The News

HRA pharma and Preglem announce successful completion of phase IIB for ulipristal acetate for the treatment of uterine fibroids

11/05/2009

•Results fully support the design of PregLem’s ongoing Phase III program
•First in class product developed to treat uterine fibroids

Paris, France and Geneva, Switzerland – 11 May 2009: HRA Pharma (www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, and PregLem, the Swiss biopharmaceutical company specializing in women’s reproductive medicine, today announced successful completion of the Phase IIb study of the compound ulipristal acetate for the treatment of uterine fibroids. The protocol was a follow-on to the recently-published Phase IIa trial which demonstrated in a placebo-controlled design that ulipristal acetate is effective in rapidly controlling bleeding and reducing fibroid volume in women with symptomatic uterine fibroids (Obstet & Gynecol2008;111(5):1129-36).

Ulipristal acetate (also known as CDB-2914 and PGL4001) is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues. The phase IIb trial was a double-blind, placebo-controlled, dose finding study of 40 patients with symptomatic uterine fibroids. Ulipristal acetate or a matching placebo was administered for 12 weeks. The primary outcome measures were shrinkage of fibroids and patient quality of life. The trial was conducted by the US National Institutes of Health (NIH) under IND and the leadership of Dr Lynnette Nieman. 

Ernest Loumaye, CEO of PregLem, commented:
“PGL4001 is the first potential medical treatment for uterine fibroids that rapidly controls the bleeding and effectively reduces the size of fibroids. We are pleased to observe the excellent efficacy of PGL4001 in quickly and sustainably controlling the symptoms related to fibroids.
Our Phase III programme which consists of two separate parallel, randomised trials is ongoing (called PEARL I&II). It involves 540 patients in 14 countries, and we remain confident to deliver results by mid 2010.”

Erin Gainer, CEO of HRA Pharma, commented:
“Thanks to our valued collaboration with the NIH and PregLem, ulipristal acetate is well on its way to realizing its potential as a promising new treatment for women who suffer from uterine fibroids. We are very pleased to have reached yet another milestone with successful completion of the PhIIb study and are looking forward to the results of PregLem’s ongoing PhIII programme.”

Uterine fibroids affect approximately 40% of women between the ages of 35 and 55, including 24 million women in Europe. The most common symptom is excessive uterine bleeding which may lead to anemia. It significantly impairs the quality of life for many women, leading in numerous cases to a hysterectomy.  There are no effective, well tolerated medical treatments available.

Dr Nieman will review the evidence for clinical effectiveness of ulipristal acetate for the treatment of uterine fibroids at the annual congress of the European Society of Gynecology in Rome (10 – 13 September 2009).