Green light for Galen menopause drug

GALEN has received regulatory approval for its new menopause drug Femring.

Galen shares rose buy 9.5% after the US Food and Drug Administration gave the all-clear to sell the drug. The Craigavon-based firm plans to launch the drug in June and forecast sales of up to $100 million over three years.

The approval is another boost for Galen and its shares, which had fallen by 20% this year on concerns that some of its HRT treatments had adverse side effects. “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,” NCB analyst David Marshall said yesterday.

NCB forecast that sales of Femring would be $3.2m in the year to September, rising to $12.8m next year and $25.6m in 2005.

Galen chief executive Roger Boissonneault said: “As the baby boomer generation ages and an increasing number of women enter menopause, addressing the symptoms of menopause is a major health concern.” Up to 52 million women in the US expect to be over the age of 50 in the next decade, the target group age for the products.

Galen said current treatments such as oestrogen tablets or patches used by women were not as effective as Femring, which could provide a three-month treatment supply in just one dose, sparing the need to take a tablet every day.

“A single Femring delivers oestrogen at a steady and consistent rate during the three-month dosing period, offering women both dual symptom relief and convenient dosing,” the company said. Galen recently acquired three women’s health drugs from Pfizer’s for up to $484 million, a move that will nearly double its sales.