OSLO, NORWAY--(Marketwired - May 15, 2013) - Intended for US Media only
Algeta ASA (
A presentation of the results in Oslo will be webcast live from 10:00 CET and can be accessed through www.algeta.com. An international conference call will take place at 14:30 CET/08:30 EST (US). Details of both events are at the end of this announcement.
"Algeta continues to advance its preparations for the commercialization of radium Ra 223 dichloride in the US to ensure it is ready to launch the product,with Bayer, if approved by the US Food and Drug Administration later this year," said Andrew Kay, Algeta's President & CEO. "We are also making good progress with the development of our Targeted Thorium Conjugate (TTC) pipeline and look forward to the results of further preclinical evaluations which will guide our choice of which TTC candidate to advance into clinical trials next year."
Radium Ra 223 dichloride (radium-223) is an investigational agent and is not approved by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other health authorities.
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,Germany) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 globally. Algeta US, LLC will co-promote radium-223, if approved, with Bayer in the US, and Algeta is eligible for milestones as well as royalties on Bayer's sales outside the US.
Highlights of the first quarter 2013
* In February 2013, the FDA granted priority review of the NDA (New Drug Application) for radium-223. The FDA grants priority review to medicines that may provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within eight months from the submission of the NDA, rather than the standard 12-month review cycle.
* In February 2013, further results from the ALSYMPCA phase III study of radium-223 were presented at the 2013 Genitourinary Cancers Symposium.
* In January 2013, the US Nuclear Regulatory Commission (NRC) issued a licensing decision on the medical use of radium-223.
* In January 2013, Algeta initiated a new TTC research program using the anti-CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.
* Algeta's US medical and commercial organization is now complete, with an experienced oncology field force of medical science liaison and radiotherapy licensing personnel, as well as sales representatives, present in all US territories for which Algeta has responsibility.
* In May 2013, Algeta received an expanded manufacturing license from the Norwegian Medicines Agency (NoMA), allowing production of radium-223 from the new commercial production facility at the Institute for Energy Technology (IFE), near Oslo.
* In April 2013, Hilde Furberg and Paolo Pucci were elected to the Board of Directors as Non-executive Directors at the Company's Annual General Meeting in April, replacing Ingrid Wiik and Joseph Anderson, who decided not to stand for re-election.
* In May 2013, and to facilitate the conjugation of thorium-227 to targeting molecules in its Targeted Thorium Conjugate (TTC) research, Algeta announced the exercise of its option to take an exclusive worldwide licence to patented Lumi4® bi-functional chelator technology from Lumiphore, Inc. (Richmond, CA, USA) and an extension of the collaboration to include additional chelator families.
* Operating revenue for the first quarter 2013 amounted to NOK 71m, compared with NOK 73m in the same period in 2012.
* Algeta's recognized share of US co-promotion activity expenses for the first quarter 2013 was NOK 34m, compared with nil in the same period in 2012.
* Core operating expenses, which exclude currency effects, interest income and costs directly related to preparation of commercial launch in the US, for the first quarter 2013 amounted to NOK 118m, compared with NOK 64m in the same period in 2012.
* Liquid funds amounted to NOK 646m as of 31 March 2013 compared with NOK 369m as of the 31 December 2012.
The First Quarter 2013 Report and accompanying presentation will be available through www.algeta.com from 07:00 CET.
Details of presentation and webcast
A presentation by Algeta's Executive Management team to investors, analysts and the press will take place in Oslo at 10:00 CET.
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The presentation will also be webcast live and can be accessed through www.algeta.com. Questions can be submitted live during the webcast.
Details of international conference call
To participate in the conference call, please dial the appropriate number below five minutes prior to the call:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 281404#
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 20 3364 5196
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 346423#
A replay version of the conference call will also be available at www.algeta.com.
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223), formerly referred to as radium-223 chloride, is an investigational alpha particle-emitting pharmaceutical in development for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other health authorities.
Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (ALGETA.OL). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding interactions with regulatory authorities, our anticipated co-promotion of radium-223 in the US, and the clinical development of our TTC program. 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. These factors include, among other things, risks or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize radium-223 and our other products, the risk that costs associated with the co-promotion of radium-223 may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.
Lumi4® is a registered mark of Lumiphore, Inc.
 Defined as the sum of External R&D expenses, Payroll and related costs, Depreciation and General and Administrative expenses. Core operating expenses do not include costs from co-promotion activities.
Press release: http://hugin.info/134655/R/1701835/562077.pdf
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Source: Algeta ASA via Thomson Reuters ONE