Press Release
<p>FERRING INITIATES LANDMARK CLINICAL TRIALS TO EVALUATE OPTIMAL DRUG PROTOCOL FOR IVF TREATMENT</p>
<p>FOR IMMEDIATE RELEASE CONTACT: Marilyn Seiger Kovak-Likly Communications 203/762-8833 First-ever Evaluation of Combination Therapy in U.S.</p>
<p>Tarrytown, NY, February 28, 2001 – Ferring Pharmaceuticals, which specializes in human-derived hormones for infertility treatment, is conducting two clinical trials to investigate the optimal dose and ratio of two hormones used to stimulate the development of multiple eggs in in vitro fertilization (IVF). This is the first time a prospective, systematic clinical evaluation of single daily dose mixed protocols has been conducted anywhere in the world. Findings from the study will help infertility specialists fine-tune the ovarian stimulation protocols used in assisted reproductive technology.</p>
<p>The clinical trials compare combinations of Ferring’s new human-derived follicle stimulating hormone (hFSH), which is currently under investigation, and Repronex<sup>®</sup> (menotropins for injection, USP), the most frequently prescribed human menopausal gonadotropin (HMG). Repronex contains equal amounts of FSH and luteinizing hormone (LH), which work both independently and synergistically to support follicular development and prepare the follicle and oocyte for ovulation.</p>
<p>“These first-ever studies are particularly relevant given our new understanding of the role of LH in ovulation induction,” said William Keye, M.D., investigator and director of the Division of Reproductive Endocrinology and Infertility at William Beaumont Hospital in Royal Oaks, MI. “We are finding that for many of our patients, returning to a protocol that includes HMG and FSH results in improved pregnancy rates. The results of these trials will help infertility specialists fine-tune ovarian stimulation protocols used in in vitro fertilization, improving a patient’s chance of a successful outcome.”</p>
<p>These studies will add important information to the growing body of evidence supporting the potential importance of LH for optimal follicle stimulation. In the November 2000 issue of Human Reproduction1, an authoritative clinical review by international experts, challenges the efficacy of recent gonadotropin treatments of FSH only compared to a dual treatment regimen of FSH and LH, which mimics the physiology of normal human follicular development.</p>
<p>Ferring’s two prospective, randomized, three-arm, parallel-group multicenter studies are being conducted with approximately 300 patients undergoing IVF-ages 18-33 at 17 centers and ages 34-40 at 12 centers. The studies will evaluate and compare the subcutaneous efficacy, safety and treatment toleration of a once-daily injection of Ferring’s human-derived FSH combined with Repronex in various continuous and sequential dose ratios. Following down regulation, a patient will be randomized into one of three treatment groups, with an assigned ratio of gonadotropins, which will be administered for five days. Doses will then be individualized for up to 15 days. The primary determinant of efficacy will be the mean number of oocytes retrieved. Secondary variables are the number of embryos transferred, peak mean serum E2 levels, and chemical, clinical and ongoing pregnancy rates.</p>
<p>“These studies will bring, for the first time, welcome insights into the clinical efficacy of mixed protocols for both younger and older women,” said Wayne Anderson, president of Ferring Pharmaceuticals Inc. “The addition of Ferring’s human-derived FSH medication will give physicians greater dosing flexibility with a highly purified modern gonadotropin treatment.” About Repronex and Ferring</p>
<p>Repronex is the only human menopausal gonadotropin (hMG) approved for both subcutaneous and intramuscular administration. It is also the lowest-cost gonadotropin* and most frequently prescribed hMG2. Repronex, like all gonadotropins, is a potent substance capable of causing mild to severe adverse reactions, including OHSS (incidence of 3.5%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe Repronex.</p>
<p>Ferring Pharmaceuticals Inc., headquartered in Tarrytown, NY, is part of the Ferring Group, a privately owned, international biopharmaceutical company that specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call 1-888-337-7464 or visit the Ferring website at www.ferringusa.com. # # # </p>
EUFLEXXA (1% sodium hyaluronate) is used to relieve knee pain due to osteoarthritis. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.
Important Safety Information
You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee performed by a qualified doctor. After you receive this injection you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time (more than one hour). The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established. The safety and effectiveness of EUFLEXXA have not been shown in people under 18 years of age.
Side effects sometimes seen when EUFLEXXA is injected into the knee joint were pain, swelling, skin irritation, and tenderness and these were generally mild and did not last long.
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