(The following press release from Bayer was received by e-mail. It was not
confirmed by the sender.)
Not intended for U.S. and UK Media - Castration-Resistant Prostate Cancer
with Bone Metastases:
Radium-223 Dichloride Granted Priority Review by U.S. FDA
Berlin, February 13, 2013 - Bayer HealthCare announced today that the U.S.
Food and Drug Administration (FDA) has granted priority review to the New
Drug Application (NDA) filed in December 2012 for the investigational
oncology compound radium-223 dichloride (radium-223). The application is
under review for the treatment of castration-resistant prostate cancer
(CRPC) patients with bone metastases.
"We are pleased that the FDA has granted priority review status to
radium-223 for the treatment of patients with CRPC that has metastasized to
the bones as it supports our ongoing effort to make this compound available
as early as possible for patients in need of new treatment options," said
Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and
Head of Global Development.
The FDA grants priority review to medicines that offer major advances in
care or that provide a treatment where no adequate therapy exists. Under
the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its
review within eight months from the submission of the NDA, rather than the
standard 12-month review cycle.
The submission was 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.
In January 2013, the U.S. Nuclear Regulatory Commission (NRC) issued a
licensing decision on the medical use of radium-223. The decision states
that U.S. medical sites can procure and administer radium-223 under 10 CFR
Part 35, Subpart E, which includes 10 CFR § 35.300.
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 prostate-specific antigen (PSA) and alkaline
phosphatase (ALP), safety, and impact on quality of life measures.
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
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the FDA, or other health authorities. Bayer has
submitted a Marketing Authorization Application to the EMA for radium-223
in December 2012 for the treatment of CRPC patients with bone metastases.
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 worldwide, and commercialize radium-223 globally. Algeta will
co-promote radium-223 with Bayer in the U.S.
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 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 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
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