Press Release
<p>FERRING PHARMACEUTICALS ANNOUNCES LAUNCH OF NEW TREATMENT FOR INFERTILITY</p>
<p><strong>MENOPUR<sup>®</sup> (menotropins for injection, USP) First Gonadotropin to Receive FDA Approval Based on Pregnancy Rates</strong> </p>
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<td valign="top" width="57"><p><b>Contact:</b></p></td>
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<td width="304">
<p>Kelly Laban<br>
Kovak-Likly Communications<br>
(203)762-8833 x15 or KLaban@KLCpr.com</p>
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<p>Ferring Pharmaceuticals announces the launch of MENOPUR<sup>®</sup> (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<sup>®</sup> is the first and only gonadotropin to be approved on the
basis of pregnancy rates. </p>
<p>Suffern, NY – April 11, 2005 – Ferring Pharmaceuticals announced today the
launch of MENOPUR<sup>®</sup> (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). </p>
<p>MENOPUR<sup>®</sup> 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<sup>®</sup> 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. </p>
<p>“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<sup>®</sup> combines the proven track record of traditional hMGs with
improved administration tolerability due to its high level of purity.” </p>
<p>MENOPUR<sup>®</sup>, 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). </p>
<p><strong>Pregnancy Outcomes Comparable to rFSH</strong><br/>
In a prospective, comparative, multinational, randomized, parallel-group,
multicenter, open-label trial comparing subcutaneous administration of MENOPUR<sup>®</sup>
and follitropin, 727 patients were randomized to receive treatment with
MENOPUR<sup>®</sup> (n=373) or Gonal-f<sup>®</sup> (n=354). The primary efficacy endpoint was ongoing
pregnancy rate following IVF or IVF with intracytoplasmic sperm injection (ICSI)
treatment. </p>
<p><strong>Ongoing pregnancy rate following IVF or IVF/ICSI treatment/</strong>* </p>
<p>Results showed that ongoing pregnancy rates for MENOPUR<sup>®</sup> (menotropins for
injection, USP) were comparable to those of recombinant FSH. </p>
<p><strong>Improved Administration Tolerability</strong><br/>
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<sup>®</sup> SC (n=61), MENOPUR<sup>®</sup> IM (n=65) or REPRONEX<sup>®</sup> (menotropins for injection,
USP) (n=64) treatment. MENOPUR<sup>®</sup>, 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<sup>®</sup>. </p>
<p><strong>Fewer injection site reactions than REPRONEX<sup>®</sup>2</strong> </p>
<table border="1" cellpadding="3" cellspacing="0" bordercolor="#000000">
<tr bgcolor="#666666">
<td width="110" valign="top" bgcolor="#666666"><p align="center" class="style23"> Parameter </p></td>
<td width="139" valign="top"><p align="center" class="style23">MENOPUR <sup>®</sup> SC (n=61) </p>
</td>
<td width="128" valign="top"><p align="center" class="style23"> MENOPUR <sup>®</sup> IM (n=65) </p>
</td>
<td width="143" valign="top"><p align="center" class="style23"> REPRONEX <sup>®</sup> SC (n=64) </p>
</td>
<td width="128" valign="top"><p align="center" class="style23">P Value</p></td>
</tr>
<tr>
<td width="110" valign="top"><p><span class="style9"><span class="style12"><span class="style15"><span class="style18"><span class="style21"><span class="style18"></span></span></span></span></span></span> </p></td>
<td width="411" colspan="3" valign="top"><p align="center" class="style24"> ———————No. of Patients (%)——————– </p></td>
<td width="128" valign="top"><p><span class="style9"><span class="style12"><span class="style15"><span class="style18"><span class="style21"><span class="style18"></span></span></span></span></span></span> </p></td>
</tr>
<tr>
<td width="110" valign="top"><p class="style24"><strong> Injection site reactions </strong></p></td>
<td width="139"><p align="center" class="style24"><strong> 4 (6.6)</strong></p></td>
<td width="128"><p align="center" class="style24"><strong> 2 (3.1)</strong></p></td>
<td width="143"><p align="center" class="style24"><strong> 22 (34.4)</strong></p></td>
<td width="128"><p align="center" class="style24"><strong> 0.001</strong></p></td>
</tr>
<tr>
<td width="110" valign="top"><p class="style24"><strong> Injection site reactions with welts/ inflammation </strong></p></td>
<td width="139"><p align="center" class="style24"><strong> 0</strong></p></td>
<td width="128"><p align="center" class="style24"><strong> 0</strong></p></td>
<td width="143"><p align="center" class="style24"><strong> 8 (12.5)</strong></p></td>
<td width="128"><p align="center" class="style24"><strong> 0.001</strong></p></td>
</tr>
</table>
<p>“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.” </p>
<p>**About MENOPUR<sup>®</sup> (menotropins for injection, USP) and REPRONEX<sup>®</sup> (menotropins
for injection, USP)** </p>
<p>MENOPUR<sup>®</sup> 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. </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
QּCAPs™ for needle-free reconstitution. </p>
<p>MENOPUR<sup>®</sup> and REPRONEX <sup>®</sup>, 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. </p>
<p>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<sup>®</sup> and/ or REPRONEX<sup>®</sup> may result in multiple
gestations. </p>
<p><strong>About Ferring Pharmaceuticals</strong><br/>
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned,
international pharmaceutical company, markets MENOPUR<sup>®</sup>, BRAVELLE<sup>®</sup> (urofollitropin
for injection, purified), REPRONEX<sup>®</sup> 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 <a href="http://www.ferringfertility.com">www.ferringfertility.com</a>. </p>
<p># # # </p>
<p><i>*Gonal-f is a registered trademark of Serono Laboratories. </p>
<p>**See attached full prescribing information.</i> </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.
Patient Treatment Information
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