Research Compares MENOPUR(R) With rFSH in GnRH Antagonist IVF Cycles

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Tue Oct 20, 2009 9:00am EDT

Ferring Pharmaceuticals Presents Study Results at American Society for
Reproductive Medicine Annual Meeting





ATLANTA, Oct. 20 /PRNewswire/ -- Ferring Pharmaceuticals presented an interim
study analysis indicating that MENOPUR® (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.  


MENOPUR® vs. rFSH in GnRH Antagonist Cycles Interim Study Analysis
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® or recombinant follicle stimulating hormone
(rFSH), and luteal support with either ENDOMETRIN® (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® group (n=68) and 40.0 percent for the rFSH group (n=75).  Results of
the analysis indicate that MENOPUR® is effective in IVF cycles using a GnRH
antagonist, and the efficacy of ENDOMETRIN® is equivalent to that of PIO for
luteal support.


"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."


AboutMENOPUR
MENOPUR® administered subcutaneously is indicated for the development of
multiple follicles and pregnancy in the ovulatory patients participating in an
ART program.


Important Safety Information
Only physicians thoroughly familiar with infertility treatment, including the
risk of multiple births and adverse reactions, should prescribe MENOPUR®. 
MENOPUR®, 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® 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®.  MENOPUR® is not indicated in women who are pregnant.  There are
limited human data on the effects of menotropins when administered during
pregnancy.


About ENDOMETRIN
ENDOMETRIN® 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.


Important Safety Information
Only physicians thoroughly familiar with infertility treatment should
prescribe ENDOMETRIN®.  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® is expected to have adverse reactions
similar to other drugs containing progesterone (breast tenderness, bloating,
mood swings, irritability, and drowsiness).  ENDOMETRIN®  is contraindicated
in women who have or have had previous allergic reactions to progesterone or
any of the ingredients in ENDOMETRIN® ; 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.


About Ferring Pharmaceuticals 
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®, BRAVELLE® (urofollitropin for injection, purified),
REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin
for injection, USP) and ENDOMETRIN® in the U.S. to infertility specialists and
their patients.  Ferring also offers the Q-CAP(TM), the first and only
needle-free reconstitution device, for use with its fertility treatments.


Ferring's line of urology products includes FIRMAGON® (degarelix for
injection) and PROSED® DS (methenamine, phenyl salicylate, methylene blue,
benzoic acid, hyoscyamine sulfate).  Ferring's orthopaedic product includes
EUFLEXXA(TM) (1% sodium hyaluronic acid).  Other products include ACTHREL®
(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. 


Please visit www.ferringfertility.com for Full Prescribing Information for
MENOPUR® and ENDOMETRIN®.


SOURCE  Ferring Pharmaceuticals Inc.

Andrea Preston, Kovak-Likly Communications, +1-203-762-8833,
apreston@klcpr.com
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