PregLem licenses additional rights for ulipristal acetate from HRA Pharma to develop a first-in-class myoma (fibroids) treatment for North American market

PregLem licenses additional rights for ulipristal acetate from HRA Pharma to develop a first-in-class myoma (fibroids) treatment for North American market
April 12, 2010 Irene Tamayo

Geneva, Switzerland and Paris France – 12 April 2010: PregLem, the European specialty biopharmaceutical company focused on women’s reproductive medicine and HRA Pharma, a privately-held European pharmaceutical company active in reproductive health and
endocrinology, announce that they have signed an agreement giving Preglem rights to develop and commercialise ulipristal acetate for benign gynaecological disorders in North America. PregLem is already developing ulipristal acetate – known as EsmyaTM– for the treatment of uterine myoma (fibroids) in Europe. It will now complete the development of Esmya™ for the North American market in uterine fibroids.

Over 20 million women in the United States and Canada suffer from symptomatic uterine myoma, a condition characterised by excessive uterine bleeding, anaemia, pain and infertility. It affects women between the ages of 35 and 50, significantly impairing quality of life. Current treatments are sub-optimal and result in many cases in hysterectomy. Approximately 600,000 hysterectomies are performed annually in the US with uterine myoma as the most common primary cause for the procedure*.

PregLem’s ongoing Phase III programme for EsmyaTM consists of two separate, parallel, randomised, double-blind studies identified as PEARL I and PEARL II. Together the Phase III trials involve 540 patients in 14 countries at 5mg and 10mg doses. Patient treatment has been completed and the final results from both studies are expected by Q3 2010.

PregLem plans to file a Marketing Authorization Application (MAA) with the European Health Authorities shortly after the release of the Phase III results. The company is currently evaluating several options for commercialization in Europe and North America.

Ernest Loumaye, CEO & Co-Founder of PregLem, said:
“The phase II results have shown that EsmyaTM is an effective treatment for myomas as it rapidly controls bleeding and significantly reduces myoma size. This product has the potential to be the first effective medical treatment for this condition with no serious side effects. We are delighted to have extended our rights to this compound which enables PregLem to develop this promising treatment for millions of women in North America.” Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues.

HRA Pharma retains the rights for development and commercialisation of ulipristal acetate for the treatment of uterine myoma at the exclusion of Europe and North America. To date, over 4000 patients have been exposed by both companies to either single or multiple doses
of the product, with no significant adverse events observed.

Erin Gainer, CEO of HRA Pharma, said:
“HRA Pharma has been built on the idea of serving unmet needs in reproductive health. We have identified ulipristal acetate at pre-clinical stage as an innovative and promising compound for contraception and gynaecological disorders, and we advanced it to clinical stage in these fields. Today we are pleased to reinforce our partnership with PregLem in North America.”

* MedTech Insights; Women’s health US markets for benign uterine management products;
2007, US Surgical procedures Volume; 2009


For further information, please contact:

Solveig Hole
CEO Office
PregLem SA
Tel: +41 (0)22 884 03 40

Capital MS&L:
Mary Clark, Supriya Mathur
Tel: +44 (0)20 7307 5330
HRA Pharma
Christina Aplington
Tel: +33 (0)1 42 22 24 10

About PregLem
PregLem is a European speciality biopharmaceutical company, dedicated to the development and commercialization of a new class of drugs for women’s reproductive health conditions. PregLem has an experienced senior management team, with a proven track record in developing, registering and commercializing reproductive health products. The company is backed by a blue chip investor base.

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About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs to promote healthy management of drugs and diseases. Headquartered in Paris, France and with offices in Germany, Italy, Spain, France and the UK, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical patient needs and improve patient health in over 50 countries across the globe.

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