Galen outlines R&D progress

Northern Ireland-based drug delivery specialist Galen Holdings says, inits annual report for 2000, that it anticipates a significant increase in R&D expenditure this year, reflecting the activities associated with its efforts to gain approval for its estradiol intravaginal ring in both the UK and USA.

The company notes that it has as number of IVR products in development for hormone replacement therapy applications, the first of which is the estradiol product, for which a first marketing authorization application was filed in the UK in 1999. A launch in the UK, where the product has just been approved, is now anticipated in the next six months, and European introductions under the mutual recognition procedure are expected thereafter.

It also says that the Phase III placebo-controlled vasomotor study required for approval in the USA is fully enrolled, and Galen is targeting the submission of a New Drug Application in first-half 2001.