Navigation Links
PregLem Announces Positive Phase III Results for Esmya(TM)
Date:6/3/2010

GENEVA, Switzerland, June 3, 2010 /PRNewswire/ --

- 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."

Key Phase III results

PEARL I was designed to demonstrate superior efficacy of Es
'/>"/>

SOURCE PregLem
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
3. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
4. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
5. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
6. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
11. CNS Response Announces Fiscal Third Quarter 2007 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)... 2014  Next month, executives from clinical trial marketing firm ... beginning with Patient-Centered Clinical Trials 2014 , to be ... , September 4-5. Patient recruitment experts Bonnie A. ... will share insights on the benefits of employing an ... – from media to mobile apps – can be used ...
(Date:8/28/2014)... , Aug. 28, 2014  Armetheon, Inc. ( ... novel mid- to late-stage cardiovascular drug candidates, today ... its first round of financing. The Series A ... Hercules Bioventures with participation from investors that included ... executive, Dr. Larry Hsu , the founder ...
(Date:8/28/2014)... (PRWEB) August 28, 2014 A ... around the world is available from Strategic Consulting, ... companies. “ Industrial Microbiology Market Review, Fourth Edition: ... Market ” (IMMR—4) tracks and compares microbiology test ... North America, Europe and Asia, and forecasts future ...
(Date:8/28/2014)... CA (PRWEB) August 28, 2014 ... is offering a promotion for Eppendorf Safe ... customers to purchase the highest quality tubes at ... are ideal for customers doing chemical, medical, pharmaceutical, ... technicians who are not regularly able to afford ...
Breaking Biology Technology:BBK Worldwide Leads Sessions at Key September Events 2Armetheon Completes $7.0 Million Series A Financing 2Armetheon Completes $7.0 Million Series A Financing 32 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 3Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 2Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 3
... EDMONTON, April 22 /PRNewswire-FirstCall/ - Quest PharmaTech ... announce that it will receive,generous support from ... (SDT) for oncology applications., Sonodynamic Therapy ... in,Hypocrellin-based photodynamic therapy for oncology and skin ...
... $250,000 under March ... ... BMRX), a leading developer and supplier of consumer-based,finger-activated products, today announced ... personnel of Sequiam,Corporation (OTC Bulletin Board: SQUME) through a previously announced,agreement ...
... Conn., April 22 Rib-X Pharmaceuticals, Inc.,("Rib-X" ... on the,discovery and development of novel antibiotics ... that Graham Johnson,Ph.D., Chief Research Officer and ... Cambridge Healthtech Institute,s 2nd Annual "The,Challenge of ...
Cached Biology Technology:Quest PharmaTech Receives Support from National Research Council's Industrial Research Assistance Program (NRC-IRAP) to develop Ultrasound Technology for the Treatment of Cancer 2bioMETRX, Inc. Initiates Integration of Personnel and Assets of Sequiam Corp. 2Rib-X Pharmaceuticals to Present at Cambridge Healthtech Institute's 2nd Annual Challenge of Antibacterial Development Conference 2
(Date:8/29/2014)... type and number of connections in transcription factor networks ... in a study published in PLOS Computational Biology ... assortativity signature contributes to a network,s resilience against mutations. ... out-out assortativity of TFN models has a greater effect ... types of assortativity," said Dov A. Pechenick, PhD, lead ...
(Date:8/29/2014)... twist them, fold them: modern materials that are light, ... as artificial skin or electronic paper. , Making such ... but a new way of working with copper nanowires ... , Previous success in the field of ultra-lightweight ... precious gold and silver nanowires. , By turning ...
(Date:8/28/2014)... an expansion of marine protected areas is needed to ... According to investigators from the Wildlife Conservation Society and ... on saving the largest numbers of species, often at ... difficult-to-replace ecological functions. , Many vital ecological ... that also are food for millions of people. ...
Breaking Biology News(10 mins):Assortativity signatures of transcription factor networks contribute to robustness 2Copper shines as flexible conductor 2Study finds marine protected areas inadequate for protecting fish and ocean ecology 2
... EUGENE, Ore. -- Using new optical equipment, a ... of virtual reality, monitored both their behavior and brain ... brain operates as it moves. The new research ... Scientific Instrumentation Inc. (ASI) -- should help neuroscientists around ...
... largest celebration of science and engineering, the USA ... D.C., April 28-29, 2012. For the second year, ... hands-on experiments. At Carnegie,s booth last year, visitors ... produced by our high pressure lab, touched the ...
... organisms, germ cells give rise to gametes and serve ... germ cell development is the decision to leave mitosis ... eggs and sperm. Germ cell development involves unique gene ... ensure success during fertilization and embryo development. Written ...
Cached Biology News:Worm-tracking challenge leads to new tool for brain research 2Worm-tracking challenge leads to new tool for brain research 3Carnegie partners with USA Science & Engineering Festival for second year 2Carnegie partners with USA Science & Engineering Festival for second year 3
albumin from bovine serum (BSA), BODIPY® FL conjugate...
Full service including gene cloning, protien expression and purification of 1 liter culture....
albumin from bovine serum (BSA), fluorescein conjugate...
GOAT ANTI HUMAN PARAINFLUENZA VIRUS 2+3...
Biology Products: