Algeta ASA : Algeta ASA : Further sub-analyses of ALSYMPCA phase III study
presented at 2013 Genitourinary Cancers Symposium
Not Intended for US Media
Abstracts #11 & #19
Effects of radium-223 dichloride on skeletal-related events and pain
associated with bone metastases from castration-resistant prostate cancer
Oslo, Norway, 15 February 2013 - Algeta ASA (OSE: ALGETA) announces that
further analyses of data subsets from the phase III ALSYMPCA study of
radium-223 dichloride (radium-223) in castration-resistant prostate cancer
(CRPC) patients have been presented at the 2013 Genitourinary Cancers
Symposium^ (14-16 February 2013, Orlando, FL, USA).
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These additional
analyses from ALSYMPCA demonstrate that, in addition to prolonging survival in
CRPC patients with bone metastases, radium-223 also improves clinically
relevant endpoints related to complications from bone metastases. If approved,
radium-223 has the potential to play a key role in the treatment of men with
CRPC that has metastasized to the bone."
Abstract #11 by Vogelzang et al. found that radium-223 treatment significantly
delayed time to first skeletal-related event (SRE) versus placebo by a median
increase of 5.8 months (median time to SRE: 15.6 vs 9.8 months; HR=0.658;
P<0.001). The analysis also showed that, compared to placebo in CRPC patients
with bone metastases, treatment with radium-223 reduced the risk of time to
first event for all four SRE components, including a 48% reduction in risk for
spinal cord compression.
Abstract #19 by Nilsson et al. described an analysis of pain parameters in
ALSYMPCA. The analysis showed that, compared to placebo in CRPC patients with
bone metastases, patients treated with radium-223 had significantly prolonged
median time to first palliative external beam radiotherapy (EBRT) (HR=0.670,
P=0.00117) and in a post-hoc analysis patients treated with radium-223 had
significantly prolonged median time to initial opioid use, with a risk
reduction of 38% compared to placebo (HR=0.621).
In the ALSYMPCA trial the most common hematologic adverse events for patients
treated with radium-223 and best standard of care (BSoC) and compared to
placebo and BSoC included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and
thrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverse events,
the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%)
and thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse
events in patients treated with radium-223 and BSoC compared to placebo and
BSoC included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs.
15%) and vomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events,
the most common events included bone pain (21% vs. 26%).
Abstract #11 - Vogelzang, N. et al. Updated analysis of radium-223 dichloride
(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 randomized
ALSYMPCA study with radium-223 dichloride (Ra-223) in castration-resistant
prostate cancer (CRPC) patients with bone metastases.
About the ALSYMPCA Trial
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial was a phase
III, randomized, double-blind, placebo-controlled international study of
radium-223 with best standard of care (BSoC) vs placebo with BSoC in
symptomatic CRPC patients with bone metastases. The trial enrolled 921
patients in more than 100 centers in 19 countries. The study treatment
consisted of up to six intravenous administrations of radium-223 or placebo
each separated by an interval of four weeks.
The primary endpoint of the study was overall survival. Secondary endpoints
included time to occurrence of skeletal-related events (SRE), time to total
alkaline phosphatase (ALP) and prostate-specific antigen (PSA) progression,
total ALP response and normalization, safety, and quality of life.
About CRPC and Bone Metastases
Prostate cancer is the most common non-cutaneous malignancy in men worldwide.
In 2008, an estimated 899,000 men were diagnosed with prostate cancer and
258,000 died from the disease worldwide. Prostate cancer is the sixth leading
cause of death from cancer in men.
A majority of men with CRPC have radiological evidence of bone metastases.
Once the cancer cells settle in the bone, they interfere with bone strength,
often leading to pain, fracture and other complications that can significantly
impair a man's health. Bone metastases secondary to prostate cancer typically
target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are
the main cause of morbidity and death in patients with CRPC.
About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor
effect on bone metastases in development for CRPC patients with bone
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the
terms of the agreement, Bayer will develop, apply for global health authority
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 June 2008.
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other
health authorities. Bayer submitted a Marketing Authorization Application to
the EMA and a New Drug Application to the FDA for radium-223 in December 2012
for the treatment of CRPC patients with bone metastases, and received priority
review for the NDA in the US.
In terms of further development activities for radium-223, Bayer intends to
conduct studies in earlier settings of prostate cancer, including combination
studies with other agents, as well as exploratory studies in other tumors such
as breast cancer and osteosarcoma.
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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.
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 radium-223 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 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 radium-223, the risk that costs associated with the co-promotion
of radium-223 may be greater than anticipated, manufacturing capacity, the
risk of non-approval of patents not yet granted, risks in obtaining regulatory
approvals for radium-223 and the other 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
Oncology (ASTRO) and the Society of Urologic Oncology (SUO).
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
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