ROCKLAND, Md., Sept. 30 /PRNewswire/ -- Serono, Inc. announced today that
the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) issued a favorable recommendation for Luveris(R) in
Serono's proposed indication of follicular development. Luveris(R) (lutropin
alfa for injection) administered with follitropin alfa for injection, is
proposed for the indication of stimulation of follicular development in
infertile hypogonadotropic hypogonadal (HH) women with profound luteinizing
hormone deficiency (LH < 1.2 IU/L). HH is a rare endocrine deficiency
affecting between 2,800 and 5,600 women in the US and can range from mild to
severe.
The FDA had previously recommended that Serono study an endpoint of
ovulation rates, an endpoint frequently used for products in ovulation
induction. However, the Committee agreed that in this rare patient population
the endpoint of follicular development was appropriate.
"We are very pleased with the recommendation of the Advisory Committee
supporting the efficacy of Luveris(R) for follicular development in this rare
patient population and will continue to work closely with the FDA as it
finalizes its review of this important new treatment," said Paul Lammers, MD,
Chief Medical Officer, Serono, Inc. "Serono's development of Luveris(R) is
part of our ongoing commitment to reproductive health and our leadership role
in this area. Luveris(R) is the third of three recombinant fertility hormones
developed exclusively by Serono."
Luveris(R) is a recombinant form of luteinizing hormone (LH), a naturally
occurring fertility hormone. It is the first and only drug product to contain
LH exclusively that can address the unmet medical need for fertility treatment
by profoundly LH deficient women. Women whose opportunities for pregnancy are
limited by profound LH deficiency have no available treatment approved
specifically for their condition. These women lack the ability to produce the
hormones needed for full development of follicles in the ovaries, ovulation,
and growth of the lining of the uterus sufficient to support implantation of a
fertilized egg and early pregnancy.
The Advisory Committee's recommendation was based on a review of the
clinical development program conducted in patients with this rare condition,
including a phase III confirmatory, double-blind, placebo-controlled,
randomized trial. In this trial, patients were treated with either Luveris(R)
or placebo, co-administered with Serono's recombinant follicle stimulating
hormone (r-hFSH), Gonal-f(R) (follitropin alfa for injection). In the
Luveris(R) and Gonal-f(R) treatment group, 17 patients (65.4%) achieved the
primary endpoint of follicular development compared to two patients (15.4%) in
the placebo and Gonal-f(R) group. The four-fold difference between the two
groups was both clinically meaningful and statistically significant (p=0.006).
In these studies, Luveris(R) was well tolerated with reported adverse
events similar to those of other currently approved recombinant gonadotropin
products.
The Advisory Committee recommendation is considered by the FDA in making
its decision regarding Luveris(R), which is expected before the end of this
year. Luveris(R) received an Orphan Drug Designation from the FDA and is
currently approved for the treatment of women with profound LH deficiency in
46 countries worldwide, including countries of the European Union such as
France, Germany and the United Kingdom.
Serono and Infertility Treatment
Serono, the global leader in infertility, 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.) 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).
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
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Related links:
http://www.seronofertility.com
http://www.seronousa.com http://www.serono.com
CONTACT:
Media, +1-781-681-2340, or fax,
+1-781-681-2935, or Investors, +1-781-681-2552, or fax,
+1-781-681-2912, both of Serono, Inc.; or Media,
+41-22-739-36-00, or fax, +41-22-739-30-85, or Investors,
+41-22-739-36-01, or fax, +41-22-739 30 22, both of Serono S.A.
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