Updated phase III data confirm overall survival benefit of Alpharadin in men with advanced prostate cancer that has spread to the bone
Not intended for US media
Overall survival in Alpharadin arm significantly increased by 44%
Median survival benefit increased to 3.6 months
Significantly delayed time to first skeletal-related event (SRE)
Submissions seeking marketing approval in US & Europe expected in 2H 2012
Further development activities to include combination trials in prostate cancer, as well as studies in breast cancer and osteosarcoma
The updated data showed that Alpharadin improved overall survival by 44% (p=0.00007, HR=0.695), resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival benefit with Alpharadin was 2.8 months at the time of the interim analysis in June 2011 and 3.6 months in this updated analysis (14.9 months in patients given Alpharadin vs. 11.3 months with placebo). These data will be presented as a late-breaking abstract in an oral abstract session on June 5, 2012 at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL (USA) (LBA No. 4512).
"Bone metastases are one of the main causes of disability and death in patients with castration-resistant prostate cancer, yet until now there has been little progress made towards developing therapies that target the cancer when it has spread to the bone," said Dr. Chris Parker of The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London, and principal investigator of ALSYMPCA. "Alpharadin is the first therapy specifically addressing cancer that has spread to the bone that has shown, in a phase III trial, to significantly improve overall survival."
In addition to improving overall survival, radium-223 dichloride led to a statistically significant delay in the time to first skeletal-related event (SRE).
The overall safety and tolerability profile for Alpharadin was consistent with previous study results. The most common hematologic adverse events included anemia (31% vs. 31%), neutropenia (5% vs 1%) and thrombocytopenia (12% vs. 6%) for patients receiving Alpharadin compared to placebo. With respect to Grade 3 and 4 adverse events, the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse events included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%), and vomiting (19% vs. 14%) for patients receiving Alpharadin as compared to placebo. With respect of Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).
Andrew Kay, President & CEO of Algeta, commented: "The results from the extensive clinical program evaluating Alpharadin continue to give us confidence in its potential, pending marketing approvals, to become a new treatment option for cancer patients with bone metastases. This is a significant achievement for Algeta. In turn, this provides a strong foundation on which we are building a global oncology company with a high quality commercial organization in the US allied to our research and development headquarters in Norway."
Alpharadin has been granted Fast Track designation by the US Food & Drug Administration (FDA). The Fast Track process is designed to facilitate the development, and expedite the review, of drugs to treat serious diseases and fill an unmet medical need. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process. Bayer plans to file Alpharadin seeking marketing approval for CRPC with regulatory authorities in the US and Europe based on the ALSYMPCA data in the second half of 2012. In terms of further development activities, Bayer intends to conduct studies in earlier settings of prostate cancer, including combination studies with other agents, as well as undertaking exploratory studies in other tumors such as breast cancer and osteosarcoma.
The presentation slides given by Dr Parker will be made available to download at www.algeta.com following the session.
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| Mike Booth|
Communications & Corporate Affairs
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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 dichloride) is being evaluated as a potential new treatment for cancer patients with bone metastases. Alpharadin is under clinical investigation in castration-resistant prostate cancer (CRPC) patients with bone metastases. Submissions seeking marketing approval for this indication are expected to be made in the second half of 2012 to regulatory authorities in both the US and Europe; Alpharadin has Fast Track designation for this indication in the US. Alpharadin, which is exclusively licensed to Bayer, is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.
Alpharadin is also under clinical investigation in endocrine-refractory breast cancer patients with bone metastases and is in a phase I/IIa trial in combination with docetaxel chemotherapy in CPRC patients with bone metastases.
Alpharadin is being evaluated and will be commercialized, if approved, under a global agreement with Bayer Pharma AG. If approved, Bayer will market Alpharadin worldwide, and Algeta will co-promote Alpharadin with Bayer in the US.
Algeta is also evaluating 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 potential future pipeline of tumor-targeting alpha-pharmaceutical candidates. Algeta has TTC agreements in place with Sanofi and Affibody.
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.
This news release contains certain forward-looking statements that relate to events and depend on circumstances that will occur in the future 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 expected timing of regulatory filings and future development activities. 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, unforeseen delays in the timing of expected regulatory filings, 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, the ability to identify and hire a sufficient number of qualified employees for the US field force, 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 costs associated with the co-promotion of Alpharadin may be greater than anticipated, 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.
 Previously referred to as radium-223 chloride.