(MRK) Positive Opinion for Merck Drug From European Medicines Agency

November 23rd, 2009

Merck (MRK) announced that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Elonva (corifollitropin alfa injection). Merck is seeking the drug’s approval as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women who have participated in an assisted reproductive technology (ART) program. On European Commission’s approval, Merck would be able to market Elonva with unified labeling valid in all European Union Member States.

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 positive opinion of the committee is based on data from Elonva’s phase III development program, the Engage trial, which is the largest double-blind fertility agent trial ever performed. The data was 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).

The fertility industry is worth an estimated £500 million (approximately $820 million) a year in the UK. We believe a positive opinion from the committee has increased the probability of final approval. Viewing the potential of the market, we expect Elonva to add value to Merck’s current product portfolio. We have a Neutral recommendation on Merck.

Zacks Investment Research

More on this topic (What's this?)
The EU’s Great Kowtow to China (Wall Street Daily, 2/2/12)
Prepare for Europe – "It's Going to Be Ugly" (Money Morning, 1/16/12)
5 Stocks That Just Turned Very Bullish (Investment Underground » Page n..., 10/18/11)
Europe’s Crisis Hits the “Real Economy” (Wall Street Daily, 2/3/12)
Read more on Merck, European Union at Wikinvest

Related Posts:

  1. (MRK) Merck Cholesterol Drug Data Sees SetbackThe effectiveness of Merck’s (MRK) cholesterol lowering drug Zetia has been put to question following...
  2. (SGP) Schering-Plough and Johnson & Johnson Score European Union Drug ApprovalYesterday, Schering-Plough Corp. (SGP) and Johnson & Johnson (JNJ) announced the approval of their drug...
  3. (MRK) Mixed News for Merck DrugLast week, Merck (MRK) received a favorable opinion from the European Medicines Agency’s (EMEA) Committee...
  4. (MRK) Merck Seeks European Union Approval of its Schering-Plough PurchaseYesterday, Merck & Co. (MRK) announced that it is seeking approval from the European Union...
  5. (MRK) Merck Updates Migraine Drug StatusYesterday, Merck (MRK) updated the status of two of its pipeline candidates, both used to...
  6. (MAA) European Medicines Agency Accepts Merck’s ApplicationWe are pleased to hear that the European Medicines Agency (EMEA) has agreed to review...


Search Posts by Tag: | | | | Drug Manufacturers - Major | Healthcare

RSS Feeds by Tag: Champion Industries Inc | CHMP | Merck & Company Inc | MRK | Drug Manufacturers - Major | Healthcare |

Other Posts by: | RSS Feed for this author