New data demonstrates both cost and efficacy benefit of MENOPUR® compared to recombinant FSH treatment

New data demonstrates both cost and efficacy benefit of MENOPUR® compared to recombinant FSH treatment

Lyon, France – 2 July, 2007 –

New data presented today at the European Society of Human Reproduction and Embryology (ESHRE) 2007 congress shows that there is a cost saving of IVF treatment with MENOPUR® (menotrophin), a human-derived gonadotrophin containing both follicle stimulating hormone (FSH) and human chorionic gonadotrophin driven luteinizing hormone activity compared with Gonal-F which contains only recombinant FSH (rFSH). MENOPUR® offered considerable cost savings when compared to Gonal-F.¹

Europe is currently facing an unprecedented ageing population and falling birth rates. The long term socio-economic consequences of falling birth rates, of which infertility is one of the contributing factors, are being highlighted by experts as an area of serious concern. With the current decline in population size, it is estimated that by 2050, one in three Europeans will be aged over 65 years. A total fertility rate (TFR) of around 2.1 children per women is needed to maintain the current population size; however, birth rates are on average closer to 1.50 children per woman.² In this context, assisted reproductive technology (ART), is increasingly important.

In addition, results of a meta-analysis of combined data from several studies suggest that treatment with MENOPUR (as the most widely-used human menopausal gonadotrophin preparation) provides benefits in clinical pregnancy and live birth rates when compared with rFSH alone.³ This data is in line with data presented at ESHRE 2006 .

Dr M Afnan, Birmingham Women’s Hospital, Assisted Conception Unit, United Kingdom, one of the key study investigators says “These data provide evidence to support the use of MENOPUR as the first-line treatment option in women undergoing assisted reproduction technology (ART) treatments, as essentially the ultimate aim of any infertility treatment has to be the live birth of a child.”

Cost efficacy data results¹

Data from both MERiT (Menotrophin vs. Recombinant FSH in vitro Fertilization Trial)⁴, the largest, prospective, randomized assessor-blind trial in IVF, and another large trial EISG (European and Israeli Study Group)⁵ were combined in order to increase statistical power on which to base the analysis.¹ Both trials, with similar designs, compared 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).

Based on the combined trial data, the average IVF costs per person with 95% bootstrap confidence intervals (CI) after one treatment cycle for MENOPUR and the recombinant treatment were £2,408 (CI:£2,392; £2,421) and £2,660 (CI:£2,644; £2,678) (p<0.01) respectively. When maternal and neonatal costs were applied to live birth data, including costs of multiple pregnancies and complications such as Ovarian Hyperstimulation Syndrome (OHSS) the average cost per delivery with MENOPUR equates to one additional IVF cycle provided every 9.5 cycles commissioned. For all cycles assessed, MENOPUR remained cost saving when all cost input variables were varied within specified ranges in the probabilistic sensitivity analysis.

Meta-analysis data³

Meta analysis was performed on a total of seven trials. A total of 1076 and 1083 patients were treated with hMG, the most widely-used hMG preparation being MENOPUR; and the most commonly administered rFSH (Gonal F).

There was a significant increase in live birth rates of 18% following hMG treatment compared with rFSH administration (RR 1.18 [95% CI 1.02-1.381], p=0.03; heterogeneity p=0.97); this was maintained regardless of the model used for pooling. Similarly, there was a significantly higher clinical pregnancy rate of 17% with hMG versus rFSH (RR 1.17 [95% CI 1.03-1.34], p=0.02; heterogeneity p=0.99).

In contrast, there was no significant difference in the treatment quantity used between the two treatment groups (WMD 42.08 [95% CI -71.74-155.901], p=0.47); however, this was associated with a high degree of heterogeneity (p=0.006). Analysis of the Number needed to treat (NNT) curve showed that for a 25% baseline chance of pregnancy with IVF, the number needed to treat to get an additional live birth with hMG compared with rFSH was 23 [95% CI 11-200].

MENOPUR®

MENOPUR® is well-tolerated,⁵ and a recognised high quality treatment associated with a significantly higher ongoing pregnancy rate in IVF cycles compared with that seen for women treated with rFSH alone.^3,6 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 programme.

MENOPUR® is used by over 75,000 patients each year and is currently licensed in over 50 countries across the world.

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 fertility, obstetrics, urology, gastroenterology and endocrinology. Ferring’s fertility portfolio of treatments gives infertile couples the chance to have babies and includes its flagship brand MENOPUR®, a recognised high quality treatment for infertility. Ferring has operating subsidiaries in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Michael George
Ferring Pharmaceuticals
+41 58 301 00 53
FICCorporateCommunications@ferring.com

References

1. Data presented at ESHRE 2007.Kennedy, R. Oral presentation 52. 02/07/2007.
2. Dr Jonathan Grant, RAND Europe. The demographic and economic impact of ART. State of the A.R.T. 2007.
3. ESHRE Lyon 2007. Abstract number 0098. Statistically significant increase in live births with hMG in IVF and ICSI cycles versus rFSH: results from a systematic review. Accessible at: http://www.eshre.com/emc.asp?pageId=902 . Last accessed 15 June 2007.
4. Nyboe Andersen A, Devroey P, Arce J-C for the MERIT (Menotrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomised, assessor-blind, controlled trial, Human Reproduction 2006; 21:3217-27).
5. 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.
6. Data presented at ESHRE 2006. Sørenson, P. Live birth rate in IVF cycles is significantly higher after stimulation with highly purified menotrophin compared with recombinant FSH. Human Reproduction, 2006; 21, suppl. 1: i124 (Poster number 322, 19/06/2006).