Algeta ASA: Radium Ra 223 Dichloride Recommended for Approval for the
Treatment of Castration-Resistant Prostate Cancer with Bone Metastases in the
Not intended for US media
Oslo, Norway, 20 September 2013 - Algeta ASA (OSE: ALGETA), announced today
that Bayer has received a positive opinion from the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)
recommending radium Ra 223 dichloride (radium-223) for approval with a
proposed indication for the treatment of adults with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral metastases.
The decision of the European Commission (EC) on the approval is expected in
the fourth quarter of 2013. Radium Ra 223 dichloride was approved by the US
Food and Drug Administration (FDA) in May under the brand name Xofigo^®.
The CHMP recommendation 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 positive opinion from the
CHMP marks an important step in the anticipated approval of radium-223 in
Europe. This recommendation, soon after Xofigo's US approval and launch, again
highlights the need for a new therapeutic option that has been shown to
significantly improve survival in prostate cancer patients whose disease has
spread to the bones. We are committed to working with Bayer to ensure patients
and physicians in Europe gain access to radium-223 as soon as possible."
"This recommendation confirms the safety and efficacy of radium-223 as a
potential treatment option for patients suffering from castration-resistant
prostate cancer with bone metastases, a debilitating and potentially deadly
condition," said Christopher Parker, MD, Principal Investigator of the
ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS
Foundation Trust, London, and The Institute of Cancer Research, London. "There
are many men with this disease who could potentially benefit from the
availability of radium-223 due to its unique ability to extend life and delay
symptomatic skeletal events such as spinal cord compression and the need for
external beam radiation therapy for bone pain."
About Radium Ra 223 Dichloride
Radium Ra 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
Radium Ra 223 dichloride (radium-223) is an alpha particle-emitting
pharmaceutical. Its 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
radium-223 is less than 100 micrometers (less than 10 cell diameters) which
minimises 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
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
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.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
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Source: Algeta ASA via Thomson Reuters ONE
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