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Algeta ASA (OSL:ALGETA) Major milestone reached as phase III trial with Alpharadin in advanced prostate cancer begins
Oslo, Norway, 13 August 2008 - Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today announces its results for the second quarter 2008. A presentation to analysts, investors and the press will take place today in Oslo at 08:15 CET and a conference call will take place at 14:30 CET - details below.
The second quarter was eventful for Algeta, with continual progress on the development of Alpharadin. Highlights of the second quarter 2008 include:
* The company began enrolling patients for the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. The international study will evaluate Algeta's targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada. The Coordinating Investigator for the study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer, based at the Institute of Cancer Research and the Royal Marsden Hospital in the UK.
* Following the approval of the IND for Alpharadin in the USA, preparations for a pharmacokinetics, biodistribution and dosimetry study (BC1-08) at the Memorial Sloan-Kettering Cancer Center in New York were finalized. Patient recruitment has begun and the first patient enrolled in August.
* Positive biodistribution and dosimetry data for Alpharadin from the BC1-05 study were presented in June at the 55th Annual Meeting of the Society for Nuclear Medicine in New Orleans, USA. The data from the trial demonstrate that intravenous Alpharadin was rapidly taken up in the bone, where it acts to destroy tumor cells. The study also shows that Alpharadin not taken up by the bone is rapidly excreted from the body, and that there is no specific uptake in normal organs.
* In June, Algeta completed the study BC1-03, designed to explore a dose-response relationship of the palliative effect of a single dose of Alpharadin. The company is conducting the final analysis of the data.
* Algeta presented preclinical data that show Alpharadin can kill cancer cells that are resistant to conventional chemotherapeutic agents as well as those that are quiescent, i.e. non-cycling cells that are also resistant to cytotoxic drugs, at the American Association for Cancer Research (AACR) Annual meeting in San Diego, USA.
* Algeta appointed Øystein Soug as Chief Financial Officer. Mr. Soug joins Algeta from the Norwegian Orkla group, where he most recently served as CFO of Sladco (Orkla's Russian division). He replaces Hellek Bråthen, who served as interim CFO since February 2008.
Key financials:
* Operating expenses for the second quarter 2008 amounted to NOK 56 million compared with NOK 38 million in the first quarter. The expenses for the first half year were NOK 93 million this year and NOK 39 million last year.
* The expenses were in line with Algeta's overall development plan for Alpharadin. Costs were higher than in previous quarters, reflecting start-up activities in the ALSYMPCA phase III trial.
* Liquid funds amounted to NOK 210 million as of 30 June 2008, compared to NOK 256 million at the end of last quarter.
Commenting on Algeta's progress during the second quarter 2008, President and CEO, Dr. Thomas Ramdahl, said: "The most significant event of the past three months and indeed the year to date was the start of our pivotal phase III study with Alpharadin for advanced prostate cancer, and we are very excited to get this important study underway. We have also made good progress in building the clinical and preclinical foundation to support successful applications for future marketing approvals for Alpharadin, and are encouraged by the enthusiastic and positive response we have received from key opinion leaders around the world for our unique approach to treating HRPC."
Presentation and conference call
A presentation to analysts, investors and press will take place today in Oslo at 08:15 CET and an international conference call will take place at 14:30 CET. Algeta's President and Chief Executive Officer, Dr. Thomas Ramdahl, and Chief Financial Officer Øystein Soug, will host the presentation and the call.
The presentation will take place at 08:15 CET at:
Hotel Continental Stortingsgaten 24/26 0117 Oslo Norway
Breakfast will be served from 07:45 CET.
To participate in the conference call, please dial the appropriate number below:
The second quarter 2008 results statement and the presentation will be made available from 08:00 CET August 15, 2008, on www.algeta.com in the Investors section. The full report also follows below.
A replay version of the call will be available until the presentation of results for the third quarter 2008. To access the replay, 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 be available during the same period at www.algeta.com.
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For further information, please contact
Dr. Thomas Ramdahl, CEO +47 23 00 79 90 / +47 913 91 458 (mob) Øystein Soug, CFO +47 23 00 79 84 / +47 906 56 525 (mob) post@algeta.com
For international enquiries: +44 (0)207 638 9571 Dr. Mark Swallow / David Dible mark.swallow@citigatedr.co.uk Citigate Dewe Rogerson
About Algeta Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.
Algeta's lead product candidate, Alpharadin, has commenced phase III clinical trials in hormone-refractory prostate cancer based on positive phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers. Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227. 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.
