New presentations allow for maximum dosing flexibility and ease of use
ROCKLAND, Mass., March 29 /PRNewswire-FirstCall/ -- Serono
(NYSE: SRA; virt-x: SEO) -- Serono, Inc., the US affiliate of Serono,
announced today that the US Food and Drug Administration (FDA) has approved
new presentations of Gonal-f(R) (follitropin alfa for injection) including a
450 IU multi-dose vial and a 75 IU mono-dose vial. Serono is the leader in
reproductive health, and Gonal-f(R) is the most prescribed gonadotropin in the
world.
The new presentations of Gonal-f(R) expand Serono's portfolio of
infertility treatments to allow for maximum dosing flexibility and ease of
use. "We are very pleased with the approval of the new presentations of
Gonal-f(R)," said Bharat Tewarie, MD, Executive Vice President, Reproductive
Health, Serono, Inc. "We believe these products will provide our customers
with the optimal flexibility they require to tailor treatment to individual
patient needs and all treatment protocols."
The new 450 IU multi-dose vial will be available in addition to the
currently marketed multi-dose presentation, while the new 75 IU mono-dose vial
will replace the current ampules. Gonal-f(R) is indicated for induction of
ovulation and pregnancy as part of hormonal treatment for infertility and
development of multiple follicles as part of an assisted reproductive
technology program. Serono expects the new Gonal-f(R) presentations to be
introduced in the US in Q2.
Gonal-f(R) is a highly consistent recombinant human follicle stimulating
hormone (r-hFSH) prescribed to supplement or replace naturally occurring FSH,
which stimulates the development of follicles in the ovaries. It is the only
FSH available in multi-dose and mono-dose vials for maximum dosing flexibility
and individualized treatment.
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. About 70% of patients who are treated
succeed in having children.
Additional Information
Side effects may occur with the use of infertility drugs and, therefore,
they 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. Reports of multiple births have been associated
with Gonal-f(R) treatment. Side effects in women using Gonal-f(R) for
ovulation induction may include headache, ovarian cysts and nausea.
About Serono, Inc. and Infertility
Serono, Inc. is dedicated to providing patient-friendly, innovative
products to help couples build families. It is the only company to offer a
full portfolio of fertility drugs for every stage of the reproductive cycle
and recombinant versions of two hormones needed to treat infertility.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a
global biotechnology leader, headquartered in Geneva, Switzerland. Serono has
seven recombinant products, Rebif(R) (interferon beta-1a), Gonal-F(R)
(follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa injection), Serostim(R)
[somatropin (rDNA origin) for injection], Saizen(R) [somatropin (rDNA origin)
for injection] and Zorbtive(TM) [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. Serono'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).
(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 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.
For more information, please contact:
Serono, Inc., Rockland, MA
Media Relations: Investor Relations:
Tel. +1 781 681 2340 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
Serono in Geneva, Switzerland:
Media Relations: Investor Relations:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 30 85 Fax: +41-22-739 30 22
http://www.serono.com Reuters: SEOZ.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:
Serono, Inc., Media, +1-781-681-2340, or Fax,
+1-781-681-2935, Investors, +1-781-681-2552, or Fax,
+1-781-681-2912; or Serono in Geneva, Switzerland, Media,
+41-22-739-36-00, Fax, +41-22-739-30-85, Investors,
+41-22-739-36-01, or +41-22-739-30-22
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