US drug approval boosts Galen 12 per cent

Shares in Craigavon-based pharmaceutical firm, Galen, climbed by 12 per cent yesterday after the company won its first US regulatory approval for an internally-developed drug.

The Food and Drug Administration (FDA) has authorised US sales of Femring, a vaginal oestrogen product designed to treat menopausal symptoms. The US market for such treatments, currently worth more than $1 billion (Eur 0.94 billion) every year, is the world's largest because of a high incidence of hysterectomies among American women.

Galen executive chairman, Dr John King, described the FDA final approval as "a very important strategic step for the company".

He said Femring, which will go to market slightly behind schedule in June, would not make a "material" contribution this year. He predicted annual revenues for the product of more than $50 million from 2007 onward.

Galen says Femring, a self-inserted ring, offers a more effective response to menopausal problems than existing products because it offers relief from both vaginal symptoms and hot flushes in one treatment.

Analysts welcomed the approval, noting that it set a positive precedent for the remainder of Galen's pipeline drugs.

"Femring is the first product which Galen has developed and taken through the FDA approval process and as such is an important milestone for the company," said NCB analyst, Mr David Marshall. Galen's shares closed 61 cents higher at Eur 5.71 last night.