Paris, France – 4 December 2007 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.

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About uterine fibroids

Uterine fibroids (also known as leiomyoma, uterine myoma or myomata) are the most common type of non-cancerous hormone-dependent tumor of the female reproductive system. The condition affects between 20-50% of women, and is most common in women between the ages of 30 and 50.  Approximately 8-16 million women in Europe have fibroids, of which some 800,000 to 3.2 million have symptoms that could require treatment ranging from heavy bleeding and pain to urinary incontinence and infertility. Treatment most frequently consists of surgery, and interventional radiology.

About HRA Pharma
HRA Pharma is a private pharmaceutical company based in Paris, France. The Company creates innovative medicines and products for women’s and reproductive health, endocrine diseases and cell-based therapies.

HRA Pharma has a proven track record of developing and commercializing products in its key therapeutic areas. Its first product, NorLevo^® emergency contraception, launched in France in 1999, is now available in over 60 countries. The Company’s other products include Gymiso^®, a prostaglandin for use in obstetrics and gynecology, Cicatridine^® which promotes vaginal healing, Mona-Lisa^®, a copper contraceptive IUD (intrauterine device), and Lysodren^®, for the treatment of adrenal cortical carcinoma. Three of HRA’s products have been recognized by the French regulatory authorities for their usefulness to patients. In addition, HRA also has distribution rights in France for eight products from Orion Pharma's (Finland) portfolio in the fields of oncology, pneumology, gynecology and neurology.

As well as its marketed products, the Company has an internal pipeline of new products in development in women’s and reproductive health and hormonal cancer therapy. HRA is also developing cell medicines for the treatment of anal and urinary incontinence and ocular myopathy through its subsidiary Celogos, a biotech company also based in France.

HRA Pharma was founded by a team of medical specialists who genuinely care about global healthcare. The Company has invested significant effort in establishing strong links with international NGOs and local authorities, which enable it to help meet the needs of women who might otherwise be unable to afford appropriate treatments/products.

For further information please visit the website at www.hra-pharma.com

About PregLem
PregLem SA is a Swiss specialty biopharmaceutical company, founded in Geneva in 2006, by Ernest Loumaye and Eric Rolin. PregLem is focused on the development and commercialization of innovative therapeutic compounds for improving the treatment of significant benign gynecological conditions and infertility. PregLem has products at pre-clinical and clinical stages of development and is seeking further partnerships and in-licensing opportunities at various stages of development. For more information: www.preglem.com  

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