Algeta ASA : US Nuclear Regulatory Commission issues a licensing decision under 10 CFR Part 35 Subpart E for radium-223

  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 
health authorities.

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 
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.

For further information, please contact:

Mike Booth                         +47 2202 4510
Communications & Corporate Affairs ir@algeta.com
Media enquiries:
Mark Swallow                       +44 207 638 9571
Citigate Dewe Rogerson             mark.swallow@citigatedr.co.uk
Knut Ekern                         +47 22 04 82 00
Gambit Hill & Knowlton             knut.ekern@hkstrategies.com
US investor enquiries:
Tricia Swanson                     +1 646 378 2953
The Trout Group                    tswanson@troutgroup.com

About Algeta

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.



Forward-looking Statements



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.
Press release

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Source: Algeta ASA via Thomson Reuters ONE
HUG#1669998
 
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