Navigation Links
Amsterdam Molecular Therapeutics Receives Opinion on Re-examination of Glybera® Marketing Authorisation Application
Date:10/21/2011

AMSTERDAM, The Netherlands, October 21, 2011 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has maintained its earlier opinion that Glybera (alipogene tiparvovec) is not approvable at this time. The decision was made contrary to the positive recommendation of CHMP Rapporteurs, the Scientific Advisory Group (SAG), an expert panel specifically selected to evaluate clinical results and the science of the product, and the Committee for Advanced Therapies (CAT), which provides guidance on advanced therapeutics such as gene and cell therapy. These expert groups after extensive review and analysis of the data advised the CHMP that Glybera should be approved now under exceptional circumstances. The CHMP Rapporteurs, SAG and the CAT concluded that data from three Glybera clinical trials demonstrated meaningful evidence of clinical efficacy, without any major safety concerns. However, the CHMP is not bound to follow this advice. While AMT carefully reviews the grounds of the CHMP refusal, the Company will focus on strategic advancement of other promising projects in its development pipeline.

"The decision from the CHMP is disappointing particularly because a treatment will now not be available to European patients who suffer from LPLD for whom Glybera is the only therapeutic option. We are encouraged by the validation provided by the CHMP Rapporteurs, Scientific Advisory Group and the Committee for Advanced Therapies regarding our gene therapy platform, indicating that safety is not an issue," said Jörn Aldag, CEO of AMT. "We are evaluating thoroughly and expediently the next steps available to the Company and will provide an update on the future developments of our validated gene therapy pipeline."

On Tuesday October 25, 2011 at 10:00 AM CET, AMT will provide an update on
'/>"/>

SOURCE Amsterdam Molecular Therapeutics (AMT) B.V
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Amsterdam Molecular Therapeutics Reports Half Year Results 2008
2. Amsterdam Molecular Therapeutics Reports Full Year Results 2008
3. Amsterdam Molecular Therapeutics Reports Half Year Results 2009
4. The University of Amsterdam Joins the MetaMiner Metabolic Diseases Project
5. Amsterdam Molecular Therapeutics Reports Full Year Results 2009
6. Amsterdam Molecular Therapeutics Reports Half-Year Results 2010
7. Amsterdam Molecular Therapeutics Successfully Lowers Cholesterol In Vivo With Enhanced Novel MicroRNA AAV Gene Therapy
8. Amsterdam Molecular Therapeutics Appoints Dr. Carlos R. Camozzi as Chief Medical Officer
9. Amsterdam Molecular Therapeutics Files Glybera® European Marketing Application for Re-examination
10. Amsterdam Molecular Therapeutics Reports Half-Year Results 2011
11. Amsterdam Molecular Therapeutics Licenses Additional Novel Gene Therapy Vectors from National Institutes of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... April 17, 2015 BellBrook Labs ... marketing support for the powerful Orthogonal Pooled Screening ... Genomics Center at the Lankenau Institute for Medical ... is to measurably improve successful drug discovery outcomes ... offering rare, drug-like libraries available nowhere else, coupled ...
(Date:4/16/2015)... Cambridge Semantics , the leading ... Web technology, and Informa , the leading ... the academic and scientific, professional and commercial business ... Data Lake for Clinical Trial and Competitive Intelligence’ ... ‘Best of Show’ Award. , The solution ...
(Date:4/16/2015)... Irvine, CA (PRWEB) April 16, 2015 ... in the Buzz of BIO Contest for ... Industry Organization (BIO), the 2015 BIO International Convention will ... in Philadelphia, Pennsylvania. During the Buzz of BIO contest, ... like to see present at the conference. The community ...
(Date:4/16/2015)... Streetsboro, Ohio (PRWEB) April 16, 2015 ... Safety Index, overexertion involving an outside source was ... injuries. This includes injuries related to lifting, pushing, ... $15.1 billion in direct costs. The David Round ... Round is committed to working hard to develop ...
Breaking Biology Technology:BellBrook Labs and Lankenau Institute Partner to Accelerate Drug Discovery using Orthogonal Pooled Screening 2Cambridge Semantics and Informa Named Bio-IT Award Finalist for Smart Data Lake Solution for Clinical Trial and Competitive Intelligence 2Cambridge Semantics and Informa Named Bio-IT Award Finalist for Smart Data Lake Solution for Clinical Trial and Competitive Intelligence 3Proove Bisociences to Participate in the Buzz of BIO at the 2015 BIO International Convention 2Proove Bisociences to Participate in the Buzz of BIO at the 2015 BIO International Convention 3The David Round Company Helps Companies Meet OSHA Standards by Combining Safety, Ergonomics, and Productivity 2
... Technologies, Inc.,(OTC Bulletin Board: AVXT) (the "Company") today ... bridge loan financing pursuant to a Convertible Note,and ... to Convertible,Note and Warrant Purchase Agreement (collectively the ... promissory notes,(the "Notes") in the aggregate principal amount ...
... SAN DIEGO, Oct. 30 Anadys Pharmaceuticals,Inc. (Nasdaq: ... ANA773 in,patients chronically infected with hepatitis C virus (HCV) ... ANA773 in both healthy volunteers and,HCV patients. ANA773 is ... of the study, patients in the first cohort will ...
... (Nasdaq:,CEPH) today announced that its Analyst Day in New ... be webcast live on the investor relations section of,its ... will review the company,s business,strategy, marketing plan and research ... November 5, 2008 beginning at,approximately 12:30 p.m. EST and ...
Cached Biology Technology:AVAX Technologies, Inc. Announces Closing of Bridge Loan Financing 2Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients 2Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients 3Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients 4Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients 5Cephalon, Inc. to Webcast Analyst Day 2Cephalon, Inc. to Webcast Analyst Day 3
(Date:3/26/2015)... The Granite Club, ... club, today announced it has implemented a state-of-the-art access ... for members and staff, while restricting access to authorized ... selected FST,s IMID Access system because it has the ... and staff, in addition to unparalleled security," said ...
(Date:3/23/2015)... Mass , March 23, 2015 SoundView Technology ... of NXT-ID,s (NASDAQ: NXTD ) Wocket smart wallet. SoundView was ... user feedback on their experience with the Wocket in multiple ... at CVS, Whole Foods and other retailers, making both debit ... Kris Tuttle also says, "If the company meets their ...
(Date:3/20/2015)... Research and Markets ( http://www.researchandmarkets.com/research/rswjb4/hand_geometry ) has ... Strategic Business Report" report to their offering. ... US$ Thousands. The report provides separate comprehensive analytics for the ... , Europe , Asia-Pacific ... World. Annual estimates and forecasts are provided for ...
Breaking Biology News(10 mins):Granite Club First Private Club in North America to Implement FST Biometrics Secure Access Solution, as Part of Multi-million Dollar Expansion 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 3Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 4Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 2Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 3Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 4
... simulations, researchers at the University of Illinois have demonstrated a ... forth through a nanopore capacitor in a semiconductor chip. The ... genomes quickly and affordably., Being able to sequence a human ... insurance companies are willing to pay) could open a new ...
... BOWLING GREEN, O.Bowling Green State University biology undergraduates will ... genomics while they learn. The University has been selected ... new Microbial Genome Annotation research program through the U.S. ... Analysis of the genomes of microorganisms is an important ...
... Investigators at the University of Rochester Medical Center have ... of hope for children with Batten disease a ... robs them of their abilities to see, reason and ... The study, highlighted in the January edition of ...
Cached Biology News:New technique could dramatically lower costs of DNA sequencing 2BGSU undergraduates to pilot groundbreaking genome project 2BGSU undergraduates to pilot groundbreaking genome project 3Research unveils new hope for deadly childhood disease 2
... 75 x 25 mm; approximately 1 ... immunohistochemistry of paraffin-embedded sections, ... markings will not rub off ... precleaned, store ...
Complete cell culture media with cytokines...
HAS1 (C-14)...
8 different frozen tissues are mounted on positively charged glass slides...
Biology Products: