Ferring Pharmaceuticals

Press Release

Study appears in June issue of Fertility and Sterility

TARRYTOWN, NY – June 10, 2002 – According to a new study published in the June issue of Fertility and Sterility, Bravelle™ (urofollitropin for injection, purified), a highly purified human-derived follicle-stimulating hormone (hFSH), administered subcutaneously (SC) and intramuscularly (IM), is comparable in activity and tolerability to recombinant follitropin beta (Follistim SC) for in vitro fertilization (IVF). Bravelle™ was approved by the U.S. Food and Drug Administration (FDA) on May 6, 2002 for ovulation induction (OI) following pituitary suppression, a common step in the treatment of infertility. These and other data supporting the use of Bravelle™ in IVF are currently under review by the FDA.

“This study demonstrates that in IVF, premium-priced recombinant FSH showed no advantage in activity or tolerability over Bravelle™, a highly purified preparation of human-derived FSH,” said Wayne Anderson, president of Ferring Pharmaceuticals. “Bravelle™ is ideally suited to meet the needs of infertility specialists and their patients by providing an affordable treatment that combines human-derived hormone efficacy with recombinant hormone-like purity.”

Study Design
Bravelle™ SC, Bravelle™ IM and Follistim SC were compared in a randomized, open-label, parallel group, multicenter trial in 177 patients, ages 18 to 39, undergoing controlled ovarian hyperstimulation for IVF. Patients who were successfully down-regulated (achieved pituitary suppression) were randomized into three groups and received Bravelle™ SC (n=60), Bravelle™ IM (n=59) or Follistim (n=58) once daily (225 IU to a maximum of 450 IU) for up to twelve days. Subsequently, human chorionic gonadotropin (hCG) was administered to the 167 patients who qualified, based on the number and size of ovarian follicles and serum E₂ levels, and oocytes were retrieved.

The primary measure of activity was the mean number of oocytes retrieved per patient in each treatment group. Secondary variables included peak mean serum E₂ levels, the percentage of cycles with oocyte retrieval, embryo transfer and chemical, clinical and ongoing pregnancy rates. Safety was measured by the numbers of patients reporting adverse events.

Study Findings

During the course of treatment, there were no significant differences among the treatment groups in mean follicle diameters, serum E₂ levels, the total number of oocytes retrieved, the number of oocytes fertilized and the number of embryos transferred. While not statistically significant, the number of patients with clinical and continuing pregnancies and live births was consistently greater in the Bravelle™ SC group than in the Bravelle™ IM or Follistim SC groups.

Results showed that all three treatments were well tolerated, but Bravelle™ SC and IM caused significantly less injection site pain than Follistim (p<.001).

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe Bravelle™. Like all gonadotropins, Bravelle™ is a potent substance capable of causing mild to severe adverse reactions, including ovarian hyperstimulation syndrome (incidence of 6/73 in OI, 17/282 in all NDA studies), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

About Bravelle™

Bravelle™, a new highly purified human-derived follicle-stimulating hormone (hFSH) for infertility treatment, contains 75 IU of FSH and up to 2% LH activity and is available for both subcutaneous (SC) and intramuscular (IM) injection. Bravelle™ is marketed by Ferring Pharmaceuticals Inc., a world leader in naturally occurring protein hormones.

Bravelle, in conjunction with human chorionic gonadotropin, is indicated for ovulation induction following pituitary suppression. Ferring’s application seeking additional indications for Bravelle™ in infertility treatment, is currently under FDA review.

Background on Human-Derived Hormones

The key differences in human-derived and genetically engineered infertility treatments are raw material sources and cost. Human-derived FSH treatments are highly purified follitropins refined from the urine of postmenopausal women. By comparison, genetically engineered products are extracted from the secretions from Chinese hamster ovary cells that are cultured in fetal calf or other mammalian serum, and approximate human hormones. Both are manufactured in compliance with extremely strict standards (including viral inactivation and confirmatory testing), but human-derived products are generally less expensive than their genetically engineered counterparts.

About Ferring

Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle™, Repronex^® and Novarel™ in the U.S. to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call 1-888-337-7464 or visit www.ferringusa.com.