New data and analyses from the phase III ALSYMPCA trial of radium Ra 223 dichloride to be presented at the European Cancer Congress (ECCO-ESMO-ESTRO) 2013
Not intended for US media
Oslo, Norway, 12 September 2013 - Algeta ASA (OSE: ALGETA), announced today that
further analyses of data subsets from the phase III ALSYMPCA study of radium Ra
223 dichloride (radium 223) will be presented at the 2013 European Cancer
Congress (ECCO/ESMO/ESTRO), 28 September- 1 October, in Amsterdam, The
Netherlands.
Under the brand name Xofigo(®), radium 223 was approved by the US Food and Drug
Administration (FDA) in May 2013 for the treatment of patients with castration-
resistant prostate cancer (CRPC), symptomatic bone metastases and no known
visceral metastatic disease and is now available in the United States at
licensed facilities.
Dr Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These data add
further to our understanding of the efficacy and safety profile of radium 223 in
prostate cancer patients with bone metastases, and highlight both the depth and
breadth of the ALSYMPCA phase III data set."
Abstract titles and session details
Time to first skeletal-related event (SRE) with radium-223 dichloride (Ra-223)
in patients with castration-resistant prostate cancer (CRPC) and bone
metastases: ALSYMPCA trial stratification factors analysis
* Abstract #2876, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Hematologic safety of radium-223 dichloride (Ra-223) in the phase 3 ALSYMPCA
trial in castration-resistant prostate cancer (CRPC) patients with bone
metastases: baseline prognostic factor subgroup analysis
* Abstract #2877, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Effects of radium-223 dichloride (Ra-223) on health-related quality of life
(QOL) outcomes in the phase 3 ALSYMPCA study in patients with castration-
resistant prostate cancer (CRPC) and bone metastases
* Abstract #2878, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Radium-223 dichloride (Ra-223) efficacy and safety in patients with castration-
resistant prostate cancer (CRPC) with bone metastases: phase 3 ALSYMPCA study
findings stratified by age group
* Abstract #2883, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
About radium Ra 223 dichloride
Radium-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
and subsequently in other territories.
Radium 223 (as Xofigo(®) injection) is approved in the United States and is
indicated for the treatment of patients with castration-resistant prostate
cancer (CRPC), symptomatic bone metastases and no known visceral metastatic
disease.
Radium 223 is an alpha particle-emitting radioactive therapeutic agent with an
anti-tumor effect on bone metastases. The active ingredient in radium 223 is the
alpha particle-emitting isotope radium-223, which 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 radium-
223 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[1].
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 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.
For full US prescribing information, visit www.xofigo-us.com.
###
Xofigo(®) is a registered trademark of Bayer
For further information, please contact:
Mike Booth +44 7866 490 850
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
Investor enquiries:
Tricia Truehart +1 646 378 2953
The Trout Group ttruehart@troutgroup.com
About Algeta
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.
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 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.
[1]Â XOFIGO Prescribing information. May 2013
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/1728746/577439.pdf
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Source: Algeta ASA via Thomson Reuters ONE
[HUG#1728746]