Ferring International SA

New Study Adds Weight to Clinical Merit of MENOPUR in IVF

    Copenhagen, Denmark (ots/PRNewswire) -

    - "Approximately five more pregnancies per 100 women treated" with MENOPUR compared to recombinant treatment

    New data presented today at the ESHRE (European Society of Human Reproduction and Embryology) congress supports the efficacy of MENOPUR (menotrophin), a highly purified, naturally-derived infertility treatment belonging to the class of drugs known as gonadotrophins, in IVF therapy.

    MERiT (Menotrophin vs. Recombinant FSH in vitro Fertilisation Trial), the largest, prospective, randomised assessor-blind trial in IVF, is a head-to-head comparison of MENOPUR, a treatment containing both FSH (follicle stimulating hormone) and hCG-driven (human chorionic gonadotrophin) LH-activity (luteinizing hormone) and Gonal-F, which contains only recombinant FSH (rFSH).(1)

    In line with previous studies(2) the direction of the findings in MERiT indicates a beneficial influence of LH-activity on ongoing pregnancy rate in IVF cycles (27% with MENOPUR and 22% with GONAL-F).(3) MERiT provides major weight in the evidence of higher efficacy of MENOPUR over recombinant FSH. Treatment with MENOPUR resulted in the production of a higher proportion of top quality embryos with an improved capacity to implant and establish a pregnancy.(4)

    "MERiT showed that out of every 100 women treated with MENOPUR, five more became pregnant, which would be clinically very important," points out MERiT clinical investigator Dr Anders Nyboe Andersen from the Rigshospitalet Fertility Clinic in Copenhagen, Denmark.(5) "To find out why and how on a biological basis we look forward to continuing studies."

    According to Dr Johan Smitz from the Follicle Biology Laboratory and Centre for Reproductive Medicine, Free University of Brussels (VUB), Belgium, the human chorionic gonadotrophin (hCG) in MENOPUR provide a potentially breakthrough clue and exciting new science. "Normal human reproduction depends on the co-ordinated activity of FSH and LH activity. The heightened hCG levels at day six of treatment and the resulting constant LH activity produced by MENOPUR appears to be an important factor in both embryo quality and pregnancy rates. Just like the ever growing story of aspirin, we are learning new things about a class of treatment which has been available and used effectively for decades."(5)

    Ongoing study

    The current MERiT results are based on the use of "fresh cycles". Live birth data are currently being collected. In addition, more than 1,000 embryos were frozen during the trial and data from these "frozen cycles" are also being gathered.

    Study design

    The MERiT study was a large, randomised, prospective assessor-blind, multinational (10-country) study involving over 730 women undergoing controlled ovarian hyperstimulation (COH) in IVF. MERiT has a state of the art study design and innovative approaches to embryo assessment, analysis of intra-follicular endocrine environment and frozen embryo cycles. Patients received either MENOPUR or rFSH by sub-cutaneous injection, in addition to identical concomitant GnRH agonist, hCG and progesterone treatment.

    Serum endocrine profiles were analysed centrally. Embryo quality was assessed according to rigorous criteria both locally and centrally, and the transfer of one or two embryos of a defined minimum quality was carried out on the third day after egg retrieval.

    MENOPUR

    MENOPUR is well-tolerated,(6) high quality and cost-effective(7) treatment associated with a significantly higher ongoing pregnancy rate in  IVF cycles compared with that seen for women treated with rFSH alone.(4) 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 Assisted Reproductive Technology (ART) programme. MENOPUR is also used to treat infertility in women caused by anovulation (low-level production of eggs).

    MENOPUR is used by more than 43,000 patients each year and is currently licensed in 44 countries across Europe.

    About Ferring:

    Ferring is a Swiss-based research driven, specialty biopharmaceutical  group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, infertility and urology.

    In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

    To learn more about Ferring or our products please visit www.ferring.com.

    (1) Wolfenson C, Groisman J, Couto AS, Hedenfalk M, Cortvrindt RG, Smitz JE, Jespersen S. Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations. Reprod Biomed Online 2005; 10(4): 442-454.

    (2) Platteau P, Smitz J, Albano C, Sorensen P, Arce JC, Devroey P. Exogenous luteinizing hormone activity may influence the treatment outcome in in vitro fertilization but not in intracytoplasmic sperm injection cycles. Fertil Steril 2004; 81(5): 1401-1404.

    (3) Ziebe S, Lundin K, Janssens R, Helmgaard L, Arce, J-C for the MERIT (Menoptrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. Comparison of embryo quality after stimulation with highly purified menotrophin and recombinant FSH in IVF cycles. Abstracts of the 21st Annual meeting of the ESHRE, Copenhagen, Denmark, 19-22 June 2005, i76 (O-205).

    (4) Nyboe Andersen A, Devroey P, Arce J-C for the MERIT (Menotrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. A randomised trial (MERIT) comparing highly purified menotrophin and recombinant FSH in IVF. Abstracts of the 21st Annual meeting of the ESHRE, Copenhagen, Denmark, 19-22 June 2005, i19 (O-054).

    (5) Speaking at the Ferring MERiT Study press conference during the time of the ESHRE congress, Bella Centre, Copenhagen, 20 June 2005

    (6) 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): 520-528

    (7) 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.

ots Originaltext: Ferring Pharmaceuticals A/S
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
Contact: Michael George, Corporate Communication Manager,
michael.george@ferring.com, Tel.: +45-2878-72-09; Kirsten Mason,
Tonic Life Communications, kirsten.mason@toniclc.com, Tel.:
+44-(0)20-7798-9900



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