Navigation Links
Amsterdam Molecular Therapeutics Announces European Commission Delays Decision on Glybera® Marketing Authorisation and Requests Further Information From the CHMP
Date:1/29/2012

vely work with the European Commission and the EMA to find the best process going forward, not only for Glybera but also for further advanced therapies on their way to patients," said Jörn Aldag, CEO of AMT. "While gaining clarity for the process involving Glybera, we will continue to implement our revised business strategy revealed following the last CHMP decision. This involves moving forward in partnering discussions for several of our gene therapy products, including hemophilia B and GDNF."

AMT's current business plan, organizational structure and financing have been developed on the basis of the current CHMP opinion for Glybera's non-approval. It involved a reduction of its workforce by about 50%. In the event that Glybera could be commercialized in Europe, the Company will evaluate how the opportunity arising from passing this important milestone could be realized most efficiently.

About Glybera®

AMT has developed Glybera as a treatment for patients with the genetic disorder lipoprotein lipase deficiency. LPLD is an orphan disease for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating and life-threatening clinical complication of LPLD. Glybera has orphan drug status in the EU and US.

About Amsterdam Molecular Therapeutics

AMT is a world leader in the development of human gene based therapies. In addition to Glybera, AMT has a product pipeline of several gene therapy products in development for hemophilia B, Duchenne muscular dystrophy, acute interm
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Amsterdam Molecular Therapeutics Receives Orphan Designation in the European Union for Hemophilia B Gene Therapy
2. Amsterdam Molecular Therapeutics Glybera(R) Significantly Reduces the Risk of Pancreatitis in LPLD Patients
3. Amsterdam Molecular Therapeutics Receives Opinion on Glybera(R) Marketing Authorisation Application
4. Pharma and Food Thought Leaders Set to Converge in Amsterdam Next April 2011
5. Amsterdam Molecular Therapeutics Reports Promising Data From Cholesterol Lowering Gene Therapy Study
6. MolecularHealth to Introduce Knowledge-Driven Solutions that Enhance Drug Safety and Enable Molecularly-Guided Treatment Decision Support
7. Molecular Imaging, Inc. Enters Relationship with Dana-Farber Cancer Institute to Expand Luciferase-reporter Cancer Cell Lines for Preclinical in vivo Imaging
8. Quest Diagnostics Launches Simplexa™ Dengue Test in Brazil, First Commercial Molecular Test Approved for Nations Public and Private Health Testing
9. Roche Diagnostics, Cedars-Sinai Medical Center Enter Strategic Alliance for Center to Operate as a Roche Molecular Center of Excellence
10. Pieris Announces Results and Successful Completion of its PRS-050 Anticalin Phase I Trial at AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference
11. GenturaDx to Host Poster Presentation at Association for Molecular Pathology 2011 Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... July 24, 2014  Alimera Sciences, Inc. (NASDAQ: ... in the research, development and commercialization of prescription ophthalmic ... quarter of fiscal year 2014 financial results after the ... conference call will follow on the same day at ... will be hosted by Dan Myers , President ...
(Date:7/24/2014)... , July 24, 2014  The American ... is supporting its mission to help address audit ... and exclusive agreement to be the information technology ... As the leading provider of billing and business ... unmatched HME industry expertise to support this important ...
(Date:7/24/2014)... MEMPHIS, Tenn. , July 24, 2014  In ... time, one in 25 patients has at least one ... and Prevention. What,s more, many of these infections prove ... are causing an alarming number of patient deaths per ... of industry conversation. Consequently, a stronger ...
Breaking Medicine Technology:Alimera Sciences To Release Second Quarter 2014 Results 2Brightree Joins AAHomecare as Corporate Partner and IT Lead on HME Audit Key 2Employees, Equipment and the Environment: Top Infection Prevention Focuses in Hospitals 2Employees, Equipment and the Environment: Top Infection Prevention Focuses in Hospitals 3
... Paper Reports Value of Specific Nutritional Products is Dependent on ... ... Researchers at,Interleukin Genetics, Inc. (Amex: ILI ), today received ... the annual Congress of the,European Society of Parenteral and Enteral ...
... - Southern,Research Institute and Gallo Research Center ... testing Naltrexone-derived,pyridomorphinan (SoRI-9409) will be published in ... Psychiatry. The publication is available online,today at ... new compound that,causes selective and long-lasting reduction ...
Cached Medicine Technology:Interleukin Genetics Wins International Award for Outstanding Research Published in the Journal, Nutrition 2Interleukin Genetics Wins International Award for Outstanding Research Published in the Journal, Nutrition 3Novel Compound Shows Promise for Treatment of Alcoholism 2Novel Compound Shows Promise for Treatment of Alcoholism 3Novel Compound Shows Promise for Treatment of Alcoholism 4
(Date:7/25/2014)... Stwd.co.uk, one of the leading dress manufacturers ... cheap evening dress for women. In addition, the ... for these items. They are available at discounted rates, ... August 30. , “We are pleased to announce our ... have a large number of stylish special occasion gowns ...
(Date:7/25/2014)... July 25, 2014 Healthpointe is ... clinic is offering Occupational Medicine services to ... happily accepting referrals and workers’ compensation cases. ... Mirada clinic include wound care treatment management, return-to-work ... assessments, pre-employment screening & physicals, and illness and ...
(Date:7/25/2014)... MEDICC announced diplomas went to 1,382 new ... University of Havana’s graduation ceremonies that also included graduates ... the 879 international graduates from 28 countries, 20 were ... Professors and hundreds of parents packed the Cuban labor ... Vice President Ramón Machado Ventura and Minister of Health ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 CMS recently ... health plans for providing inadequate access to prescription drugs. ... to the health and safety of beneficiaries in areas ... coverage determinations, and CMS is taking quick and firm ... Atlantic Information Services webinar, “Avoiding Costly Part D ...
(Date:7/25/2014)... 2014 According to the ... by Vkool.com, this is a comprehensive guide ... some common types of hemorrhoids including:, ... ,     Young children with hemorrhoids , ...     Very large hemorrhoids and chronic hemorrhoids ...
Breaking Medicine News(10 mins):Health News:Famous Supplier Stwd.co.uk Announces Its New Selection of Evening Dresses for Women 2Health News:Healthpointe Offering Occupational Medicine Services in La Mirada 2Health News:MEDICC Congratulates 20 New MDs for the USA Graduating from Cuba’s Latin American Medical School 2Health News:MEDICC Congratulates 20 New MDs for the USA Graduating from Cuba’s Latin American Medical School 3Health News:Aug. 5 Webinar to Offer Strategies for Preventing Rx Access Issues and Avoiding Part D Sanctions 2Health News:Hemorrhoid No More Pdf Review Exposes Jessica Wright's Guide For Treating Hemorrhoids – Vkool.com 2Health News:Hemorrhoid No More Pdf Review Exposes Jessica Wright's Guide For Treating Hemorrhoids – Vkool.com 3
... Parents on How to Help Children Cope, WESTPORT, ... that responds to disasters and works to improve the,lives ... of crisis experts,to assist children and families affected by ... will be posted to San Diego, will provide assistance ...
... People with Diabetes Affected ... by California Wildfires, ALEXANDRIA, Va., ... for people with diabetes who,are affected by the California wildfires. ... supplies to manage their health. 1) Medication and Supplies -- ...
... of children with attention deficit hyperactivity disorder (ADHD) at ... was missing: the fathers., Fabiano, an assistant professor in the ... a graduate assistant at the UB Center for Children ... has helped more than 2,500 children with behavioral, emotional ...
... Fisher,Scientific Inc. (NYSE: TMO ), the world ... ground on a new $17 million (USD) facility ... services in that,country. The facility will focus on ... pharmaceutical samples to,patients participating in clinical trials across ...
... Md., Oct. 23 Martek Biosciences,Corporation (Nasdaq: ... of a,district court in Dusseldorf, Germany, has orally ... company,s patent infringement suit against (i) Lonza,Ltd., (ii) ... Food Ingredients GmbH. In a separate suit against ...
... BOTHELL, Wash., Oct. 23 Cardiac Science,Corporation (Nasdaq: ... cardiac monitoring,and defibrillation products, announced today that it ... Tuesday, October 30, 2007 after the,market close. The ... and,investors for 4:30 p.m. Eastern Time to discuss ...
Cached Medicine News:Health News:Save the Children to Help Youngsters Impacted by California Wildfires 2Health News:Save the Children to Help Youngsters Impacted by California Wildfires 3Health News:Save the Children to Help Youngsters Impacted by California Wildfires 4Health News:Save the Children to Help Youngsters Impacted by California Wildfires 5Health News:Emergency Preparedness for People With Diabetes 2Health News:Getting fathers involved in children's ADHD treatment programs 2Health News:Getting fathers involved in children's ADHD treatment programs 3Health News:Thermo Fisher Scientific Expands Clinical Trial Services Capabilities with New Facility in India 2Health News:Thermo Fisher Scientific Expands Clinical Trial Services Capabilities with New Facility in India 3Health News:Thermo Fisher Scientific Expands Clinical Trial Services Capabilities with New Facility in India 4Health News:Martek Wins German DHA Patent Infringement Actions Against Lonza and One of Nutrinova's Customers in Suits Relating to DHA Product Marketed for Use in Functional Foods and Dietary Supplements 2Health News:Martek Wins German DHA Patent Infringement Actions Against Lonza and One of Nutrinova's Customers in Suits Relating to DHA Product Marketed for Use in Functional Foods and Dietary Supplements 3Health News:Cardiac Science Corporation Schedules Third Quarter Earnings Release and Announces Conference Call 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: