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MENOPUR(tm) , a highly purified formulation of natural hormones, is as effective and well tolerated as genetically engineered products for the treatment of infertility

Release issued 17th September 2002

September 11th, 2002

Copenhagen, Denmark

MENOPUR(tm)(menotropin), a highly purified formulation of two hormones essential for ovulation (luteinising hormone [LH] and follicle stimulating hormone [FSH]), is at least as effective and well tolerated as genetically-engineered, so called recombinant FSH in women undergoing in-vitro fertilisation treatment according to a new study published today in the leading fertility journal, Fertility and Sterility.

Recently there has been a trend to move towards human- derived products in in-vitro fertilisation programmes because more expensive recombinant treatments are unable to show improved efficacy or tolerability. MENOPUR(tm), manufactured by Ferring Pharmaceuticals, was introduced in 2000 in response to market demand for a highly purified human-derived product.

Furthermore, the results from the study support the role of LH activity in combination with FSH in ovarian stimulation protocols. Luteinising hormone activity has been shown to encourage the development of larger follicles that are more likely to produce healthy embryos and reduce the number of small follicles, which are associated with ovarian hyperstimulation syndrome (OHSS), which can lead to polycystic ovary disease. Furthermore, a lack of LH activity has been linked to poor egg development, embryo development

and implantation rates. Including LH activity improves the chances of becoming pregnant in women with naturally low LH levels, therefore MENOPUR(tm) offers a convenient source of both hormones.

Although no significant differences were observed for the number of successful pregnancies, the study slightly favoured MENOPUR(tm) which if extrapolated would result in 30 additional pregnancies for every 1,000 induced women, suggesting a real benefit for MENOPUR(tm).

The safety and tolerance of both products was assessed by the number and severity of side effects, miscarriage and abortion rate and the frequency of OHSS. The study showed comparable profiles for both treatments indicating that MENOPUR(tm) is as good as the expensive recombinant products.

A total of 781 women were recruited from centres in Belgium, Germany, Israel, The Netherlands, Switzerland and the UK.

References:

1 The European and Israeli Study Group on highly purified menotrophin versus recombinant follicle stimulating hormone. Efficacy and safety of highly purified menotrophin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomised, comparative trial. Fertility and Sterility 2002;78:520-528.

Ferring is a research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, obstetrics, gynecology, infertility and urology.

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

For more information, please contact:

Sharmi Albrechtsen

Ferring International Center

Telephone: + 45 28 78 72 09

Email: sharmi.albrechtsen@ferring.com

To learn more about Ferring please visit us at:

www.Ferring.com

Company details

If you want to find out more about the company visit Ferring Pharmaceuticals profile.

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