Algeta ASA : Algeta reports results for the first quarter 2012

Not intended for US media

Oslo, Norway, 3 May 2012 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces its results for the first quarter 2012.

A presentation of the results in Oslo will be webcast live from 10:00 CET and can be accessed at www.algeta.com/ webcast. An international conference call will take place at 14:30 CET/08:30 Eastern time (US). Details of both events are at the end of this announcement.

Commenting on the results, Andrew Kay, Algeta's President and CEO, said: "It has been an extremely productive first quarter of 2012 for Algeta. As a result, we are now in a very strong position as we approach the first submissions for marketing approval of Alpharadin, which we continue to expect Bayer to make in mid 2012. Our key strategic objectives for the balance of 2012 are clear: to support Bayer's filing for regulatory approval of Alpharadin and continue to build a high quality US organization as we prepare, pending approval, for launch and commercialization in the US. We believe that Alpharadin has the potential to become a major new therapeutic option for cancer patients with bone metastases and we, together with Bayer, are focused on making Alpharadin a success."

Highlights of the first quarter 2012:

• An updated analysis performed on data from all 921 castration-resistant prostate cancer (CRPC) patients randomized into the pivotal phase III ALSYMPCA study was announced. The analysis confirmed the results of the interim analysis from June 2011 and showed an increase in median overall survival of 3.6 months in the Alpharadin arm vs. the placebo arm. Compared to the previously announced interim analysis, the hazard ratio was unchanged and the p-value improved. 

The updated survival analysis will be presented in the Late Breaker Abstract oral presentation session at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago in early June 2012.

• Additional results from the ALSYMPCA phase III study were presented in February at the 2012 Genitourinary Cancers Symposium. The results highlighted the impact of Alpharadin on skeletal-related events (SREs) associated with bone metastases in CRPC patients. Alpharadin treatment delayed time to first SRE by 64% vs. placebo (13.5 months vs. 8.4 months for placebo), as well as lengthening time to occurrence of three out of four SRE components. 

• An Expanded Access Program (EAP) was initiated in February by Bayer to provide Alpharadin to CRPC patients with symptomatic bone metastases. Alpharadin will be made available to patients through qualified clinical sites in the US participating in this program. 

• In January 2012, Jeff Albers was appointed as President, Algeta US. He was formerly Vice President, US Hematology & Oncology Business, at Genzyme. Algeta US subsequently hired Philina Lee, formerly Global Product Manager for Jevtana® (cabazitaxel) at Sanofi, as Director of US Marketing. Algeta US is now focused on building a field force including marketing and medical affairs personnel ahead of the launch of Alpharadin. 

• The building of the new commercial production facility, services and QC labs have been completed, and the production line has been delivered, assembled and installed. Algeta recognized a milestone payment of EUR 2.6m (NOK 20m) from Bayer during 1Q 2012 in relation to progress. Product batches required for regulatory submissions are on schedule to be produced in time to support filing, around mid-year, for the marketing approval of Alpharadin. 

• In February, Algeta raised NOK 271m (approximately USD 47m) in net proceeds in a private placement and subsequent repair offering totalling 2.1 million new shares. Algeta intends to use the proceeds to establish what it believes would be an optimal level of commercial operations in the US in connection with the launch of Alpharadin, pending approval. In addition, a substantial proportion of the proceeds will be used to advance the research and development of the TTC platform.  

Post-period events

• In April, Algeta exercised its option in full to co-promote Alpharadin in the US with Bayer upon approval by FDA. Algeta will now be eligible to receive 50 percent of the profits related to sales of the drug in the US, upon approval, and will be responsible for 50 percent of the costs of commercializing Alpharadin in this territory. 

• In April, Algeta announced that its research collaboration with Sanofi (previously Genzyme) has been extended for a further year. This collaboration, which was originally announced in April 2011, is focused on evaluating the potential of linking the alpha-emitter thorium-227 to a novel and proprietary antibody from Sanofi to create a potential tumor-targeting alpha-pharmaceutical (also known as a Targeted Thorium Conjugate, or TTC). 

Key financials

• Operating revenue for the first quarter 2012 amounted to NOK 73m, compared with NOK 56m in the same period in 2011. 

• Operating expenses for the first quarter 2012 amounted to NOK 64m, compared with NOK 63m in the same period in 2011. 

• As of 31 March 2011, net cash and cash equivalents amounted to NOK 527m compared to NOK 317m at the end of the fourth quarter 2011. 

The full First Quarter Report 2012 and accompanying presentation will be available at www.algeta.com in the Investors section 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.

Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway.

The presentation will also be webcast live and can be accessed at www.algeta.com/webcast. 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:

USA: +1 866 5088 015
UK: +44 203 147 4601
Norway: +47 21 01 09 30
Sweden: +46 850 559 840
Switzerland: +41 225 802 964
For other countries, please see the attached list of access numbers.

Participant pin code: 537060#

To access the replay, please dial:

SE: +46 (0)8 506 269 49
UK: +44 207 750 99 28
US: 18663056292
Conference reference: 266998#

A replay of the conference call will also be available at www.algeta.com.

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For further information, please contact

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta's lead product Alpharadin (radium-223 chloride) is being evaluated as a potential new treatment for cancer patients with bone metastases. Alpharadin is under clinical investigation in castration-resistant prostate cancer (CRPC) patients with bone metastases. Submissions seeking marketing approval for this indication are expected to be made in mid 2012 to regulatory authorities in both the United States and Europe; Alpharadin has Fast Track designation for this indication in the US. Alpharadin is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.

Alpharadin is also under clinical investigation in endocrine-refractory breast cancer patients with bone metastases and is in a phase I/IIa trial in combination with docetaxel chemotherapy in CPRC patients with bone metastases.

Alpharadin is being evaluated and will be commercialized, if approved, under a global agreement with Bayer Pharma AG. If approved, Bayer will market Alpharadin worldwide, and Algeta will co-promote Alpharadin with Bayer in the US.

Algeta is also evaluating the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a potential future pipeline of tumor-targeting alpha-pharmaceutical candidates.

The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statements
This news release contains certain forward-looking statements 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. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance to the correctness of such statements. 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, unforeseen delays in the timing of expected regulatory filings, risks or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules and alpha particle payloads, 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 Alpharadin and our other products, the risk that costs associated with the co-promotion of Alpharadin 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 Alpharadin 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.

 The Group's operating expenses (defined as the sum of External R&D expenses, Payroll and related costs, Depreciation and General and administrative expenses) exclude currency effects and interest income

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