Algeta ASA : Algeta ASA : US FDA Grants Priority Review to the New Drug Application for Radium-223 Dichloride for Castration

   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
Media enquiries:
Mark Swallow                       +44 207 638 9571
Citigate Dewe Rogerson   
Knut Ekern                         +47 22 04 82 00
Gambit Hill & Knowlton   
US investor enquiries:
Tricia Swanson                     +1 646 378 2953
The Trout Group          

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

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 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.
Press release


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information contained therein.

Source: Algeta ASA via Thomson Reuters ONE
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