Galen lifted by HRT approval

Pharmaceutical firm Galen cheered investors today after it emerged its hormone replacement treatment had been given the thumbs up by US regulators.

Galen has received an approval letter from the Food and Drug Administration and will now work with the regulator on labelling before launching in the US.

Chief executive Roger Boissonneault called the step a “great achievement”.

“The US is the most significant market for this product and we believe that this innovative form of delivery will be well received by the patient,” he added.

“We look forward to finalising labelling with the FDA and preparing our sales and marketing team for launch.”

Used to treat symptoms of the menopause, the oestrogen replacement delivery system is an intra-vaginal ring which delivers 50 or 100 micrograms of the drug a day over a three-month period.

Hormone replacement therapy (HRT) is usually taken in tablet form.

It will be manufactured by Galen at its facility in Larne, Northern Ireland and marketed in the US by its subsidiary Warner Chilcott.

Analysts are expecting the US launch in early 2003 and news this was on track cheered the City. Shares rose 25p to 427.5p – a 6% jump.

Galen, based in Craigavon, Northern Ireland, develops and manufactures branded prescription pharmaceutical products and has already launched the hormone device in the UK under the brand name Menoring.

The group’s core areas are women’s health, analgesics and incontinence.