Press Release
<p>COMPARATIVE STUDY SHOWS SAFER, MORE CONTROLLED STIMULATION WITH MENOPUR<sup><sup>®</sup></sup> THAN GONAL-f<sup><sup>®</sup></sup> IN OVULATION INDUCTION</p>
<p><strong>CONTACT:</strong> Marilyn Seiger <strong>FOR IMMEDIATE RELEASE</strong><br/>
Kovak-Likly Communications<br/>
203-762-8833, mseiger@klcpr.com </p>
<p><strong>COMPARATIVE STUDY SHOWS SAFER, MORE CONTROLLED STIMULATION WITH MENOPUR<sup>®</sup> THAN GONAL-f<sup>®</sup> IN OVULATION INDUCTION</strong><br/>
<strong>LH-Modified Follicular Development Could Improve Safety in OI and Lower Risk of Multiple Pregnancies</strong> </p>
<p>Suffern, NY – June 7, 2006 – A head-to-head study of MENOPUR<sup>®</sup> (menotropins for injection,
USP), highly purified human menopausal gonadotropin (HP-hMG), and Gonal-f<sup>®</sup> (follitropin
alpha for injection), recombinant follicle stimulating hormone (rFSH), demonstrated that the
ovulation rate with MENOPUR<sup>®</sup> is comparable to that obtained with rFSH in ovulation induction
(OI) protocols. Of the 184 patients in the study, there were no multiple pregnancies with the
MENOPUR<sup>®</sup> group while the incidence was 12 percent in the Gonal-f group. OI therapy, which
uses medication to stimulate the ovaries to produce a single follicle and induce ovulation, is the
predominant treatment for anovulatory infertility. </p>
<p>The study suggests that the hCG-driven luteinizing hormone (LH) activity in MENOPUR<sup>®</sup>
induces a different follicular development profile compared to the use of FSH alone. This could
result in a safer, more controlled stimulation cycle with a lower risk of multiple pregnancies,
excessive response, and ovarian hyperstimulation syndrome (OHSS), which is excessive
stimulation of the ovaries. The study is available online at
http://humrep.oxfordjournals.org/cgi/reprint/del085v1 and will be published in an upcoming issue
of Human Reproduction. </p>
<p>“These data demonstrate that the incorporation of hCG-driven LH activity in the
stimulation protocol promotes single follicular development, which can lead to a reduction in
multiple pregnancies and their associated complications,” said lead investigator, Prof. Peter
Platteau, Center for Reproductive Medicine, Free University of Brussels. “This finding suggests
that the use of hMG could result in a safer, more controlled stimulation cycle. Single follicular
development and singleton pregnancy are important goals of fertility treatment, as there are
substantial social, economic and health consequences of multiple pregnancies.” </p>
<p><strong>About the Study</strong><br/>
This was a randomized, open-label, assessor-blind, parallel-group, multinational OI
study of 184 women, ages 18-39 years, with anovulatory infertility WHO Group II and resistant
to clomiphene citrate. Patients were randomized to undergo stimulation with HP-hMG (n=91) or
rFSH (n=93) using a low-dose step-up protocol. The starting dose of both treatments was
75 IU; after the first 7 days, the follicular response was evaluated and, if necessary, the dose
was adjusted by 37.5 IU every 7 days for up to 6 weeks. </p>
<p>The ovulation rate was comparable in both groups, at 83.5 percent in the HP-hMG group
and 84.9 percent in the rFSH group. Subjects in the HP-hMG group had significantly fewer
intermediate-sized follicles (12-16 mm) than those in the rFSH group (1.04 and 1.91,
respectively, p=0.009). This result could be responsible for the decreased estradiol levels and
lack of multiple births in the MENOPUR arm. Development of a single dominant follicle was
achieved by 63.7 percent in the HP-hMG group compared to 54.8 percent in the rFSH group.
While there were no multiple pregnancies with HP-hMG, two of the 16 (12.5 percent)
pregnancies with rFSH were multiple gestations. The singleton live birth rate was comparable. </p>
<p>One subject in the HP-hMG group and three subjects in the rFSH group reported OHSS.
The percentage of subjects who had OHSS or cycle cancellation from an excessive response
was 2.2 percent with HP-hMG and 9.8 percent with rFSH (p=0.058). The incidence of preterm
birth (<37 weeks) was 27.8 percent in the rFSH group, while all infants in the HP-hMG group
were born at term. The frequency and profile of adverse events was similar in both groups. </p>
<p><strong>About MENOPUR<sup>®</sup></strong><br/>
MENOPUR<sup>®</sup> administered subcutaneously is indicated for the development of multiple
follicles and pregnancy in the ovulatory patients participating in an ART (Assisted Reproductive
Technology) program. </p>
<p>MENOPUR<sup>®</sup> is supplied in sterile vials as a lyophilized powder or pellet. MENOPUR<sup>®</sup>
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 Q</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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