Ferring Pharmaceuticals presented the results of a number of studies in assisted reproductive technology (ART) treatments at the 64th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in San Francisco, November 8-12, 2008. Four studies compared ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, to intramuscular (IM) progesterone-in-oil (PIO) for luteal support. Additional studies assessed the benefits of once-daily combined gonadotropin dosing compared with twice-daily dosing, and the safety and efficacy of MENOPUR(R) (menotropins for injection, USP) in polycystic ovarian syndrome (PCOS) patients.

"Four studies presented this year demonstrate that ENDOMETRIN has comparable efficacy and pregnancy rates to IM progesterone, and is a more patient-friendly, convenient form of administration," said Paul Korner, MD, vice president, medical affairs, Ferring Pharmaceuticals, Inc. "Other studies presented provide the infertility community with clinically relevant information about physiological differences in treatment with human menopausal gonadotropin (hMG), which contains both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity, compared with recombinant FSH only."

Efficacy of ENDOMETRIN vs. IM Progesterone

Findings from four studies showed that in women undergoing IVF, serum progesterone levels and pregnancy rates of women using progesterone vaginal inserts (ENDOMETRIN) and IM-PIO for luteal support were similar. A retrospective analysis in a large IVF program evaluated serum progesterone levels and pregnancy outcomes with ENDOMETRIN vaginal inserts (n=568) compared with IM-PIO (n=751). Both the mean initial serum progesterone levels (ENDOMETRIN 47 ng/ml, PIO 50 ng/ml) and clinical pregnancy rates (ENDOMETRIN 35.4%, PIO 35.1%) were similar.

Other studies showed similar results. In one, serum progesterone levels following use of ENDOMETRIN (n=98) and IM-PIO (n=275) were not statistically different. However, during the early weeks of pregnancy, mean progesterone levels (ng/ml) in patients who used ENDOMETRIN were significantly higher than levels achieved in women who used IM-PIO. At more than 26 days following oocyte retrieval, ng/ml for ENDOMETRIN was 110 and IM-PIO, 87 (p=.04).

Another study compared results in 145 women receiving ENDOMETRIN and 399 taking IM-PIO to determine the outcome of IVF with the long protocol. Clinical pregnancy rates were the same in both treatment groups.

In a study of 82 women with endometriosis who underwent IVF, those who used ENDOMETRIN for luteal support had significantly higher ongoing pregnancy rates (55%) than those who used IM-PIO (37%), and progesterone levels during the luteal phase were comparable.

MENOPUR vs. rFSH Only in PCOS Patients

In a retrospective cohort study, 64 women with polycystic ovarian syndrome (PCOS) undergoing IVF used MENOPUR with or without FSH in a long luteal phase agonist protocol. The control group (n=46) received FSH only. Patients receiving MENOPUR had shorter stimulations but used more gonadotropins (LH + FSH). Those in the FSH-only group had significantly more cycles cancelled for over-stimulation than the study population. There was no difference in embryos transferred or pregnancy rates between the two groups. The study demonstrated that stimulations with hMG are shorter (11.3 days vs. 12.6 days), use more total gonadotropins, and most importantly, have a lower cancellation rate (3.6% vs. 20%) due to over-response than stimulations using only FSH.

"Concerns that patients with PCOS should be stimulated with FSH alone because of their high endogenous LH levels may not be accurate. This study demonstrates that using MENOPUR improves controlled response in PCOS patients undergoing IVF compared to cycles using FSH alone," added Dr. Korner.

Once-Daily vs. Twice-Daily Dosing in Mixed Stimulation Protocols

Two studies compared once with twice daily gonadotropin dosing, using both hMG (MENOPUR) and FSH (BRAVELLE). Results of a prospective randomized study of 87 patients showed that once-daily dosing, administered as a single combined gonadotropin injection, which adds to patient comfort, decreased gonadotropin usage without compromising treatment success. Pregnancy rates for the two groups were not different, but the twice-daily group required significantly more FSH and hMG.

Another prospective, randomized, comparative study showed that a once-daily injection for a mixed stimulation protocol demonstrated superior clinical outcomes compared to a twice-a-day dosing schedule. The ongoing pregnancy rate was significantly higher (85%, p=0.007) with the once-daily protocol compared to the twice-a-day injection (38%). In addition, the cancellation rate was higher in the two-shot protocol (20%) vs. the single shot protocol (7%).

About ENDOMETRIN

ENDOMETRIN administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to two percent included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than two percent. ENDOMETRIN is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness).

About MENOPUR

MENOPUR administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe MENOPUR. MENOPUR, like all gonadotropins, is a potent substance capable of causing mild to severe reactions, including OHSS (overall incidence of 3.8%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

About BRAVELLE

BRAVELLE administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. BRAVELLE administered SC or IM, in conjunction with hCG, is indicated in patients who have previously received pituitary suppression. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe BRAVELLE. BRAVELLE, like all gonadotropins, is a potent substance capable of causing mild to severe reactions, including OHSS (overall incidence of 6.0%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, manufactures and markets the largest family of fertility treatments in the U.S. The Company markets MENOPUR, BRAVELLE, REPRONEX(R) (menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN in the U.S. to infertility specialists and their patients. Ferring also offers the Q-CAP(TM), the first and only needle-free reconstitution device, for use with its fertility treatments.

Ferring's line of orthopaedic and urology products includes EUFLEXXA(R) (1% sodium hyaluronate) hyaluronic acid for pain from osteoarthritis in the knee and PROSED(R)/DS for the relief of discomfort of the lower urinary tract. Other products include: ACTHREL(R) (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome; and DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis.

The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology, infertility and orthopaedics.

Please visit ferringusa for full prescribing information for MENOPUR, BRAVELLE and ENDOMETRIN.

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