Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant
Corifollitropin alfa meets primary endpoints in ENGAGE Trial
KENILWORTH, N.J., July 8, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- 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 gonadotropin (hCG). The primary endpoint was ongoing pregnancy rate assessed at 10 weeks or more after embryo transfer. The number of oocytes retrieved was the co-primary endpoint. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar between both groups, 7.0 percent in the corifollitropin alfa group (1.9 percent severe) and 6.3 percent in the follitropin beta group (1.3 percent severe).
About corifollitropin alfa
Corifollitropin alfa is being developed as a potential treatment in Controlled Ovarian Stimulation (COS) for the development of multiple follicles and pregnancy in women participating in an Assisted Reproductive Technology (ART) program. The corifollitropin alfa regimen is being developed in a GnRH antagonist protocol.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to Earn Trust, Every Day with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for corifollitropin alfa. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2008 Q1 10-Q.