US Nuclear Regulatory Commission issues a licensing decision under 10 CFR Part 35 Subpart E for radium-223 dichloride

14 januari 2013 Not Intended for US Media Oslo, Norway, 14 January 2013 - Algeta ASA (OSE: ALGETA) announces that the US Nuclear Regulatory Commission (NRC) has issued a licensing decision on the medical use of radium-223 dichloride (radium-223). The NRC licensing decision follows the recommendation from the Advisory Committee on the Medical Use of Isotopes (ACMUI) report, dated 20 November 2012. Radium-223 is an investigational agent and is not approved by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other health authorities. The US NRC has ruled that sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR § 35.300. It has also ruled that physicians authorized under 10 CFR § 35.390 or 10 CFR § 35.396 can be authorized for the medical use of radium-223. The US NRC has notified the Agreement States regarding their licensing decision on radium-223. In December 2012, Bayer submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for radium-223 for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Radium-223 has been granted fast track designation for this indication by FDA. ### About Radium-223 Dichloride Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on bone metastases in development for CRPC patients with bone metastases. In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin, Germany) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 globally. Algeta will co-promote radium- 223 with Bayer in the US, and is eligible for milestones as well as royalties on Bayer's sales outside the US. The ALSYMPCA trial was initiated by Algeta in June 2008. For further information, please contact: Mike Booth +47 2202 4510 Communications & Corporate Affairs ir@algeta.com Media enquiries: Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk Knut Ekern +47 22 04 82 00 Gambit Hill & Knowlton knut.ekern@hkstrategies.com US investor enquiries: Tricia Swanson +1 646 378 2953 The Trout Group tswanson@troutgroup.com About Algeta 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. Forward-looking Statements 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 anticipated co-promotion of radium-223 in the US.  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 for the US field force, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize radium-223, the risk that costs associated with the co-promotion of radium-223 may be greater than anticipated, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and the other risks and uncertainties described in our annual report. This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. Press release: http://hugin.info/134655/R/1669998/542661.pdf This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Algeta ASA via Thomson Reuters ONE [HUG#1669998]