Algeta ASA : Algeta results for the fourth quarter and full year 2012

    Algeta ASA : Algeta results for the fourth quarter and full year 2012

Not Intended for US Media

Oslo, Norway, 28 February 2013 -  Algeta ASA (OSE: ALGETA), a company  focused 
on the  development  of  novel targeted  cancer  therapeutics,  announces  its 
results for the fourth quarter and full year 2012.

A presentation of the results in Oslo will be webcast live from 10:00 CET  and 
can be accessed through www.algeta.com. An international conference call  will 
take place at 14:30 CET/08:30 EST (US). Details of both events are at the  end 
of this announcement.

"Algeta made significant achievements across  its business in 2012,  including 
commercial preparations  and  expanding  its  manufacturing  capabilities  for 
radium-223  dichloride  (radium-223)  as   well  as  initiating  further   R&D 
collaborations for the  development of  our Targeted  Thorium Conjugate  (TTC) 
pipeline. This progress means that Algeta entered 2013 well placed to  deliver 
on its vision  to be a  world-class oncology company  bringing novel  targeted 
medicines to cancer patients through its leadership in alpha-pharmaceuticals,"
said Andrew Kay, Algeta's President &  CEO. "In parallel, we continue to  make 
significant investments in building  our commercial operations for  radium-223 
in the US and look forward, with  Bayer and if approved, to co-promoting  this 
novel product for  castration-resistant prostate cancer  (CRPC) patients  with 
bone metastases in the world's largest pharmaceutical market."

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.

Highlights of the fourth quarter 2012:

  *In December, Bayer submitted applications seeking marketing  authorization 
    to the EMA and the FDA for  radium-223 for the treatment of CRPC  patients 
    with bone metastases.  The first complete  submission triggered a  EUR50m 
    milestone payment from Bayer to Algeta

  *In November, Algeta  and Bayer  advanced the BC1-10  trial (radium-223  in 
    combination with  docetaxel chemotherapy)  into  the phase  IIa  (expanded 
    safety cohort) portion  of the  study, based on  the results  of the  dose 
    escalation (phase I)  phase. Enrolment of  approximately 45 CRPC  patients 
    with symptomatic bone metastases has begun in eight centers across the  US 
    and Europe. 

  *In November,  Algeta  entered  a research  collaboration  with  Ablynx  to 
    evaluate a novel TTC based  on combining Algeta's proprietary  thorium-227 
    alpha-pharmaceutical payload with  tumor-targeting Nanobodies^®  generated 
    by Ablynx.

  *In  November,   Algeta   further  strengthened   its   R&D   capabilities, 
    particularly  in  chelation   and  conjugation   technologies,  with   the 
    appointment of Dr Alan Cuthbertson as Senior Vice President, Research  and 
    Development. 

Post-period events

  *In February  2013,  the  FDA  granted  priority  review  of  the  NDA  for 
    radium-223. 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.

  *In February 2013,  further results from  the ALSYMPCA phase  III study  of 
    radium-223 were presented at the 2013 Genitourinary Cancers Symposium. Two
    presentations were made, highlighting the beneficial impact of  radium-223 
    on the  pain and  analgesic use  of CRPC  patients, as  well as  providing 
    further analyses on the positive impact on skeletal-related events  (SREs) 
    associated with bone metastases from castration-resistant prostate cancer.
    

  *In January  2013, the  US  Nuclear Regulatory  Commission (NRC)  issued  a 
    licensing decision on the medical use of radium-223, ruling that sites can
    procure  and   administer  radium-223   under   the  same   framework   as 
    routinely-used nuclear medicines.  In addition, the  NRC will not  require 
    additional licensing  to  administer  radium-223 for  physicians  who  are 
    already licensed to dispense similar medications.

  *In January 2013,  Algeta initiated a  new TTC research  program using  the 
    anti-CD22 monoclonal antibody (epratuzumab) developed by Immunomedics. 

  *In February 2013, and as part of the prioritization of the TTC  portfolio, 
    Algeta   deemed   PDGFR-beta    to   be   an    unsuitable   target    for 
    alpha-pharmaceutical development. Accordingly, the decision has been taken
    to terminate this element of the Affibody agreement.

Key financials

  *Operating revenue for the  fourth quarter and full  year 2012 amounted  to 
    NOK440m and NOK627m, respectively, compared with NOK73m and NOK250m in
    the same periods in 2011.

  *Core operating  expenses^[1],  which exclude  currency  effects,  interest 
    income and costs directly related  to preparation of commercial launch  in 
    the US, for the fourth quarter and full year 2012 amounted to NOK99m  and 
    NOK316m, respectively, compared  with NOK84m  and NOK 289m  in the  same 
    periods in 2011. 
  *Algeta's recognized share  of US  co-promotion activity  expenses for  the 
    fourth quarter and full  year 2012 was NOK28m  and NOK72m. In 2011,  the 
    activity had not yet commenced.

  *Liquid funds amounted  to NOK369m as  of the 31  December 2012,  compared 
    with NOK426m as of 30 September 2012, and NOK317m at the end of December
    2011. 

The Fourth Quarter  and Full  Year 2012 Report  and accompanying  presentation 
will be available through www.algeta.com from 07:00 CET.

Details of presentation and webcast

A presentation by Algeta's senior  management team to investors, analysts  and 
the press will take place in Oslo at 10:00 CET.

Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway.

The presentation  will  also be  webcast  live  and can  be  accessed  through 
www.algeta.com. Questions can be submitted live during the webcast.

Details of international conference call

To participate  in the  conference call,  please dial  the appropriate  number 
below five minutes prior to the call:

US: +1877423 0830
UK: +4420 7153 9154
Norway: +47 21 06 61 13
Sweden: +468-506443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44580 65 22

Participant pin code: 434633#

----

To access the replay, please dial:

US: +1877679 2989
UK: +44 20 3364 5196
Norway: +47 23 50 02 03
Sweden: +46 8-505564 73

Conference reference: 345360#

A  replay  version  of  the  conference   call  will  also  be  available   at 
www.algeta.com.

                                     ###

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 / Renate Birkeli        +47 23 00 67 32
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 interactions with  regulatory 
authorities, our anticipated co-promotion of radium-223 in the US,  additional 
clinical development of radium-223 and our TTC program. 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 success of future clinical trials, collaborations with other companies  in 
the development of  targeting molecules, 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  and  our  other  products,  the  risk  that   costs 
associated  with  the   co-promotion  of  radium-223   may  be  greater   than 
anticipated, the risk that research & development will not yield new  products 
that  achieve  commercial  success,   manufacturing  capacity,  the  risk   of 
non-approval of  patents  not  yet  granted,  risks  in  obtaining  regulatory 
approvals for radium-223 and our other products and difficulties of  obtaining 
relevant governmental  approvals for  new products,  and the  other risks  and 
uncertainties described in our annual report.

[1]Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, excluding net loss from
co-promotion while including some US overhead costs

This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Fourth Quarter Presentation 2012
Press release
Annual report 2012
Fourth Quarter Report 2012

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Source: Algeta ASA via Thomson Reuters ONE
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