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/

Copyright