FERRING PHARMACEUTICALS ANNOUNCES LAUNCH OF NEW TREATMENT FOR INFERTILITY
MENOPUR® (menotropins for injection, USP) First Gonadotropin to Receive FDA Approval Based on Pregnancy Rates
Contact: |
Kelly Laban |
Ferring Pharmaceuticals announces the launch of MENOPUR® (menotropins for injection, USP), which recently received a New Drug Application approval from the U.S. Food and Drug Administration for subcutaneous injection for patients participating in Assisted Reproductive Technology (ART). MENOPUR® is the first and only gonadotropin to be approved on the basis of pregnancy rates.
Suffern, NY – April 11, 2005 – Ferring Pharmaceuticals announced today the launch of MENOPUR® (menotropins for injection, USP), a purified human menopausal gonadotropin (hMG) indicated for the development of multiple follicles and pregnancy in patients undergoing Assisted Reproductive Technology (ART), such as in vitro fertilization (IVF).
MENOPUR® is the first and only fertility treatment approved by the FDA on the basis of pregnancy rates; all other currently marketed gonadotropins gained FDA clearance on the basis of oocytes retrieved. MENOPUR® is a preparation of naturally derived gonadotropins that has undergone an exacting purification process. In clinical studies, it was shown to be comparable in efficacy to recombinant FSH while demonstrating fewer injection site reactions than the currently available hMG.
“Human menopausal gonadotropins have been the cornerstone of fertility treatment for nearly 50 years,” said Wayne Anderson, President, Ferring Pharmaceuticals. “In fact, they are the standard by which all subsequent gonadotropins have been measured. MENOPUR® combines the proven track record of traditional hMGs with improved administration tolerability due to its high level of purity.”
MENOPUR®, which received approval from the U.S. Food and Drug Administration (FDA) on October 29, 2004, contains equal amounts of follicle stimulating hormone (FSH) and luteinizing hormone (LH).
Pregnancy Outcomes Comparable to rFSH
In a prospective, comparative, multinational, randomized, parallel-group,
multicenter, open-label trial comparing subcutaneous administration of MENOPUR®
and follitropin, 727 patients were randomized to receive treatment with
MENOPUR® (n=373) or Gonal-f® (n=354). The primary efficacy endpoint was ongoing
pregnancy rate following IVF or IVF with intracytoplasmic sperm injection (ICSI)
treatment.
Ongoing pregnancy rate following IVF or IVF/ICSI treatment/*
Results showed that ongoing pregnancy rates for MENOPUR® (menotropins for injection, USP) were comparable to those of recombinant FSH.
Improved Administration Tolerability
In a randomized, open-label, multicenter, comparative clinical trial, 190
infertile female patients undergoing ovarian stimulation to produce multiple
follicles for IVF with embryo transfer (ET) were randomized to receive either
MENOPUR® SC (n=61), MENOPUR® IM (n=65) or REPRONEX® (menotropins for injection,
USP) (n=64) treatment. MENOPUR®, administered both SC and IM, was shown to
result in significantly fewer injection site reactions (p=0.001) and fewer
injection site reactions with welts and/ or inflammation (p=0.001) than REPRONEX®.
Fewer injection site reactions than REPRONEX®2
Parameter |
MENOPUR ® SC (n=61) |
MENOPUR ® IM (n=65) |
REPRONEX ® SC (n=64) |
P Value |
|
———————No. of Patients (%)——————– |
|
||
Injection site reactions |
4 (6.6) |
2 (3.1) |
22 (34.4) |
0.001 |
Injection site reactions with welts/ inflammation |
0 |
0 |
8 (12.5) |
0.001 |
“Human menopausal gonadotropins are a critical component of many Assisted Reproductive Technology treatment protocols,” said William Keye, M.D., Director, division of reproductive endocrinology and IVF programs, department of obstetrics and gynecology, William Beaumont Hospital. “This new, improved hMG formulation provides an important benefit for patients who experience discomfort caused by injecting their hMG medication.”
**About MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP)**
MENOPUR® is used to stimulate the development of multiple follicles and pregnancy in women participating in an Assisted Reproductive Technology (ART) program whose ovaries are unable to produce eggs for functional reasons, rather than due to primary ovarian failure.
MENOPUR® is supplied in sterile vials as a lyophilized powder or pellet. MENOPUR® delivers 75 IU FSH and 75 IU LH activity and is supplied in a box containing five vials of medication, five vials of diluent (NDC 55566-7501-1), and five QּCAPs™ for needle-free reconstitution.
MENOPUR® and REPRONEX ®, like all gonadotropins, are potent substances capable of causing mild to severe adverse reactions, including OHSS (incidence of 3.8% and 3.5%, respectively), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.
Both treatments are marketed by Ferring Pharmaceuticals Inc., a world leader in naturally occurring protein hormones. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe these medications. Like other products for ovarian stimulation, treatment with MENOPUR® and/ or REPRONEX® may result in multiple gestations.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned,
international pharmaceutical company, markets MENOPUR®, BRAVELLE® (urofollitropin
for injection, purified), REPRONEX® and NOVAREL™ (chorionic gonadotropin for
injection, USP) 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. 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.
# # #
*Gonal-f is a registered trademark of Serono Laboratories.
**See attached full prescribing information.