Press Release

Held at 60th Annual Meeting of the American Society for Reproductive Medicine

PHILADELPHIA - October 18, 2004 - Optimizing the ART Process Now and in the Future: From Gonadotropins to Enhanced Evaluation of Embryonic Development, a continuing education (CME) symposium supported by an unrestricted educational grant from Ferring Pharmaceuticals, was held today at the 60th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Philadelphia.

The symposium focused on technologies used in producing gonadotropins; protocol selection principles for women undergoing ovarian stimulation; active management of gonadotropin-stimulated cycles; and evolving technologies in laboratory procedures and embryo selection.

Comparison of Recombinant and Urinary Therapies
Recombinant and Urinary Gonadotropins: Comparison of Efficacy, Safety and Consistency was presented by Scott C. Chappel, PhD, Venture Partner, Apple Tree Partners, and former Chief Scientific Officer, Serono. Dr. Chappel compared recombinant and urinary gonadotropins on efficacy, safety and consistency. He concluded that urinary and recombinant therapies are equally effective, with no consensus on superiority. Dr. Chappel explained the purification and testing processes for both therapies, the collection process for urinary FSH and the production of recombinants from recombinant-derived cell banks.

“While there are safety concerns associated with the production of bulk material from cell banks and purifying material for recombinants, as well as from the collection of urinary gonadotropins, these processes are well-controlled, well-established and safe,” concluded Dr. Chappel.

“As for batch-to-batch consistency, it is virtually impossible to demonstrate any difference in consistency between urinary and recombinant gonadotropins as long as they are normalized by bioactivity using the same international standards with the same biological assay. There are many other variations that occur in this process–patient to patient, lab to lab, and cycle synchronization–that negate or diminish the importance of consistency within gonadotropins.”

Dr. Chappel also reviewed the evolution of hMG and recombinant therapies, pointing out that hMG therapy, the cornerstone of infertility treatment, has been used and studied for more than 40 years, and is the standard by which recombinant FSH is evaluated. Recombinant FSH was introduced ten years ago.

HMG-Supplied LH Activity
Human Menopausal Gonadotropin-Supplied Luteinizing Hormone Activity: Helpful, Harmful, or Necessary? was presented by Richard P. Marrs, MD, Managing Partner, California Fertility Partners. Dr. Marrs stated that GnRH antagonists can have a dose-dependent effect on luteinizing hormone (LH) levels, which correlates with cycle outcomes. He also stated that the use of FSH-only stimulation in cycles of profound LH suppression (<1.5 IU/L) has been demonstrated to have a negative impact on ART treatment. Dr. Marrs showed evidence demonstrating that in patients with severely depressed LH levels, controlled ovarian stimulation (COS) and pregnancy outcome are affected. There is no evidence that adding LH activity to COS has any negative clinical impact.

Dr. Marrs also concluded that in patients receiving highly purified human menopausal gonatropins (HP-hMG), ongoing pregnancy rates correlate with serum human chorionic gonadotropin (hCG) levels. His final remark was that hMG-induced increases in LH and hCG concentrations, which constitute the LH activity, appear to have a positive contribution to cycle outcomes.

Preimplantation Genetic Diagnosis
Richard Scott, MD, partner, Reproductive Medicine Associates of New Jersey discussed Preimplantation Genetic Diagnosis (PGD), a technique that can be used with in vitro fertilization (IVF) procedures to test embryos for genetic disorders prior to their transfer to the uterus.

Attending physicians will receive up to 1.5 CME credit hours in Category 1 toward the American Medical Association Physician’s Recognition Award. The ASRM is accredited by the Accreditation Council for Continuing Medical Education (ACCME).

Background on Human-Derived Hormones
The key differences in human-derived and genetically engineered infertility treatments are raw material sources and cost. Human-derived FSH treatments are highly-purified follitropins refined from the urine of postmenopausal women. By comparison, genetically engineered products are extracted from the secretions from Chinese hamster ovary cells that are cultured in fetal calf or other mammalian serum, and approximate human hormones. Both are manufactured in compliance with extremely strict standards (including viral inactivation and confirmatory testing), but human-derived products are generally less expensive than their genetically engineered counterparts.

About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle™, Repronex™ and Novarel™ in the U.S. to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call 888-337-7464 or visit www.ferringusa.com or www.ferringfertility.com.