Ovidrel(R) PreFilled Syringe is the first ready-to-inject liquid infertility
treatment approved by the FDA
ROCKLAND, Mass., Oct. 8 /PRNewswire-FirstCall/ -- Serono, Inc., the US
affiliate of Serono S.A. (NYSE: SRA and virt-x: SEO), announced today that the
United States Food and Drug Administration (FDA) has approved its new
pre-filled syringe for Ovidrel(R) (choriogonadotropin alfa injection), making
it the first liquid, ready-to-inject therapy for infertility treatment in the
US.
Designed to make infertility treatment easier for patients, the new
Ovidrel(R) Pre-Filled Syringe is the only liquid infertility treatment
approved by the FDA that patients can administer in one single step. Unlike
other infertility treatments, the Ovidrel(R) PreFilled Syringe does not
require patients to mix medication prior to injection. It is also the only
available recombinant version of human chorionic gonadotropin (hCG), one of
three hormones required to treat infertility. Essentially equivalent in
structure to naturally occurring hCG, Ovidrel(R) triggers ovulation in women
being treated for infertility.
"The administration of the hormone medication needed to trigger ovulation
is one of the most crucial steps in the infertility treatment cycle," said
Raymond W. Ke, MD, Associate Professor of Obstetrics and Gynecology at the
University of Tennessee and Director of IVF for Fertility Associates of
Memphis, Tennessee. "Having Ovidrel(R) in a pre-filled syringe will make that
step easier for patients and may alleviate some of the difficulties and
stresses associated with infertility treatment."
The new pre-filled syringe for Ovidrel(R) will continue to carry the same
indication as the currently marketed product for triggering ovulation in women
undergoing infertility treatment.
"We are very pleased that the FDA has approved the Ovidrel(R) PreFilled
Syringe," said Bharat Tewarie, MD, Executive Vice President, Reproductive
Health, Serono, Inc. "We are committed to advancing infertility treatment by
developing safe, effective and patient-friendly products manufactured using
state-of-the-art technology."
Serono expects Ovidrel(R) PreFilled Syringe to be available in November,
replacing the currently available powder form of Ovidrel(R).
Additional Product Information
Ovidrel(R) is one of a complete line of widely prescribed Serono
infertility therapies used to promote follicle growth, ovulation and
maturation of eggs in the ovaries of women undergoing assisted reproductive
technologies (ART), such as in vitro fertilization, and to induce ovulation in
women with infertility due to anovulation.
Ovidrel(R) PreFilled Syringe is well tolerated. Side effects may include
injection site bruising, pain or inflammation, tiredness, nausea, headache and
abdominal pain. With all assisted reproduction there is a risk of ovarian
hyperstimulation syndrome, multiple pregnancy or miscarriage.
Infertility is defined as the inability of a couple 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, representing about
10 percent of couples in their childbearing years. Infertility is just as
likely to be related to male factors as female factors, which each account for
about a third of infertility problems. The remaining third are either a
combination of male and female factors or are unexplained.
Serono and Infertility Treatment
Serono, the world leader in reproductive health, is dedicated to providing
patient-friendly, innovative products to help couples build families. Serono
is the only company to offer a full portfolio of fertility drugs for every
stage of the reproductive cycle and recombinant versions of the three hormones
needed to treat infertility: Gonal-f(R) (follitropin alfa for injection), to
stimulate the ovaries and produce eggs; Luveris(R) (lutropin alfa for
injection), to stimulate follicular development in women who are profoundly LH
deficient; Cetrotide(R) (cetrorelix acetate for injection) to control hormonal
surges; Ovidrel(R) (choriogonadotropin alfa for injection), to help follicles
mature and release eggs; and Crinone(R) (progesterone gel), to help establish
and maintain a pregnancy. (Luveris(R) is not approved in the US.)
For more information on infertility and full prescribing information for
Serono's US marketed fertility products visit http://www.seronofertility.com.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a
global biotechnology leader. The Company has six recombinant products on the
worldwide market, Gonal-F(R) (follitropin alfa for injection), Luveris(R)
(lutropin alfa), Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa for
injection), Rebif(R) (interferon beta-1a), Serostim(R) [somatropin (rDNA
origin) for injection] and Saizen(R) [somatropin (rDNA origin) for injection].
(Luveris(R) is not approved in the USA.)[1] In addition to being the world
leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth. The Company's research programs are focused
on growing these businesses and on establishing new therapeutic areas.
Currently, there are over 30 projects in development.
Serono was awarded the International James D. Watson 2003 Helix Award from
the Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
In 2002, Serono achieved worldwide revenues of $1.546 billion, and a net
income of $321 million, making it the third largest biotech company in the
world. The Company operates in 45 countries, and its products are sold in over
100 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).
[1] Package inserts for Serono's US marketed products are available at
http://www.seronousa.com or by calling 1-888-275-7376.
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 April 17, 2003. 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.
SOURCE Serono, Inc.
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Related links:
http://www.serono.com
http://www.seronousa.com
CONTACT:
Serono, Inc., Rockland, MA, Media,
+1-781-681-2340, Fax, +1-781-681-2935; Investors,
+1-781-681-2552, Fax, +1-781-681-2912; Serono in Geneva,
Switzerland, Media, +41-22-739-36-00, Fax, +41-22-739-30-85;
Investor Relations, +41-22-739-36-01, Fax, +41-22-739-30-22
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