December 12, 2012
Not intended for U.S. and UK Media

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 metastases.

"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
oncology portfolio."

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 measures.

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
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, 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 at
www.healthcare.bayer.com.

Our online press service is just a click away: press.healthcare.bayer.com


Find more information at www.bayerpharma.com.

Forward-looking statements<br/>
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 situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer's public reports which are available on the
Bayer website at www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.

<br/>

Services

Download