Algeta ASA : US FDA Grants Priority Review to the New Drug Application for Radium-223 Dichloride for Castration-Resistant Prostate Cancer with Bone Metastases
Not Intended for US Media
Oslo, Norway, 13 February 2013 - Algeta ASA (OSE: ALGETA) announces that Bayer
has received notification from the US Food and Drug Administration (FDA)
granting priority review of 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.
Andrew Kay, Algeta's President & CEO, said: "With the granting of priority
review for the NDA for radium-223 in the US, there is recognition that radium-
223 has the potential to offer a new treatment option for CRPC patients with
bone metastases. While we await the final decision from the regulators later
this year, we continue with our commercialization planning in the US and look
forward, with Bayer and pending approval, to making this novel compound
available to patients."
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 US Nuclear Regulatory Commission (NRC) issued a licensing
decision on the medical use of radium-223. The decision states that US medical
sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E,
which includes 10 CFR Â§ 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 bone metastases.
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.
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.
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 CRPC.
For further information, please contact:
Mike Booth +47 2202 4510
Communications & Corporate Affairs email@example.com
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson firstname.lastname@example.org
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton email@example.com
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group firstname.lastname@example.org
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
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 potential timeline of FDA approval of radium-
223 and our anticipated co-promotion of radium-223 in the US. Â 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.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
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