Shares in Northern Ireland pharmaceuticals group Galen have risen strongly. The group said British regulators had agreed in principle to allow it to market an intra-vaginal ring (IVR) for the delivery of hormone replacement therapy. The shares closed 30p higher on 820p sterling (€5.23).
The device, the first in a range of similar products under development, offers an alternative to patches and pills. The silicone ring is inserted vaginally and works for up to three months.
Galen has received an "approvable letter" from the UK Committee on Safety of Medicines for its first IVR. It delivers oestrogen and is aimed principally at women who have undergone a hysterectomy.
Galen's chairman, Mr John King, hopes to receive final UK approval for the product in March or April, pending agreement on its label. The launch will follow shortly afterwards. The IVR will be marketed in Europe 12-18 months later. The firm plans to file for approval with US regulators around April or May this year.
"This is the first rung of the ladder. This product range, after a period of four to five years, could have potential turnover of around $100 million (€106.7 million) a year internationally," Mr King said.
In addition to delivering oestrogen via the IVR, Galen is investigating delivery of other hormones and anti-infective agents.
Analysts said the introduction of the IVR product range would help shift Galen's pharmaceutical product mix towards higher-margin branded items.
Dublin-based group Elan has also announced new developments. It said it had obtained positive results from Phase II testing of its Antegren drug for the treatment of multiple sclerosis and Crohn's disease. Elan and its partner, US group Biogen, are proceeding to Phase III trials and will be conferring with regulatory authorities.
Elan's chairman, Mr Donal Geaney, said: "We are delighted that these positive results support the continued and accelerated development of Antegren as a potentially important new therapy for the treatment of MS and Crohn's disease."
The announcement pushed Elan shares ahead on the New York Stock Exchange where they were trading almost $1 higher on $49.63 at lunchtime.
