October 18, 2004

SERONO'S LUVERIS APPROVED BY FDA

Serono SA received Food and Drug Administration approval for its pharmaceutical name Luveris (lutropin alfa for injection) to be used in combination with the firm's Gonal-f (follitropin alfa for injection) to stimulate follicular development in infertile, hypogonadotropic hypogonadal (HH) women who have profound luteinizing hormone (LH) deficiency.

Serono said HH is a rare endocrine deficiency in which women are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support implantation of a fertilized egg and early pregnancy.

Luveris is the first recombinant form of LH to receive approval from the FDA, making Serono the only company to market three recombinant fertility hormones in the United States. Serono said it will complete a phase-out of its older-generation urinary products (with the exception of the Japanese market) by the end of 2004.

Luveris has been designated an orphan drug by the FDA. According to Reuters, analysts expect the pharma brand to generate peak annual sales in the range of $40 million to $50 million worldwide.

May 28, 2004

GONAL-F PEN APPROVED FOR TREATING INFERTILITY

The Food and Drug Administration approved Serono SA's Gonal-f RFF Pen (follitropin alfa injection) for use in the treatment of infertility.

Available in 300, 450 or 900 international units of liquid Gonal-f filled-by-mass, the prefilled Gonal-f RFF Pen is a multiple-dose follicle-stimulating hormone designed to allow easy and accurate dose delivery.

The product is indicated for inducing ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. The pharma brand is also indicated to develop multiple follicles in ovulatory women who are participating in assisted reproductive technology programs.

The hormone works to supplement or replace follicle-stimulating hormones that naturally occur and stimulate follicles in the ovaries.

Serono expects the product will be available in the United States in the third quarter.