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ARES-SERONO REPORTS THE WORLD'S FIRST BIRTH FOLLOWING INFERTILITY TREATMENT WITH RECOMBINANT FOLLICLE STIMULATING HORMONE

 ARES-SERONO REPORTS THE WORLD'S FIRST BIRTH FOLLOWING INFERTILITY
 TREATMENT WITH RECOMBINANT FOLLICLE STIMULATING HORMONE
 BOSTON, Oct. 5 /PRNewswire/ -- The Ares-Serono Group today reported the first human birth ever obtained in the world after infertility treatment with Gonal-F(R), the company's recombinant human follicle stimulating hormone (r-hFSH). The mother of twin babies born Friday, Oct. 2 in Switzerland, suffered from primary tubal infertility (occlusion of both Fallopian tubes). She was treated at the Fertility Unit of the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland and was administered Gonal-F within the framework of a multinational clinical trial.
 This phase III clinical trial is designed to assess the efficacy and safety of Gonal-F in stimulating ovarian follicular development in women undergoing in-vitro fertilization (IVF) and embryo transfer (IVF-ET). To date, more than 20 pregnancies have been obtained in Europe during this clinical trial. Several pregnancies have also been recorded in a similar Gonal-F trial currently on-going in the United States. Phase III clinical trials represent the final phase of testing before the study results are compiled and submitted for marketing approval.
 Gonal-F was developed by Ares Serono's R & D organization, based on the cloning work completed at Ares Advanced Technology, the company's worldwide center for biotechnology research in Randolph, Mass.
 "For Ares-Serono, the first birth ever obtained in the world with a recombinant product is a significant milestone in the company's 40 year history of infertility treatment," said Fabio Bertarelli, chief executive officer of The Ares Serono Group. "this birth, and the others that will follow, are the successful outcome of the important human and financial effort we have dedicated to the research and development of recombinant FSH."
 FSH of urinary origin has been used since the early 1960s to improve ovulation, and thus fertility, in women who do not ovulate properly. Since the 1980s, FSH has been prescribed to stimulate follicle and egg maturation for in-vitro fertilization and embryo transfer (IVF/ET). In the male, FSH is also currently used to initiate or improve sperm production when natural FSH secretion is impaired. Ares-Serono has been marketing gonadotropins(a) of urinary origin for therapeutic use for more than 30 years(b).
 Identical to the natural hFSH molecule, Gonal-F is among the first recombinant human glycoproteins to be obtained from mammalian host cells. Gonal-F can be produced in almost unlimited quantities, thus solving problems related to raw material (urine) collection. In addition, its extremely high purity and specific activity make it suitable for subcutaneous injection.
 It is estimated that infertility affects one out of six couples of childbearing age worldwide. The causes of infertility are numerous, but are generally related to three important factors: ovulatory dysfunction, tubal damage or male infertility.
 IVF is an established therapy for some tubal infertility (partial or full occlusion of the Fallopian tubes), as well as for certain types of endometriosis(c). in addition, IVF is used to treat specific male infertilities. A recent study on the expectations of assisted reproduction techniques, including IVF, concluded that when the woman is under the age of 40 and the partner does not suffer from sperm dysfunction, the pregnancy and birth rates per cycle of treatment are similar to the average pregnancy and birth rates per monthly reproductive cycle for fertile couples(d) (around 20-25 percent)
 Commenting on this first birth ever obtained after infertility treatment with r-hFSH, the investigator in charge, Dr. Marc Germond, head of the Fertility Unit at the CHUV, declared, "I am pleased that the pregnancy came to term without difficulty. The first result will be confirmed by further successful births from pregnancies already obtained in other centers. The future availability of a product with such a high purity guarantees the optimization and reliability of the treatment.
 Full analysis of the efficacy and safety of Gonal-F(R) in a large population of patients will be reported after completion of the multicenter clinical trials. The only genetic engineering process to produce biologically active recombinant gonadotropins is covered by patents owned by Ares-Serono.
 The Ares-Serono Group is a leading Swiss developer and marketer of pharmaceutical and diagnostic products with executive headquarters in Geneva, Switzerland and operating headquarters in Boston. Acknowledged as the world leader in the treatment of infertility, the Group operates subsidiaries and manufacturing facilities in more than 20 countries. Shares of Ares-Serono S.A., the parent company of the Group, are traded on the major Swiss stock exchanges.
 ----
 Note to Editors: Photos of the twin babies born following infertility treatment with Gonal-F are available upon request.
 a Gonadotropins (fertility hormones include):
 -- Human chorionic gonadotropin (secreted by the placenta);
 -- Human menopausal gonadotropins (FSH -follicle stimulating
 hormone and LH -lutenizing hormone), both found in minute
 quantities in the urine of post-menopausal women.
 b Ares-Serono has acquired extensive experience in the collection
 and purification of natural gonadotropins. To produce
 Gonadotropin-based infertility drugs, thousands of liters of post-
 menopausal urine need to be collected everyday.
 c Endometriosis; presence of endometrial tissue (the normal
 uterine lining) in abnormal sites such as the Fallopian tubes or
 the ovaries, often causing painful menstruation and infertility.
 d M.Hull et AL., British Medical Journal, Vol. 304/June 1992
 -0- 10/5/92
 /CONTACT: Gina Cella of Ares-Serono, 617-982-9000/ CO: Ares-Serono Inc. ST: Massachusetts IN: MTC SU:


TM -- NE021 -- 6676 10/05/92 14:55 EDT
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