Corporate Banner
Satellite Banner
RNAi
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Algeta Celebrates the Opening of Commercial Production Facility for Xofigo®

Published: Friday, June 21, 2013
Last Updated: Thursday, June 20, 2013
Bookmark and Share
Official opening of new facility at the Institute for Energy Technology (IFE) in Kjeller, Norway.

Algeta ASA has celebrated the official opening of its commercial production facility for Xofigo® (radium Ra 223 dichloride) at the Institute for Energy Technology (IFE) in Kjeller, Norway.

Andrew Kay, Algeta’s President & CEO, and senior management colleagues will be joined by Trond Giske, the Norwegian Minister for Trade and Industry, Eva S. Dugstad, President of IFE and Andreas Fibig, President & Chairman of the Board of Management, Bayer HealthCare Pharmaceuticals, and other distinguished guests for an official ribbon cutting ceremony this afternoon.

Xofigo was approved by the US Food and Drug Administration (FDA) on 15 May for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. It is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA.

Algeta US, LLC and Bayer Healthcare are co-promoting the product in the US. Xofigo has been launched in the US, triggering a EUR 50 million milestone payment to Algeta from Bayer. Bayer Healthcare has licensed the full rights to Xofigo outside of the US.

Radium Ra 223 dichloride (radium 223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US.

Bayer submitted a Marketing Authorization Application to the EMA for radium 223 in December 2012 for the treatment of CRPC patients with bone metastases.

Andrew Kay, Algeta’s President & CEO, said: “The recent approval and launch of Xofigo in the US are momentous achievements for Algeta and put us firmly on the path to deliver on our vision of becoming a world-class oncology company bringing novel targeted medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals. IFE has been an important partner to Algeta throughout the clinical development of radium 223, and it has been instrumental in helping us build a commercial production facility for the global supply of Xofigo. We are all extremely grateful for the expertise, dedication and support that IFE has provided to Algeta on this journey and look forward to continuing our productive partnership.”

“Today's opening of a new commercial production facility at IFE underlines the Norwegian pharmaceutical industry’s ability to develop products with significant global potential. We are proud to have played an integral part in the development of Xofigo that has required state-of-the-art quality manufacturing throughout its path to market. The new facility which is being officially opened today has been designed according to highest quality standards - from raw material handling to the release of the final commercial product,” said Eva S. Dugstad, President of the IFE.

“On behalf of Bayer, I am proud and excited to be part of this collaboration with our Norwegian partners, Algeta and IFE,” said Andreas Fibig, Head of the Pharmaceuticals Division of Bayer.

Fibig continued, “Now is the time for the patients to gain from it. Our hope is that Xofigo can help patients with bone metastases caused by prostate cancer all over the world. There is a great need for new treatment options for these patients, and our clinical studies show that Xofigo can help patients to live longer. For me, representing a pharma company having ‘Science for a better life’ as its mission, it is deeply gratifying to know that what will be produced here will improve many peoples’ lives.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Algeta Appoints Dr Andreas Menrad as CSO
Dr Menrad will be responsible for developing and executing the Company’s research strategy.
Monday, August 19, 2013
Algeta Announces First Sale of Xofigo® in the United States
First sale triggers EUR 50 million milestone payment from Bayer.
Thursday, May 30, 2013
Algeta: FDA Approves Xofigo (radium-223 dichloride)
Xofigo shown in a pivotal phase III trial to significantly improve overall survival.
Friday, May 17, 2013
Algeta’s Partner Bayer Submits Radium-223 for EU Marketing Authorization
Submission to trigger €50 million milestone payment to Algeta.
Monday, April 22, 2013
Algeta Elects New Non-executive Members
Hilde Furberg and Paolo Pucci elected as new members of Algeta’s Board of Directors.
Friday, April 12, 2013
Algeta Initiates New Oncology Research Program to Conjugate Thorium-227 to Epratuzumab
CD22 is a well-validated target for hematological cancers.
Tuesday, January 29, 2013
New Analyses from Phase III ALSYMPCA Trial Presented at ESMO 2012
Radium-223 dichloride (Alpharadin) was significantly superior to placebo in health-related quality of life (QOL) measures.
Monday, October 01, 2012
Updated Phase III Data Confirm Overall Survival Benefit of Alpharadin in Men with CRPC
Submissions seeking marketing approval in US & Europe expected in 2H 2012.
Monday, June 04, 2012
Jeffrey W. Albers Appointed President of Algeta US
Mr. Albers will join Algeta’s executive management team and takes up his position immediately.
Tuesday, January 17, 2012
Algeta Awarded Grant to Develop Targeted Thorium Conjugates
Company has been awarded a NOK 10.5 million grant from the Research Council of Norway.
Tuesday, January 03, 2012
Algeta Appoints Mike Booth as Senior Vice President, Communications and Corporate Affairs
New role created to enhance Algeta's global corporate communications and investor relations activities.
Friday, December 30, 2011
Alpharadin Significantly Improves Overall Survival for CRPC Patients with Bone Metastases
First presentation of full ALSYMPCA phase III data as part of Presidential Session featuring Best and Late-Breaking Abstracts at 2011 EMCC.
Monday, October 10, 2011
Algeta Signs License with Affibody for Tumor-Targeting Molecules
Algeta gains access to two proprietary Affibody® molecules for use in cancer therapy.
Tuesday, August 30, 2011
FDA Grants Fast Track Designation to Alpharadin
Fast Track designation granted to Alpharadin for the treatment of castration-resistant prostate cancer in patients with bone metastases.
Friday, August 26, 2011
Scientific News
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
"Gene Fusion" Drives Childhood Brain Cancers
Study co-led by Penn scientists highlights potential targets for future cancer therapies.
Enzyme Links Age-Related Inflammation, Cancer
Researchers have shown that an enzyme key to regulating gene expression -- and also an oncogene when mutated -- is critical for the expression of numerous inflammatory compounds that have been implicated in age-related increases in cancer and tissue degeneration.
Viral Gene Editing System Corrects Genetic Liver Disease
Penn study has implications for developing safe therapies for an array of rare diseases via new gene cut-and-paste methods.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Curing Disease by Repairing Faulty Genes
New delivery method boosts efficiency of CRISPR genome-editing system.
'Junk' DNA Plays Role in Preventing Breast Cancer
Supposed "junk" DNA, found in between genes, plays a role in suppressing cancer, according to new research by Universities of Bath and Cambridge.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!