Published on June 4, 2010 at 1:13 AM
- PEARL I Trial Meets Primary Efficacy and Safety Endpoints
- PregLem Preparing for Submission to the European Medicines Agency in 2010
PregLem, the European specialty biopharmaceutical company focused on women's reproductive medicine, announces positive Phase III data from its second pivotal study (PEARL I) for its lead product Esmya (ulipristal acetate), as an effective treatment for uterine fibroids (myoma) - a condition that affects millions of women worldwide.
The final set of positive Phase III results, combined with the positive PEARL II results announced in May 2010, will enable PregLem to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by the end of 2010. Upon approval, PregLem expects to launch the product in major European markets.
Ernest Loumaye, CEO & Co-Founder of PregLem, said:
"These results are another important milestone in PregLem's growth strategy. With positive results from two independent Phase III studies on our lead candidate, we now have the opportunity to move the company forward from its current focus on drug development towards our ambition of becoming a self-sustaining specialty biopharmaceutical company. Our immediate focus is on preparing the MAA dossier. However, we are simultaneously leveraging our unique research and market insight to start preparing for the launch of Esmya, our first product in Europe."
SOURCE PregLem