Not intended for US media
Xofigo® (radium Ra 223 dichloride) granted Marketing Authorization in the European Union
Oslo, Norway, 15 November 2013 - Algeta ASA (OSE: ALGETA) announces today that Bayer has received marketing authorisation from the European Commission for Xofigo® 1000 kBq/ml solution for injection (radium Ra 223 dichloride) for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The marketing authorization provides approval for the commercialization of Xofigo in all 28 countries of the EU, and in Norway, Iceland and Liechtenstein following national approval.
This decision follows a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in September of this year. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Andrew Kay, Algeta's President & CEO, said: "Today's decision by the European Commission to approve Xofigo in the EU is another major milestone achieved for Algeta. It marks the start of what we hope will become an important royalty stream based on Bayer's ex-US sales, in addition to the 50% share of the profits we expect to receive from the co-promotion of Xofigo in the US. Our partnership with Bayer is proving to be very productive and we are delighted with the progress being made."
"Prostate cancer is the commonest cancer in men, and often spreads to the bones," said Christopher Parker, MD, Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Honorary Reader in Prostate Oncology at The Institute of Cancer Research, London. "Bone metastases lead to pain, fracture and other complications that can significantly impair the patient's health and well-being. Xofigo targets bone metastases, delivering a localized effect to offer patients prolonged survival, making it an exciting advance in the treatment of this cancer."
About Xofigo® (radium Ra 223 dichloride)
Xofigo® is an alpha particle-emitting pharmaceutical. Xofigo's active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy. The alpha particle range from Xofigo is less than 100 micrometers (less than 10 cell diameters), which minimizes damage to the surrounding normal tissue.
Xofigo is approved in the US 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 radium-223. Under the terms of this agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.
Xofigo® is a registered trademark of Bayer
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Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. 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 Bayer's promotion of Xofigo in Europe. 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, general economic and business conditions, 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, risks in obtaining additional regulatory approvals for radium-223 and the other risks and uncertainties described in our annual report.