Expanded Access Program for investigational drug Alpharadin (radium-223 chloride) initiated in the United States
(Thomson Reuters ONE) -
Not intended for US media
Oslo, Norway, 2 February 2012 - Algeta ASA (OSE: ALGETA) announces that Bayer
HealthCare Pharmaceuticals, Inc., with agreement from the US Food and Drug
Administration (FDA), has initiated an expanded access program to provide the
investigational drug Alpharadin (radium-223 chloride) to castration-resistant
prostate cancer (CRPC) patients with symptomatic bone metastases. Alpharadin
will be made available to patients through qualified clinical sites in the
United States participating in this program.
Expanded access refers to the use of an investigational drug, under certain
circumstances, to treat patients with a serious disease or condition who cannot
participate in a controlled clinical trial*.
For more information on this program, visit www.clinicaltrials.gov
[NCT01516762].
About Alpharadin (radium-223 Chloride)
In September 2009, Algeta and Bayer signed an agreement for the development and
commercialization of Alpharadin. Under the terms of the agreement, Bayer will
develop, apply for global health authority approvals, and commercialize
Alpharadin globally, while Algeta retains an option for co-promotion and profit-
sharing in the United States.
Alpharadin is an investigational agent and is not approved by the FDA, the
European Medicines Agency (EMA), or other health authorities.
*ClinicalTrials.gov. Understanding Clinical Trials. Available at:
http://clinicaltrials.gov/ct2/info/understand#Q20. Accessed on January 30, 2012.
Bayer HealthCare Pharmaceuticals Inc. is the US-based pharmaceuticals business
of Bayer HealthCare LLC, a subsidiary of Bayer AG.
###
For further information, please contact
Mike Booth +47 2202 4510
Communications & Corporate Affairs ir(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow mark.swallow(at)citigatedr.co.uk
Citigate Dewe Rogerson
US investor enquiries: +1 646 378 2928
Jessica Lloyd jlloyd(at)troutgroup.com
The Trout Group
About Algeta
Algeta is a company focused on developing novel targeted therapies for patients
with cancer based on its alpha-pharmaceutical platform.
Algeta's lead product Alpharadin (radium-223 chloride) is in development as a
potential new treatment for cancer patients with bone metastases. It is in pre-
registration for castration-resistant prostate cancer (CRPC) patients with bone
metastases, and filings are expected mid 2012 in the USA and Europe; Alpharadin
has Fast Track designation for this indication in the USA.
Alpharadin is also under clinical investigation in breast cancer patients with
bone metastases and in combination with docetaxel chemotherapy in CPRC patients
with bone metastases.
Alpharadin is being developed and will be commercialized, pending approval,
under a global agreement with Bayer Pharma AG.
Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs),
which are based on conjugating the alpha-emitter thorium-227 to targeting
molecules, as a basis of a future pipeline of tumor-targeting alpha-
pharmaceutical candidates.
The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock
Exchange (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
Forward-looking Statements
This news release contains certain forward-looking statements based on
uncertainty, since they relate to events and depend on circumstances that will
occur in the future and which, by their nature, will 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 to the correctness of such
statements. 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
and alpha particle payloads, risks associated with technological development,
growth management, general economic and business conditions and the pricing
environment, the impact of competition, the ability to successfully
commercialize Alpharadin and our other products, 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 Alpharadin 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.
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/1582198/494303.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#1582198]
Unternehmensinformation / Kurzprofil:
Datum: 02.02.2012 - 14:56 Uhr
Sprache: Deutsch
News-ID 110512
Anzahl Zeichen: 6475
contact information:
Town:
Oslo
Kategorie:
Business News
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"Expanded Access Program for investigational drug Alpharadin (radium-223 chloride) initiated in the United States"
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