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3rd June 2010
PregLem Announces Additional Positive Phase III Results for Esmya
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18th May 2010
PregLem Announces Positive Phase III Results for Esmya as an Effective Treatment for Uterine Fibroids
PregLem, a biopharmaceutical company focused on women’s reproductive medicine, announces positive Phase III results of Esmya(TM)
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10th March 2010
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2nd February 2010
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3rd June 2010PregLem Announces Additional Positive Phase III Results for Esmya
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 around the world.
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. Subject to approval, the product may be launched in Europe at the end of 2011.
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 biopharmaceutical company. Our immediate focus is on preparing the MAA dossier. However, we are simultaneously starting leveraging our unique research and market insight to start building the sales infrastructure that will enable us to launch our first product in Europe.”
Key Phase III results
PEARL I was designed to demonstrate superior efficacy of Esmya versus placebo for the treatment of symptomatic uterine fibroids in women with heavy bleeding leading to anemia. It was a randomized, parallel group, double-blind, placebo-controlled, multi-center study with a total of 242 patients. It compared 5mg and 10mg doses of Esmya and placebo once daily for three months with concomitant iron administration in all three arms.
The study met its two co-primary efficacy endpoints. Esmya demonstrated statistically significant superior efficacy to placebo in reducing excessive uterine bleeding measured as a percentage of patients with a reduction of PBAC (Pictorial Blood Assessment Chart) score lower than 75 and in reduction of total fibroids volume assessed by centralized MRI reading.
Esmya also showed superior efficacy to placebo in correcting anaemia caused by uterine fibroids and suppressing fibroids related pain using the McGill Short Form questionnaire (SF-MPQ). Both the PBAC and SF-MPQ are validated self-reporting tools.
Ernest Loumaye added: “The combined PEARL I and II data shows that Esmya 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.”
Professor Tetyana Tatarchuk, the Principal investigator from the Institute of Obstetrics and Gynecology in City Clinical Hospital (Ukraine), said:
“These data are very convincing. A medical treatment for alleviating the symptoms related to fibroids and reduce the fibroids volume would be very useful in our day-to-day management of this significant and distressing condition. These results clearly illustrate the potential for Esmya to offer an effective and well tolerated treatment for this condition.”
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.
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