Not intended for US media
Oslo, Norway, 20 June 2013 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, today celebrates 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 Authorisation 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. "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."
About Xofigo® (radium Ra 223 dichloride)
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta US, LLC is co-promoting Xofigo with Bayer in the US.
For full prescribing information visit www.xofigo-us.com.
Xofigo® is a registered trademark of Bayer
For further information, please contact:
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Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding our co-promotion of Xofigo in the US and our ability to manufacture radium 223 on a global scale. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks or uncertainties associated with the ability to identify and hire a sufficient number of qualified employees in the US, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the co-promotion of Xofigo may be greater than anticipated, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining additional regulatory approvals for radium 223 and the other risks and uncertainties described in our annual report.
[i] XOFIGO Prescribing information. May 2013