label Expansion for Merck KGaA Drug - Analyst Blog

Merck KGaA(MKGAF) was recently buoyed by the news of European Commission (EC) approving its lead drug Rebif for the treatment of patients who have experienced a single demyelinating event, and are at high risk of getting multiple sclerosis (MS). Approval is for the drug’s 44 micrograms formulation which can be used thrice a week.

The approval did not come as a big surprise for the company, as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of Rebif for the extended indication in November last year. Merck KGaA had submitted the European application for the said 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) Tysabri and Avonex and Teva Pharmaceuticals’ (TEVA) Copaxone.

Although, we currently have a Zacks #5 Rank (short-term Strong Sell rating) on Merck KGaA, we are encouraged by this development as it would bring incremental drug sales, which climbed 8.4% during the third quarter of 2011. Moreover, we believe that this development will strengthen Merck KGaA’s MS portfolio.