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Ferring Pharmaceuticals Presents Key MENOPUR(R) Data at 2011 Annual Meeting of American Society for Reproductive Medicine



10/17/2011 11:01:59 AM

PARSIPPANY, N.J., Oct. 14, 2011 /PRNewswire/ -- Ferring Pharmaceuticals, Inc. announced today that it will present key MENOPURĀ® (highly purified menotropin) results from the MEGASET (MENOPUR in GnRH Antagonist Cycles With Single Embryo Transfer) trial at the 2011 American Society for Reproductive Medicine (ASRM) annual meeting in Orlando, Fla. from Oct. 15 to 19, 2011.

Key MEGASET Data Highlights

  • Biomarkers, gene expression and blastocyst quality linked to top blastocyst development
  • Live birth rates confirming the MEGASET primary endpoint of ongoing pregnancies
  • Outcomes in women with elevated progesterone levels at the end of ovarian stimulation
  • Implantation potential and pregnancy sustainability based on blastocyst expansion and hatching status

"The volume and scope of data being presented at this year's congress demonstrates Ferring's continued commitment to innovative research in the field of reproductive medicine, as exemplified by such drugs as MENOPUR," said Edward Trott, Vice President of Medical Affairs at Ferring Pharmaceuticals, Inc.

Infertility is a condition of the reproductive system that impairs the conception of children[1]. It affects approximately 6.1 million individuals throughout the United States, or 10 percent of American couples of childbearing age[1]. The diagnosis of infertility is usually given to couples who have been attempting to conceive for at least one year without success. Twenty-five percent of infertile couples have more than one reason that causes their infertility[1].

Oral Presentations

Human Cumulus Cell Biomarkers for Predicting Top Blastocyst Development and Pregnancy in Single Blastocyst Transfer

Program #: O55
Date: Monday, Oct. 17, 2011
Session Time: 4:15 p.m. 6:15 p.m.
Session Title: Outcome PredictorsClinical: ART

Gene Expression Profile of Cumulus Cells as Non-Invasive Test to Predict Implantation Potential in Combination with Morphological Evaluation of Embryo/Blastocyst Quality

Program #: O61
Date: Monday, Oct. 17, 2011
Session Time: 4:15 p.m. 6:15 p.m.
Session Title: Outcome PredictorsClinical: ART

Elevated Serum Progesterone at End of Stimulation with Recombinant FSH, but not with Highly Purified Menotropin, is Associated with Poor Outcome in GnRH Antagonist Cycles

Program #: O181
Date: Tuesday, Oct. 18, 2011
Session Time: 4:15 p.m. 6:15 p.m.
Session Title: Outcome PredictorsClinical: ART

Baseline Serum Anti-Mullerian Hormone (AMH) Levels Correlate with Ovarian Response in GnRH Antagonist Cycles Using Highly Purified Menotropin or Recombinant FSH

Program #: O214
Date: Tuesday, Oct. 18, 2011
Session Time: 5:15 p.m. 6:15 p.m.
Session Title: Reproductive Endocrinology: Clinical

Blastocyst Quality in Relation to Pregnancy Rate and Early Pregnancy Loss

Program #: O341
Date: Wednesday, Oct. 19, 2011
Session Time: 3:45 p.m. 5:45 p.m.
Session Title: Outcome PredictorsLab: ART

Poster Presentations

Live Birth Rate after Single Blastocyst Transfer in a GnRH Antagonist Cycle Using Highly Purified Menotropin or Recombinant FSH for Controlled Ovarian Stimulation

Poster No.: P234
Date: Tuesday, Oct. 18, 2011
Session Time: 7:00 a.m. 9:00 a.m.
Session Topic: ART In Vitro Fertilization

Blastocyst Quality According to Embryo Development on Days Three and Four

Poster No.: P466
Date: Wednesday, Oct. 19, 2011
Session Time: 7:00 a.m. 9:00 a.m.
Session Topic: Embryo Biology

Cumulus Cells Gene Expression Profile Following Controlled Ovarian Stimulation with HP-hMG or rFSH in a GnRH Antagonist Protocol: New Indicators of Ovarian Microenvironment Health

Poster No.: P511
Date: Wednesday, Oct. 19, 2011
Session Time: 7:00 a.m. 9:00 a.m.
Session Topic: Ovarian Stimulation

ASRM abstracts are available and can be viewed online at www.asrm.org.

About MEGASET

The MEGASET (MENOPUR in GnRH Antagonist Cycles with Single Embryo Transfer) study was initiated as a randomized, multicentre study, and was designed to demonstrate non-inferiority compared to rFSH with respect to ongoing pregnancy rates. The study demonstrated that controlled ovarian stimulation with MENOPUR in a GnRH antagonist protocol gave ongoing pregnancy rates comparable to those achieved with recombinant follitropin beta.

Additionally, MEGASET data presented originally at the European Society of Human Reproduction and Embryology (ESHRE) meeting showed that the use of GnRH antagonist protocol in ICSI cycles with mild stimulation and single-embryo transfer in both groups was associated with:

  • High pregnancy rates
  • Low rates of complications such as multiple pregnancies and ovarian hyperstimulation syndrome (OHSS)
  • No difference between groups in the incidence of OHSS, but signs of ovarian excessive response were significantly higher in women treated with recombinant follicle stimulating hormone (rFSH)

About MENOPUR
MENOPUR is a well-tolerated,[2],[3] high quality and cost-effective[4] treatment associated with higher live birth rate in IVF cycles compared with that seen for women treated with rFSH.[5],[6] It belongs to a class of drugs known as gonadotrophins and contains both FSH (follicle stimulating hormone) and hCG-driven (human chorionic gonadotrophin) LH-activity (luteinizing hormone). MENOPUR is used to stimulate the development of multiple follicles in women participating in an ART program. MENOPUR is also used to treat infertility in women caused by anovulation (no development of follicles and no ovulation). MENOPUR is used by approximately half a million patients each year and is currently licensed in 97 countries across the world.

Important Safety Information

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 adverse reactions, including OHSS (overall incidence 3.8 percent), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. MENOPUR is contraindicated in women who have a high FSH level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; an organic intracranial lesion such as a pituitary tumor; sex hormone dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; prior hypersensitivity to menotropins or MENOPUR. MENOPUR is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring's fertility portfolio of treatments gives infertile couples the chance to have babies and includes its flagship brand MENOPUR (HP-hMG), a recognized high quality treatment for infertility. Ferring has operating subsidiaries in over 45 countries. To learn more about Ferring or our products please visit www.ferring.com.

References

[1] American Pregnancy Association (2007). Fertility FAQ. Retrieved from http://www.americanpregnancy.org/infertility/fertilityfaq.html, Oct. 14, 2011.

[2] Nyboe Andersen A., A. Pellicer A., Devroey P., Arce J.C. Randomised trial (MEGASET) comparing highly purified menotropin and recombinant FSH in a GnRH antagonist cycle with single blastocyst transfer. O-296 ESHRE 2011

[3] European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial. Fertil Steril 2002;78(3): 520528.

[4] Lloyd A, Kennedy R, Hutchinson J, Sawyer W. Economic evaluation of highly purified menotropin compared with recombinant follicle stimulating hormone in assisted reproduction. Fertil Steril 2003: 80(5): 1108-1113.

[5] Platteau P, Nyboe Andersen A, Loft A, Smitz J, Danglas P, Devroey P. Highly purified HMG versus recombinant FSH for ovarian stimulation in IVF cycles. Reprod Biomed Online 2008;17(2): 190198Al-Inany HG, Abou-Setta

[6] AM, Aboulghar MA, Mansour RT, Serour GI. Highly purified hMG achieves better pregnancy rates in IVF cycles but not ICSI cycles compared with recombinant FSH: a meta-analysis. Gynecol Endocrinol 2009;25(6):372-8.

SOURCE Ferring Pharmaceuticals, Inc.


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