Oslo, Norway, 14 December 2012 – Algeta ASA (OSE: ALGETA) announces
that Bayer has submitted a New Drug Application (NDA) to the US Food and
Drug Administration (FDA) for radium-223 dichloride (radium-223) for the
treatment of castration-resistant prostate cancer (CRPC) patients with bone
“Algeta has made significant progress during 2012 across all areas of its business and
the submissions by Bayer for marketing approval of radium-223 in both Europe and
now the US are great achievements on which to conclude the year,”
said Andrew Kay,Algeta’s President & CEO.
“Meanwhile, we continue to make significant investments in building our commercial operations in the US and we look forward, if approved, to copromoting this novel product for CRPC patients with bone metastases in this important market.”
Bayer submitted a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) on 12 December 2012 for radium-223 for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone metastases. Under the terms of the 2009 agreement with Bayer, the first complete submission for marketing approval triggers a €50 million milestone payment from Bayer to Algeta.
“This submission of radium-223 for the treatment of men with CRPC that has
metastasized to the bone brings us closer to a new treatment option for patients in the US dealing with this advanced form of cancer,”
said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
“We are looking forward to continuing discussions with the regulatory authorities to bring this innovative treatment option to patients as quickly as we can.”
The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in
SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. 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, 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.
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
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 the
receipt of milestone payments, the build out of our US commercial organization and
future development activities. 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 success of future clinical trials, 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 and
our other products, the risk that costs associated with the co-promotion of radium-223may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.