Schering-Plough Announces Phase II and III Data for Corifollit...( Single-dose of investigational sustai...)

Single-dose of investigational sustained follicle stimulant achieves similar efficacy to daily injections of follitropin beta given over a one week period in Phase III Study

AMSTERDAM, July 1 /PRNewswire-FirstCall/ -- Schering-Plough Corp., (NYSE: SGP) today announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days. The ENGAGE data was presented along with data from the Phase III ENSURE trial and the Phase II REALIZE trial at the 25th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam, The Netherlands.

"The burden of fertility treatment is a major challenge for women experiencing difficulty conceiving," said Thomas Koestler, executive vice president and president, Schering-Plough Research Institute. "Schering-Plough is committed to making fertility treatments easier, and these results demonstrate that corifollitropin alfa in combination with a GnRH antagonist may be an effective treatment that can reduce the number of injections and the length of treatment protocols."

ENGAGE is the largest double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of the ENGAGE non-inferiority trial, obtained in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of 200 IU rFSH (follitropin beta) for seven days (38.1 percent per started cycle).(1) ENGAGE also demonstrated that a single injection of 150 mcg corifollitropin alfa achieved similar oocyte and embryo quality compared to a daily dose of 200 IU rFSH given for one week.(2)
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