OSLO, NORWAY--(Marketwire - February 15, 2013) -
Intended for US Media only
Abstracts #11 & #19
Algeta ASA (OSE: ALGETA) announces that further
sub-analyses of data from the phase III ALSYMPCA study of radium Ra 223
dichloride (radium-223) in castration-resistant prostate cancer (CRPC)
have been presented at the 2013 Genitourinary Cancers Symposium (14-16
February 2013, Orlando, FL, USA).
Radium-223 is an investigational alpha particle-emitting
development for CRPC patients with bone metastases and is not approved
European Medicines Agency (EMA), the US Food and Drug Administration
other health authorities.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These
analyses from ALSYMPCA continue to support radium-223's potential in
treatment of men with CRPC that has metastasized to the bone."
Abstract #11 by Vogelzang et al. found that radium-223 treatment
delayed time to first skeletal-related event (SRE) versus placebo by a
increase of 5.8 months (median time to SRE: 15.6 vs 9.8 months;
Abstract #19 by Nilsson et al. described an analysis of pain
ALSYMPCA. The analysis showed that, compared to placebo in CRPC patients
bone metastases, patients treated with radium-223 had significantly
median time to first palliative external beam radiotherapy (EBRT)
In the ALSYMPCA trial the most common hematologic adverse events for
treated with radium-223 and best standard of care (BSoC) and compared to
and BSoC included anemia (31% vs. 31%), neutropenia (5% vs.
thrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverse
most common events included anemia (13% vs. 13%), neutropenia (2% vs.
thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse
patients treated with radium-223 and BSoC compared to placebo and BSoC
bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs.
vomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events, the
common events included bone pain (21% vs. 26%).
In September 2009, Algeta signed an agreement with Bayer Pharma AG
Germany) for the development and commercialization of radium-223.
terms of the agreement, Bayer will develop, apply for global health
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
Abstract #11 - Vogelzang, N. et al. Updated analysis of radium-223
(Ra-223) impact on skeletal-related events (SRE) in patients
with castration-resistant prostate cancer (CRPC) and bone metastases
from the phase III
randomized trial (ALSYMPCA).
Abstract #19 - Nilsson, S. et al. Pain analysis from the phase III
ALSYMPCA study with radium-223 dichloride (Ra-223)
in castration-resistant prostate cancer (CRPC) patients with bone
About the ALSYMPCA Trial
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial was a phase
randomized, double-blind, placebo-controlled international study of
with best standard of care (BSoC) vs placebo with BSoC in symptomatic
patients with bone metastases. The trial enrolled 921 patients in more than
centers in 19 countries. The study treatment consisted of up to six
administrations of radium-223 or placebo each separated by an interval of
The primary endpoint of the study was overall survival. Secondary
included time to occurrence of skeletal-related events (SRE), time to
alkaline phosphatase (ALP) and prostate-specific antigen (PSA)
total ALP response and normalization, safety, and quality of life.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States
than skin cancer).Approximately 16% of prostate cancer cases are
regional or distant, which means that the cancer has spread beyond the
to nearby or distant areas of the body (metastasis).
A majority of men with CRPC have radiological evidence of bone
Bone metastases secondary to prostate cancer typically target the lumbar
vertebrae and pelvis.In fact, bone metastases are the main cause of
and death in patients with CRPC.
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223), formerly referred to as
chloride, is an investigational alpha particle-emitting
development for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by the
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or
health authorities. Bayer submitted a Marketing Authorization Application
EMA and a New Drug Application to the FDA for radium-223 in December
the treatment of CRPC patients with bone metastases.
Algeta is a company focused on developing novel targeted therapies for
with cancer based on its alpha-pharmaceutical platform. The
headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC,
Cambridge, MA performing commercial marketing operations in the US.
listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information
This news release contains certain forward-looking statements that are
uncertainty, as they relate to events and depend on circumstances that
occur in the future and which, by their nature, may have an impact on
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
looking statements will prove to be correct. These forward looking
include statements regarding our anticipated co-promotion of radium-223
US. There are a number of factors that could cause actual
developments to differ materially from those expressed or implied by
forward-looking statements. These factors include, among other things,
uncertainties associated with the ability to identify and hire a
number of qualified employees for the US field force, growth management,
economic and business conditions and the pricing environment, the
competition, the ability to successfully commercialize radium-223, the risk
costs associated with the co-promotion of radium-223 may be greater
anticipated, manufacturing capacity, the risk of non-approval of patents
granted, risks in obtaining regulatory approvals for radium-223 and the
risks and uncertainties described in our annual report.
The 2013 Genitourinary Cancers Symposium is co-sponsored by the American
Society of Clinical Oncology (ASCO), the American Society for Radiation
(ASTRO) and the Society of Urologic Oncology (SUO).
 American Cancer Society. Prostate Cancer: Detailed Guide. October 26,
Accessed May 17, 2012
 National Cancer Institute, Surveillance Epidemiology and End Results
SEER Stat Facts: Prostate; Survival & Stage, 2002-2008
 Sartor, O. "Radiopharmaceutical and chemotherapy combinations in
castrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-
 Bone and Cancer Foundation. Questions & Answers about Prostate Cancer
Metastases and Treatment-Related Osteoporosis. Available at:
 Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding
prostate cancer metastatic to bone." Cancer & Metastasis
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Source: Algeta ASA via Thomson Reuters ONE