OSLO, NORWAY--(Marketwire - Feb 28, 2013) -
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
can be accessed through www.algeta.com. An international conference call
take place at 14:30 CET/08:30 EST (US). Details of both events are at the
"Algeta made significant achievements across its business in 2012,
commercial preparations and expanding its manufacturing capabilities for
Ra 223 dichloride (radium-223) as well as initiating further R&D
for the development of our Targeted Thorium Conjugate (TTC) pipeline.
progress means that Algeta entered 2013 well placed to deliver on its
be a world-class oncology company bringing novel targeted medicines to
patients through its leadership in alpha-pharmaceuticals," said Andrew
Algeta's President & CEO. "In parallel, we continue to make
investments in building our commercial operations for radium-223 in the
Radium-223 is an investigational agent and is not approved by the
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or
In September 2009, Algeta signed an agreement with Bayer Pharma AG
Germany) for the development and commercialization of radium-223.
terms of the agreement, Bayer will develop, apply for global health
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
Bayer's sales outside the US.
Highlights of the fourth quarter 2012:
* In December, Bayer submitted applications seeking marketing
the EMA and the FDA for radium-223 for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone
The first complete submission triggered a EUR 50m milestone payment
* In November, Algeta entered a research collaboration with Ablynx to
a novel TTC based on combining Algeta's proprietary thorium-227
alpha-pharmaceutical payload with tumor-targeting
generated by Ablynx.
* In November, Algeta further strengthened its R&D capabilities,
in chelation and conjugation technologies, with the appointment of Dr
Cuthbertson as Senior Vice President, Research and Development.
* In February 2013, the FDA granted priority review of the NDA for
223. The FDA grants priority review to medicines that may
treatment where no adequate therapy exists. Under the Prescription Drug
Fee Act (PDUFA), the FDA aims to complete its review within eight
from the submission of the NDA, rather than the standard 12-month
* In February 2013, further results from the ALSYMPCA phase III
radium-223 were presented at the 2013 Genitourinary Cancers Symposium.
* In January 2013, the US Nuclear Regulatory Commission (NRC)
licensing decision on the medical use of radium-223.
* In January 2013, Algeta initiated a new TTC research program using the
CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.
* In February 2013, and as part of the prioritisation of the TTC
Algeta deemed PDGFR-beta to be an unsuitable target for alpha-
development. Accordingly, the decision has been taken to terminate
element of the Affibody agreement.
* Operating revenue for the fourth quarter and full year 2012
NOK 440m and NOK 627m, respectively, compared with NOK 73m and NOK
the same periods in 2011.
* Core operating expenses, which exclude currency effects, interest
and costs directly related to preparation of commercial launch in the
for the fourth quarter and full year 2012 amounted to NOK 99m and NOK
respectively, compared with NOK 84m and NOK 289m in the same periods in
* Algeta's recognized share of US co-promotion activity expenses
fourth quarter and full year 2012 was NOK 28m and NOK 72m. In
activity had not yet commenced.
* Liquid funds amounted to NOK 369m as of the 31 December 2012, compared
NOK 426m as of 30 September 2012, and NOK 317m at the end of December
The Fourth Quarter and Full Year 2012 Report and accompanying presentation
be available through www.algeta.com from 07:00 CET.
Details of presentation and webcast
A presentation by Algeta's senior management team to investors, analysts
press will take place in Oslo at 10:00 CET.
Haakon VIIs gate 1
The presentation will also be webcast live and can be accessed
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
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
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223), formerly referred to as
chloride, is an investigational alpha particle-emitting
development for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by the
European Medicines Agency (EMA) or other health authorities.
Algeta is a company focused on developing novel targeted therapies for
with cancer based on its alpha-pharmaceutical platform. The
headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC,
Cambridge, MA performing commercial marketing operations in the US.
listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information
This news release contains certain forward-looking statements that are
uncertainty, as they relate to events and depend on circumstances that
occur in the future and which, by their nature, may have an impact on
operations and the financial condition of Algeta. Such forward-
statements reflect our current views and are based on the information
available to Algeta. Algeta cannot give any assurance as to whether such
looking statements will prove to be correct. These forward looking
include statements regarding interactions with regulatory
anticipated co-promotion of radium-223 in the US, additional
development of radium-223 and our TTC program. There are a number of
that could cause actual results and developments to differ materially from
expressed or implied by these forward-looking statements. These factors
among other things, risks or uncertainties associated with the success of
clinical trials, collaborations with other companies in the
targeting molecules, the ability to identify and hire a sufficient
qualified employees for the US field force, growth management, general
and business conditions and the pricing environment, the impact of
the ability to successfully commercialize radium-223 and our other
risk that costs associated with the co-promotion of radium-223 may be
than anticipated, the risk that research & development will not
products that achieve commercial success, manufacturing capacity, the
non-approval of patents not yet granted, risks in obtaining regulatory
for radium-223 and our other products and difficulties of obtaining
governmental approvals for new products, and the other risks and
described in our annual report.
 Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, excluding net loss
co-promotion while including some US overhead costs
Algeta results for the fourth quarter and full year 2012:
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Source: Algeta ASA via Thomson Reuters ONE