September 25, 2006

                        
Study Shows Patient Preference for Gonal-F ® RFF Pen to Treat  Infertility

(Rockland, MA)  – 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® RFF Pen (follitropin alfa injection) to their previous fertility treatment with conventional vials/ampules and syringes.  The study was published last week by the peer-reviewed journal Current Medical Research and Opinion (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® 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® 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 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® 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® RFF Pen delivers a liquid formulation of Gonal-f® 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.   The majority of patients who complete treatment eventually succeed in having a child.

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® 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® 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® RFF Pen to vials/ampules and syringes.  All patients who completed the primary endpoint (61/61, 100%) preferred the Gonal-f® 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® 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® 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® (interferon beta-1a), Gonal-f® (follitropin alfa for injection), Luveris® (lutropin alfa for injection), Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection), Serostim® [somatropin (rDNA origin) for injection], Saizen® [somatropin (rDNA origin) for injection] and Zorbtive™ [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®. 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 www.fertilitylifelines.com or by calling 1-866-LETS-TRY (1-866-538-7879).

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FOR IMMEDIATE RELEASE

July 19, 2005

Abington Reproductive Medicine to Test Accuracy of Ovulation Predictor
Clinical Trial Results to Significantly Assist Infertile Couples

(Abington, PA) – Abington Reproductive Medicine, the area’s premiere reproductive endocrinology and infertility practice, is one of three privileged medical practices launching a clinical trial testing the accuracy of an FDA-approved fertility and ovulation predictor. The predictor, named FertiliTrac, is manufactured by BioSense Corporation, a Doylestown, PA-based company specializing in diagnostic devices for female reproductive health and related pathologies.

The FertiliTrac is a small device that resembles a thermometer. It is used as an accurate method of natural family planning and also as a way to increase chances of conception. Trial participants will use the device to obtain daily ovulation readings for 90 consecutive days while recording their experiences in a diary. The study will also involve simple laboratory and ultrasound monitoring.

Dr. Stephen Somkuti, M.D., Ph.D. will lead the trial at Abington Reproductive Medicine. Somkuti is the director of the Toll Center for Reproductive Sciences and serves in the Division of Reproductive Endocrinology, Department OB/GYN at Abington Memorial Hospital.

“The results of this study will help infertile patients all over the world achieve their ultimate goal – pregnancy,” Somkuti says. “Working with BioSense on this project is an honor and reaffirms Abington Reproductive Medicine’s commitment to women’s health and fertility.”

Concurrent trials of FertiliTrac as it relates to cervical cancer detection and screening for preterm birth are simultaneously occurring under the direction of two physicians at Temple University Hospital. Confirmation of FertiliTrac’s utility in each area of study will arm physicians everywhere with the means to provide patients with faster, less expensive and more accurate reproductive health diagnoses.   

To become a trial participant or receive more information, please call Abington Reproductive Medicine at 215-887-2010, x110 or visit www.abington-repromed.com. All participants will receive compensation upon completion of the study.

About Abington Reproductive Medicine

Abington Reproductive Medicine (ARM) is committed to developing close, caring relationships with patients. Using the latest technology and equipment, the practice provides cost effective and cost-conscious care, without sacrificing personal attention. ARM offers patients treatments such as Autologous Endometrial Coculture (AEC), which was co-developed by Larry Barmat, M.D., and Preimplantation Genetic Diagnosis (PGD). As one of the few practices in the world to perform AEC on a regular basis, ARM was noted in the March 2003 issue of Popular Science. Through groundbreaking procedures like AEC and PGD, the practice continues to help growing numbers of couples and singles fulfill their dreams of having children. ARM is located in the Abington IVF and Genetics, Toll Center for Reproductive Medicine at Abington Memorial Hospital in Abington, Pennsylvania.

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