Algeta results for the third quarter 2010 |
Friday, 12. November 2010 07:00 |
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Oslo, Norway, 12 November 2010 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, today announces its results for the third quarter ending 30 September 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. An international conference call will take place at 14:30 CET. To participate in the conference call, please dial the appropriate number below five minutes prior to the call: 800 80 119 (in Norway) +47 23 18 45 01 (from abroad) To access the replay, please dial +47 23 18 45 02. Enter account no. 1428 followed by #, then press 1, conference no. 428 followed by #. Press 1 to play. A replay version of the conference call will also be available at www.algeta.com. Highlights of the third quarter 2010: * Recruitment into the ALSYMPCA phase III trial of Alpharadin (radium-223 chloride) for treating bone metastases arising from castration-resistant prostate cancer (CRPC) exceeded 830 patients at the end of October 2010. Algeta and its partner Bayer Schering Pharma AG ("Bayer") anticipate that enrolment of 900 patients into the ALSYMPCA trial will be completed as planned around the end of 2010. Results of the trial are anticipated in 2012, which if positive, could allow a regulatory filing in 2012 as planned * In August, the first patient was dosed in a phase I/IIa clinical study evaluating the potential for Alpharadin to be used in combination with docetaxel chemotherapy in CRPC patients with bone metastases. The trial is being conducted at Memorial Sloan Kettering Cancer Center (New York, USA) * In July, Algeta concluded agreements for the exclusive manufacture and supply of Alpharadin for future commercial sale, triggering a NOK 40m (EUR 5m) milestone payment from Bayer. Algeta also significantly extended its collaboration with Institute for Energy Technology (IFE) to expand the existing Alpharadin production facility at IFE and build a state of the art commercial manufacturing facility in readiness to supply the expected world demand following approval and launch Post-period update * Clinical data from Algeta's phase I and phase II clinical program with Alpharadin were presented at the 35(th) ESMO Congress (8-12 October) and at the 52(nd) annual ASTRO meeting (31 Oct-4 Nov). Findings presented support the specific targeting mode of action of Alpharadin to bone metastases and its highly favorable safety profile and also that it is easy to use, requires no specialized equipment and is convenient for patients * In October, Algeta entered into an agreement with Lumiphore that provides Algeta with exclusive access to Lumiphore's Lumi4® chelator technology. The Company will evaluate Lumi4® for binding the alpha-emitter thorium-227 and its linking to tumor-targeting molecules, such as antibodies * In November, Algeta announced the appointment of Dr. Lars Abrahmsén who will join the Algeta management team as Senior Vice President, Protein Therapeutics to advance the development of Algeta's Thorium platform. Dr. Abrahmsén was previously CSO of Affibody AB, a Swedish company developing proprietary tumor-targeting molecules for therapeutic and diagnostic purposes. He has a wealth of experience, working mostly in oncology, in protein engineering, including monoclonal antibody production and conjugation, gained at Affibody, Genentech and at Pharmacia Key financials: * Operating revenue for the third quarter amounted to NOK 96m, including recognition of deferred upfront signing fees, cost-sharing revenues from Bayer as well as a NOK 40 (EUR 5m) milestone. Operating revenue for the third quarter last year was NOK 7m * Operating expenses for the third quarter amounted to NOK 60m compared with NOK 51m in the third quarter 2009 * The income statement shows a net profit of NOK 37m for the third quarter * Liquid funds amounted to NOK 414m as of 30 September 2010, compared to NOK 514m at the end of December 2009 Andrew Kay, Algeta's President and CEO, said: "We are very close to completing the recruitment of our pivotal phase III trial with Alpharadin, which will mark a major milestone for the Company. I would like to recognise the sustained efforts of the clinical & development teams, the investigators and partners in keeping the trial on schedule and getting us to this position. "We believe Algeta is well positioned to grow shareholder value over the next 6-12 months and we look forward to the future with confidence." "Building on the success of Alpharadin, we plan to progress our Thorium platform with the aim of creating targeted cancer therapeutics that combine the unique advantages of alpha-emitters as a potent, localized cancer-killing 'payload' with the specific targeting capabilities of antibodies and other molecules. ### For further information, please contact +47 2300 7990 / +47 4840 1360 (mob) +47 2300 7990 / +47 9065 6525 (mob) Andrew Kay, CEO Øystein Soug, CFO post@algeta.com International media enquiries: Mark Swallow/David Dible +44 207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk US investor enquiries: Jessica Lloyd +1 646 378 2928 The Trout Group 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 (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 prostate cancer (CRPC). Alpharadin is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa trial in combination with docetaxel chemotherapy in for bone metastases CRPC 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#1461823] Press release: http://hugin.info/134655/R/1461823/400998.pdf Third Quarter Presentation 2010: http://hugin.info/134655/R/1461823/400997.pdf Third Quarter Report 2010: http://hugin.info/134655/R/1461823/400996.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 |
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