Press releases

 

Highlights of the first quarter 2010:

 

• Recruitment of patients into the ALSYMPCA phase III trial of Alpharadin (radium 223 chloride) for treating bone metastases arising from castration-resistant (hormone-refractory) prostate cancer (CRPC) continues well and ahead of schedule.

 

• 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.

 

• Continued progress towards initiating a phase I/IIa clinical study evaluating Alpharadin in combination with docetaxel chemotherapy in CRPC patients with bone metastases. The trial is expected to start in mid 2010.

 

• New analyses from Alpharadin phase I and II clinical development program presented at 2010 Genitourinary Cancers Symposium support earlier findings that Alpharadin is specifically targeted to bone metastases and has a highly favorable safety profile.

 

• First phase of manufacturing strategy completed for supply of Alpharadin for future commercial use and clinical trials through collaboration with Oslo-based Institute for Energy Technology (IFE).

 

Post-period update

 

• Sample size re-estimation of Algeta's pivotal ALSYMPCA trial, planned for the first half of 2010, was completed successfully on schedule. The sample size re-estimation confirmed that the current plan to recruit 750 patients into the ALSYMPCA study will meet the goals originally set for the study.

 

• Algeta and its partner Bayer Schering Pharma AG ("Bayer") have in parallel decided to increase recruitment for ALSYMPCA to 900 patients. This will increase the power of the trial to 90% thereby further increasing the statistical likelihood of proving the efficacy of Alpharadin. It will also allow the study to recruit more US patients, and allow US clinical oncologists to gain experience with the use of Alpharadin. Recruitment in ALSYMPCA passed 600 patients during April.

 

• Importantly, based on the rapid recruitment already seen in this pivotal study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will still complete as planned in the second half of 2010 with results of the trial anticipated in 2012. This would allow for a filing in 2012 as planned.

 

Key financials:

 

• Operating revenue for the first quarter amounted to NOK 64 million compared to NOK 24m in the last quarter and zero in the same period in 2009. The amount included recognition of deferred upfront signing fees and cost-sharing payments from Bayer.

 

• Operating expenses for the quarter amounted to NOK 64 million compared with NOK 57 million in the last quarter and NOK 41 million in the first quarter 2009.

 

• Liquid funds amounted to NOK 504 million as of 31 March 2010, compared to NOK 514 million at the end of the last quarter and NOK 327 million at the end of the first quarter 2009.

 

Andrew Kay, Algeta's President and CEO, said: "Algeta, in close collaboration with Bayer, our partner for Alpharadin, is very pleased with progress made in our pivotal ALSYMPCA phase III trial since the start of 2010. The recruitment rate into the trial remains very good and the sample size re-estimation we have just completed confirms the trial is robust. The companies' decision to increase the size of ALSYMPCA from 750 to 900 is expected to further improve the likelihood of proving the efficacy of Alpharadin and should allow for a filing in 2012 as planned."

 

"In addition, the start of a Phase II clinical trial for bone metastases in breast cancer patients was particularly exciting as it, if successful, will highlight the potential of Alpharadin to treat bone metastases in a second major cancer population after prostate cancer. In addition, we continue to evaluate promising opportunities that will enable us to develop new, targeted cancer product candidates based on our preclinical thorium alpha-pharmaceutical platform."

 

 

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From 09:45 CET a presentation of the results will be webcast live. It can be accessed from www.algeta.com/webcast where questions can be submitted live during the presentation. The webcast can also be accessed after the presentation.

 

 

For further information, please contact

 

Andrew Kay, CEO Øystein Soug, CFO	+47 2300 7990 / +47 4840 1360 (mob) +47 2300 7990 / +47 9065 6525 (mob) post@algeta.com
International media enquiries: Mark Swallow/Helena Galilee/David Dible Citigate Dewe Rogerson	+44 207 638 9571 mark.swallow@citigatedr.co.uk
US investor enquiries: Jessica Lloyd The Trout Group	+1 646 378 2928 jlloyd@troutgroup.com

 

 

 

 

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 partnered 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.

 

 

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This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)