Not Intended for US Media
Oslo, Norway, 16 May 2013 - Algeta ASA (OSE: ALGETA) announces that further analyses of data subsets from the phase III ALSYMPCA study of the recently FDA-approved Xofigo® (radium 223 dichloride, radium 223) will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), 31 May-4 June, in Chicago, IL (USA).
Hematologic safety of Ra-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases from the phase 3 ALSYMPCA trial
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Abstract #5060, General Poster Session: Genitourinary (Prostate) Cancer
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Monday, 3 June, 8:00am - 11:45am, S Hall A2
Efficacy and safety of radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases who did or did not receive prior docetaxel (D) in the phase 3 ALSYMPCA trial
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Abstract #5068, General Poster Session: Genitourinary (Prostate) Cancer
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Monday, 3 June, 8:00am - 11:45am, S Hall A2
Pain analysis from the phase 3 randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases
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Abstract #5038, General Poster Session: Genitourinary (Prostate) Cancer
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Monday, 3 June, 8:00am - 11:45am, S Hall A2
Correlation between baseline variables and survival in the radium-223 dichloride (Ra-223) phase III ALSYMPCA trial with attention to total ALP changes
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Abstract #5080, General Poster Session: Genitourinary (Prostate) Cancer
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Monday, 3 June, 8:00am - 11:45am, S Hall A2
About Xofigo® (radium 223 dichloride)
Xofigo® with the active ingredient radium 223 dichloride (radium 223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Radium 223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium 223 is less than 100 micrometers, which may limit the damage to the surrounding normal tissue.
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium 223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize radium 223 globally. Algeta US, LLC will co-promote radium 223 with Bayer in the US.
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.
For full prescribing information visit www.xofigo-us.com (http://www.xofigo-us.com/).
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Xofigo® is a registered trademark of Bayer.
For further information about Algeta, please contact:
| Mike Booth / Renate Birkeli | +47 23 00 67 32 |
| Communications & Corporate Affairs | ir@algeta.com (mailto:ir@algeta.com) |
| Media enquiries: | |
| Mark Swallow | +44 207 638 9571 |
| Citigate Dewe Rogerson | mark.swallow@citigatedr.co.uk (mailto:mark.swallow@citigatedr.co.uk) |
| Knut Ekern | +47 22 04 82 00 |
| Gambit Hill & Knowlton | knut.ekern@hkstrategies.com (mailto:knut.ekern@hkstrategies.com) |
| Investor enquiries: | |
| Tricia Swanson | +1 646 378 2953 |
| The Trout Group | tswanson@troutgroup.com (mailto: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 (http://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 Xofigo 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 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.
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
