Algeta ASA: Xofigo® (radium Ra 223 dichloride) granted Marketing Authorization in the European Union
(Thomson Reuters ONE) -
Not intended for US media
Xofigo(®) (radium Ra 223 dichloride) granted Marketing Authorization in the
European Union
Oslo, Norway, 15 November 2013 - Algeta ASA (OSE: ALGETA) announces today that
Bayer has received marketing authorisation from the European Commission for
Xofigo(®) 1000 kBq/ml solution for injection (radium Ra 223 dichloride) for the
treatment of adults with castration-resistant prostate cancer, symptomatic bone
metastases and no known visceral metastases. The marketing authorization
provides approval for the commercialization of Xofigo in all 28 countries of the
EU, and in Norway, Iceland and Liechtenstein following national approval.
This decision follows a positive recommendation from the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in
September of this year. The approval of Xofigo is based on data from the pivotal
Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Andrew Kay, Algeta's President & CEO, said: "Today's decision by the European
Commission to approve Xofigo in the EU is another major milestone achieved for
Algeta. It marks the start of what we hope will become an important royalty
stream based on Bayer's ex-US sales, in addition to the 50% share of the profits
we expect to receive from the co-promotion of Xofigo in the US. Our partnership
with Bayer is proving to be very productive and we are delighted with the
progress being made."
"Prostate cancer is the commonest cancer in men, and often spreads to the
bones," said Christopher Parker, MD, Principal Investigator of the ALSYMPCA
trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation
Trust, and Honorary Reader in Prostate Oncology at The Institute of Cancer
Research, London. "Bone metastases lead to pain, fracture and other
complications that can significantly impair the patient's health and well-being.
Xofigo targets bone metastases, delivering a localized effect to offer patients
prolonged survival, making it an exciting advance in the treatment of this
cancer."
About Xofigo(®) (radium Ra 223 dichloride)
Xofigo(®) is an alpha particle-emitting pharmaceutical. Xofigo's active moiety
mimics calcium and selectively targets bone, specifically areas of bone
metastases, by forming complexes with the bone mineral hydroxyapatite. The high
linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high
frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a
potent cytotoxic effect. Additional effects on the tumour microenvironment
including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
The alpha particle range from Xofigo is less than 100 micrometers (less than 10
cell diameters), which minimizes damage to the surrounding normal tissue.
Xofigo is approved in the US for the treatment of patients with castration-
resistant prostate cancer, symptomatic bone metastases and no known visceral
metastatic disease.
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of radium-223. Under the terms of this agreement, Bayer will
develop, apply for health authority approvals worldwide and commercialize Xofigo
globally. Algeta is eligible for royalties and milestones based on Bayer's sales
of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer
in the US.
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Xofigo(®) is a registered trademark of Bayer
For further information, please contact:
Mike Booth +1 646 410 1884
Communications & Corporate Affairs ir(at)algeta.com
Media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow(at)citigatedr.co.uk
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton knut.ekern(at)hkstrategies.com
Investor enquiries:
Tricia Truehart +1 646 378 2953
The Trout Group ttruehart(at)troutgroup.com
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
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 our co-promotion of Xofigo in the US and Bayer's
promotion of Xofigo in Europe. 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, manufacturing
capacity, risks in obtaining additional regulatory approvals for radium-223 and
the other risks and uncertainties described in our annual report.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Press release:
http://hugin.info/134655/R/1743543/586531.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#1743543]
Unternehmensinformation / Kurzprofil:
Datum: 15.11.2013 - 11:16 Uhr
Sprache: Deutsch
News-ID 317037
Anzahl Zeichen: 7495
contact information:
Town:
Oslo
Kategorie:
Business News
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