Algeta ASA : US FDA Grants Priority Review to Bayer's NDA for Radium Ra 223 Dichloride for Castration-Resistant Prostate Cancer

Algeta ASA : US FDA Grants Priority Review to Bayer's NDA for Radium Ra 223 
Dichloride for Castration-Resistant Prostate Cancer with Bone
OSLO, NORWAY -- (Marketwire) -- 02/13/13 --  Intended for US Media
Algeta ASA  (OSE: ALGETA) announces that Bayer has   received 
notification  that  the  New  Drug  Application  (NDA)  for
investigational compound Radium Ra 223 Dichloride (radium-223)
has been accepted
for  filing and granted priority  review by the US 
Food and Drug Administration
(FDA).   The  application  is  currently
 under  review  for  the treatment  of castration-resistant prostate
cancer (CRPC) patients with bone metastases. 
Andrew  Kay,  Algeta's  President  &  CEO,  said: "With the granting
of priority
review for the NDA for Radium Ra 223 dichloride
(radium-223) in the US, there is recognition  that  Radium  Ra  223
dichloride  (radium-223) has the potential to offer  a treatment
option for CRPC patients with bone metastases where little or no 
therapy exists. While we await the  final decision from the
regulators later
this  year,  and  together  with  Bayer,  we continue
with our commercialization
planning  and look forward to a potential 
approval, and to making this compound
available to patients." 
The  FDA  grants  priority  review  to  medicines that provide a
treatment where
little  or no adequate therapy exists. Under  the
Prescription Drug User Fee Act (PDUFA),  the FDA aims  to complete
its  review within six  months of the 60-day
filing  receipt  of  the
 NDA  submission  (eight months total), rather than the standard
12-month review cycle. 
In  September 2009, Algeta  signed an  agreement with  Bayer Pharma 
AG (Berlin,
Germany)  for  the  development  and  commercialization of
radium-223. Under the terms  of the agreement,  Bayer will develop, 
apply for global health authority
approvals, and commercialize
radium-223 globally. Algeta will co-promote radium-223 with Bayer in
the US, and is eligible for milestones as well as royalties on
Bayer's sales outside the US. 
About Radium Ra 223 Dichloride 
Radium  Ra  223 Dichloride  (radium-223), formerly  referred  to  as
chloride,  is  an  investigational  alpha 
particle-emitting pharmaceutical  in develo
pment for CRPC patients
with bone metastases. 
Radium-223 is  an  investigational  agent  and  is  not approved by
the European
Medicines  Agency  (EMA),  the  US  Food  and Drug
Administration (FDA) or other
health authorities. Bayer submitted a
Marketing Authorization Application to the EMA  and a New Drug 
Application to the FDA  for radium-223 in December 2012 for the
treatment of CRPC patients with bone metastases. 
In  January 2013, the US Nuclear Regulatory  Commission (NRC) issued
a licensing
decision  on the medical use of  radium-223. The decision
states that US medical
sites  can procure  and administer  radium-223
under 10 CFR  Part 35, Subpart E, which includes 10 CFR Section 
About CRPC and Bone Metastases 
Prostate cancer is the most common cancer among men in the United
States (other
than skin cancer)[1].Approximately 16% of prostate
cancer cases are considered
regional or distant, which means that the
cancer has spread beyond the prostate
to nearby or distant areas of
the body (metastasis)[2]. A majority of men with CRPC have
radiological evidence of bone metastases[3].
Bone metastases
secondary to prostate cancer typically target the lumbar
vertebrae and pelvis[4].In fact, bone metastases are the main
cause of morbidity
and death in patients with CRPC[5]. 
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
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 the
potential timeline  of FDA approval of radium-223 and  our 
anticipated  co-promotion  of radium-223 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
for  the
 US  field  force,  growth  management,  general  economic and
conditions  and the pricing environment, the  impact of
competition, the ability
to  successfully commercialize  radium-223,
the risk  that costs associated with
the  co-promotion of  radium-223
may be  greater than anticipated, manufacturing
capacity,  the  risk 
of  non-approval  of  patents  not  yet  granted, risks in obtaining 
 regulatory   approvals   for  radium-223 and  the  other  risks
uncertainties described in our annual report. 
[1] American
Cancer Society. Prostate Cancer: Detailed Guide. October 26,
Available at:
May 17, 2012 
[2] National Cancer Institute, Surveillance Epidemiology and End
Results (SEER).
SEER Stat Facts: Prostate; Survival & Stage, 2002-2008 
[3] Sartor, O. "Radiopharmaceutical and chemotherapy combinations in
castrate-resistant prostate cancer: a new beginning." JCO.
[4] Bone and Cancer Foundation. Questions & Answers about Prostate
Cancer Bone
Metastases and Treatment-Related Osteoporosis. Available
May 17, 2012 
[5] Lange PH, Vasella RL. "Mechanisms, hypotheses and questions
regarding prostate cancer metastatic to bone." Cancer & Metastasis
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