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Following the announcement in July 2008 of the successful completion of the Engage trial, Schering-Plough's corifollitropin alpha (Org-36286) has now been accepted for review by the European Medicine Agency. Org-36286 is a new biological entity developed by Schering-Plough for controlled ovarian stimulation to induce the development of multiple follicles in patients undergoing assisted reproduction techniques.
Infertility is defined as the inability of conceiving after 12 months of frequent unprotected intercourse. There are five million infertile women across France, Germany, Italy, Spain and the UK, however only 1.8% of this population will receive in vitro fertilization, according to a recent Datamonitor survey of 180 infertility specialists. Respondents in the US, Europe and Japan stated the most common reasons for not seeking treatment were the high cost and the inconvenience of the treatment process.
Org-36286 is the first long acting follicle stimulating hormone (FSH). Owing to the long half-life of the compound, Org-36286 hopes to replace the first seven daily injections of current gonadotropins with one injection of corifollitropin alpha, thus reducing the stress that the treatment brings to patients. In the Phase III Engage clinical trial it was shown that the ongoing pregnancy rate resulting from one injection of Org-36286 was similar to the rate of patients receiving 200IU of recombinant FSH. Given this potential, Datamonitor believes that Org-36286 will bring some benefit to patients in terms of convenience and forecasts the treatment to generate revenues of $140m in the seven major markets by 2016 following predicted launch in 2011.
However, according to Datamonitor's survey, interviewed physicians do not perceive Org-36286 as being better than available options so the challenge for Schering-Plough will be to differentiate the product from its own Puregon (follitropin beta) brand and rival drugs, while convincing payers of its benefits. In addition, uptake could be limited by its side-effect profile, namely the potential increase in the risk of hyperstimulation which causes the formation of multiple luteinized cysts in the ovaries. Finally, although Org-36286 attempts to address an important market unmet need in terms of reducing the number of injections, there is arguably a greater opportunity in developing oral formulations.
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