Ferring Pharmaceuticals

Press Release

CONTACT: Marilyn Seiger FOR IMMEDIATE RELEASE
Kovak-Likly Communications
203-762-8833, mseiger@klcpr.com

COMPARATIVE STUDY SHOWS SAFER, MORE CONTROLLED STIMULATION WITH MENOPUR^® THAN GONAL-f^® IN OVULATION INDUCTION
LH-Modified Follicular Development Could Improve Safety in OI and Lower Risk of Multiple Pregnancies

Suffern, NY – June 7, 2006 – A head-to-head study of MENOPUR^® (menotropins for injection, USP), highly purified human menopausal gonadotropin (HP-hMG), and Gonal-f^® (follitropin alpha for injection), recombinant follicle stimulating hormone (rFSH), demonstrated that the ovulation rate with MENOPUR^® is comparable to that obtained with rFSH in ovulation induction (OI) protocols. Of the 184 patients in the study, there were no multiple pregnancies with the MENOPUR^® group while the incidence was 12 percent in the Gonal-f group. OI therapy, which uses medication to stimulate the ovaries to produce a single follicle and induce ovulation, is the predominant treatment for anovulatory infertility.

The study suggests that the hCG-driven luteinizing hormone (LH) activity in MENOPUR^® induces a different follicular development profile compared to the use of FSH alone. This could result in a safer, more controlled stimulation cycle with a lower risk of multiple pregnancies, excessive response, and ovarian hyperstimulation syndrome (OHSS), which is excessive stimulation of the ovaries. The study is available online at http://humrep.oxfordjournals.org/cgi/reprint/del085v1 and will be published in an upcoming issue of Human Reproduction.

“These data demonstrate that the incorporation of hCG-driven LH activity in the stimulation protocol promotes single follicular development, which can lead to a reduction in multiple pregnancies and their associated complications,” said lead investigator, Prof. Peter Platteau, Center for Reproductive Medicine, Free University of Brussels. “This finding suggests that the use of hMG could result in a safer, more controlled stimulation cycle. Single follicular development and singleton pregnancy are important goals of fertility treatment, as there are substantial social, economic and health consequences of multiple pregnancies.”

About the Study
This was a randomized, open-label, assessor-blind, parallel-group, multinational OI study of 184 women, ages 18-39 years, with anovulatory infertility WHO Group II and resistant to clomiphene citrate. Patients were randomized to undergo stimulation with HP-hMG (n=91) or rFSH (n=93) using a low-dose step-up protocol. The starting dose of both treatments was 75 IU; after the first 7 days, the follicular response was evaluated and, if necessary, the dose was adjusted by 37.5 IU every 7 days for up to 6 weeks.

The ovulation rate was comparable in both groups, at 83.5 percent in the HP-hMG group and 84.9 percent in the rFSH group. Subjects in the HP-hMG group had significantly fewer intermediate-sized follicles (12-16 mm) than those in the rFSH group (1.04 and 1.91, respectively, p=0.009). This result could be responsible for the decreased estradiol levels and lack of multiple births in the MENOPUR arm. Development of a single dominant follicle was achieved by 63.7 percent in the HP-hMG group compared to 54.8 percent in the rFSH group. While there were no multiple pregnancies with HP-hMG, two of the 16 (12.5 percent) pregnancies with rFSH were multiple gestations. The singleton live birth rate was comparable.

One subject in the HP-hMG group and three subjects in the rFSH group reported OHSS. The percentage of subjects who had OHSS or cycle cancellation from an excessive response was 2.2 percent with HP-hMG and 9.8 percent with rFSH (p=0.058). The incidence of preterm birth (<37 weeks) was 27.8 percent in the rFSH group, while all infants in the HP-hMG group were born at term. The frequency and profile of adverse events was similar in both groups.

About MENOPUR^®
MENOPUR^® administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART (Assisted Reproductive Technology) program.

MENOPUR^® is supplied in sterile vials as a lyophilized powder or pellet. MENOPUR^® delivers 75 IU FSH and 75 IU LH activity and is supplied in a box containing five vials of medication, five vials of diluent (NDC 55566-7501-1), and five Q