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Bayer Submits Radium-223 Dichloride for EU Marketing Authorization for the
Treatment of Castration-Resistant Prostate Cancer with Bone Metastases
Berlin, December 12, 2012 - Bayer HealthCare today announced that the
company has submitted a Marketing Authorization Application to the European
Medicines Agency (EMA) for radium-223 dichloride (radium-223) for the
treatment of castration-resistant prostate cancer (CRPC) patients with bone
"This submission reflects our commitment to developing innovative cancer
treatments for patients for whom only limited therapy options are available
today," said Kemal Malik, MD, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. "With its novel mode of action
and the proven survival benefit, radium-223 represents an innovation in the
treatment of prostate cancer and is an important example of our growing
The submission is based on data from the pivotal Phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate CAncer) trial. In the study, radium-223
significantly increased overall survival by 44 percent (HR=0.695,
p=0.00007), resulting in a 30.5 percent reduction in the risk of death
compared to placebo. The median overall survival (OS) benefit in patients
with radium-223 was 3.6 months, based on 14.9 months OS with radium-223
plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC.
These updated results were presented at the 48th Annual Meeting of the
American Society of Clinical Oncology (ASCO) in June 2012.
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%).
About the ALSYMPCA Trial
The ALSYMPCA trial was a Phase III, randomized, double-blind,
placebo-controlled international study comparing radium-223 dichloride vs.
placebo in symptomatic CRPC patients with bone metastases treated with BSoC
compared with placebo plus BSoC. 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), changes and
time to progression in PSA and ALP, safety, and impact on 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
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
In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway)
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. 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 U.S. Food and Drug Administration (FDA), or
other health authorities.
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.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a
portfolio of innovative treatments. Bayer’s oncology franchise now includes
two oncology products and several other compounds in various stages of
clinical development. Together, these products reflect the company’s
approach to research, which prioritizes novel targets and pathways with the
potential to transform the way that cancer is treated across tumor types
and stages of disease.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec
31, 2011) and is represented in more than 100 countries. More information
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This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
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which are available on the Bayer website at http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
This press release is available here:
Yours BayNews Editorial Team
51368 Leverkusen, Germany
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