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The ongoing pregnancy rate, the primary endpoint of this non-inferioritytrial, obtained in the 150 mcg corifollitropin alfa treatment arm (38.9percent per started cycle) was similar to that achieved in patients receiving200 IU recombinant FSH (follitropin beta) (38.1 percent per started cycle).The number of oocytes retrieved (co-primary endpoint) was within the limits ofclinical equivalence, and the estimated difference of +1.2 was in favor of thecorifollitropin alfa 150 mcg treatment arm.
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Further results will be submitted for presentation at a future medicalmeeting.
Study Design
ENGAGE is the largest double-blind fertility trial ever performed. ENGAGEwas a non-inferiority trial designed to compare corifollitropin alfa 150 mcgto 200 IU follitropin beta. A total of 1,509 patients (>60 kg) at 34 IVFclinics in North America and Europe were randomized to receive eithercorifollitropin alfa 150 mcg or a daily dose of 200 IU recombinant FSH,followed by recombinant FSH (maximum 200 IU/day) from stimulation day 8onward. Starting on stimulation day 5, all patients were scheduled to receive0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering offinal oocyte maturation by a urinary human chorionic gonadotropin (hCG). Theprimary endpoint was ongoing pregnancy rate assessed at 10 weeks or more afterembryo transfer. The number of oocytes retrieved was the co-primary endpoint.The incidence of ovarian hyperstimulation syndrome (OHSS) was similar betweenboth groups, 7.0 percent in the corifollitropin alfa group (1.9 percentsevere) 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 inControlled Ovarian Stimulation (COS) for the development of multiple folliclesand pregnancy in women participating in an Assisted Reproductive Technology(ART) program. The corifollitropin alfa regimen is being developed in a GnRHantagonist protocol.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global healthcare company. Through its own biopharmaceutical research and collaborationswith partners, Schering-Plough creates therapies that help save and improvelives around the world. The company applies its research-and-developmentplatform to human prescription and consumer products as well as to animalhealth products. Schering-Plough's vision is to Earn Trust, Every Day with thedoctors, patients, customers and other stakeholders served by its colleaguesaround the world. The company is based in Kenilworth, N.J., and its Web siteis www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press releaseincludes certain "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995, including statementsrelating to the plans for, the potential of and the potential market forcorifollitropin alfa. Forward-looking statements relate to expectations orforecasts of future events. Schering-Plough does not assume the obligation toupdate any forward-looking statement. Many factors could cause actual resultsto differ materially from Schering-Plough's forward-looking statements,including market forces, economic factors, product availability, patent andother intellectual property protection, current and future branded, generic orover-the-counter competition, the regulatory process, and any developmentsfollowing regulatory approval,
