Study Shows Patient Preference for Gonal-f(R) RFF Pen to Treat Infertility
26 September 2006 - 1:00AM
PR Newswire (US)
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. DATASOURCE: Serono,
Inc. CONTACT: Dana Jessup (Media Relations), of Serono, Inc.,
+1-781-681-2443; or Robert Bennett (Investor Relations),
+1-781-681-2552 Web site: http://www.seronousa.com/
http://www.fertilitylifelines.com/
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