SERONO INTRODUCES TWO INNOVATIVE PRODUCTS TO ITS PORTFOLIO FOR FERTILITY TREATMENT IN THE US

06-Feb-2001

Serono S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) announces the launch of two new enhancements to its portfolio of patient-friendly fertility products in the US. Both new products--Ovidrel® and Cetrotide™--contribute to making infertility treatment simpler and more convenient for patients.

Ovidrel®1 (choriogonadotropin alfa for injection) is the first and only recombinant human chorionic gonadotropin (hCG) available in the world and the only hCG approved for administration by subcutaneous injection in the US. Ovidrel® is prescribed to women undergoing infertility treatment. It is used after ovarian stimulation with follicle stimulating hormone to help follicles mature in the ovaries of women undergoing assisted reproductive technologies (ART), such as in vitro fertilization. It is also used to trigger ovulation in infertile women with ovarian dysfunction.

For the first time, fertility specialists and patients will be able to use both recombinant hCG and recombinant follicle stimulating hormone (r-hFSH) in the course of a treatment cycle. Serono's recombinant method of manufacturing Ovidrel® and Gonal-F® (follitropin alfa for injection, r-hFSH) ensures purity and consistency and enables subcutaneous administration of these infertility medicines. For many women, the subcutaneous route of administration reduces the inconvenience and discomfort associated with infertility treatment because the subcutaneous route of injection requires a smaller needle and less painful injections than previously available hormone treatments.

1 Trade names differ between the US (Ovidrel®) and Europe (Ovidrelle®)

Cetrotide™ (cetrorelix acetate for injection), a gonadotropin releasing hormone (GnRH) antagonist, offers a new and convenient treatment to prevent premature ovulation in women undergoing controlled ovarian stimulation for ART. Cetrotide™ is unique in that it offers the simplicity and flexibility of a single 3 mg dose or daily 0.25 mg doses over 5-7 days administered by subcutaneous injection. The use of Cetrotide™ as part of infertility protocols results in a dramatic reduction in treatment duration and number of injections as compared to conventional therapies, using GnRH agonists, which could require up to 27 injections per treatment cycle.

"Infertile couples face many challenges in the course of their treatment," commented David Keefe, M.D., director of the infertility programs at New England Medical Center (Boston, MA) and Women and Infant's Hospital (Providence, RI). "These new products will make the course of infertility therapy simpler for patients because they mean fewer, easier to administer injections. This is especially important for the many women who juggle demanding careers with a course of infertility treatment."

Serono's vision is to develop and market innovative products to assist infertile couples at every stage of the reproductive cycle, from ovulation to early pregnancy, and to help them fulfill their dream of having a baby.

"The introduction of Ovidrel® and Cetrotide™ to the US infertility market are the latest examples of Serono's leadership in infertility treatment," said Mike Allen, Executive Vice President, Reproductive Health, Serono, Inc.

Serono's Patient-Friendly Fertility Products

In addition to Ovidrel® and Cetrotide™, Serono's reproductive health product portfolio includes Gonal-F® (follitropin alfa for injection), a follicle stimulating hormone that is subcutaneously administered for ovarian stimulation, and Crinone® (progesterone gel), a non-injectable form of progesterone therapy with a unique and convenient delivery system that is administered for luteal phase support. With the initial approval of Gonal-F® in 1995 in Europe, Serono was the first company to market a product derived from recombinant DNA technology for the treatment of infertility. Gonal-F® is the world's leading recombinant treatment for male and female in

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