New data and analyses from the phase III ALSYMPCA trial of Xofigo(R) (radium Ra 223 dichloride) injection to be presented at the European Cancer Congress (ECCO-ESMO-ESTRO) 2013

OSLO, Norway, Sept. 12, 2013 (GLOBE NEWSWIRE) --

Intended for US media only Algeta ASA (OSE:ALGETA), announced today that further analyses of data subsets from the phase III ALSYMPCA study of Xofigo(®) (radium Ra 223 dichloride) injection will be presented at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO), 28 September- 1 October, in Amsterdam, The Netherlands. Xofigo(®) was approved by the US Food and Drug Administration (FDA) in May 2013 for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. Dr Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These data add to the growing body of scientific knowledge of Xofigo, and also serve to illustrate the depth and breadth of the ALSYMPCA phase III data set." Abstract titles and session details Time to first skeletal-related event (SRE) with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) and bone metastases: ALSYMPCA trial stratification factors analysis * Abstract #2876, Poster Session: Genitourinary Malignancies - Prostate Cancer * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4 Hematologic safety of radium-223 dichloride (Ra-223) in the phase 3 ALSYMPCA trial in castration-resistant prostate cancer (CRPC) patients with bone metastases: baseline prognostic factor subgroup analysis * Abstract #2877, Poster Session: Genitourinary Malignancies - Prostate Cancer * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4 Effects of radium-223 dichloride (Ra-223) on health-related quality of life (QOL) outcomes in the phase 3 ALSYMPCA study in patients with castration- resistant prostate cancer (CRPC) and bone metastases * Abstract #2878, Poster Session: Genitourinary Malignancies - Prostate Cancer * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4 Radium-223 dichloride (Ra-223) efficacy and safety in patients with castration- resistant prostate cancer (CRPC) with bone metastases: phase 3 ALSYMPCA study findings stratified by age group * Abstract #2883, Poster Session: Genitourinary Malignancies - Prostate Cancer * Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4 About Xofigo (radium Ra 223 dichloride) Radium-223 dichloride (radium 223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium 223 in December 2012 and subsequently in other territories. Radium 223 (as Xofigo(®) injection) is approved in the United States and is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Radium 223 is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in radium 223 is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium- 223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti- tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue[1]. In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium 223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US. Important Safety Information for Xofigo (radium Ra 223 dichloride) Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman. In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure. Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than to equal to 1.5 × 10(9)/L, the platelet count greater than or equal to 100 × 10(9)/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10(9)/L and the platelet count greater than or equal to 50 × 10(9)/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care. Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued. Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations. The most common adverse reactions (greater than or equal to 10%) in the Xofigo arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (greater than or equal to 10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia (35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%). For full US prescribing information, visit www.xofigo-us.com. ### Xofigo(®) is a registered trademark of Bayer For further information, please contact: Mike Booth +44 7866 490 850 Communications & Corporate Affairs ir@algeta.com Media enquiries: Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk Kari Watson +1 781 235 3060 MacDougall Biomedical Communications kwatson@macbiocom.com Investor enquiries: Tricia Truehart +1 646 378 2953 The Trout Group ttruehart@troutgroup.com About Algeta Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. 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. Forward-looking Statements 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 our co-promotion of Xofigo in the US and Bayer's promotion of Xofigo in Europe. 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, general economic and business conditions, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the co-promotion of Xofigo may be greater than anticipated, manufacturing capacity, risks in obtaining additional regulatory approvals for radium 223 and the other risks and uncertainties described in our annual report. [1] XOFIGO Prescribing information. May 2013 Press release: http://hugin.info/134655/R/1728821/577445.pdf [HUG#1728821] Source:Algeta ASA