Serono receives FDA approval for Gonal-f RFF Pen to treat infertility

Geneva, Switzerland and Rockland, MA, May 27, 2004 -- Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that the United States Food and Drug Administration (FDA) has approved a prefilled device that delivers a new liquid formulation of the most prescribed gonadotropin in the world: Gonal-f RFF Pen (follitropin alfa injection).

Gonal-f RFF Pen is the first and only prefilled and ready-to-use multi-dose FSH (follicle stimulating hormone) in the US. It will be available in three sizes that deliver either 300 IU, 450 IU or 900 IU of liquid Gonal-f filled-by-mass, which can be administered in multiple doses. Developed to make infertility treatment easier, it provides patients with a new way to administer Gonal-f by simply dialing the correct dose without the need to mix medication or load cartridges. It was designed specifically for the treatment of infertility to allow patients to easily and accurately deliver a precise daily dose of medication.

"We are proud to be the first company to offer a prefilled and ready-to-use pen, providing a new option for infertility patients that is easy and simple to use, " said Bharat Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc. "Serono is the world leader in reproductive health, and we are again demonstrating our commitment to continually improve the patient experience. Gonal-f RFF Pen, in addition to our multi-dose and single-dose vial presentations, gives us the most extensive and complete portfolio of infertility products to allow for enhanced dosing flexibility and individualized treatment." Serono expects Gonal-f RFF Pen to be available in the US in Q3 of this year.

Gonal-f RFF Pen is indicated for induction of ovulation and pregnancy in anovuluatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. It is also indicated for the development of multiple follicles in ovulatory women part

Contact: Aimee White
Edelman Public Relations

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