Schering-Plough Announces Phase II and III Data for Corifollit...(of FSH activity. Due to its ability to ...)

Date:7/1/2009

of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of rFSH preparation in a COS treatment cycle. The corifollitropin alfa regimen is being developed in a GnRH antagonist protocol. Corifollitropin alfa was filed in the European Union in late 2008.

Corifollitropin alfa Important Safety Information

The most frequently reported adverse drug reactions during treatment with corifollitropin alfa in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), pelvic pain and discomfort, headache, nausea, fatigue and breast complaints (including tenderness). They are reported with an incidence between 1% and 6%.

About Infertility

Infertility is a disease or condition that impairs the body's ability to perform the basic function of reproduction.(7) It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse.(8) Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six months of unprotected intercourse.(9) Around 15 percent of couples of reproductive age have a fertility problem.(8)

There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.(8)

With infertile couples, the source of infertility lies with the male in 40 percent of cases and 40 percent with the female. The remaining 20 percent is either a joint problem or unknown, because the cause has not been identified. There are a variety of treatments available for infertility; these include surgery, hormone treatments, insemination, IVF and natural treatments, among others.(8)

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