US approval for Galen hormone drug seen as breakthrough

Northern Ireland drug company Galen has won approval from the US Food and Drugs Administration (FDA) for a hormone replacement therapy (HRT) product.

The approval, subject to agreement over labelling, comes just days after Germany's pharmaceutical giant Schering failed to secure FDA sanction for its key hormone treatment.

The approval is seen as a breakthrough by the company, which bought US prescription drug group Warner Chilcott in 2000.

"It is the most significant in-house technology and this is the first US approval we have obtained for it," said Mr David Kelly, senior vice-president, finance and planning, with the Co Armagh-based group. "In that sense it is a trailblazer, although we do market two oestrogen replacement therapies acquired from Bristol Myers Squibb in the US."

Galen now hopes to introduce the product into the key US market early next year. It will manufacture the product at its plant in Larne, Co Antrim, and distribute it through Warner Chilcott.

The company anticipates developing the US market gradually but has pencilled in peak sales of between $50 million (€51.5 million) and $100 million for the treatment.

That would be substantial for a company that last year reported full-year sales across its product range of £183 million sterling (€292 million) last year. Peak sales' levels in the US are not expected for three to four years.

Mr Roger Boissonneault, chief executive, said: "This approval is a great achievement for the Galen team, both in the United States and Northern Ireland. The US is the most significant market for this product and we believe this innovative form of delivery will be well received by the patient."

The estradiol acetate intra-vaginal ring already sells in Britain under the name Menoring. It delivers between 50 and 100 micrograms of drug over a 90-day period to women in menopause.

HRT has spooked investors and regulators since US rival Wyeth hit trouble in July. A large US study showed that women taking Wyeth's hormone replacement Prempro had increased risks of breast cancer, stroke and heart disease.

Mr Kelly said the company's success in getting the FDA to permit use of the treatment in the US was a relief after the bad press received over the Wyeth study. "We've been fighting fires on the issue of the safety of these treatments for the last three months. What this approval shows is that, with a well-thought through and presented application, you can still get products through the FDA."

Galen shares, which have suffered in the wake of the controversy over HRT treatments in the US, moved ahead by almost 7.5 per cent in London trading to 432.5 pence sterling. In Dublin, where there is little trade in the stock, the share was stable on €6.40.

There had been fears in the market that the treatment would fail to get the necessary approval because of concerns over side effects exposed in the Wyeth study. Galen has consistently argued that its treatment does not suffer from similar problems.

The approval granted yesterday is the penultimate stage in the FDA vetting process before marketing of the drug is permitted.