OSLO, NORWAY--(Marketwired - May 15, 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 first quarter
A presentation of the results in Oslo will be webcast live from 10:00
CET and can be accessed through 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 continues to advance its preparations for the commercialization of
radium Ra 223 dichloride in the US to ensure it is ready to launch the
product,with Bayer, if approved by the US Food and Drug Administration
later this year," said Andrew Kay, Algeta's President & CEO. "We are also
making good progress with the development of our Targeted Thorium Conjugate
(TTC) pipeline and look forward to the results of further preclinical
evaluations which will guide our choice of which TTC candidate to advance
into clinical trials next year."
Radium Ra 223 dichloride (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 US, LLC will co-promote radium-223, if approved, with
Bayer in the US, and Algeta is eligible for milestones as well as
royalties on Bayer's sales outside the US.
Highlights of the first quarter 2013
* In February 2013, the FDA granted priority review of the NDA (New
Drug Application) 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
* 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.
* Algeta's US medical and commercial organization is now complete,
with an experienced oncology field force of medical science liaison and
radiotherapy licensing personnel, as well as sales representatives,
present in all US territories for which Algeta has responsibility.
* In May 2013, Algeta received an expanded manufacturing license
from the Norwegian Medicines Agency (NoMA), allowing production of
radium-223 from the new commercial production facility at the
Institute for Energy Technology (IFE), near Oslo.
* In April 2013, Hilde Furberg and Paolo Pucci were elected to the
Directors as Non-executive Directors at the Company's Annual General
in April, replacing Ingrid Wiik and Joseph Anderson, who decided
stand for re-election.
* In May 2013, and to facilitate the conjugation of thorium-227 to
molecules in its Targeted Thorium Conjugate (TTC) research, Algeta
the exercise of its option to take an exclusive worldwide
patented Lumi4® bi-functional chelator technology from
(Richmond, CA, USA) and an extension of the collaboration to
additional chelator families.
* Operating revenue for the first quarter 2013 amounted to NOK 71m,
with NOK 73m in the same period in 2012.
* Algeta's recognized share of US co-promotion activity expenses for the
quarter 2013 was NOK 34m, compared with nil in the same period in 2012.
* Core operating expenses, which exclude currency effects, interest
and costs directly related to preparation of commercial launch in the
for the first quarter 2013 amounted to NOK 118m, compared with NOK 64m
the same period in 2012.
* Liquid funds amounted to NOK 646m as of 31 March 2013 compared
369m as of the 31 December 2012.
The First Quarter 2013 Report and accompanying presentation will be
through www.algeta.com from 07:00 CET.
Details of presentation and webcast
A presentation by Algeta's Executive Management team to investors,
the 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: 281404#
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: 346423#
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-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, and the clinical development of 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
risks or uncertainties associated with the success of future clinical
collaborations with other companies in the development of targeting
growth management, general economic and business conditions and the
environment, the impact of competition, the ability to
commercialize radium-223 and our other products, the risk that costs
with the co-promotion of radium-223 may be greater than anticipated, the
that research & development will not yield new products that achieve
success, manufacturing capacity, the risk of non-approval of patents
granted, risks in obtaining regulatory approvals for radium-223 and our
products and difficulties of obtaining relevant governmental approvals
products, and the other risks and uncertainties described in our annual
Lumi4® is a registered mark of Lumiphore, Inc.
 Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses. Core operating
not include costs from co-promotion activities.
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originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE