Press Release
<p>RESEARCH COMPARES MENOPUR<sup><sup>®</sup></sup> WITH rFSH IN GNRH ANTAGONIST IVF CYCLES</p>
<p><strong>Ferring Pharmaceuticals Presents Study Results at
American Society for Reproductive Medicine Annual Meeting</strong></p>
<p><strong>ATLANTA – October 20, 2009 – </strong>Ferring Pharmaceuticals presented an interim study analysis indicating that MENOPUR<sup>®</sup> (menotropins for injection, USP) is effective in in vitro fertilization (IVF) cycles using a gonadotropin-releasing hormone (GnRH) antagonist. The results were presented in a poster at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Atlanta, October 17-21, 2009. </p>
<p><strong>MENOPUR<sup>®</sup> vs. rFSH in GnRH Antagonist Cycles Interim Study Analysis</strong></p>
<p>In an interim analysis of a multicenter, randomized, open-label exploratory study of IVF cycles using a GnRH antagonist, patients were randomized prior to stimulation with either MENOPUR<sup>®</sup> or recombinant follicle stimulating hormone (rFSH), and luteal support with either ENDOMETRIN<sup>®</sup> (progesterone) Vaginal Insert 100 mg or progesterone-in-oil (PIO). The overall continuing pregnancy rate was 43.1 percent (n=143), with pregnancy rates of 46.7 percent for the MENOPUR<sup>®</sup> group (n=68) and 40.0 percent for the rFSH group (n=75). Results of the analysis indicate that MENOPUR<sup>®</sup> is effective in IVF cycles using a GnRH antagonist, and the efficacy of ENDOMETRIN<sup>®</sup> is equivalent to that of PIO for luteal support.</p>
<p>“We are very encouraged by these interim results,” said Ed Trott, vice president, medical affairs. “We anticipate that the final results of the study will add to the growing body of evidence suggesting that hMG offers better embryo quality and higher implantation and live birth rates when compared to using rFSH alone.”</p>
<p><strong>About MENOPUR </strong></p>
<p>MENOPUR<sup>®</sup> administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.</p>
<p><strong>Important Safety Information</strong></p>
<p>Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe MENOPUR<sup>®</sup>. MENOPUR<sup>®</sup>, like all gonadotropins, is a potent substance capable of causing mild to severe adverse reactions, including OHSS (overall incidence 3.8%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. MENOPUR<sup>®</sup> is contraindicated in women who have a high FSH level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; an organic intracranial lesion such as a pituitary tumor; sex hormone dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; prior hypersensitivity to menotropins or MENOPUR<sup>®</sup>. MENOPUR<sup>®</sup> is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.</p>
<p><strong>About ENDOMETRIN</strong></p>
<p>ENDOMETRIN<sup>®</sup> administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.</p>
<p><strong>Important Safety Information</strong></p>
<p>Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN<sup>®</sup>. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2 percent included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2 percent. ENDOMETRIN<sup>®</sup> is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN<sup>®</sup> is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN<sup>®</sup> ; a known missed abortion or ectopic pregnancy; liver disease; known or suspected breast cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.</p>
<p><strong>About Ferring Pharmaceuticals </strong></p>
<p>Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets MENOPUR<sup>®</sup>, BRAVELLE<sup>®</sup> (urofollitropin for injection, purified), REPRONEX<sup>®</sup> (menotropins for injection, USP), NOVAREL<sup>®</sup> (chorionic gonadotropin for injection, USP) and ENDOMETRIN<sup>®</sup> in the U.S. to infertility specialists and their patients. Ferring also offers the Q∙CAP™, the first and only needle-free reconstitution device, for use with its fertility treatments.
Ferring’s line of urology products includes FIRMAGON<sup>®</sup> (degarelix for injection) and PROSED<sup>®</sup> DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate). Ferring’s orthopaedic product includes EUFLEXXA™ (1% sodium hyaluronic acid). Other products include ACTHREL<sup>®</sup> (corticorelin ovine triflutate for injection) and DESMOPRESSIN.
The Ferring Group specializes in the research, development and commercialization of
compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology, infertility and orthopaedics. For more information, call 888-337-7464 or visit www.ferringusa.com or www.ferringfertility.com. </p>
<p><em>Please visit www.ferringfertility.com for Full Prescribing Information for MENOPUR<sup>®</sup> and ENDOMETRIN<sup>®</sup>.</em></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.
Please see Full Prescribing Information.
Please see Important Information for Patients.
PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS WEB SITE.
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Euflexxa® is a registered trademark of Ferring Pharmaceuticals Inc.
