Algeta ASA : US Nuclear Regulatory Commission issues a licensing decision
under 10 CFR Part 35 Subpart E for radium-223 dichloride
Not Intended for US Media
Oslo, Norway, 14 January 2013 - Algeta ASA (OSE: ALGETA) announces that the US
Nuclear Regulatory Commission (NRC) has issued a licensing decision on the
medical use of radium-223 dichloride (radium-223). The NRC licensing decision
follows the recommendation from the Advisory Committee on the Medical Use of
Isotopes (ACMUI) report, dated 20 November 2012.
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
The US NRC has ruled that sites can procure and administer radium-223 under 10
CFR Part 35, Subpart E, which includes 10 CFR § 35.300. It has also ruled that
physicians authorized under 10 CFR § 35.390 or 10 CFR § 35.396 can be
authorized for the medical use of radium-223. The US NRC has notified the
Agreement States regarding their licensing decision on radium-223.
In December 2012, Bayer submitted a Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) and a New Drug Application (NDA) to the
US Food and Drug Administration (FDA) for radium-223 for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone metastases.
Radium-223 has been granted fast track designation for this indication by FDA.
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
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.
For further information, please contact:
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US investor enquiries:
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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 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 report.
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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