Algeta ASA : 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 § 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
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 firstname.lastname@example.org
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson email@example.com
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton firstname.lastname@example.org
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group email@example.com
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 potential timeline of FDA
approval of radium-223 and our anticipated co-promotion of radium-223 in the
US. 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
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
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