Press Release
<p>FDA APPROVES BRAVELLE™ FOR IN VITRO FERTILIZATION</p>
<p><strong>Clinical Trial Demonstrates State-of-the-Art Performance With Significantly Less Injection Site Pain Than Follistim</strong></p>
<table width="400" border="0" cellspacing="0" cellpadding="0">
<tr>
<td style="font-size:8pt;" align="left" valign="top"><b>Contact:</b></td>
<td style="font-size:8pt;" align="left" valign="top">Kelly Laban<br>
Kovak-Likly Communications<br>
203.762.8833 or Klaban@KLCpr.com</td>
</tr>
</table>
<p>SUFFERN, NY – December 19, 2002 – Ferring Pharmaceuticals’ new infertility treatment
Bravelle™ (urofollitropin for injection, purified), approved by the U.S. Food and Drug
Administration (FDA) for ovulation induction following pituitary suppression on
May 6, 2002, received FDA approval today for use in <i>in vitro </i>fertilization<i> </i>(IVF).<br/>
Bravelle™ is a highly purified, human-derived follicle-stimulating hormone (hFSH)
administered by subcutaneous (SC) injection in IVF treatment cycles. </p>
<p>The new indication followed clinical evaluation demonstrating that Bravelle™ SC
provides state-of-the-art performance, comparable in efficacy and safety to Follistim<sup>®</sup>
SC (recombinant follitropin beta) in IVF, with significantly less injection site pain.<br/>
Bravelle™ and Follistim were also comparable in mean number of stimulation days,
number of vials used and estradiol levels measured during the treatment cycle. </p>
<p>“Bravelle™ is well suited to meet the needs of both physicians and patients,” said
Kenneth B. Kashkin, M.D., vice president, medical and regulatory affairs. “Physicians
can feel confident that Bravelle™ offers the predictability and clinical performance
required by today’s IVF protocols, along with additional important patient benefits. In
our clinical studies, patients using Bravelle™ reported significantly less injection site
pain than those using Follistim. In addition, Bravelle™ is the most affordably priced
product in its category, an important benefit since infertility treatment is generally not
fully covered by insurance.” </p>
<p>Follistim (follitropin beta for injection) is a registered trademark of Organon Inc. </p>
<p><strong>A Human-Derived FSH Proven as Effective as Genetically Engineered FSH</strong> </p>
<p>Bravelle™ was compared to Follistim in a randomized, assessor-blind, parallel
group, multicenter trial in 120 patients undergoing controlled ovarian hyperstimulation
for IVF. The pregnancy outcomes in patients receiving human chorionic gonadotropin
(hCG) were equivalent for Bravelle™ SC and Follistim SC.<sup>1</sup> </p>
<table border=1 cellspacing=0 cellpadding=0 width=450>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top bgcolor="#F2F2F2" >
<b>Study outcomes in patients receiving hCG
</b> </td>
<td style="font-size:8pt;" width=202 valign=top bgcolor="#F2F2F2" >
<b>Bravelle™ SC
(n=57)
</b> </td>
<td style="font-size:8pt;" width=180 valign=top bgcolor="#F2F2F2" >
<b>Follitropin beta SC
(n=59)
</b> </td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Oocytes retrieved
</td>
<td style="font-size:8pt;" width=202 valign=top >
12.4
</td>
<td style="font-size:8pt;" width=180 valign=top >
12.1
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Clinical pregnancy
</td>
<td style="font-size:8pt;" width=202 valign=top >
43.9%
</td>
<td style="font-size:8pt;" width=180 valign=top >
45.8%
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Continuing pregnancy
</td>
<td style="font-size:8pt;" width=202 valign=top >
40.3%
</td>
<td style="font-size:8pt;" width=180 valign=top >
45.8%
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Live birth
</td>
<td style="font-size:8pt;" width=202 valign=top >
26.3%
</td>
<td style="font-size:8pt;" width=180 valign=top >
32.2%
</td>
</tr>
</table>
<p>A second prospective, parallel-group, multicenter, open-label trial in 118 patients
undergoing controlled ovarian hyperstimulation for IVF was published in the June issue
of <i>Fertility and Sterility</i> and showed that there were no significant differences in efficacy
and safety between the treatment groups.<sup>2</sup> </p>
<table border=1 cellspacing=0 cellpadding=0 width=450>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top bgcolor="#F2F2F2" >
<b>Study outcomes in patients receiving hCG</b> </td>
<td style="font-size:8pt;" width=202 valign=top bgcolor="#F2F2F2" >
<b>Bravelle™ SC (n=56)</b> </td>
<td style="font-size:8pt;" width=180 valign=top bgcolor="#F2F2F2" >
<b>Follitropin beta SC (n=56)</b> </td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Oocytes retrieved
</td>
<td style="font-size:8pt;" width=202 valign=top >
14.3
</td>
<td style="font-size:8pt;" width=180 valign=top >
13.6
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Clinical pregnancy
</td>
<td style="font-size:8pt;" width=202 valign=top >
46.4%
</td>
<td style="font-size:8pt;" width=180 valign=top >
32.1%
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Continuing pregnancy
</td>
<td style="font-size:8pt;" width=202 valign=top >
44.6%
</td>
<td style="font-size:8pt;" width=180 valign=top >
30.4%
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=182 valign=top >
Live birth
</td>
<td style="font-size:8pt;" width=202 valign=top >
37.5%
</td>
<td style="font-size:8pt;" width=180 valign=top >
25.0%
</td>
</tr>
</table>
<p>In both trials, patients experienced significantly less injection site pain with
Bravelle™ compared with Follistim on the majority of treatment days. </p>
<p><strong>Lowest Priced FSH Available</strong><br/>
Based on wholesale acquisition cost, Bravelle™ is the most affordably priced
product in its category, an important benefit since infertility treatment is generally not
fully covered by insurance. In the two studies, patients used approximately 30 vials of medication during the treatment cycle. In this case, the projected savings with Bravelle™ would range from $447 to $520. </p>
<table border=1 cellspacing=0 cellpadding=0 width=450>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top bgcolor="#F2F2F2" >
<b>Number
of Vials Utilized
</b> </td>
<td style="font-size:8pt;" width=97 valign=top bgcolor="#F2F2F2" >
<b>Bravelle™
</b> </td>
<td style="font-size:8pt;" width=118 valign=top bgcolor="#F2F2F2" >
<b>Gonal-F<sup><sup>®</sup></sup>
</b> </td>
<td style="font-size:8pt;" width=118 valign=top bgcolor="#F2F2F2" >
<b>Follistim<sup><sup>®</sup></sup>
</b> </td>
<td style="font-size:8pt;" width=135 valign=top bgcolor="#F2F2F2" >
<b>Difference
in cost per number of vials utilized </b>
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top >
1
</td>
<td style="font-size:8pt;" width=97 valign=top >
$49
</td>
<td style="font-size:8pt;" width=118 valign=top >
$64
</td>
<td style="font-size:8pt;" width=118 valign=top >
$66
</td>
<td style="font-size:8pt;" width=135 valign=top >
$15 -
$17
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top >
10
</td>
<td style="font-size:8pt;" width=97 valign=top >
$490
</td>
<td style="font-size:8pt;" width=118 valign=top >
$639
</td>
<td style="font-size:8pt;" width=118 valign=top >
$664
</td>
<td style="font-size:8pt;" width=135 valign=top >
$149 -
$174
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top >
20
</td>
<td style="font-size:8pt;" width=97 valign=top >
$980
</td>
<td style="font-size:8pt;" width=118 valign=top >
$1,278
</td>
<td style="font-size:8pt;" width=118 valign=top >
$1,327
</td>
<td style="font-size:8pt;" width=135 valign=top >
$298 -
$347
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top >
30
</td>
<td style="font-size:8pt;" width=97 valign=top >
$1,470
</td>
<td style="font-size:8pt;" width=118 valign=top >
$1,917
</td>
<td style="font-size:8pt;" width=118 valign=top >
$1,990
</td>
<td style="font-size:8pt;" width=135 valign=top >
$447 -
$520
</td>
</tr>
<tr align="center">
<td style="font-size:8pt;" width=139 valign=top >
40
</td>
<td style="font-size:8pt;" width=97 valign=top >
$1,960
</td>
<td style="font-size:8pt;" width=118 valign=top >
$2,556
</td>
<td style="font-size:8pt;" width=118 valign=top >
$2,654
</td>
<td style="font-size:8pt;" width=135 valign=top >
$596 -
$694
</td>
</tr>
</table>
<p>Comparison based on lowest priced package. Dollars rounded to whole numbers.
Gonal-F (follitropin alfa for injection) is a registered trademark of Serono Laboratories, Inc. </p>
<p><strong>Bravelle™: The Natural Choice</strong> </p>
<p>Bravelle™ is a highly purified, human-derived follicle-stimulating hormone
(hFSH) that is used to induce ovulation. In IVF, it is also used to control the timing of
egg ripening and increase the chance of producing a substantial number of eggs. </p>
<p>Only physicians thoroughly familiar with infertility treatment, including the risk of
multiple births and adverse reactions, should prescribe Bravelle™. Like all
gonadotropins, Bravelle™ is a potent substance capable of causing mild to severe
adverse reactions, including ovarian hyperstimulation syndrome (incidence of 6.8%),
with or without pulmonary or vascular complications, in women undergoing therapy for
infertility. </p>
<p><strong>Background on Human-Derived Hormones</strong><br/>
The key differences in human-derived and genetically engineered infertility
treatments are raw material sources and cost. Human-derived FSH treatments are
highly purified follitropins extracted from the urine of postmenopausal women. By
comparison, genetically engineered products are derived from the secretions from
Chinese hamster ovary cells that are grown in fetal calf or other mammalian serum, and
approximate human hormones. Both are manufactured in compliance with extremely
strict standards (including viral inactivation and confirmatory testing), but human-derived products are generally less expensive than their genetically engineered
counterparts. </p>
<p><strong>About Ferring</strong><br/>
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned,
international pharmaceutical company, markets Bravelle™, Repronex<sup>®</sup> and Novarel™ in
the U.S. to infertility specialists and their patients. The Ferring Group specializes in the
research, development and commercialization of compounds in general and pediatric
endocrinology, urology, gastroenterology, obstetrics/ gynecology and infertility. </p>
<p>For more information, call 1-888-337-7464 or visit www.ferringusa.com. </p>
<p># # # </p>
<p>For full prescribing information contact Kelly Laban at 203-762-8833. </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
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.