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 (http://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.
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For further information, please contact
| Mike Booth Communications & Corporate Affairs | +47 2202 4510 ir@algeta.com (mailto:ir@algeta.com) |
| International media enquiries: Mark Swallow Citigate Dewe Rogerson | +44 207 638 9571 mark.swallow@citigatedr.co.uk (mailto:mark.swallow@citigatedr.co.uk) |
| US investor enquiries: Jessica Lloyd The Trout Group | +1 646 378 2928 jlloyd@troutgroup.com (mailto:jlloyd@troutgroup.com) |
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.
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
