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Algeta results for the fourth quarter and full year 2012


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© Marketwire 2013
2013-02-28 07:11:25 -

OSLO, NORWAY -- (Marketwire) -- 02/28/13 --



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 fourth quarter
and full year 2012.



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



"Algeta made significant achievements across its business in 2012,
including
commercial preparations and expanding its manufacturing capabilities for
Radium
Ra 223 dichloride (radium-223) as well as initiating further R&D
collaborations
for the development of our Targeted Thorium Conjugate (TTC) pipeline.
This
progress means that Algeta entered 2013 well placed to deliver on its
vision to
be a world-class oncology company bringing novel targeted medicines to
cancer
patients through its leadership in alpha-pharmaceuticals," said Andrew
Kay,
Algeta's President & CEO. "In parallel, we continue to make
significant
investments in building our commercial operations for radium-223 in the
US."



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.



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.





Highlights of the fourth quarter 2012:



* In December, Bayer submitted applications seeking marketing
authorization to
the EMA and the FDA for radium-223 for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone
metastases.
The first complete submission triggered a EUR 50m milestone payment
from Bayer
to Algeta.



* In November, Algeta entered a research collaboration with Ablynx to
evaluate
a novel TTC based on combining Algeta's proprietary thorium-227
alpha-pharmaceutical payload with tumor-targeting
Nanobodies(®)
generated by Ablynx.



* In November, Algeta further strengthened its R&D capabilities,
particularly
in chelation and conjugation technologies, with the appointment of Dr
Alan
Cuthbertson as Senior Vice President, Research and Development.



Post-period events



* In February 2013, the FDA granted priority review of the NDA for
radium-
223. The FDA grants priority review to medicines that may
provide a
treatment where no adequate therapy exists. Under the Prescription Drug
User
Fee Act (PDUFA), the FDA aims to complete its review within eight
months
from the submission of the NDA, rather than the standard 12-month
review
cycle.



* In February 2013, further results from the ALSYMPCA phase III
study of
radium-223 were presented at the 2013 Genitourinary Cancers Symposium.



* In January 2013, the US Nuclear Regulatory Commission (NRC)
issued a
licensing decision on the medical use of radium-223.



* In January 2013, Algeta initiated a new TTC research program using the
anti-
CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.



* In February 2013, and as part of the prioritisation of the TTC
portfolio,
Algeta deemed PDGFR-beta to be an unsuitable target for alpha-
pharmaceutical
development. Accordingly, the decision has been taken to terminate
this
element of the Affibody agreement.



Key financials



* Operating revenue for the fourth quarter and full year 2012
amounted to
NOK 440m and NOK 627m, respectively, compared with NOK 73m and NOK
250m in
the same periods in 2011.



* Core operating expenses[1], which exclude currency effects, interest
income
and costs directly related to preparation of commercial launch in the
US,
for the fourth quarter and full year 2012 amounted to NOK 99m and NOK
316m,
respectively, compared with NOK 84m and NOK 289m in the same periods in
2011.



* Algeta's recognized share of US co-promotion activity expenses
for the
fourth quarter and full year 2012 was NOK 28m and NOK 72m. In
2011, the
activity had not yet commenced.



* Liquid funds amounted to NOK 369m as of the 31 December 2012, compared
with
NOK 426m as of 30 September 2012, and NOK 317m at the end of December
2011.



The Fourth Quarter and Full Year 2012 Report and accompanying presentation
will
be available through www.algeta.com : www.algeta.com from 07:00 CET.



Details of presentation and webcast



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



Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway.



The presentation will also be webcast live and can be accessed
through
www.algeta.com : www.algeta.com . Questions can be submitted live during the webcast.



Details of international conference call



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: 434633#



----



To access the replay, please dial:



US: +1 877 679 2989
UK: +44 20 3364 5196
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73



Conference reference: 345360#



A replay version of the conference call will also be
available at
www.algeta.com : www.algeta.com .



###



About Radium Ra 223 Dichloride



Radium Ra 223 dichloride (radium-223), formerly referred to as
radium-223
chloride, is an investigational alpha particle-emitting
pharmaceutical in
development for CRPC patients with bone metastases.



Radium-223 is an investigational agent and is not approved by the
FDA, the
European Medicines Agency (EMA) or other health authorities.



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 : 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 interactions with regulatory
authorities, our
anticipated co-promotion of radium-223 in the US, additional
clinical
development of radium-223 and our TTC program. 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 success of
future
clinical trials, collaborations with other companies in the
development of
targeting molecules, the ability to identify and hire a sufficient
number of
qualified employees for the US field force, growth management, general
economic
and business conditions and the pricing environment, the impact of
competition,
the ability to successfully commercialize radium-223 and our other
products, the
risk that costs associated with the co-promotion of radium-223 may be
greater
than anticipated, the risk that research & 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] Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, excluding net loss
from
co-promotion while including some US overhead costs



Algeta results for the fourth quarter and full year 2012:
hugin.info/134655/R/1681797/549901.pdf : hugin.info/134655/R/1681797/549901.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#1681797]




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