First head-to-head clinical study of GnRH antagonists in the treatment of
infertility
PHILADELPHIA, Oct. 19 /PRNewswire-FirstCall/ -- Serono (virt-x SEO and
NYSE: SRA) - In the first clinical trial to directly compare gonadotropin
releasing hormone (GnRH) antagonists, patients using Cetrotide(R) (cetrorelix
acetate for injection) required fewer injections compared to patients using
Ganirelix Acetate (formerly known as Antagon(TM) Injection) to prevent
premature ovulation during infertility treatment. The data were presented
today at the 60th Annual Meeting of the American Society for Reproductive
Medicine (ASRM) by John G. Wilcox, MD, FCOG, Assistant Clinical Professor in
the Department of Obstetrics and Gynecology at the University of Southern
California School of Medicine and Managing Partner of Huntington Reproductive
Center in Pasadena, CA.
"This study shows that hormonal surges can be inhibited with a single
injection for the majority of patients until follicles are large enough for
oocyte retrieval and subsequent fertilization," said Dr. Wilcox.
"Cetrotide(R) offers patients a similar safety profile as well as similar
efficacy compared to Ganirelix Acetate, but Cetrotide(R) has the added benefit
of significantly fewer injections."
Most of the patients who used Cetrotide(R) (66.7%) required one injection
while most of the patients who used Ganirelix Acetate (62.5%) required four or
more injections to achieve the same endpoint.
"Cetrotide(R) is an important part of Serono's full portfolio of patient-
friendly products designed to make infertility treatment easier," said Bharat
Tewarie, MD, MBA, Executive Vice President, Reproductive Health, Serono, Inc.
"The ease-of-use it offers demonstrates our commitment to improving the
patient experience."
Gonadotropin releasing hormone (GnRH) antagonists are used in the
treatment of infertility to prevent the spontaneous release of LH (luteinizing
hormone), a hormonal event that impacts the development of eggs. They work by
directly blocking the trigger effect of GnRH to stop a possible LH surge
before it begins, allowing eggs to reach the level of development needed for
fertilization.
Infertility is defined as the inability to achieve pregnancy after one
year of regular, unprotected intercourse (six months if the woman is over 35).
It affects about 6.1 million Americans, which represents about 10 percent of
couples in their childbearing years. The majority of patients who complete
treatment ultimately succeed in having a child.
About the Study
The prospective, open-label, randomized, comparative study was conducted
at 16 medical centers in the United States and included 185 infertile patients
undergoing ART procedures. A single subcutaneous injection of Cetrotide(R) 3
mg or a daily subcutaneous injection of Ganirelix Acetate 250 mcg was
administered in a flexible protocol to prevent premature LH surge when the
lead follicle was greater than or equal to 14 mm. Daily Cetrotide(R) 0.25 mg
was administered if the criteria for recombinant human chorionic gonadotropin
(hCG) administration were not met four days after receiving Cetrotide(R) 3 mg.
Most women receiving Cetrotide(R) (66.7%) received only a single dose. Of the
remaining patients, 89.8% needed only one additional dose. The overall
pregnancy rate for the Cetrotide arm was 51.7% (45/87), and the overall
pregnancy rate for the Ganirelix Acetate arm was 48.9% (43/88), with no
statistically significant difference between treatment groups. These results,
presented at ASRM, represent a final analysis of data.
Additional Information
Side effects may occur with the use of infertility drugs and, therefore,
should only be prescribed by physicians who are thoroughly familiar with
infertility problems and their management. Ovarian hyperstimulation syndrome
(OHSS) with or without vascular and pulmonary complications can occur with the
use of infertility drugs. Mild and short lasting injection reactions like
reddening, itching and swelling at the injection sites have occurred in women
using Cetrotode(R). Nausea and headache have also been reported.
About Serono, Inc. and Fertility
Serono, Inc., a subsidiary of Serono S.A., is a leader in fertility
health, dedicated to developing patient-friendly, innovative products that
help people build families. It is the only company to offer a full portfolio
of fertility medications for every stage of the reproductive cycle and
recombinant versions of three hormones used in the treatment of infertility,
including the newly approved Gonal-f(R) RFF Pen (follitropin alfa injection).
For more information, please contact Fertility LifeLines(TM), a toll-free
educational service that offers customized information and support to people
with fertility health concerns, available at 1-866-LETS-TRY (1-866-538-7879).
About Serono S.A.
Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R) (interferon beta-1a), Gonal-f(R) (follitropin
alfa for injection), Luveris(R) (lutropin alfa for injection), Ovidrel
PreFilled Syringe(R)/Ovitrelle(R) (choriogonadotropin alfa injection),
Serostim(R) [somatropin (rDNA origin) for injection], Saizen(R) [somatropin
(rDNA origin) for injection], Zorbtive(TM) [somatropin (rDNA origin) for
injection] and Raptiva(R) (efalizumab). In addition to being the world leader
in reproductive health, Serono has strong market positions in neurology,
metabolism and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses and on
establishing new therapeutic areas. Currently, there are approximately 30
ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a
net income of US$390.0 million, making it the third largest biotech company in
the world. Its products are sold in over 90 countries. Bearer shares of Serono
S.A., the holding company, are traded on the virt-x (SEO) and its American
Depositary Shares are traded on the New York Stock Exchange (SRA).
Some of the statements in this press release are forward looking. Such
statements are inherently subject to known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements
of Serono S.A. and affiliates to be materially different from those expected
or anticipated in the forward-looking statements. Forward-looking statements
are based on Serono's current expectations and assumptions, which may be
affected by a number of factors, including those discussed in this press
release and more fully described in Serono's Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on March 25, 2004. These
factors include any failure or delay in Serono's ability to develop new
products, any failure to receive anticipated regulatory approvals, any
problems in commercializing current products as a result of competition or
other factors, our ability to obtain reimbursement coverage for our products,
and government regulations limiting our ability to sell our products. Serono
has no responsibility to update the forward-looking statements contained in
this press release to reflect events or circumstances occurring after the date
of this press release.
Package inserts for Serono's US marketed products are available at
http://www.seronousa.com or by calling 1-888-275-7376.
For more information, please contact:
Media Relations, USA:
Dana Jessup
Tel: +1 781 681 2443
Fax: +1 781 6812937
http://www.seronousa.com
Corporate Media Relations:
Tel: +41 22 739 36 00
Fax: +41 22 739 30 85
http://www.serono.com
Investor Relations, USA
Susan Ince
Tel: +1 781 681 2552
Fax: +1 781 681 2912
Corporate Investor Relations:
Tel: +41 22 739 36 01
Fax: +41 22 739 30 22
Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
SOURCE Serono, Inc.
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Related links:
http://www.seronousa.com
http://www.serono.com
CONTACT:
Media Relations, USA: Dana Jessup of
Serono, +1-781-681-2443, Fax: +1-781-681-2937; Corporate Media
Relations: +41 22 739 36 00, Fax: +41 22 739 30 85; Investor
Relations, USA, Susan Ince of Serono, +1-781-681-2552, Fax:
+1-781-681-2912; or Corporate Investor Relations: +41 22 739 36
01, Fax: +41 22 739 30 22
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