Not Intended for US Media
Oslo, Norway, 28 February 2013 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces its results for the fourth quarter and full year 2012.
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 made significant achievements across its business in 2012, including commercial preparations and expanding its manufacturing capabilities for radium-223 dichloride (radium-223) as well as initiating further R&D collaborations for the development of our Targeted Thorium Conjugate (TTC) pipeline. This progress means that Algeta entered 2013 well placed to deliver on its vision to be a world-class oncology company bringing novel targeted medicines to cancer patients through its leadership in alpha-pharmaceuticals," said Andrew Kay, Algeta's President & CEO. "In parallel, we continue to make significant investments in building our commercial operations for radium-223 in the US and look forward, with Bayer and if approved, to co-promoting this novel product for castration-resistant prostate cancer (CRPC) patients with bone metastases in the world's largest pharmaceutical market."
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.
Highlights of the fourth quarter 2012:
In December, Bayer submitted applications seeking marketing authorization to the EMA and the FDA for radium-223 for the treatment of CRPC patients with bone metastases. The first complete submission triggered a EUR 50m milestone payment from Bayer to Algeta
In November, Algeta and Bayer advanced the BC1-10 trial (radium-223 in combination with docetaxel chemotherapy) into the phase IIa (expanded safety cohort) portion of the study, based on the results of the dose escalation (phase I) phase. Enrolment of approximately 45 CRPC patients with symptomatic bone metastases has begun in eight centers across the US and Europe.
In November, Algeta entered a research collaboration with Ablynx to evaluate a novel TTC based on combining Algeta's proprietary thorium-227 alpha-pharmaceutical payload with tumor-targeting Nanobodies® generated by Ablynx.
In November, Algeta further strengthened its R&D capabilities, particularly in chelation and conjugation technologies, with the appointment of Dr Alan Cuthbertson as Senior Vice President, Research and Development.
In February 2013, the FDA granted priority review of the NDA for radium-223. The FDA grants priority review to medicines that offer major advances in care or that 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. Two presentations were made, highlighting the beneficial impact of radium-223 on the pain and analgesic use of CRPC patients, as well as providing further analyses on the positive impact on skeletal-related events (SREs) associated with bone metastases from castration-resistant prostate cancer.
In January 2013, the US Nuclear Regulatory Commission (NRC) issued a licensing decision on the medical use of radium-223, ruling that sites can procure and administer radium-223 under the same framework as routinely-used nuclear medicines. In addition, the NRC will not require additional licensing to administer radium-223 for physicians who are already licensed to dispense similar medications.
In January 2013, Algeta initiated a new TTC research program using the anti-CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.
In February 2013, and as part of the prioritization of the TTC portfolio, Algeta deemed PDGFR-beta to be an unsuitable target for alpha-pharmaceutical development. Accordingly, the decision has been taken to terminate this element of the Affibody agreement.
Operating revenue for the fourth quarter and full year 2012 amounted to NOK 440m and NOK 627m, respectively, compared with NOK 73m and NOK 250m in the same periods in 2011.
- Core operating expenses, which exclude currency effects, interest income and costs directly related to preparation of commercial launch in the US, for the fourth quarter and full year 2012 amounted to NOK 99m and NOK 316m, respectively, compared with NOK 84m and NOK 289m in the same periods in 2011.
Algeta's recognized share of US co-promotion activity expenses for the fourth quarter and full year 2012 was NOK 28m and NOK 72m. In 2011, the activity had not yet commenced.
Liquid funds amounted to NOK 369m as of the 31 December 2012, compared with NOK 426m as of 30 September 2012, and NOK 317m at the end of December 2011.
The Fourth Quarter and Full Year 2012 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 senior 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: 434633#
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: 345360#
A replay version of the conference call will also be available at www.algeta.com.
About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on bone metastases in development for CRPC patients with bone metastases.
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 will co-promote radium-223 with Bayer in the US, and is eligible for milestones as well as royalties on Bayer's sales outside the US. The ALSYMPCA trial was initiated by Algeta in June 2008.
For further information, please contact:
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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 (Ticker: ALGETA). 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, additional clinical development of radium-223 and 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, the ability to identify and hire a sufficient number of qualified employees for the US field force, 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.
 Defined as the sum of External R&D expenses, Payroll and related costs, Depreciation and General and Administrative expenses, excluding net loss from co-promotion while including some US overhead costs