Breaking News

Tweet TWEET

Algeta ASA: Radium Ra 223 Dichloride Recommended for Approval for the Treatment of Castration-Resistant Prostate Cancer with

    Algeta ASA: Radium Ra 223 Dichloride Recommended for Approval for the
Treatment of Castration-Resistant Prostate Cancer with Bone Metastases in the
                                European Union

Not intended for US media

Oslo, Norway, 20 September  2013 - Algeta ASA  (OSE: ALGETA), announced  today 
that Bayer  has  received  a  positive opinion  from  the  European  Medicines 
Agency's  (EMA)  Committee  for  Medicinal  Products  for  Human  Use   (CHMP) 
recommending radium  Ra  223  dichloride  (radium-223)  for  approval  with  a 
proposed indication  for the  treatment  of adults  with  castration-resistant 
prostate cancer, symptomatic bone metastases and no known visceral metastases.
The decision of the  European Commission (EC) on  the approval is expected  in 
the fourth quarter of 2013.  Radium Ra 223 dichloride  was approved by the  US 
Food and Drug Administration (FDA) in May under the brand name Xofigo^®.

The CHMP recommendation is based on  data from the pivotal phase III  ALSYMPCA 
(ALpharadin in SYMptomatic Prostate CAncer) trial.

Andrew Kay, Algeta's President & CEO, said: "Today's positive opinion from the
CHMP marks an  important step  in the  anticipated approval  of radium-223  in 
Europe. This recommendation, soon after Xofigo's US approval and launch, again
highlights the  need for  a new  therapeutic  option that  has been  shown  to 
significantly improve survival in prostate  cancer patients whose disease  has 
spread to the bones. We are committed to working with Bayer to ensure patients
and physicians in Europe gain access to radium-223 as soon as possible."

"This recommendation  confirms the  safety  and efficacy  of radium-223  as  a 
potential treatment option  for patients  suffering from  castration-resistant 
prostate cancer with  bone metastases, a  debilitating and potentially  deadly 
condition,"  said  Christopher  Parker,  MD,  Principal  Investigator  of  the 
ALSYMPCA trial and  Consultant Clinical  Oncologist at The  Royal Marsden  NHS 
Foundation Trust, London, and The Institute of Cancer Research, London. "There
are many  men  with  this  disease who  could  potentially  benefit  from  the 
availability of radium-223 due to its unique ability to extend life and  delay 
symptomatic skeletal events such as spinal  cord compression and the need  for 
external beam radiation therapy for bone pain."

About Radium Ra 223 Dichloride

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 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 
disease.

Radium  Ra  223   dichloride  (radium-223)  is   an  alpha   particle-emitting 
pharmaceutical. Its active moiety mimics calcium and selectively targets bone,
specifically areas  of bone  metastases, by  forming complexes  with the  bone 
mineral hydroxyapatite. The high linear energy transfer of alpha emitters  (80 
keV/micrometer) leads  to a  high  frequency of  double-strand DNA  breaks  in 
adjacent tumour  cells, resulting  in a  potent cytotoxic  effect.  Additional 
effects on the tumour  microenvironment including osteoblasts and  osteoclasts 
also contribute  to  the in  vivo  efficacy.  The alpha  particle  range  from 
radium-223 is less than  100 micrometers (less than  10 cell diameters)  which 
minimises damage to the surrounding normal tissue.

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.

                                     ###

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
Knut Ekern                         +47 22 04 82 00
Gambit Hill & Knowlton             knut.ekern@hkstrategies.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 
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 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.

This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Press release

------------------------------------------------------------------------------

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#1730402
 
Press spacebar to pause and continue. Press esc to stop.