HRA Pharma enters licensing agreement with PregLem to develop and commercialise ulipristal for gynecological disorders
HRA Pharma, a pharmaceutical company developing and marketing innovative medicines and products for women's health and endocrine diseases, announced today that it has entered into a licensing agreement with PregLem, for the European development and commercialisation of HRA Pharma’s selective progesterone receptor modulator, ulipristal, for the treatment of various benign gynecological disorders. PregLem is a Swiss specialty biopharmaceutical company specialised in the treatment of significant benign gynecological conditions and infertility.
HRA Pharma retains the rights for development and commercialisation of ulipristal in the rest of the world. HRA Pharma will receive payments from PregLem upon the achievement of specific development and regulatory milestones as well as royalties on sales. HRA Pharma has already successfully completed a Phase II clinical trial for ulipristal to treat uterine fibroids. PregLem will further develop ulipristal in this indication by undertaking a pivotal Phase III program in 2008.
Dr André Ulmann, CEO of HRA Pharma said, “We are delighted to enter into this agreement with PregLem. We believe that our drug constitutes a true innovation in treatments for women’s health and we are convinced that PregLem will successfully realize its potential.†Dr Ernest Loumaye, CEO of PregLem, said: “As yet, there is no entirely effective and well-tolerated pharmacological treatment for uterine fibroids, a condition which affects millions of women each year. We are excited about the prospect of developing ulipristal treatment for this and other gynaecological disorders. Ulipristal has shown promising results in trials to date.†HRA Pharma is also developing ulipristal in a range of contraceptives. The drug is currently undergoing Phase III trials in the US and EU as a second-generation post-coital contraceptive. Development is also underway in collaboration with the Population Council for using ulipristal as a regular contraceptive in novel delivery systems.