Algeta Announces That Xofigo(R) (Radium Ra 223 Dichloride) Injection Has Been Approved by the US FDA as Treatment for Castration

Algeta Announces That Xofigo(R) (Radium Ra 223 Dichloride) Injection Has Been 
Approved by the US FDA as Treatment for Castration-Resistant
Prostate Cancer With Bone Metastases 
OSLO, NORWAY -- (Marketwired) -- 05/15/13 --  Intended for US Media
only 
* Algeta  to  host  international  conference  call  scheduled for
tomorrow at     08:00 CET, 02:00 Eastern time - details below 
Oslo, Norway, 15 May 2013 - Algeta ASA (OSE: ALGETA) announces that
Bayer has
received US Food and Drug Administration (FDA) approval for
Xofigo((R)) (radium Ra 223 dichloride) injection for the treatment of
patients with castration- resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastatic disease.
Xofigo is the first alpha particle-emitting radioactive therapeutic
agent approved by the FDA. It has demonstrated improvement in overall
survival (OS) and delay in time to first symptomatic skeletal event
(SSE) compared to placebo in the pivotal phase III ALSYMPCA trial[1]. 
The commercial production of Xofigo is underway, and first doses are
expected to be ready for patient treatment within a few weeks. Bayer
has worldwide exclusive
marketing rights for Xofigo. Algeta US, LLC
and Bayer Healthcare will co- promote
the product in the US. 
Andrew  Kay, Algeta's President & CEO, said:  "We are delighted that
the FDA has taken  the decision to approve Xofigo so quickly. We are
extremely pleased to be able  to make Xofigo available to US patients
with castration-resistant prostate
cancer, symptomatic bone
metastases and no known visceral metastatic disease. We will  now
finalize  our launch  preparations in  the US,  with the intention of
launching  Xofigo, with  Bayer, as  soon as  possible. This  approval
is a major
milestone  for Algeta and puts us firmly on the path to
deliver on our vision to be  a world-class oncology company bringing
medicines to cancer patients through
our leadership in alpha
particle-emitting pharmaceuticals." 
"Most  men with  castration-resistant prostate  cancer develop  bone
metastases,
which  can decrease  overall survival,"  said Oliver 
Sartor, MD, North American
Principal  Investigator for the pivotal
trial and medical director of the Tulane
Cancer  Center (New Orleans,
LA). "Xofigo  has demonstrated an anti-tumor effect
on  b
one
metastases and will  be an important addition  to the treatment of
this
cancer." 
Bone is the most common site in the body to be affected by metastatic
cancer,
and bone metastases are particularly prevalent in patients
with prostate cancer[2]. Approximately 90% of patients with
metastatic prostate cancer show
evidence of bone
metastases[3](,)[4](,)[5](,)[6] Bone metastases can lead to an
increase in frequency of skeletal events[7] and are shown to be the
main cause
of morbidity and death in patients with CRPC[8]. 
Jan  Manarite, senior educational  facilitator for the  Prostate
Cancer Research
Institute  also added, "It is  encouraging to have a 
new treatment for men with
castration-resistant  prostate  cancer, 
who  are  dealing with bone metastases.
Xofigo  provides  another 
new  option  to  treat  this cancer using a different
approach." 
Efficacy  and  Safety  Data  Supporting  Xofigo((R))  (radium  Ra 
223 dichloride)
Approval 
The  approval of  Xofigo is  based on  data from  the pivotal phase
III ALSYMPCA
(ALpharadin  in  SYMptomatic  Prostate  CAncer)  trial.
At the interim analysis,
Xofigo  significantly  improved  OS 
[HR=0.695 (95% CI 0.552-0.875), p=0.00185];
median OS was 14.0 months
with Xofigo plus best standard of care vs. 11.2 months
with  placebo 
plus  best  standard  of  care(1).  Additionally,  at the
interim
analysis there was a delay in the time to first symptomatic
skeletal event (SSE)
for patients treated with Xofigo vs. placebo(1). 
An updated analysis, conducted after the study was unblinded, showed
improvement
in  overall survival with  a median OS  of 14.9 months
vs. 11.3 months; HR=0.695
(95% CI 0.581-0.832)(1). 
The  most common  adverse reactions  (greater than  or equal to 10%)
in patients
receiving  Xofigo  in  the  ALSYMPCA  trial  were nausea,
diarrhea, vomiting and peripheral  edema. The most common hematologic
laboratory abnormalities (greater
than or equal to 10%) were anemia,
lymphocytopenia, leukopenia, thrombocytopenia
and neutropenia(1). 
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. 
About the ALSYMPCA Trial 
The ALSYMPCA trial was a phase III, randomized, double-blind,
placebo- controlled
international  study of Xofigo with best standard 
of care vs. placebo with best
standard  of care in  symptomatic CRPC
patients  with bone metastases. The trial
enrolled  921 patients  in 
more  than  100 centers  in  19 countries. The study
treatment 
consisted of  up to  six intravenous  injections of Xofigo or
placebo
each separated by an interval of four weeks. 
The  primary endpoint of  the study was  overall survival (OS).  A
key secondary
endpoint  was  time  to  first  symptomatic  skeletal
event (SSE), as defined as external  beam  radiation  therapy  (EBRT)
 to  relieve  skeletal symptoms, new symptomatic  pathologic bone
fracture, occurrence of spinal cord compression, or tumor-related
orthopedic surgical intervention. 
About CRPC and Bone Metastases 
Prostate cancer is the most common cancer among men in the United
States (other
than skin cancer)[9]. Approximately 4% of prostate
cancer cases are considered
distant, which means that the cancer has
spread beyond the prostate to distant
areas of the body
(metastasized)[10]. If prostate cancer starts to spread to
other
areas of the body, it most commonly goes to the bones(7). About the
Patient Assistance Program 
Bayer  and Algeta  offer patient  assistance through  Xofigo Access
Services(SM)
which  will  assist  with  obtaining  coverage  and 
patient  support of Xofigo.
Patients   and   providers   may  
contact   the  program  at  1-855- 6XOFIGO (1- 855-696-3446) for
additional information. 
Details of international conference call 
A  conference call for investors, analysts and the press, and hosted
by Algeta's
senior  management team,  will take  place tomorrow  at
08:00 CET, 02:00 Eastern
time.  To participate in the conference
call, please dial the appropriate number
below five minutes prior to
the call: 


 
US: +1 866 966 5335
UK: +44 20 3003 2666 (toll free 0808 109 0700)
Norway: +47 21 56 33 18 (toll free 800 19 457)
 
Password: Algeta
 
----
 
To access the replay (available for seven days), please dial:
 
US: +1 866 583 1035
UK: +44 20 8196 1998
Norway: toll free 800 19 101
 
Participant pin code: 9227182

 
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. 
Xofigo((R)) is a registered trademark of Bayer. 
Xofigo Access Services(SM) is a service mark of Bayer. 


 
[1] XOFIGO Prescribing information. May 2013
[2] Coleman R. Metastatic bone disease: clinical features, pathophysiology
and
treatment strategies. Cancer Treat Rev. 2001;27:165-176
[3] Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus
prednisone
for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512
[4] Petrylak DP, et al. Docetaxel and estramustine compared with
mitoxantrone
and prednisone for advanced refractory prostate cancer. N Engl J Med.
2004;351:1513-1520
[5] Scher, HI, et al. Increased Survival with Enzalutamide in Prostate
Cancer
after Chemotherapy. N Engl J Med. 2012;DOI10.1056
[6] Fizazi, K, et al. Abiraterone acetate for treatment of metastatic
castration-resistant prostate cancer: final overall survival analysis of
the
COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study.
Lancet
Oncol 2012; 13:983-92
[7] Saad, MD, et. al. "Guidelines for the management of castration-
resistant
prostate cancer." Can Urol Assoc 2010;4(6):380-4
[8] Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding
prostate cancer metastatic to bone." Cancer & Metastasis
Reviews.1999;17:331-336
[9] American Cancer Society. Prostate Cancer: Detailed Guide. Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf
[10] National Cancer Institute, Surveillance Epidemiology and End Results
(SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008

 
Press release: http://hugin.info/134655/
R/1702307/562444.pdf 
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Source: Algeta ASA via Thomson Reuters ONE 
[HUG#1702307] 
For further information, please contact:
Mike Booth
+47 2202 4510
Communications & Corporate Affairs
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Media enquiries:
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