The most consistent FSH is now available in an accurate and
Easy-to-use pre-filled pen
GENEVA, Feb. 25 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and
NYSE: SRA) announced today that the European Commission has approved its
GONAL-f(R) Filled-by-Mass solution for injection in a pre-filled pen, which
delivers the company's market-leading recombinant human follicle-stimulating
hormone.
"As the worldwide leader in infertility treatment, Serono is committed to
developing innovative products," said Ernesto Bertarelli, Chief Executive
Officer of Serono. "The GONAL-f(R) (FbM) Prefilled Pen delivers the most
consistent FSH in the only ready-to-use pre-filled pen available on the
market."
To make infertility treatment easier and more accurate for patients, the
new GONAL-f(R) (FbM) Prefilled Pen is specifically designed for infertility
treatment and will be available in 3 multidose presentations; 300 IU/0.5 ml
(22 micron g/0.5 ml), 450 IU/0.75 ml (33 micron g/0.75 ml) and 900 IU/1.5 ml
(66 micron g/1.5 ml).
"This is the first ready-to-use pen that enables us to combine the
efficacy of the most consistent FSH with the flexibility to individualize the
dosing in ovulation induction and Assisted Reproductive Techniques for each
patient," said Professor Christoph Keck, M.D., from the Department of
Obstetrics and Gynecology of the University of Freiburg, Germany. "Having
GONAL-f(R) (FbM) in a pre-filled, ready-to-use pen will make the
administration easier for the patients, and help them to ensure that they have
injected the right dose."
The GONAL-f(R) (FbM) Prefilled Pen will continue to carry the same
indications as the currently marketed product for a) anovulation in women who
have been unresponsive to treatment with clomiphene citrate, b) stimulation of
multifollicular development in patients undergoing superovulation for assisted
reproductive technologies, c) in association with a luteinising hormone (LH)
preparation for the stimulation of follicular development in women with severe
LH and FSH deficiency and d) for stimulation of spermatogenesis in men who
have congenital or acquired hypogonadotrophic hypogonadism.
Serono expects the GONAL-f(R) (FbM) Prefilled Pen to be introduced in
Europe during the first half of this year.
Additional Product Information
GONAL-f(R) Filled-by-Mass (follitropin alpha) is a recombinant human
follicle-stimulating hormone, which is equivalent in its structure to the
naturally occurring human FSH in the body. GONAL-f(R) (FbM) is used in
clinical practice to treat infertile women and men with low or lacking
naturally occurring FSH. It is the world's leading treatment for male and
female infertility and is registered in more than 80 countries around the
world.
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), to stimulate
the ovaries and produce eggs; Luveris(R) (lutropin alfa), to stimulate
follicular development in women who are profoundly LH deficient; Cetrotide(R)
(cetrorelix acetate) to prevent a premature ovulation; Ovitrelle(R)
(choriogonadotropin alfa), to help follicles mature and release eggs; and
Crinone(R) (progesterone gel), to help establish and maintain a pregnancy.
For more information on infertility visit http://www.fertility.com and for
Serono's marketed fertility products visit http://www.serono.com (1)
About Serono
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (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.
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 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.
(1) These websites are not intended for US residents. US residents should
consult the Serono Inc. fertility website at http://www.seronofertility.com
or http://www.seronousa.com.
SOURCE Serono
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Related links:
http://www.serono.com
http://www.seronofertility.com http://www.seronousa.com
CONTACT:
Serono in Geneva, Switzerland: Media
Relations: +41-22-739-36-00, Fax: +41-22-739-30-85, or Investor
Relations: +41-22-739-36-01, Fax: +41-22-739-30-22; or Serono,
Inc., Rockland, MA, USA: Investor Relations: +1-781-681-2552,
Fax: +1-781-681-2912
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