EU Approves Merck's Elonva - Analyst Blog

Recently, Merck & Co. Inc. (MRK) received approval from the European Commission (EC) for its fertility drug Elonva (corifollitropin alfa injection). The drug will be used as a treatment in controlled ovarian stimulation (COS) coupled with a GnRH antagonist for the development of multiple follicles in women who have participated in an assisted reproductive technology (ART) program. 

This approval does not come as a surprise as in 2009 Elonva received a recommendation for approval from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP). 

Elonva is the first in a class of sustained follicle stimulants (SFS). It scores better than the current available treatment option - a single subcutaneous injection of Elonva is likely to replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle. 

The approval is based on data from Elonva’s phase III development program, the Engage trial (n=1506 patients), which is the largest double-blind fertility agent trial ever performed. Data were quite encouraging for Elonva. The primary endpoint of the trial, the ongoing pregnancy rate (assessed at ten weeks or more after embryo transfer) for Elonva treatment arm was similar to the patients receiving a daily dose of rFSH for seven days (38.9% vs 38.1% per started cycle respectively). 

Viewing the huge potential of the fertility industry market, we expect Elonva to add value to Merck’s current product portfolio. 

Elonva became part of Merck’s portfolio following its merger with Schering-Plough. While this is a positive development related to Schering’s portfolio, the company received a setback earlier this year for a late-stage HIV treatment drug vicriviroc. We have a Neutral recommendation on Merck.
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