Algeta ASA : Algeta celebrates the official opening of its commercial
production facility for Xofigo® (radium Ra 223 dichloride) at the Institute
for Energy Technology (IFE) in Norway
Not intended for US media
Oslo, Norway, 20 June 2013 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, today celebrates the
official opening of its commercial production facility for Xofigo^® (radium Ra
223 dichloride) at the Institute for Energy Technology (IFE) in Kjeller,
Andrew Kay, Algeta's President & CEO, and senior management colleagues will be
joined by Trond Giske, the Norwegian Minister for Trade and Industry, Eva S.
Dugstad, President of IFE and Andreas Fibig, President & Chairman of the Board
of Management, Bayer HealthCare Pharmaceuticals, and other distinguished
guests for an official ribbon cutting ceremony this afternoon.
Xofigo was approved by the US Food and Drug Administration (FDA) on 15 May for
the treatment of patients with castration-resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastatic disease. It is
the first alpha particle-emitting radioactive therapeutic agent approved by
the FDA. Algeta US, LLC and Bayer Healthcare are co-promoting the product in
the US. Xofigo has been launched in the US, triggering a EUR 50 million
milestone payment to Algeta from Bayer. Bayer Healthcare has licensed the full
rights to Xofigo outside of the US.
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 for the treatment of CRPC patients with bone metastases.
Andrew Kay, Algeta's President & CEO, said: "The recent approval and launch of
Xofigo in the US are momentous achievements for Algeta and put us firmly on
the path to deliver on our vision of becoming a world-class oncology company
bringing novel targeted medicines to cancer patients through our leadership in
alpha particle-emitting pharmaceuticals. IFE has been an important partner to
Algeta throughout the clinical development of radium 223, and it has been
instrumental in helping us build a commercial production facility for the
global supply of Xofigo. We are all extremely grateful for the expertise,
dedication and support that IFE has provided to Algeta on this journey and
look forward to continuing our productive partnership."
"Today's opening of a new commercial production facility at IFE underlines the
Norwegian pharmaceutical industry's ability to develop products with
significant global potential.We are proud to have played an integral part in
the development of Xofigo that has required state-of-the-art quality
manufacturing throughout its path to market. The new facility which is being
officially opened today has been designed according to highest quality
standards - from raw material handling to the release of the final commercial
product," said Eva S. Dugstad, President of the IFE.
"On behalf of Bayer, I am proud and excited to be part of this collaboration
with our Norwegian partners, Algeta and IFE," said Andreas Fibig, Head of the
Pharmaceuticals Division of Bayer. "Now is the time for the patients to gain
from it. Our hope is that Xofigo can help patients with bone metastases caused
by prostate cancer all over the world. There is a great need for new treatment
options for these patients, and our clinical studies show that Xofigo can help
patients to live longer. For me, representing a pharma company having 'Science
for a better life' as its mission, it is deeply gratifying to know that what
will be produced here will improve many peoples' lives."
About Xofigo^® (radium Ra 223 dichloride)
Xofigo is indicated for the treatment of patients with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral metastatic
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].
In September 2009, Algeta signed an agreement with Bayer for the development
and commercialization of Xofigo. Under the terms of the agreement, Bayer will
develop, apply for health authority approvals worldwide and commercialize
Xofigo globally. Algeta US, LLC is co-promoting Xofigo with Bayer in the US.
For full prescribing information visit www.xofigo-us.com.
Xofigo^® is a registered trademark of Bayer
For further information, please contact:
Mike Booth / Renate Birkeli +47 23 00 67 32
Communications & Corporate Affairs email@example.com
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson firstname.lastname@example.org
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton email@example.com
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group firstname.lastname@example.org
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.
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 our ability to manufacture radium 223 on a global scale. 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 in the US, growth management, general economic and
business conditions and the pricing environment, 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,
manufacturing capacity, the risk of non-approval of patents not yet granted,
risks in obtaining additional regulatory approvals for radium 223 and the
other risks and uncertainties described in our annual report.
[i]XOFIGO Prescribing information. May 2013
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
This announcement is distributed by Thomson Reuters on behalf of Thomson
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
information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
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