Algeta Results for the Second Quarter and for First Half of 2009
(Thomson Reuters ONE) - ALSYMPCA phase III trial recruitment on schedule and excitingresearch highlights potential of alpha-pharmaceutical platform togenerate innovative targeted cancer therapiesOslo, Norway, 14 August 2009 - Algeta ASA (OSE: ALGETA), the cancertherapeutics company, today announces its results for the secondquarter 2009. A presentation to investors, analysts and the presswill take place in Oslo at 09:45 CET. Algeta's President & CEO AndrewKay, CTO Thomas Ramdahl and CFO Oystein Soug will present.An international conference call will take place today at 15:00 CET -details below.Highlights of the second quarter 2009: * Patient recruitment into the ALSYMPCA phase III trial with Alpharadin is going as planned with more than 100 centers in 17 countries on line at end of July 2009. Preparations are underway to begin enrolling US patients into this pivotal study before the end of the year. * The significant promise of Algeta's alpha-pharmaceutical platform and pipeline was highlighted in a series of papers presented at the 56th annual Society for Nuclear Medicine 2009 meeting (Toronto, Canada; 13-17 June). The exciting findings made by scientists from the Norwegian Radium Hospital and other leading Norwegian research institutes in collaboration with Algeta demonstrated the targeted and localized anticancer potential of the alpha-emitter thorium-227 linked to trastuzumab (Herceptin®) and to rituximab (Rituxan®), against breast cancer and lymphoma cells, respectively. * Dr. Gillies O'Bryan-Tear was appointed Chief Medical Officer on 24 July bringing more than 20 years' experience in senior roles managing and advising on the clinical development and registration of new drugs. He has extensive development and clinical knowledge in oncology and has developed and successfully launched major oncology products. Dr. O'Bryan-Tear has been Acting CMO for Algeta since March 2009 and has been a consultant to the Company on the clinical development of Alpharadin since 2004.Highlights of the first quarter 2009: * Successful end-of-phase II meeting in January with US Food and Drug Administration for Alpharadin, a new targeted treatment for bone metastases in patients with hormone-refractory prostate cancer (HRPC), enables Algeta to commence activities for the enrolment of US patients into its global ALSYMPCA phase III trial during 2009. The first patient to be treated in the US is expected in the second half of the year. This trial began in Europe during June 2008 and is progressing on schedule worldwide. * Algeta raised NOK 250 million (USD 37 million) in a private placement and repair offering during the first quarter primarily to support the ALSYMPCA trial. The funds will also be used to conduct further trials both to validate potential label extensions for Alpharadin in metastatic prostate cancer and to validate the use of Alpharadin in treating bone metastases in breast cancer patients. The private placement was led by Abingworth LLP, an international investment group dedicated exclusively to the life sciences and healthcare sectors. * Andrew Kay joined Algeta as President and CEO in January bringing more than 25 years of commercial experience in the pharmaceutical sector, where he has managed the licensing and/or launch of several successful new oncology products that have grown to become blockbuster products.Key financials: * Operating expenses for the second quarter 2009 amounted to NOK 45 million compared with NOK 56 million in the second quarter 2008. * Operating expenses for the first half of 2009 were NOK 86 million * Liquid funds amounted to NOK 293 million as of 30 June 2009, compared to NOK 327 million at the end of March 2009 and NOK 133 million at the end of December 2008.Commenting on today's results, Andrew Kay, Algeta's President andCEO, said: "The successful fundraising and FDA meeting on Alpharadinin the first quarter has put Algeta in excellent shape to progressour global phase III ALSYMPCA trial and our recruitment plans remainon schedule. We believe that Alpharadin has blockbuster commercialpotential and this pivotal trial is designed to confirm that thisnovel alpha-pharmaceutical is an effective treatment for treatingbone metastases in prostate cancer patients, has the potential toextend survival and significantly enhance patient quality of life.Furthermore, Alpharadin's benign side effect profile also suggests itmay be an important addition to cancer treatment regimes when bonemetastases are diagnosed."More recently, we have seen exciting results of researchhighlighting the potential of our broader alpha-pharmaceuticalplatform to create a pipeline of new molecular entities that may beable to extend the benefits of alpha-pharmaceuticals to treat a widerange of soft tissue tumors."Presentation and International conference callThe presentation will take place at 09:45 CET at:Hotel ContinentalStortingsgaten 24/260117 OsloNorway.A conference call for analysts, investors and press will take placetoday at 15:00 CET.To participate in the conference call, please dial the appropriatenumber below:800 80 119 (in Norway)+47 23 00 04 00 (from abroad)The results report and the presentation will be made available onwww.algeta.com in the Investors section from 08:00 CET.To access the replay, please dial +47 67 89 40 91. 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 beavailable at www.algeta.com. ###For further information, please contactAndrew Kay, CEO +47 2300 7990 / +47 4840 1360 (mob)ÿystein Soug, CFO +47 2300 7990 / +47 9065 6525 (mob) post(at)algeta.comFor international enquiries: +44 207 638 9571Mark Swallow/Helena Galilee/David mark.swallow(at)citigatedr.co.ukDibleCitigate Dewe RogersonAbout AlgetaAlgeta ASA is a cancer therapeutics company built on world-leading,proprietary technology. Algeta is developing a new generation oftargeted cancer therapeutics (alpha-pharmaceuticals) that harness theunique characteristics of alpha particle emitters and are potent,well-tolerated and convenient to use.Algeta's lead alpha-pharmaceutical candidate, Alpharadin (based onradium-223), has blockbuster potential for treating bone metastasesarising from multiple major cancer types, owing to its bone-targetingnature, potent efficacy (therapeutic and palliative) and benign,placebo-like safety profile. Development of Alpharadin is mostadvanced targeting bone metastases resulting from hormone-refractoryprostate cancer (HRPC), and it entered an international phase IIIclinical trial (ALSYMPCA) in mid-2008 based on compelling clinicalresults from a comprehensive phase II program.Algeta's strategy is to launch Alpharadin as a first or second linetreatment for cancer patients with bone metastases either alone or incombination with current standard of care therapies, therebymaximizing its commercial potential.Algeta is also developing other technologies for deliveringalpha-pharmaceuticals. These include microparticles, liposomes, andmethods to enhance the potency of therapeutic antibodies and othertumor-targeting molecules by linking them to the alpha particleemitter thorium-227. The Company is headquartered in Oslo, Norway,and was founded in 1997. Algeta listed on the Oslo Stock Exchange inMarch 2007 (Ticker: ALGETA).Alpharadin and Algeta are trademarks of Algeta ASA.Forward-looking StatementThis news release contains forward-looking statements and forecastsbased on uncertainty, since they relate to events and depend oncircumstances that will occur in the future and which, by theirnature, will have an impact on results of operations and thefinancial condition of Algeta. There are a number of factors thatcould cause actual results and developments to differ materially fromthose expressed or implied by these forward-looking statements.Theses factors include, among other things, risks associated withtechnological development, the risk that research & development willnot yield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable businessdeals, the risk of non-approval of patents not yet granted anddifficulties of obtaining relevant governmental approvals for newproducts. ###http://hugin.info/134655/R/1334654/316902.pdfhttp://hugin.info/134655/R/1334654/316905.pdfhttp://hugin.info/134655/R/1334654/316908.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.08.2009 - 08:01 Uhr
Sprache: Deutsch
News-ID 4708
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 312 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Algeta Results for the Second Quarter and for First Half of 2009"
steht unter der journalistisch-redaktionellen Verantwortung von
Algeta ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
