Schering-Plough Announces Phase III Data for Sustained Follicle... ( Corifollitropin alfa meets pr...)

Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant

Date:7/8/2008

Corifollitropin alfa meets primary endpoints in ENGAGE Trial

KENILWORTH, N.J., July 8 /PRNewswire-FirstCall/ -- Schering-Plough Corp., (NYSE: SGP) announced today that corifollitropin alfa, its experimental, sustained follicle stimulant (SFS) met its primary endpoints in the Phase III ENGAGE trial, according to data presented during a Schering-Plough-sponsored symposium at the 24th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Barcelona, Spain.

The ongoing pregnancy rate, the primary endpoint of this 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 200 IU recombinant FSH (follitropin beta) (38.1 percent per started cycle). The number of oocytes retrieved (co-primary endpoint) was within the limits of clinical equivalence, and the estimated difference of +1.2 was in favor of the corifollitropin alfa 150 mcg treatment arm.

Further results will be submitted for presentation at a future medical meeting.

Study Design

ENGAGE is the largest double-blind fertility trial ever performed. ENGAGE was a non-inferiority trial designed to compare corifollitropin alfa 150 mcg to 200 IU follitropin beta. A total of 1,509 patients (>60 kg) at 34 IVF clinics in North America and Europe were randomized to receive either corifollitropin alfa 150 mcg or a daily dose of 200 IU recombinant FSH, followed by recombinant FSH (maximum 200 IU/day) from stimulation day 8 onward. Starting on stimulation day 5, all patients were scheduled to receive 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by a urinary human chorionic g
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