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:4/1/2015)... , April 1, 2015  Spherix Incorporated (Nasdaq: ... to the fostering and monetization of intellectual property, ... privately held full service global investment bank specializing ... an industry note featuring Spherix. The ... a Senior Analyst at Chardan, was published on ...
(Date:4/1/2015)... , April 1, 2015 ... developing novel biological drugs to treat cancer, viral ... announce the appointment of Christina Coughlin ... responsible for providing medical and regulatory leadership to ... Dr. Coughlin has extensive experience in ...
(Date:3/31/2015)... Materials in Society Lecture Series ... 30 2015   Elsevier , a world-leading ... and publishing home of Materials Today , announced that ... Materials in Society  Lecture Series . The ... International Conference on Materials for Advanced Technologies (ICMAT) ...
(Date:3/31/2015)... SALT LAKE CITY , March 31, 2015 /PRNewswire-USNewswire/ ... second milestone with the selection of ten proposals ... The MCRI is the first patient-led, scientifically validated ... patients. Stage 2 of the MCRI ... "After careful review of a large number of ...
Breaking Biology Technology:Chardan Capital Issues Industry Note Covering Spherix 2Chardan Capital Issues Industry Note Covering Spherix 3Immunocore Appoints Dr. Christina Coughlin as Chief Medical Officer 2Immunocore Appoints Dr. Christina Coughlin as Chief Medical Officer 3Immunocore Appoints Dr. Christina Coughlin as Chief Medical Officer 4Elsevier Materials Science Council Introduces the Materials in Society Lecture Series at the International Conference on Materials for Advanced Technologies (ICMAT) 2Elsevier Materials Science Council Introduces the Materials in Society Lecture Series at the International Conference on Materials for Advanced Technologies (ICMAT) 3Myeloma Crowd Research Initiative Selects 10 High-Risk Multiple Myeloma Proposals For Further Review 2
... Ltd.,(SWX: ARPN) today announced that Dr Jurgen Raths will ... Raths commands extensive,knowledge in the commercialisation of drugs for ... built and lead the European,Critical Care sales, medical and ... At the Annual General Meeting of 7 May, ...
... ,Exelixis, Inc. (Nasdaq: EXEL ) announced today that ... Exelixis, will present at the,Morgan Stanley Global Healthcare Unplugged ... 30, 2008. Dr. Scangos will discuss updates to,the company,s ... be webcast and may be accessed in the Event,Calendar ...
... Inc. (Nasdaq: IDIX ) announced today that ... upcoming Morgan Stanley Global,Healthcare Unplugged Conference on Wednesday, ... Ritz Carlton in Key Biscayne, Florida., The ... can be,accessed under "Calendar of Events" in the ...
Cached Biology Technology:Leadership Change to Enable Arpida to Become a Fully Integrated Pharmaceutical Company 2Leadership Change to Enable Arpida to Become a Fully Integrated Pharmaceutical Company 3Leadership Change to Enable Arpida to Become a Fully Integrated Pharmaceutical Company 4
(Date:4/1/2015)... April 1, 2015   Medisafe ™, the leading ... across iOS and Android smartphones ... biofeedback into the platform to allow patients to track ... the first time, patients will be able to visualize ... impacts important biometrics, such as glucose levels and blood ...
(Date:3/24/2015)... , Mar. 24, 2015 Research and Markets ... the "Global Iris Recognition Market 2015-2019" report ... Global Iris Recognition market to grow at a CAGR ... This report covers the present scenario and the growth ... period 2015-2019. To calculate the market size, the report ...
(Date:3/23/2015)... March 23, 2015   HOYOS Labs , a ... today announced that the Company will demonstrate multiple biometrics-based ... and consumers at Connect:ID on March 23 through 25, ... Labs will highlight the IEEE Biometric Open Protocol Standard; ... and enterprise access control system. BOPS was invented by ...
Breaking Biology News(10 mins):Medisafe Announces Launch of Biometric Integration, Enabling Patients to Stay Adherent to Their Meds and See Tangible Health Results 2Global Iris Recognition Market 2015-2019 with 3M Cogent, Bioenable Technologies, Cross Match Technology, Iris ID Systems & Safran Dominating 2HOYOS Labs to Showcase Host of Biometrics Technologies at Connect:ID in Washington, D.C. 2HOYOS Labs to Showcase Host of Biometrics Technologies at Connect:ID in Washington, D.C. 3
... be the impact of the next green revolution on global ... climate change? To what extent can biofuels help make America ... be discussed at the International Annual Meetings of the American ... and Soil Science Society of America (SSSA), Oct. 31-Nov. 3 ...
... NY, October 28, 2010Mary Ann Liebert, Inc. announces the ... area of systems neuroscience, Brain Connectivity . This ... source of cutting-edge basic and clinical neuroscience research aimed ... the brain and how these connections are altered by ...
... by Lupus Research Institute-funded investigator Emily Baechler Gillespie, PhD, at ... clinical laboratory for development and could soon result in a ... to determine when a lupus flare is imminent. ... way to predict when a person with systemic lupus is ...
Cached Biology News:Media alert: Agronomists, crop and soil scientists to convene in Long Beach 2New Brain Connectivity journal captures latest advances in neuroscience research 2New clinical test to predict lupus flares moves closer to the market 2
... (Intein Mediated Purification with an Affinity Chitin-binding ... engineered protein splicing elements (termed inteins) to ... column (1-4) (Figures 1 and 2). This ... systems by its ability to separate a ...
... Analysis Note: The kit contains all ... convenient determination of NADPH-cytochrome c reductase activity ... purified microsomes [endoplastic reticulum (ER)]. It has ... tissues such as liver, kidney, brain, spleen, ...
... provides the reagents to efficiently differentiate ... myotubes. By efficiently promoting myogenic differentiation, ... in studies examining myogenesis, transcription factor ... muscle cell replacement therapy. By providing ...
... CHEMICON's Cell Transformation Detection Assay is an ... is considered the most stringent assay for ... this assay, cells (pre-treated with carcinogens or ... in soft agar medium for 21-28 days. ...
Biology Products: