ROCKLAND, Mass., Sept. 25 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO
and NYSE: SRA) today announced the results of a Phase IIIb, prospective,
open-label study in which patients reported that they preferred the
Gonal-f(R) RFF Pen (follitropin alfa injection) to their previous fertility
treatment with conventional vials/ampules and syringes. The study was
published by the peer-reviewed journal Current Medical Research and Opinion
(http://www.cmrojournal.com).
"Patient satisfaction is a critical component to infertility treatment
success," said Stephen G. Somkuti, MD, PhD, the lead author and
coordinating investigator from Abington Reproductive Medicine, Abington,
PA. "By providing products that patients prefer, fertility centers may
minimize treatment dropout rates while increasing the chance of a positive
outcome."
All participants who stated an injection preference (n = 61/61) found
use of the Gonal-f(R) RFF Pen to be less stressful than methods involving
vials/ampules and syringes (95% confidence interval [94.1%, 100.0%]) and
would recommend it to other women considering gonadotropin treatment (p <
0.001). In addition, 89% (n = 54/61) of patients found instructions for
using the Pen very easy to understand compared with 29% (n = 17/59) who
found the same for vials/ampules and syringes. When using the Pen, a
significantly smaller proportion of patients contacted their healthcare
provider two or more times to ask questions about dose preparation (3%, n =
2/61) compared to when using vials/ampules and syringes (19%, n = 11/59, p
= 0.007).
"Serono is committed to advancing the field of reproductive health by
improving the patient experience," said David Stern, Executive Vice
President, Endocrinology, Serono, Inc. "This study strongly supports the
use of the Gonal-f(R) RFF Pen, which was designed to be quick and easy for
patients to use. Through other research, we also know that support services
such as Fertility LifeLines also help people manage their experience with
infertility." Patients can call Fertility LifeLines at 1-866-LETS-TRY
(1-866-538-7879) or visit http://www.fertilitylifelines.com for information
on Serono's fertility products as well as general information on
infertility and options on paying for treatment.
The most prescribed gonadotropin in the world, Gonal-f(R) is a highly
consistent recombinant form of human follicle stimulating hormone (r-hFSH)
prescribed to supplement or replace naturally occurring FSH, which
stimulates the development of follicles in the ovaries. A prefilled and
ready-to-use multi-dose device, Gonal-f(R) RFF Pen delivers a liquid
formulation of Gonal-f(R) RFF without needing to mix medications or load
cartridges.
About 12 percent of women (7.3 million) in the United States aged 15-44
had difficulty getting pregnant or carrying a baby to term in 2002,
according to the National Center for Health Statistics of the Centers for
Disease Control and Prevention(1). The majority of patients who complete
treatment eventually succeed in having a child(2).
About the Study
The Phase IIIb, prospective, open-label study was conducted at nine
fertility centers in the United States and included 62 premenopausal women
ages 18-40 years undergoing ovulation induction for oligoanovulatory
infertility. Using the Gonal-f(R) RFF Pen, patients administered a fixed
dose of recombinant follitropin alfa for 5 days followed by dose adjustment
if necessary until a lead follicle reached a mean diameter >/= 14 mm.
Eligible patients had undergone at least one treatment cycle of
gonadotropin therapy administered with vials/ampules and syringes within
the past 6 months. Patient satisfaction with prior gonadotropin therapy was
measured using a pre-treatment questionnaire while patient satisfaction
with the Gonal-f(R) RFF Pen was measured using an in-treatment
questionnaire as well as a post-treatment interview that asked participants
to compare their treatment experiences and choose a preferred injection
method. The primary endpoint was the proportion of patients who preferred
the Gonal-f(R) RFF Pen to vials/ampules and syringes. All patients who
completed the primary endpoint (61/61, 100%) preferred the Gonal-f(R) RFF
Pen. The majority of women ovulated (79%) and pregnancy was achieved in 12
women (20%). Of these 12 pregnancies, eight were clinical (fetal sac),
three were biochemical, and one was ectopic. No patients withdrew from the
study due to adverse events.
Safety Information
Side effects may occur with the use of infertility medications 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 gonadotropin treatment. Side
effects in women using Gonal-f(R) RFF Pen for infertility treatment may
include headache, stomach pain, bloating, nausea and injection site
bruising.
About Serono, Inc. and Fertility
Serono, Inc., a subsidiary of Serono S.A., is a leader in fertility
health, dedicated to developing patient-friendly, innovative products and
services that help people build families. It is the only company to offer a
full portfolio of fertility medications for every stage of the reproductive
cycle and recombinant versions of three hormones used in the treatment of
infertility, including the Gonal-f(R) RFF Pen (follitropin alfa injection).
About Serono
Serono, Inc., located in Rockland, Massachusetts, is the US affiliate
of Serono S.A., a global biotechnology leader, headquartered in Geneva,
Switzerland. The Company has seven recombinant products, Rebif(R)
(interferon beta-1a), Gonal-f(R) (follitropin alfa for injection),
Luveris(R) (lutropin alfa for injection), Ovidrel(R) Prefilled Syringe
(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] on the market in the
US.
Serono, S.A. is the world leader in reproductive health and has strong
market positions in neurology, metabolism and growth. Serono S.A.'s
research programs are focused on growing these businesses and on
establishing new therapeutic areas, including oncology and autoimmune
diseases.
In 2005, Serono, whose products are sold in over 90 countries, achieved
worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was
US$106.1 million, reflecting a charge of US$725 million taken relating to
the settlement of the US Attorney's Office investigation of Serostim(R).
Excluding this charge as well as other non-recurring items, adjusted net
income grew 28.4% to US$565.3 million in 2005. 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).
Package inserts for Serono's US marketed products are available at
http://www.fertilitylifelines.com or by calling 1-866-LETS-TRY (1-866-538-
7879).
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 US Securities and Exchange Commission on
February 28, 2006. 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, the outcome of government investigations and
litigation 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:
Dana Jessup
Tel. +1 781 681 2443
Fax: +1 781 681 2935
http://www.fertilitylifelines.com
Investor Relations:
Robert Bennett
Tel. +1 781 681 2552
Fax: +1 781 681 2912
http://www.seronousa.com
(1) Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility,
family planning, and reproductive health of U.S. women: Data from the 2002
National Survey of Family Growth. National Center for Health Statistics.
Vital Health Stat 23(25). 2005.
(2) Corson S. Conquering Infertility. Vancouver, BC:EMIS-Canada;1999.
SOURCE Serono, Inc.
 back to top
Related links:
http://www.seronousa.com
http://www.fertilitylifelines.com
CONTACT:
Dana Jessup (Media Relations), of Serono,
Inc., +1-781-681-2443; or Robert Bennett (Investor Relations),
+1-781-681-2552
|
