Ovitrelle(R) - The World's Only Recombinant, Filled-By-Mass and Consistent hCG
Is Now Available in a Ready-To-Use Pre-Filled Syringe That Will
Allow Patients to Administer hCG With One Simple Step
GENEVA, Oct. 30 /PRNewswire-FirstCall/ -- Serono S.A. (virt-x: SEO and
NYSE: SRA), announced today that the European Commission has approved its new
pre-filled syringe for Ovitrelle(R) (choriogonadotropin alfa).
Designed to make infertility treatment easier for patients, the new
Ovitrelle(R) Solution for Injection is designed so that patients can
administer their r-hCG in one single step. Unlike other hCG treatments, the
Ovitrelle(R) Solution for Injection 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, Ovitrelle(R) triggers ovulation in women being treated for
infertility.
"hCG administration is a single, once only injection and therefore getting
it right is essential to the success of the cycle," said Professor Matts
Wikland M.D, PhD of the Fertility Center at Carlanderska Hospital, Gothenburg,
Sweden. "Having Ovitrelle(R) as a liquid in a ready to use pre-filled syringe
will make the process significantly easier for patients and help to ensure
that they do not incorrectly reconstitute or administer this crucial
injection."
The new pre-filled syringe for Ovitrelle(R) will continue to carry the
same indication as the currently marketed product for triggering ovulation and
luteinization in women undergoing infertility treatment.
"We are extremely pleased that the European Commission has approved the
Ovitrelle(R) Solution for Injection in a pre-filled syringe," said
Hans Christian Rohde, Corporate Vice President, Reproductive Health, Serono.
"We are constantly striving to introduce the most consistent products and to
deliver them in the most accurate devices to help to increase the treatment
efficiency in assisted cycles."
Serono expects Ovitrelle(R) Solution for Injection in a pre-filled syringe
to be available in December, replacing the currently available powder form of
Ovitrelle(R).
Additional Product Information
Ovitrelle(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.
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 10 million Europeans, 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) FbM (follitropin alfa for injection
filled-by-mass), 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; Ovitrelle(R) (choriogonadotropin alfa
for injection), to help follicles mature and release eggs; and Crinone(R)
(progesterone gel), to help establish and maintain a pregnancy.
For more information on infertility and full prescribing information for
Serono's marketed fertility products visit http://www.serono.com.
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.
About Serono
Serono is a global biotechnology leader. The Company has six recombinant
products on the market, Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(R) (Luveris(R) is not approved in the USA).
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 Helix 2003 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 US$ 1.538 billion, and a
net income of US$321 million, making it the third largest biotech company in
the world. The Company operates in 44 countries, and its products are sold in
94 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).
SOURCE Serono S.A.
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Related links:
http://www.serono.com
http://www.seronousa.com
CONTACT:
Serono in Geneva, Switzerland: Media
Relations: +41-22-739-36-00, Fax: +41-22-739-30-85, Investor
Relations: +41-22-739-36-01, Fax: +41-22-739-30-22, or Serono,
Inc., Rockland, MA: Media Relations: +1-781-681-2340, Fax:
+1-781-681-2935, Investor Relations: +1-781-681-2552, Fax:
+1-781-681-2912
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