OSLO, Norway, Sept. 12, 2013 (GLOBE NEWSWIRE) --

Intended for US media only

Algeta ASA (OSE:ALGETA), announced today that
further  analyses of data subsets from the phase III ALSYMPCA study of Xofigo(®)
(radium  Ra  223 dichloride)  injection  will  be presented at the 2013 European
Cancer  Congress (ECCO/ESMO/ESTRO),  28 September- 1 October, in  Amsterdam, The

Xofigo(®) was approved by the US Food and Drug Administration (FDA) in May 2013
for  the treatment of patients with castration-resistant prostate cancer (CRPC),
symptomatic  bone metastases and no known visceral metastatic disease and is now
available in the United States at licensed facilities.

Dr  Gillies O'Bryan-Tear, Algeta's Chief Medical  Officer, said: "These data add
to  the  growing  body  of  scientific  knowledge  of  Xofigo, and also serve to
illustrate the depth and breadth of the ALSYMPCA phase III data set."

Abstract titles and session details

Time  to first skeletal-related event (SRE) with radium-223 dichloride (Ra-223)
in   patients   with   castration-resistant  prostate  cancer  (CRPC)  and  bone
metastases: ALSYMPCA trial stratification factors analysis
  * Abstract #2876, Poster Session: Genitourinary Malignancies - Prostate
  * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4

Hematologic  safety  of  radium-223 dichloride  (Ra-223) in the phase 3 ALSYMPCA
trial   in  castration-resistant  prostate  cancer  (CRPC)  patients  with  bone
metastases: baseline prognostic factor subgroup analysis
  * Abstract #2877, Poster Session: Genitourinary Malignancies - Prostate
  * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4

Effects  of  radium-223 dichloride  (Ra-223) on  health-related  quality of life
(QOL)  outcomes  in  the  phase  3 ALSYMPCA  study  in patients with castration-
resistant prostate cancer (CRPC) and bone metastases
  * Abstract #2878, Poster Session: Genitourinary Malignancies - Prostate
  * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4

Radium-223 dichloride  (Ra-223) efficacy and safety in patients with castration-
resistant  prostate cancer (CRPC)  with bone metastases:  phase 3 ALSYMPCA study
findings stratified by age group
  * Abstract #2883, Poster Session: Genitourinary Malignancies - Prostate
  * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4

About Xofigo (radium Ra 223 dichloride)

Radium-223 dichloride  (radium 223) is  currently not  approved by  the European
Medicines  Agency (EMA) or  other authorities outside  the US. Bayer submitted a
Marketing  Authorisation Application to the EMA for radium 223 in December 2012
and subsequently in other territories.

Radium  223 (as Xofigo(®)  injection) is  approved in  the United  States and is
indicated  for  the  treatment  of  patients  with castration-resistant prostate
cancer  (CRPC),  symptomatic  bone  metastases  and no known visceral metastatic

Radium 223 is an alpha particle-emitting radioactive therapeutic agent with an
anti-tumor effect on bone metastases. The active ingredient in radium 223 is the
alpha particle-emitting isotope radium-223, which mimics calcium and forms
complexes with the bone mineral hydroxyapatite at areas of increased bone
turnover, such as bone metastases. The high linear energy transfer of radium-
223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti-
tumor effect on bone metastases. The alpha particle range from radium-223 is
less than 100 micrometers which may limit the damage to the surrounding normal
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization  of radium 223. Under  the terms of  the agreement, Bayer will
develop, apply for health authority approvals worldwide and commercialize Xofigo
globally. Algeta is eligible for royalties and milestones based on Bayer's sales
of  Xofigo outside the US, and Algeta  US, LLC is co-promoting Xofigo with Bayer
in the US.

Important Safety Information for Xofigo (radium Ra 223 dichloride)

Xofigo  is contraindicated in women  who are or may  become pregnant. Xofigo can
cause fetal harm when administered to a pregnant woman.

In  the  randomized  trial,  2% of  patients  in the Xofigo arm experienced bone
marrow  failure or  ongoing pancytopenia,  compared to  no patients treated with
placebo.  There were two deaths due to bone marrow failure. For 7 of 13 patients
treated  with Xofigo bone marrow failure was ongoing at the time of death. Among
the   13 patients  who  experienced  bone  marrow  failure,  54% required  blood
transfusions.  Four percent  (4%) of  patients in  the Xofigo  arm and 2% in the
placebo  arm permanently discontinued therapy due to bone marrow suppression. In
the  randomized trial, deaths related to vascular hemorrhage in association with
myelosuppression  were  observed  in  1% of  Xofigo-treated patients compared to
0.3% of patients treated with placebo. The incidence of infection-related deaths
(2%),  serious  infections  (10%),  and  febrile  neutropenia (less than 1%) was
similar for patients treated with Xofigo and placebo. Myelosuppression - notably
thrombocytopenia,  neutropenia, pancytopenia, and leukopenia - has been reported
in patients treated with Xofigo.

Monitor  patients with evidence  of compromised bone  marrow reserve closely and
provide  supportive care measures when  clinically indicated. Discontinue Xofigo
in  patients  who  experience  life-threatening complications despite supportive
care for bone marrow failure.

Monitor  blood counts at  baseline and prior  to every dose  of Xofigo. Prior to
first  administering  Xofigo,  the  absolute  neutrophil  count  (ANC) should be
greater than to equal to 1.5 × 10(9)/L, the platelet count greater than or equal
to  100 × 10(9)/L, and  hemoglobin greater  than or  equal to  10 g/dL. Prior to
subsequent  administrations,  the  ANC  should  be  greater than or equal to 1 ×
10(9)/L and  the  platelet  count  greater  than  or  equal  to  50 ×  10(9)/L.
Discontinue  Xofigo if  hematologic values  do not  recover within  6 to 8 weeks
after the last administration despite receiving supportive care.

Safety  and  efficacy  of  concomitant  chemotherapy  with  Xofigo have not been
established.  Outside of a clinical trial, concomitant use of Xofigo in patients
on   chemotherapy   is  not  recommended  due  to  the  potential  for  additive
myelosuppression.  If  chemotherapy,  other  systemic radioisotopes, or hemibody
external  radiotherapy  are  administered  during  the  treatment period, Xofigo
should be discontinued.

Xofigo  should be received, used, and administered only by authorized persons in
designated  clinical settings. The  administration of Xofigo  is associated with
potential  risks to other persons from radiation or contamination from spills of
bodily  fluids such as  urine, feces, or  vomit. Therefore, radiation protection
precautions must be taken in accordance with national and local regulations.

The  most common adverse reactions (greater than  or equal to 10%) in the Xofigo
arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs
15%), vomiting  (19% vs 14%), and peripheral edema  (13% vs 10%). Grade 3 and 4
adverse  events  were  reported  in  57% of  Xofigo-treated  patients and 63% of
placebo-treated  patients. The most  common hematologic laboratory abnormalities
in  the  Xofigo  arm  (greater  than  or  equal  to  10%) vs  the  placebo  arm,
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia
(35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).

For full US prescribing information, visit www.xofigo-us.com.


Xofigo(®) is a registered trademark of Bayer

For further information, please contact:

  Mike Booth                             +44 7866 490 850

  Communications & Corporate Affairs     ir@algeta.com

  Media enquiries:

  Mark Swallow                           +44 207 638 9571

  Citigate Dewe Rogerson                 mark.swallow@citigatedr.co.uk

  Kari Watson                            +1 781 235 3060

  MacDougall Biomedical Communications   kwatson@macbiocom.com

  Investor enquiries:

  Tricia Truehart                        +1 646 378 2953

  The Trout Group                        ttruehart@troutgroup.com

About Algeta

Algeta  is a  company focused  on developing,  manufacturing and marketing novel
targeted  therapies for  patients with  cancer. 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 our  co-promotion of Xofigo  in the US and Bayer's
promotion  of Xofigo in Europe.  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, general economic and business conditions, the impact of competition, the
ability  to successfully  commercialize Xofigo,  the risk  that costs associated
with  the co-promotion of Xofigo may  be greater than anticipated, manufacturing
capacity,  risks in obtaining additional regulatory approvals for radium 223 and
the other risks and uncertainties described in our annual report.

[1] XOFIGO Prescribing information. May 2013

Press release: http://hugin.info/134655/R/1728821/577445.pdf