New infertility study – Significant difference between treatments

New infertility study – Significant difference between treatments

San Antonio, USA – October 15th, 2003 –

New results from a large multicenter study indicate that women undergoing IVF¹ treatment with MENOPUR² have a remarkable improved chance of becoming pregnant vs. women treated with recombinant FSH.³ MENOPUR contains a combination of hormones similar to those present in the natural reproductive cycle. MENOPUR is approved in 26 countries around the world and is currently under investigation in the United States.

Data from an international study involving 727 patients in ART⁴, show a significantly increased number of pregnancies following treatment with MENOPUR compared to recombinant FSH therapy in a group of women undergoing IVF. The data show that 31% of women in the MENOPUR group became pregnant vs. only 20% of patients in the recombinant FSH. The results were unveiled today at the American Society for Reproductive Medicine Annual Congress, ASRM, in San Antonio, USA.

MENOPUR contains a combination of hormones with Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH⁵) activity similar to those involved in the natural reproductive cycle. According to Dr. Pascal Danglas, Executive Vice President
Clinical and Product Development, Ferring Group, the LH activity is the key difference between the two treatments. According to the most prevalent reproductive theories both FSH and LH activity are necessary for successful egg maturation and implantation. This combination is part of the explanation for the improved pregnancy rates.

“The outcome of the study is very important. Infertility treatment is an exhausting process for an infertile couple – both physically and psychologically. A 50% increase in pregnancy rate must be considered a major improvement and should be studied further”, says Dr. Pascal Danglas.

14% of couples are facing problems with infertility and the number is increasing, mainly because many women are opting to postpone motherhood. In the group of 30-35 year olds, the infertility rate increases to 25%. One third of births are by women above 30 years of age.

Today, reproductive medicine offers a variety of procedures to assist couples in achieving pregnancy, but more than half of the couples with more than two years of infertility treatment still fail to achieve pregnancy. With advances in infertility research and wider availability of newer techniques, the success rate of infertility treatment is going up but there is a continuous need for new and more effective treatments. Based on the results of this study, MENOPUR must be considered one of the most effective IVF therapies today.

Ferring manufactures a wide range of infertility products as well as medicine for delaying preterm birth. The company continues the research and development of new products within infertility and obstetrics.

“The combination of FSH and LH activity is an important contributor to egg maturation and implantation, and as such MENOPUR represents an opportunity to mimic the natural reproductive cycle. Ferring is dedicated to successful pregnancies and continues research activities into the mechanisms of infertility. In the light of the findings in this study additional prospectively-designed clinical trials to further evaluate the benefits of MENOPUR are being initiated”, says Michel Pettigrew, Chief Operating Officer of the Ferring Group.

Ferring was established in Europe but operates globally today. The company employs more than 2,200 people in 40 countries.

About Ferring Pharmaceuticals

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, gynecology, 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 us at
www.Ferring.com.

References

1. 1. In Vitro Fertilization (IVF) — Literally means “in glass.” Fertilization takes place outside the body in a small glass dish.
   2. MENOPUR is a registered trademark of Ferring BV and/or its affiliates.
      MENOPUR — is the highly purified menotropin preparation and provides high quality and cost-effective treatment for infertile couples. MENOPUR contain equal amounts of FSH and LH activity (75 IU FSH and 75 IU LH). MENOPUR is used to treat women with anovulation, to stimulate ovarian follicular development, as well as to treat infertility in men with hypo- or normagonadotropic hypogonadism, and in combination with hCG to stimulate spermatogenesis. MENOPUR is currently under investigation in the United States.
   3. Follicle Stimulating Hormone (FSH) — A pituitary hormone that stimulates spermatogenesis and follicular development. In the man FSH stimulates the Sertoli cells in the testicles and supports sperm production. In the woman FSH stimulates the growth of the ovarian follicle. Elevated FSH levels are indicative of gonadal failure in both men and woman.
   4. Assisted Reproductive Technology (ART) — Several procedures employed to bring about conception without sexual intercourse, including IUI, IVF, GIFT and ZIFT.
   5. Luteinizing Hormone (LH) — A pituitary hormone that stimulates the gonads. In the man LH is necessary for spermatogenesis (Sertoli cell function) and for the production of testosterone (Leydig cell function). In the woman LH is necessary for the production of estrogen. When estrogen reaches a critical peak, the pituitary releases a surge of LH (the LH spike), which releases the egg from the follicle.
   6. Gonadotropins — Hormones that control reproductive function: e.g. Follicle Stimulating Hormone and Luteinizing Hormone.