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2012-05-16 14:05 CEST
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Updated survival results from phase III trial of Alpharadin (radium-223 chloride) in castration-resistant prostate cancer (CRPC) to be presented as Late-Breaking Abstract at ASCO 2012

Not intended for US media
  
Oslo, Norway, 16 May 2012 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces that further data from the phase III ALSYMPCA study of Alpharadin (radium-223 chloride) will be presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), 1-5 June (Chicago, IL, USA).

Details of the presentations, including an oral presentation of a Late-breaking Abstract, are as follows:

 

Final overall survival analysis results from the phase III, double-blind, randomized, multinational study of radium-223 chloride (Alpharadin) in the treatment of patients with castration-resistant prostate cancer (CRPC) with bone metastases (ALSYMPCA)

 

Late-Breaking Abstract #LBA4512, Oral Abstract Session: Genitourinary (Prostate) Cancer
Tuesday, 5 June, 10:45 a.m. - 11:00 a.m., E Arie Crown Theater
Presented by Dr. Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK), Principal Investigator for ALSYMPCA.

Radium-223 chloride (Ra-223) impact on skeletal-related events (SREs) & ECOG performance status (PS) in patients with castration-resistant prostate cancer (CRPC) with bone metastases: interim results of a phase III trial (ALSYMPCA)

 

Abstract #4551, Poster Discussion: Genitourinary (Prostate) Cancer Poster Session
Monday, 4 June, 8:00 a.m. - 12:00 p.m., E450A, Poster Board 5
Poster Discussion: Monday, 4 June 11:30 a.m. - 12:30 p.m., E Arie Crown Theater
Presented by Dr. Oliver Sartor, Medical Director Tulane Cancer Center, Tulane Medical School and Principal Investigator of the US arm of ALSYMPCA

Presentations and posters will be available to download at www.algeta.com following these sessions.

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For further information, please contact

Mike Booth
Communications & Corporate Affairs
+47 2202 4510
ir@algeta.com
International media enquiries:
Mark Swallow
Citigate Dewe Rogerson
+44 207 638 9571
mark.swallow@citigatedr.co.uk
US investor enquiries:
Jessica Lloyd
The Trout Group

 
+1 646 378 2928
jlloyd@troutgroup.com

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

 

Algeta's lead product Alpharadin (radium-223 chloride) is being evaluated as a potential new treatment for cancer patients with bone metastases. Alpharadin is under clinical investigation in castration-resistant prostate cancer (CRPC) patients with bone metastases. Submissions seeking marketing approval for this indication are expected to be made in mid 2012 to regulatory authorities in both the United States and Europe; Alpharadin has Fast Track designation for this indication in the US. Alpharadin, which is exclusively licensed to Bayer, is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.

 

Alpharadin is also under clinical investigation in endocrine-refractory breast cancer patients with bone metastases and is in a phase I/IIa trial in combination with docetaxel chemotherapy in CPRC patients with bone metastases.

 

Alpharadin is being evaluated and will be commercialized, if approved, under a global agreement with Bayer Pharma AG. If approved, Bayer will market Alpharadin worldwide, and Algeta will co-promote Alpharadin with Bayer in the US.

 

Algeta is also evaluating the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a potential future pipeline of tumor-targeting alpha-pharmaceutical candidates. Algeta has TTC agreements in place with Sanofi and Affibody.

 

The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statements

 

This news release contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will 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 to the correctness of such statements. 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, unforeseen delays in the timing of expected regulatory filings, risks or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules and alpha particle payloads, 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 Alpharadin and our other products, the risk that costs associated with the co-promotion of Alpharadin may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for Alpharadin and our other products and difficulties of obtaining relevant governmental approvals for new products, 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
May 16, 2012

HUG#1612664