Warner Chilcott gets approval for new menopause treatment

Dublin and New York-listed Warner Chilcott expects to launch a hormone treatment for women on the US market in the first quarter of next year, after successfully getting regulatory approval for the product.

The company announced yesterday that the US Food and Drug Administration (FDA) had approved its product, Femtrace, for some symptoms of menopause.

Warner Chilcott filed the new drug application (NDA) last December. Following yesterday's announcement, the company said that it expected to begin selling the drug in the US during the first quarter of 2005.

The company is also awaiting the outcome of applications for another hormone treatment, Femhrt, and Doryx, an antibiotic for the treatment of acne.

It also revealed yesterday that it plans to file an application for a psoriasis treatment, Dovobet. It has agreed to license the drug from Leo Pharma to sell it in the US if it gets FDA approval. Dovobet is already approved and sold in 23 other countries.

Warner Chilcott'soperating profits dropped 6 per cent year-on-year to $40.6 million (€33.5 million) in its third quarter, which ended in June. Revenue fell by 12.5 per cent to $119 million, but sales from continuing operations grew 13 per cent to €113 million.

The company said that sales of its anti-depressant, Sarafem, had recorded a near 70 per cent drop in the period to $6.7 million. Market forecasts expected a figure of between $14 million and $19 million.

Last month the company won a legal battle in the US preventing a competitor from selling a generic version of Sarafem. Losing the case could have cost it 15 per cent of its earnings, analysts said.