PEARL II study meets both primary efficacy and safety endpoints PEARL I results expected in June 2010
Geneva, Switzerland, 18 May 2010 – PregLem, the European specialty biopharmaceutical company focused on women’s reproductive medicine, announces positive Phase III results of Esmya™ (ulipristal acetate) for the treatment of symptomatic uterine fibroids (myoma).
The PEARL II study assessed the efficacy and safety of Esmya™ compared to the only currently approved treatment, a GnRH (gonadotropin-releasing hormone) agonist.
The PEARL II study was designed to assess the efficacy and safety of Esmya™ , an oral therapy, compared to the injectable GnRH agonist Leuprorelin, for the treatment of symptomatic uterine fibroids in patients eligible for surgery. This randomised, parallel group, double-blind, double-dummy, multi-center study involved a total of 307 patients and compared Esmya™ 5mg or 10mg orally, once-a-day with Leuprorelin 3.75 mg monthly injections.
The study met its primary efficacy and safety endpoints. Esmya™ met the pre-defined, non inferiority efficacy endpoint versus Leuprorelin to reduce excessive uterine bleeding caused by uterine myomas. The primary endpoint was change from baseline in the bleeding intensity score. This was measured as a percentage of patients with a reduction of PBAC (Pictorial Blood Assessment Chart) score to lower than 75 after 3 months of treatment. Esmya™ demonstrated superior safety and tolerance with statistical significance versus Leuprorelin regarding castration-related symptoms and their consequences. The principal parameters were serum oestradiol levels and hot flushes.
Prof. Jacques Donnez, from Louvain University (Belgium), the Principal investigator said:
“These data are very promising. There has been a lack of innovative and effective products to treat uterine fibroids. This is a significant and distressing problem for many women and has a serious impact on their lives. These results clearly illustrate the potential for Esmya™ to offer an effective and well tolerated treatment for this condition.”
Ernest Loumaye, CEO & Co-Founder of PregLem, said:
“These results are a major milestone for PregLem. The data clearly demonstrate that Esmya™ is effective in rapidly controlling bleeding, reducing pain, reducing fibroid size and improving the patient’s quality of life. It has the potential to be the first effective medical treatment for this condition with no serious side effects for millions of women around the world. We expect results from the PEARL I Study in June 2010. Based on these results, PregLem plans to file a Marketing Authorization Application (MAA) with the European Health Authorities by Q4 2010.”
Uterine fibroids affect approximately 40% of women between the ages of 35 and 55, including 24 million women in Europe and over 20 million women in North America. The condition is characterised by excessive uterine bleeding, anaemia, pain and infertility. It significantly impairs the quality of life for many women, leading in many cases to a hysterectomy. There are no effective, well tolerated medical treatments available. GnRH agonists are the only approved treatment of symptomatic uterine fibroids but the use has been relatively limited due to their side effect profile which causes suppression of oestrogen to castration levels, resulting in hot flushes, depression, mood swings, loss of libido, vaginitis and loss of bone mineral density.
For further information, please contact:
Tel: +41 (0)22 884 03 40
Mary Clark, Supriya Mathur
Tel: +44 (0)20 7307 5330
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.
Visit www.preglem.com for more information.
Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues. PregLem’s Phase III programme for Esmya™ consists of two separate, parallel, randomised, double-blind studies identified as PEARL I and PEARL II. Together the Phase III trial involves 540 patients in 14 countries at 5mg and 10mg doses.