Galen gets US OK for Femring

Northern Ireland's Galen Holdings has been granted US Food and DrugAdministration approval to market Femring (estradiol acetate), its vaginal ring product for the treatment of hot flashes and vaginal symptoms in post-hysterectomy, post-menopausal women. Femring is already available in Europe (it is sold in the UK as Menoring), but the USA is expected to be the major market for the product as there are around 600,000 hysterectomies in the USA each year.

Galen notes that Femring is the first estrogen replacement therapy product to be cleared in the USA to treat both hot flashes and vaginal symptoms in these patients and releases the hormone over three months, offering convenience and stable blood levels in comparison to oral estrogen tablets.

Analysts at Merrill Lynch says they expect the product to be priced at around $75 per ring on its introduction in the USA, which is expected to take place in June. However, they predict significant sampling activities to take place after launch as the product makes inroads into the ERT market. Femring will be available in two strengths, 0.05 mg/day or 0.1 mg/day.