Algeta celebrates the official opening of its commercial production facility for Xofigo(R) (radium Ra 223 dichloride) injection

Algeta celebrates the official opening of its commercial production facility 
for Xofigo(R) (radium Ra 223 dichloride) injection at the
Institute for Energy Technology (IFE) in Norway 
OSLO, NORWAY -- (Marketwired) -- 06/20/13 --  Intended for US media
only 
Algeta ASA (OSE: ALGETA), a company focused on the development of
cancer therapeutics, today celebrates the official opening of its
commercial   production   facility  for  Xofigo(R)  (radium  Ra  223
dichloride)
injection at the Institute for Energy Technology (IFE) in
Kjeller, Norway. 
Andrew  Kay, Algeta's President & CEO,  and senior management
colleagues will be joined  by Trond Giske,  the Norwegian Minister 
for Trade and  Industry, Eva S. Dugstad,  President of IFE and
Andreas Fibig,  President & Chairman of the Board
of  Management,
Bayer HealthCare Pharmaceuticals, and other distinguished guests
for
an official ribbon cutting ceremony this afternoon. 
Xofigo  was approved by the US Food  and Drug Administration (FDA) on
15 May for the  treatment  of  patients  with  castration-resistant
prostate cancer (CRPC),
symptomatic  bone metastases and no known
visceral metastatic disease. It is the first alpha particle-emitting
radioactive therapeutic agent approved by the FDA.
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  and Bayer Healthcare 
are co-promoting the product in the  US.   Xofigo  has  been 
launched  in  the  US, triggering a EUR 50 million
milestone  payment
to Algeta from Bayer.  Bayer Healthcare has licensed the full
rights
to Xofigo outside of the US. 
Radium  Ra 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. 
Andrew  Kay, Algeta's President & CEO, said:  "The recent approval
and launch of Xofigo  in the US are momentous achievements for Algeta
and put us firmly on the path  to  deliver  on  our  vision  of 
becoming  a world-class oncology company
bringing  medicines to
cancer patients through our leadership in alpha particle-emitting
pharmaceuticals. IFE has been an important partner to Algeta
throughout the  clinical development of radium 223, and it has been
instrumental in helping
us  build a commercial production  facility
for the global  supply of Xofigo. We are  all extremely grateful  for
the expertise,  dedication and support that IFE has  provided  to 
Algeta  on  this  journey  and look forward to continuing our
productive partnership." 
"Today's  opening of a new commercial  production facility at IFE
underlines the Norwegian pharmaceutical industry's ability to develop
products with significant
global  potential. We  are  proud  to  have
 played  an  integral  part  in the
development  of Xofigo  that has 
required quality  manufacturing throughout its path to market. The
new facility which is being officially opened today has been
designed
 according to highest quality standards - from raw material handling
to the  release of the final commercial product," said Eva S. Dugstad,
President of the IFE. 
"On  behalf of Bayer,  I am proud  and excited to  be part of this
collaboration
with  our Norwegian partners,  Algeta and IFE,"  said
Andreas Fibig, President & Chairman  of the Board of Management,
Bayer HealthCare Pharmaceuticals. "Now is the  time for the  patients
to gain  from it. Our  hope is that  Xofigo can
help
castration-resistant  prostate cancer patients  with symptomatic
bone metastases
and no known visceral metastatic disease all over the
world." 
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 radium-223 may cause
double-strand DNA breaks in adjacent cells, resulting in an
anti-tumor effect on bone metastases[i]. 
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 
co-promotion  of  Xofigo  in the US and our ability  to manufacture 
radium 223 on  a global  scale. 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. 
[i] XOFIGO Prescribing information. May 2013 
Press release: http://hugin.info/134655/R/1710715/567381.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#1710715] 
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 
Kari Watson
+1 781 235 3060
MacDougall Biomedical Communications
kwatson@macbiocom.com 
US investor enquiries: 
Tricia Swanson
+1 646 378 2953
The Trout Group
tswanson@troutgroup.com
 
 
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