Conference call will be held today at 1pm CET, 12pm UK & 7am Eastern
Oslo, Norway, 12 April 2012 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces that it has exercised its option to co-promote Alpharadin for the treatment of cancer patients with bone metastases in the United States.
Under the terms of the global development and commercialization agreement for Alpharadin signed between Algeta and Bayer Pharma AG (Bayer) in 2009, Algeta will now be eligible to receive 50 percent of the profits attributable to sales of the drug in the US and will be responsible for 50 percent of the costs of commercializing Alpharadin in this territory.
Alpharadin (radium-223 chloride), which is exclusively licensed to Bayer, is an investigational agent and is not approved by either the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), or other health authorities. The FDA has granted Fast Track Designation to Alpharadin in its lead indication and regulatory filings by Bayer seeking marketing approval in the US and Europe are expected in mid 2012.
Algeta has begun building its commercial operation in anticipation of the approval and launch of Alpharadin in the US. To such an end, Algeta has established a subsidiary in the US ("Algeta US") to carry out the co-promotion of Alpharadin, pursuant to its 2009 agreement with Bayer. The headquarters of this operation will be located in Cambridge, MA. In January 2012, Algeta US hired Jeff Albers, formerly Vice President, US Hematology & Oncology Business, at Genzyme as President. Algeta US has subsequently hired Philina Lee, formerly Global Product Manager for Jevtana (cabazitaxel) at Sanofi, as Director of US Marketing. Algeta US is now focused on building a field force including marketing and medical affairs personnel ahead of the launch of Alpharadin. This process will be accelerated as a result of Algeta's successful fundraising in February 2012.
Andrew Kay, Algeta's President and CEO, said: "We are delighted with the Board's decision to exercise Algeta's co-promotion option, as we believe this to be in the best interests of the Company and its shareholders. It will allow us to move ahead rapidly with the building of a high-quality commercial operation in the USA, the world's largest pharmaceutical market. We believe that Alpharadin has the potential to bring a new therapeutic option to cancer patients with bone metastases and we, together with Bayer, are focused on making Alpharadin a success."
In September 2009, Bayer signed an agreement with Algeta 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 retained an option for up to 50/50 co-promotion and profit-sharing in the United States, which it has now exercised in full.
Conference call
A conference call to discuss this decision and its implications will be held today at 1pm CET, 12pm UK & 7am Eastern. To participate, please dial the appropriate number below five minutes prior to the call:
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+47 23 18 45 55 (from Norway and abroad)
To access the replay, please dial +47 23 18 45 02. Enter account no. 1870 followed by #, then press 1, conference no. 870 followed by #. Press 1 to play. A replay version of the conference call will also be available at www.algeta.com (http://www.algeta.com/).
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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, 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.
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
