- PEARL I Trial Meets Primary Efficacy and Safety Endpoints
- PregLem Preparing for Submission to the European Medicines Agency in2010
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PregLem, the European specialty biopharmaceutical company focused onwomen's reproductive medicine, announces positive Phase III data from itssecond pivotal study (PEARL I) for its lead product Esmya (ulipristalacetate), as an effective treatment for uterine fibroids (myoma) - acondition that affects millions of women worldwide.
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The final set of positive Phase III results, combined with the positivePEARL II results announced in May 2010, will enable PregLem to submit aMarketing Authorisation Application (MAA) to the European Medicines Agency(EMA) by the end of 2010. Upon approval, PregLem expects to launch theproduct in major European markets.
Ernest Loumaye, CEO & Co-Founder of PregLem, said:
"These results are another important milestone in PregLem's growthstrategy. With positive results from two independent Phase III studies on ourlead candidate, we now have the opportunity to move the company forward fromits current focus on drug development towards our ambition of becoming aself-sustaining specialty biopharmaceutical company. Our immediate focus ison preparing the MAA dossier. However, we are simultaneously leveraging ourunique research and market insight to start preparing for the launch ofEsmya, our first product in Europe."
Key Phase III results
PEARL I was designed to demonstrate superior efficacy of Esmya versusplacebo for the treatment of symptomatic uterine fibroids in women with heavybleeding leading to anaemia. It was a randomised, parallel group,double-blind, placebo-controlled, multi-centre study with a total of 242patients. It compared 5mg and 10mg doses of Esmya and placebo once daily forthree months with concomitant iron administration in all three arms.
The study met its two co-primary efficacy endpoints. Esmya demonstratedstatistically significant superior efficacy to placebo in reducing excessiveuterine bleeding measured as a percentage of patients with a reduction ofPBAC (Pictorial Blood Assessment Chart) score lower than 75 and in reductionof total fibroids volume assessed by centralised MRI reading.
Esmya also showed superior efficacy to placebo in correcting anaemiacaused by uterine fibroids and suppressing fibroids-related pain using theMcGill Short Form questionnaire (SF-MPQ). Both the PBAC and SF-MPQ arevalidated self-reporting tools.
Ernest Loumaye added:
"The combined PEARL I and II data shows that Esmya has the potential tobe the first effective medical treatment for this condition, with no seriousside effects, for millions of women around the world."
Professor Tetyana Tatarchuk, the Principal investigator from theInstitute of Obstetrics and Gynaecology in City Clinical Hospital (Ukraine),said:
"These data are very convincing. A medical treatment for alleviating thesymptoms related to fibroids and reducing the fibroids volume would be veryuseful in our day-to-day management of this significant and distressingcondition. These results clearly illustrate the potential for Esmya to offeran effective and well tolerated treatment for this condition."
Uterine fibroids affect approximately 40% of women between the ages of 35and 55, including 24 million women in Europe and over 20 million women inNorth America. The condition is characterised by excessive uterine bleeding,anaemia, pain and infertility. It significantly impairs the quality of lifefor many women, leading in many cases to a hysterectomy. There are noeffective, well tolerated medical treatments available. GnRH agonists are theonly approved treatment of symptomatic uterine fibroids but their use hasbeen relatively limited due to their side effect profile which causessuppression of oestrogen to castration levels, resulting in hot flushes,depression, mood swings, loss of libido, vaginitis and loss of bone mineraldensity.
About PregLem
PregLem is a European speciality biopharmaceutical company dedicated tothe development and commercialization of a new class of drugs for women'sreproductive health conditions. PregLem has an experienced senior managementteam, with a proven track record in developing, registering andcommercialising reproductive health products. The company is backed by a bluechip investor base.
Visit http://www.preglem.com for more information.
About Esmya(TM)
Ulipristal acetate is a first-in-class, orally active selectiveprogesterone receptor modulator which reversibly blocks the progesteronereceptors in target tissues.
PregLem's Phase III programme for Esmya consists of two separate,parallel, randomised, double-blind studies identified as PEARL I and PEARLII. Together the Phase III trials involved 540 patients in 14 countries at5mg and 10mg doses.For further information, please contact: PregLem: Désirée Andrey CEO Office PregLem SA Tel: +41(0)22-884-03-40 [email protected] Capital MS&L: Mary Clark, Anna Davies Tel: +44(0)20-7307-5330 [email protected]
SOURCE PregLem
