Navigation Links
Amicus Therapeutics Announces Third Quarter 2009 Financial Results and Strategic Business Updates
Date:10/29/2009

ance to Amicus."

Amicus will continue to manage global clinical operations for Amigal Phase 3 development and expects to initiate more than thirty investigational sites worldwide. As previously announced, the first global Phase 3 Amigal study is a 60 patient randomized, double-blind placebo controlled six month study intended to support U.S. registration. The primary surrogate endpoint agreed to with the U.S. Food and Drug Administration (FDA) is a histological evaluation of the change in GL-3 levels in the interstitial capillary cells of the kidney. The first patient was randomized into this study in mid-October. The Company estimates it will complete enrollment for this trial by the end of 2010 and expects to have data available in mid-2011. A separate Phase 3 study for registration in the European Union comparing Amigal with Fabrazyme® is required by the European Medicines Agency (EMEA). Amicus expects to provide a further update on that proposed study for the EMEA in 2010 as the supply constraints with Fabrazyme become clearer.

Key Strategic Priorities and Workforce Reduction:

As part of its strategic business plan, Amicus will focus its resources in three key areas:

  • The Phase 3 development of Amigal for Fabry disease;
  • Advancement of its lead pre-clinical programs that utilize its pharmacological chaperone technology for the treatment of diseases of neurodegeneration. The Company has an advanced pre-clinical program in Parkinson's disease, as well as an earlier stage pre-clinical program in an as yet undisclosed neurodegenerative target disease; and
  • Advancement of pharmacological chaperones used in combination with enzyme replacement therapies (ERT) for the treatment of lysosomal storage diseases.

"By focusing our resources on these three value creating centers within Amicus, we will balance the execution of our global late stage clinical program in Fabry di
'/>"/>

SOURCE Amicus Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related biology technology :

1. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotech & Medtech 2007 Conference
2. Amicus Therapeutics Announces Third Quarter 2007 Financial Results
3. Meredith Martin Addy Named Chair of AIPLAs Amicus Committee
4. Amicus Therapeutics to Present at the Lazard Capital Markets Fourth Annual Healthcare Conference
5. Amicus Therapeutics to Host R&D Day
6. Amicus Therapeutics Announces Positive Results From Phase 2 Clinical Trials of Amigal(TM) for Fabry Disease
7. Amicus Therapeutics Announces Fourth Quarter and Full Year 2007 Financial Results & Program Advancements
8. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
9. Amicus Therapeutics to Present at the BIO CEO & Investor Conference 2008
10. Amicus Therapeutics Presents Positive Data from Phase 2 Clinical Trial of Plicera(TM) for Gaucher Disease
11. Amicus Therapeutics to Present at the Morgan Stanley Global Healthcare Unplugged Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)... (PRWEB) August 28, 2014 Sterlitech is ... polymeric membranes to its stable of products . ... molecular weight cut-offs and include membrane filters with surface ... increase in customer demand for our membrane process testing ... variety of flat sheet membranes,” explains Sterlitech President Mark ...
(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)... York, NY (PRWEB) August 28, 2014 ... renewed its long term partnership with PTI Inspection ... provide clients with state of the art leak testing ... of the art instruments currently available. As part of ... new High Voltage Leak Detection Instrument developed ...
(Date:8/27/2014)... (PRWEB) August 27, 2014 In ... through Lawrence Livermore National Security LLC ... develop and deliver a state-of-the-art laser system for ... (ELI Beamlines), under construction in the Czech Republic. ... the laser system, called the " High repetition-rate ...
Breaking Biology Technology:Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 3Whitehouse Labs Renews Partnership with PTI Inspection Systems 2Whitehouse Labs Renews Partnership with PTI Inspection Systems 3LLNL Synchs up with ELI Beamlines on Timing System 2LLNL Synchs up with ELI Beamlines on Timing System 3
... Jan. 3 Cambrex,Corporation (NYSE: CBM ) ... President and Chief Executive Officer, will make a ... on January 8, 2008 at,9:00 a.m. PST at ... (Logo: http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO ), A live ...
... Thoratec,Corporation (Nasdaq: THOR ), a world leader ... it will be participating in the JP,Morgan Healthcare ... president and chief executive officer, will provide an,update ... Standard Time (11:30,a.m., Eastern Standard Time)., The ...
... Calif., Jan. 3 /Xinhua-PRNewswire-FirstCall/ --,Kiwa Bio-Tech Products ... its Fertilizer Products in Dingxing, Hebei on ... large volume distribution,businesses in 7 counties in ... agreements were reached with local dealers to ...
Cached Biology Technology:Kiwa Bio-Tech Products Group Holds a Fertilizer Products Exhibition in Hebei 2Kiwa Bio-Tech Products Group Holds a Fertilizer Products Exhibition in Hebei 3
(Date:8/29/2014)... Until recently, little has been known about what genetic ... team of scientists, one of whom is a University ... showing that genes controlling the development of the brain ... domestication., The study was published Aug. 28 in ... It is online at http://www.sciencemag.org/ ., The domestication ...
(Date:8/29/2014)... German . ... cycle on Earth and in biological wastewater treatment plants. ... on nitrite as their source of energy. An international ... at the University of Vienna, has now shown that ... of energy. The oxidation of hydrogen with oxygen enables ...
(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 ...
Breaking Biology News(10 mins):New research reveals how wild rabbits were genetically transformed into tame rabbits 2New research reveals how wild rabbits were genetically transformed into tame rabbits 3Hydrogen powers important nitrogen-transforming bacteria 2Hydrogen powers important nitrogen-transforming bacteria 3Copper shines as flexible conductor 2
... Massey Cancer Center researchers have uncovered a new mechanism ... stimulate the development of novel regimens in which it ... with blood cancers and solid tumors. , In ... associate director for translational research and co-leader of the ...
... to dressing their children, at least among side-blotched lizards, ... at the University of California, Santa Cruz, have found ... color patterns in their offspring in response to social ... for the rest of their lives. The mother's influence ...
... genetic factors and certain adverse events related to smallpox ... issue of The Journal of Infectious Diseases, now available ... other live vaccines. , Immunization against infectious agents has ... and the eradication of smallpox from the world is ...
Cached Biology News:Researchers shed light on mechanism of action used by anti-cancer drug 2Study shows lizard moms dress their children for success 2Study shows lizard moms dress their children for success 3Study shows lizard moms dress their children for success 4Genetic factors are linked to fever following smallpox vaccination 2