Navigation Links
AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
Date:9/16/2009

QUEBEC CITY, Sept. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the North American market, has received orphan-drug designation for this compound from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, Keryx announced that it had reached agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial with perifosine in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.

Juergen Engel, Ph. D., President and CEO of AEterna Zentaris stated, "We are very pleased with perifosine gaining Orphan Drug Designation from the FDA as it would provide extra market exclusivity protection for this compound. We now look forward to the start of Keryx's Phase 3 trial in multiple myeloma by year-end."

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. It also provides tax credits for clinical research costs, the ability to apply
'/>"/>

SOURCE AETERNA ZENTARIS INC.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. AEterna Zentaris to Present at Upcoming Rodman Renshaw Annual Global Investment Conference
2. AEterna Zentaris Announces Results from Two Phase 3 Studies with Cetrorelix in Benign Prostatic Hyperplasia
3. AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results
4. AEterna Zentaris to Present at Upcoming Canaccord Adams 29th Annual Global Growth Conference
5. AEterna Zentaris to Announce Second Quarter 2009 Financial and Operating Results on August 11, 2009
6. AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
7. AEterna Zentaris: New Data Published on its Ghrelin Antagonist Compound, AEZS-123 (JMV2959), Supports its Use in Alcohol Addiction
8. AEterna Zentaris Receives US$10 Million from Institutional Investors
9. AEterna Zentaris to Report Data from Safety Study of Phase 3 Program in Benign Prostatic Hyperplasia with Cetrorelix Ahead of Schedule
10. AEterna Zentaris Opens Extended Study for Cetrorelix in Benign Prostatic Hyperplasia
11. AEterna Zentaris Discloses Preliminary Phase 2 Trial Results for Perifosine in Combination with Radiotherapy for Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... (PRWEB) July 10, 2014 EvoDerma ’s ... convenience. This rejuvenating device now comes with a second treatment ... over time. , The new cup is thinner on the ... works to target rough, thin and uneven surfaces on the ... cup for a stimulating treatment on areas such as the ...
(Date:7/10/2014)... , July 10, 2014 /PRNewswire-iReach/ -- Tute ... interpretation, today announced an agreement with Lineagen, ... for Lineagen,s NextStep Dx PLUS.  Lineagen, ... and neurological disorders, currently offers FirstStep Dx ... testing service used by healthcare providers as ...
(Date:7/10/2014)... 17, 2014 Using microscopic polymer light resonators ... researchers at MIT,s Quantum Photonics Laboratory have developed ... the parts-per-billion range. Optical sensors are ideal for ... signal-to-noise ratio, compact, lightweight nature, and immunity to ... had been developed before, the MIT team conceived ...
(Date:7/10/2014)... upside down forever. Nanophysics makes sure of that. Mechanics researchers ... published in Physical Review E . Knowledge that can ... seem to be able to sit still forever, and walk ... We will soon be able to buy smart new fasteners ... the fact is, sooner or later the grip is lost, ...
Breaking Biology Technology:Introducing a New Bonus Treatment Cup for EvoDerma’s NOOME Anti-Aging Motion 2Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 2Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 3Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 4Swell new sensors 2Even geckos can lose their grip 2
... CHAPEL HILL, N.C., Oct. 7 Seasoned ... dynamic new set of natural,treatment techniques that are ... such as pain, stress, anxiety, phobias, weight,loss, and ... (PTSD).,Known as "Energy Psychology" (and crossing over into ...
... for Fourth Consecutive Year, INDIANAPOLIS, Oct. ... of the magazine,s Top 500 innovative users ... handful of companies in the biotech,and pharmaceutical ... 86, in the 2008 report,outperformed others in ...
... CARLOS, Calif., Oct. 7 Nektar,Therapeutics (Nasdaq: NKTR ... present at the upcoming Natixis Bleichroeder Second Annual Hidden ... Monday, October 13,2008 at 2:30 p.m. ET., The ... posted,on the Investor Relations, Events Calendar section of the ...
Cached Biology Technology:Upcoming 'Energy Psychology' Event - New Breakthrough 'Do It Yourself' Healing 2InformationWeek Puts Roche Diagnostics on Top 500 Innovative Tech Users List 2
(Date:7/11/2014)... at the Department of Energy,s Oak Ridge National ... by R&D Magazine in recognition of the year,s ... the tremendous value of our National Labs," said ... at the National Labs continues to help our ... scientific and technological innovations necessary to remain globally ...
(Date:7/11/2014)... awarded Michael F. Holick, PhD, MD, of Boston University ... Avioli Award. Holick, a professor of medicine, physiology and ... understanding of vitamin D and its role in disease ... the American Society for Bone and Mineral Research (ASBMR) ... It is named for ASBMR,s first president and founding ...
(Date:7/11/2014)... Cell scientists have set a "mouse TRAP" to capture ... a recent study published in the Journal of ... a technique called TRAP to extract cellular and genetic ... by scientists at the Rockefeller Institute for Medical Research ... the protein-making machinery, or ribosomes, of the cell type ...
Breaking Biology News(10 mins):ORNL wins eight R&D 100s 2ORNL wins eight R&D 100s 3ORNL wins eight R&D 100s 4BUSM's Michael F. Holick receives American Society for Bone and Mineral Research award 2
... Heart Institute at Intermountain Medical Center have developed a ... cardiologists the ability to see the precise source of ... a condition that affects nearly three million Americans. ... of the heart three dimensionally significantly improves the chances ...
... three are historically recognized as due to plague, but ... 21st centuries AD there were microbiological evidences that the ... "For a long time scholars from different disciplines have ... past pandemics. Only ancient DNA analyses carried out on ...
... May 9, 2013 Wexford Science & Technology, LLC, ... Wake Forest Innovation Quarter , today announced that ... underway represents an additional $150 million investment in downtown ... investment in the Innovation Quarter to more than $250 ...
Cached Biology News:Intermountain Medical Center reseachers develop new 3-D technology to treat atrial fibrillation 2Intermountain Medical Center reseachers develop new 3-D technology to treat atrial fibrillation 3Scientists confirm that the Justinianic Plague was caused by the bacterium Yersinia pestis 2Wexford Science & Technology Makes $150 Million Investment in Wake Forest Innovation Quarter 2Wexford Science & Technology Makes $150 Million Investment in Wake Forest Innovation Quarter 3
... anti-phospho-IRS1 (Tyr896) ... to amino acid region encompassing ... phospho-IRS1 (Tyr896). ... Quality Assurance: ...
Goat polyclonal to PPP2R5D Immunogen: Peptide with sequence KRAEEFLTASQEAL, from C Terminus of the protein sequence according to NP_006236...
...
Monoclonal Mouse Anti-Human Cytokeratin 16 (48 kD)...
Biology Products: