Algeta ASA : Further sub-analyses of ALSYMPCA phase III study presented at 2013 Genitourinary Cancers Symposium
February 15, 2013 - Oslo, Norway
Intended for US Media only
Abstracts #11 & #19
Algeta ASA (OSE: ALGETA) announces that furthersub-analyses of data from the phase III ALSYMPCA study of radium Ra 223dichloride (radium-223) in castration-resistant prostate cancer (CRPC)patientshave been presented at the 2013 Genitourinary Cancers Symposium (14-16February 2013, Orlando, FL, USA).
Radium-223 is an investigational alpha particle-emittingpharmaceutical indevelopment for CRPC patients with bone metastases and is not approvedby theEuropean Medicines Agency (EMA), the US Food and Drug Administration(FDA) orother health authorities.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "Theseadditionalanalyses from ALSYMPCA continue to support radium-223's potential inthetreatment of men with CRPC that has metastasized to the bone."
Abstract #11 by Vogelzang et al. found that radium-223 treatmentsignificantlydelayed time to first skeletal-related event (SRE) versus placebo by amedianincrease of 5.8 months (median time to SRE: 15.6 vs 9.8 months;HR=0.66;P<0.001).
Abstract #19 by Nilsson et al. described an analysis of painparameters inALSYMPCA. The analysis showed that, compared to placebo in CRPC patientswithbone metastases, patients treated with radium-223 had significantlyprolongedmedian time to first palliative external beam radiotherapy (EBRT)(HR=0.670,P=0.00117).
In the ALSYMPCA trial the most common hematologic adverse events forpatientstreated with radium-223 and best standard of care (BSoC) and compared toplaceboand BSoC included anemia (31% vs. 31%), neutropenia (5% vs.1%) andthrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverseevents, themost common events included anemia (13% vs. 13%), neutropenia (2% vs.1%) andthrombocytopenia (6% vs. 2%). The most common non-hematologic adverseevents inpatients treated with radium-223 and BSoC compared to placebo and BSoCincludedbone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs.15%) andvomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events, themostcommon events included bone pain (21% vs. 26%).
In September 2009, Algeta signed an agreement with Bayer Pharma AG(Berlin,Germany) for the development and commercialization of radium-223.Under theterms of the agreement, Bayer will develop, apply for global healthauthorityapprovals, and commercialize radium-223 globally. Algetawill co-promote radium-223 with Bayer in the US, and is eligible formilestones as well as royalties onBayer's sales outside the US. The ALSYMPCA trial was initiated by Algeta inJune2008.
Abstract #11 - Vogelzang, N. et al. Updated analysis of radium-223dichloride(Ra-223) impact on skeletal-related events (SRE) in patientswith castration-resistant prostate cancer (CRPC) and bone metastasesfrom the phase IIIrandomized trial (ALSYMPCA).
Abstract #19 - Nilsson, S. et al. Pain analysis from the phase IIIrandomizedALSYMPCA study with radium-223 dichloride (Ra-223)in castration-resistant prostate cancer (CRPC) patients with bonemetastases.
About the ALSYMPCA Trial
The ALSYMPCA (ALpharadin in SYMptomatic prostate cancer) trial was a phaseIII,randomized, double-blind, placebo-controlled international study ofradium-223with best standard of care (BSoC) vs placebo with BSoC in symptomaticCRPCpatients with bone metastases. The trial enrolled 921 patients in more than100centers in 19 countries. The study treatment consisted of up to sixintravenousadministrations of radium-223 or placebo each separated by an interval offourweeks.
The primary endpoint of the study was overall survival. Secondaryendpointsincluded time to occurrence of skeletal-related events (SRE), time tototalalkaline phosphatase (ALP) and prostate-specific antigen (PSA)progression,total ALP response and normalization, safety, and quality of life.
About CRPC and Bone Metastases
prostate cancer is the most common cancer among men in the United States(otherthan skin cancer).Approximately 16% of prostate cancer cases areconsideredregional or distant, which means that the cancer has spread beyond theprostateto nearby or distant areas of the body (metastasis).A majority of men with CRPC have radiological evidence of bonemetastases.Bone metastases secondary to prostate cancer typically target the lumbarspine,vertebrae and pelvis.In fact, bone metastases are the main cause ofmorbidityand death in patients with CRPC.About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223), formerly referred to asradium-223chloride, is an investigational alpha particle-emittingpharmaceutical indevelopment for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by theEuropeanMedicines Agency (EMA), the US Food and Drug Administration (FDA) orotherhealth authorities. Bayer submitted a Marketing Authorization Applicationto theEMA and a New Drug Application to the FDA for radium-223 in December2012 forthe treatment of CRPC patients with bone metastases.
Algeta is a company focused on developing novel targeted therapies forpatientswith cancer based on its alpha-pharmaceutical platform. TheCompany isheadquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC,based inCambridge, MA performing commercial marketing operations in the US.Algeta islisted on the Oslo Stock Exchange (Ticker: ALGETA). For more informationpleasevisit www.algeta.com.
This news release contains certain forward-looking statements that arebased onuncertainty, as they relate to events and depend on circumstances thatwilloccur in the future and which, by their nature, may have an impact onresults ofoperations and the financial condition of Algeta.Such forward-looking statements reflect our current views and are basedon the information currentlyavailable to Algeta. Algeta cannot give any assurance as to whether suchforwardlooking statements will prove to be correct. These forward lookingstatementsinclude statements regarding our anticipated co-promotion of radium-223in theUS. There are a number of factors that could cause actualresults anddevelopments to differ materially from those expressed or implied bytheseforward-looking statements. These factors include, among other things,risks oruncertainties associated with the ability to identify and hire asufficientnumber of qualified employees for the US field force, growth management,generaleconomic and business conditions and the pricing environment, theimpact ofcompetition, the ability to successfully commercialize radium-223, the riskthatcosts associated with the co-promotion of radium-223 may be greaterthananticipated, manufacturing capacity, the risk of non-approval of patentsnot yetgranted, risks in obtaining regulatory approvals for radium-223 and theotherrisks and uncertainties described in our annual report.
The 2013 Genitourinary Cancers Symposium is co-sponsored by the AmericanSociety of Clinical Oncology (ASCO), the American Society for RadiationOncology(ASTRO) and the Society of Urologic Oncology (SUO).
 American Cancer Society. prostate cancer: Detailed Guide. October 26,2012.Available at:http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf.Accessed May 17, 2012
 National Cancer Institute, Surveillance Epidemiology and End Results(SEER).SEER Stat Facts: Prostate; Survival & Stage, 2002-2008
 Sartor, O. "Radiopharmaceutical and chemotherapy combinations inmetastaticcastrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-2418
 Bone and Cancer Foundation. Questions & Answers about prostate cancerBoneMetastases and Treatment-Related Osteoporosis. Available at:http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf.Accessed May17, 2012
 Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regardingprostate cancer metastatic to bone." Cancer & MetastasisReviews.1999;17:331-336
This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
For further information, please contact:
+47 2202 4510
Communications & Corporate Affairs
+44 207 638 9571
Citigate Dewe Rogerson
+1 781 235 3060
MacDougall Biomedical Communications
US investor enquiries:
+1 646 378 2953
The Trout Group