Galen's first IVR product approvable in UK for HRT

Northern Ireland-based specialty pharmaceutical company Galen Holdingshas received an approvable letter from the UK Committee on Safety of Medicines for its first intravaginal ring-based product.

Galen's proprietary IVR delivery system can be used to deliver a range of medicines for up to three months and, in this first application, it will deliver estradiol for the relief of post-menopausal systems. The company anticipates authorization to begin marketing the hormone replacement therapy product in the UK in the coming months, and says it will subsequently be submitted for approval through the European Union mutual recognition procedure.

The company's executive chairman, John King, noted that Galen has enlarged its UK sales and marketing organization in anticipation of the UK approval of the estradiol IVR and is ready to initiate its launch plan. In addition, Phase III clinical activities in the USA are nearing completion, and the company anticipates filing a New Drug Approval application for the product in the first half of this year.