| Algeta results for the second quarter and first half 2010 |
| Friday, 13. August 2010 08:03 |
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| Oslo, Norway, 13 August 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, today announces its results for the second quarter and the six months ending 30 June 2010. A presentation of the results will be webcast live from 09.45 CET and can be accessed from www.algeta.com/webcast where questions can be submitted live during the presentation. Highlights of the second quarter 2010: * Algeta and its partner Bayer Schering Pharma AG ("Bayer") decided to increase recruitment for the ALSYMPCA phase III trial of Alpharadin (radium 223 chloride) for treating bone metastases arising from castration-resistant (hormone-refractory) prostate cancer (CRPC) to 900 patients. This decision increases the power of the trial to 90% and further increases the statistical likelihood of proving the efficacy of Alpharadin. * Recruitment in ALSYMPCA passed 700 patients during June 2010. Based on the rapid recruitment rate in this pivotal study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will be completed as planned towards the end of the second half of 2010 with results of the trial anticipated in 2012. This would allow a regulatory filing in 2012 as planned. * Analyses of clinical data from Algeta's phase I and phase II clinical program with Alpharadin were presented at the 46th Annual Meeting of the American Society for Clinical Oncology (ASCO) in June 2010. Findings support specific targeting of Alpharadin to bone metastases and a highly tolerable safety profile. These data were also presented at the 2010 Genitourinary Cancers Symposium in March 2010. * A phase I/IIa clinical study evaluating Alpharadin in combination with docetaxel chemotherapy in CRPC patients with bone metastases was initiated on schedule at the end of June 2010 at Memorial Sloan Kettering Cancer Center. The first patient was dosed on 10 August. Highlights of the first quarter 2010: * Alpharadin clinical development program expanded with the first patients recruited into an open label phase II study to treat bone metastases in endocrine-refractory breast cancer. This is the second tumor type under investigation with Alpharadin. Post-period update * Algeta concluded agreements for the exclusive manufacture and supply of Alpharadin for future commercial sale, triggering a EUR 5m milestone payment from Bayer. The second agreement sees Algeta significantly extend its collaboration with Norway's Institute for Energy Technology (IFE), which currently manufactures Alpharadin for the ALSYMPCA study and other clinical trials. In conjunction with Algeta, IFE will expand the existing Alpharadin production facility at IFE. The upgrade, which will be paid for by Algeta, will create a state-of-the-art manufacturing platform to supply the expected commercial world demand following approval and launch. Key financials: * Operating revenue for the second quarter amounted to NOK 54m compared to NOK 64m in the first quarter and zero in the same period in 2009. The amount included recognition of deferred upfront signing fees and cost-sharing revenues from Bayer. Operating revenue for the first half of 2010 were NOK 119m compared to zero in the same period in 2009 . * Operating expenses for the second quarter amounted to NOK 54 million compared with NOK 45m in the second quarter 2009. Operating expenses for the first half of 2010 were NOK 118m compared to NOK 86 in the same period in 2009. * Liquid funds amounted to NOK 445m as of 30 June 2010, compared to NOK 514m at the end of December 2009. Andrew Kay, Algeta's President and CEO, said: "Algeta continued to make good progress across its entire business during the first half of 2010. The clinical development of Alpharadin in conjunction with our partner Bayer is advancing as planned and we have signed an agreement with IFE to build our state-of-the-art manufacturing facility for commercial supply. We are also working together with Bayer to build the profile of this exciting potential new treatment for bone metastases with the medical community. In addition, Algeta has recently begun to execute the new strategy for our Thorium platform and we have initiated key technology programmes. The momentum we have generated post our deal with Bayer means that Algeta is well positioned to grow shareholder value over the next 6-12 months and we look forward to the future with confidence." ### For further information, please contact Andrew Kay, CEO +47 2300 7990 / +47 4840 1360 (mob) Øystein Soug, CFO +47 2300 7990 / +47 9065 6525 (mob) post@algeta.com International media enquiries: +44 207 638 9571 Mark Swallow/Helena Galilee/David Dible mark.swallow@citigatedr.co.uk Citigate Dewe Rogerson US investor enquiries: +1 646 378 2928 Jessica Lloyd jlloyd@troutgroup.com The Trout Group About Algeta Algeta is a focused oncology company developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. Algeta's lead product Alpharadin (based on radium-223) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects. The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring in up to 90% of certain late-stage cancers, e.g. prostate, breast and lung. Alpharadin is being developed under a development and commercialization agreement with Bayer Schering Pharma AG, a major pharmaceutical company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer. Alpharadin is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients. Algeta also aims to develop a future pipeline of tumor-targeting alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227, through selective in-licensing and/or acquiring innovative technologies and tumor-targeting molecules. The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA). Alpharadin and Algeta are trademarks of Algeta ASA. Forward-looking Statement This news release contains forward-looking statements and forecasts 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. 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. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products. ### This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act) [HUG#1437780] Second Quarter Presentation 2010: http://hugin.info/134655/R/1437780/382471.pdf Press release: http://hugin.info/134655/R/1437780/382473.pdf Second Quarter Report 2010: http://hugin.info/134655/R/1437780/382472.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. All reproduction for further distribution is prohibited. Source: Algeta ASA via Thomson Reuters ONE |
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