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Algeta ASA: New data and analyses from clinical trials of Xofigo(R) (radium Ra 223 dichloride) to be presented at ASCO

Algeta ASA: New data and analyses from clinical trials of Xofigo(R) (radium Ra 
223 dichloride) to be presented at ASCO 
OSLO, NORWAY -- (Marketwired) -- 05/16/13 --  Intended for US Media
only 
Algeta ASA (OSE: ALGETA) announces that further analyses of data
subsets from the phase III ALSYMPCA study of the recently FDA-approved
Xofigo(R) (radium Ra 223 dichloride, radium 223) will be presented at
the 49(th) Annual Meeting of the American Society of Clinical
Oncology (ASCO),31 May-4 June, in Chicago, IL (USA). 
Hematologic   safety   of   Ra-223 dichloride  (Ra-223) in
castration-resistant prostate  cancer (CRPC) patients with bone 
metastases from the phase 3 ALSYMPCA trial 
* Abstract #5060, General Poster Session: Genitourinary (Prostate)
Cancer 
* Monday, 3 June, 8:00am - 11:45am, S Hall A2 
Efficacy  and safety  of radium-223 dichloride  (Ra-223) in
castration-resistant prostate  cancer (CRPC) patients with bone
metastases who did or did not receive prior docetaxel (D) in the phase
3 ALSYMPCA trial 
* Abstract #5068, General Poster Session: Genitourinary (Prostate)
Cancer 
* Monday, 3 June, 8:00am - 11:45am, S Hall A2 
Pain  analysis  from  the  phase  3 randomized  ALSYMPCA  study with
radium-223
dichloride (Ra-223) in castration-resistant prostate
cancer (CRPC) patients with
bone metastases 
* Abstract #5038, General Poster Session: Genitourinary (Prostate)
Cancer 
* Monday, 3 June, 8:00am - 11:45am, S Hall A2 
Correlation between baseline variables and survival in the radium-223
dichloride
(Ra-223) phase III ALSYMPCA trial with attention to total
ALP changes 
* Abstract #5080, General Poster Session: Genitourinary (Prostate)
Cancer 
* Monday, 3 June, 8:00am - 11:45am, S Hall A2 
About Xofigo(R)
(radium Ra 223 dichloride) 
Xofigo  is  indicated  for  the  treatment of patients with
castration-resistant prostate  cancer, symptomatic bone  metastases
and no known visceral metastatic disease. 
Xofigo is an alpha particle-emitting radioactive therapeutic agent
with an anti-tumor  effect on bone metastases.  The active ingredient
in  Xofigo 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 Xofigo 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 dichloride is less than 100 micrometers, which may limit
the damage to the surrounding normal tissue(1). 
In September 2009, Algeta signed an agreement with Bayer for the
development and commercialization  of  Xofigo.  Under  the  terms  of
 the agreement, Bayer will
develop, apply for health authority
approvals worldwide and commercialize Xofigo
globally. Algeta US, LLC
will co-promote 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 x
10(9)/L, the platelet count greater than or equal to  100 x 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 x 10(9)/L and  the  platelet  count  greater  than  or 
equal  to  50 x 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 patients
receiving Xofigo were nausea, diarrhea, vomiting, and
peripheral edema. 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   Xofigo-treated
 patients  (greater  than  or  equal  to  10%) were
anemia,
lymphocytopenia, leukopenia, thrombocytopenia, and
neutropenia. 
For full prescribing information visit www.xofigo-us.com. 
### 
Xofigo(R) is a registered trademark of Bayer. 
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 Xofigo 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 in the US, growth
management, general economic and business conditions  and the pricing
environment, 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, the  risk  of  non-approval  of  patents  not
 yet  granted,  risks in obtaining
additional   regulatory  approvals
 for  radium  223 and  the  other  risks and
uncertainties described
in our annual report. 
600-203-0001-13 
Press release: http://hugin.info/134655/R/1702356/562483.pdf 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. 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 the information contained therein. 
Source: Algeta ASA via Thomson Reuters ONE 
[HUG#1702356] 
For further information about Algeta, 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 
Kari Watson
+1 781 235 3060
MacDougall Biomedical Communications
kwatson@macbiocom.com 
Investor enquiries:
Tricia Swanson
+1 646 378 2953
The Trout Group
tswanson@troutgroup.com
 
 
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