Algeta ASA : Algeta Results for the Third Quarter 2013

| Source: Algeta ASA

OSLO, Norway, Nov. 6, 2013 (GLOBE NEWSWIRE) --

Intended for US media only

Algeta ASA  (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the third quarter 2013.

A  presentation of the results  in Oslo will be  webcast live from 10:00 CET and
can  be accessed through An international  conference call will
take  place at 14:30 CET/ 08:30 Eastern Time. Details  of both events are at the
end of this announcement.

"We  are very  pleased with  the initial  phase of  the US  commercialization of
Xofigo(®)  (radium  223 dichloride)  injection",  commented  Andrew  Kay, Algeta
President  & CEO.  "Since approval  in late  May, the  launch strategy  has been
executed  well by the teams from Algeta and Bayer, and that is reflected in both
the  encouraging  sales  figures  for  this  quarter  as  well  as the number of
facilities  that are now licensed  and ready to treat  patients with Xofigo. The
recent  positive CHMP  opinion for  Xofigo in  Europe is  a key step towards its
anticipated  approval and highlights the need  for new therapies for castration-
resistant prostate cancer patients."

Oystein  Soug, Algeta's Chief Financial Officer,  added, "The first full quarter
of  Xofigo  sales  place  Algeta  on  a  clear  and  defined  trajectory towards
profitability.  Algeta  is  an  ambitious  company,  and  our proven development
expertise,  our growing commercial  experience in oncology  and our strengthened
financial  profile give us the confidence to  seek to build a broad portfolio of
novel cancer therapeutics beyond Xofigo."

Highlights of the third quarter 2013:

Xofigo (radium Ra 223 dichloride)

  * In  the  third  quarter  2013, net  sales  of  Xofigo  in  the US market (as
    recognized by Bayer) amounted to NOK 99m (USD 17m).
  * Xofigo  was approved in the  US in May 2013, and  Algeta and Bayer have been
    working  together to execute  the launch strategy.  A key focus  has been to
    support  the licensing of clinical centers  to enable them to start treating
    patients.  Progress  has  been  good,  and facility licensing has progressed
    faster  than expected with  626 sites across the  US classified as "Patient-
    Ready" on 18 October.
  * On  20 September 2013, the  European Medicines  Agency's (EMA) Committee for
    Medicinal  Products for Human Use (CHMP)  recommended the approval of Xofigo
    for  the proposed  indication of  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.
  * Data from the phase III ALSYMPCA trial were published in the 18 July 2013
    issue of the New England Journal of Medicine[1].
  * Further  analyses of  data subsets  from the  phase III  ALSYMPCA study were
    presented  at the  2013 European Cancer  Congress (ECCO/ESMO/ESTRO),  on 30
    September, in Amsterdam, The Netherlands.

  * On   4 September  2013, Algeta  raised  USD 120m  from  a  Convertible  Bond
    offering.  The Company intends to  use the net proceeds  of the offering for
    general   corporate   purposes,  for  its  working  capital  needs  and  the
    development of its product candidates. The Company may also use a portion of
    the  net proceeds to invest in products or technologies complementary to its
  * In  August,  Dr  Andreas  Menrad  was  appointed  Chief  Scientific Officer,
    bringing  more  than  20 years  of  experience  in  oncology and therapeutic
    antibody development. He was formerly Chief Scientific Officer at Ablynx NV,
    and  worked  previously  at  Genzyme  (Sanofi)  as  General Manager and Vice
    President of Antibody Therapeutics.
Key financials

  * Operating  revenue for the  third quarter 2013 amounted  to NOK 55m compared
    with NOK 60m in the same period in 2012.
  * Algeta's  recognized share of  the net result  of US co-promotion activities
    for  the  third  quarter  2013 was  an  expense of NOK 27m, compared with an
    expense  of NOK 17m in the same period in 2012. Algeta recognizes 50% of the
    net result of Xofigo co-promotion activities in the US.
  * Core operating expenses[2], which exclude currency effects, interest income
    and costs directly related to the commercial launch of Xofigo in the US, for
    the third quarter 2013 amounted to NOK 124m, compared with NOK 74m in the
    same period in 2012.
  * Cash  on hand amounted  to NOK 1,465m as  at 30 September 2013 compared with
    NOK 369m as of the 31 December 2012.
The Third Quarter Report 2013 and accompanying presentation will be available on from 07:00 CET today.

Details of presentation and webcast

A  presentation by Algeta's executive management team to investors, analysts and
the press will take place in Oslo at 10:00 CET.

KS-Agenda Møtesenter
Haakon VIIs gate 9
0161 Oslo

Details of international conference call

Algeta  will  also  host  an  international  conference  call at 14:30 CET/08:30
Eastern Time.

To  participate in the conference call, please dial the appropriate number below
five minutes prior to the call:

US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22

Participant pin code: 873878#

To access the replay, please dial:

US: +1 877 679 2989
UK: +44 203 364 5200
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73

Conference reference: 348995#

A replay of the conference call will also be available at

About Xofigo(®) (radium Ra 223 dichloride)

Xofigo  is approved in the  United States and is  indicated for the treatment of
patients  with castration-resistant prostate cancer, symptomatic bone metastases
and no known visceral metastatic disease.

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.

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. The alpha particle range from radium-223 is less than 100
micrometers which may limit the damage to the surrounding normal tissue[i].
Important Safety Information for Xofigo (radium Ra 223 dichloride) in the US

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 × 10(9)/L, the platelet count greater than or equal
to  100 × 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 ×
10(9)/L and  the  platelet  count  greater  than  or  equal  to  50 ×  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 the Xofigo
arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs
15%), vomiting  (19% vs 14%), and peripheral edema  (13% vs 10%). 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  the  Xofigo  arm  (greater  than  or  equal  to  10%) vs  the  placebo  arm,
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia
(35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).

For full US prescribing information visit:


Xofigo(®) is a registered trademark of Bayer AG

For further information, please contact:

 Mike Booth                             +1 646 410 1884

 Communications & Corporate Affairs

 Media enquiries:

 Mark Swallow                           +44 207 638 9571

 Citigate Dewe Rogerson       

 Kari Watson                            +1 781 235 3060

 MacDougall Biomedical Communications

 Investor enquiries:

 Tricia Truehart                        +1 646 378 2953

 The Trout Group              

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

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 the
development  of our other product candidates. 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,  the risk that  research & business  development will not yield new
products  that achieve commercial  success, manufacturing capacity,  the risk of
non-approval of patents not yet granted, risks in obtaining regulatory approvals
for  radium 223 and  our other  products and  difficulties of obtaining relevant
governmental  approvals for new products, and  the other risks and uncertainties
described in our annual report.

[1] Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker,
C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.
[2] Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses. Core operating expenses do
not include costs from co-promotion activities.
[i] XOFIGO Prescribing information. May 2013

Third Quarter Presentation 2013:
Press Release:
Third Quarter Report 2013: