World Leader in Alpha-pharmaceuticals A new class of drugs for cancer patients Carnegie Healthcare Seminar March 2012 Andrew Kay, CEO 2012 Presentation 1203 v3
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THESE FORWARD-LOOKING INFORMATION AND STATEMENTS CAN BE IDENTIFIED BY THE FACT THAT THEY DO NOT RELATE ONLY TO HISTORICAL OR CURRENT FACTS. FORWARD-LOOKING STATEMENTS SOMETIMES USE WORDS SUCH AS "AIM", "ANTICIPATE", "EXPECT", "ESTIMATE", "PLAN", "MILESTONE", "BELIEVE", OR OTHER WORDS OF SIMILAR MEANING. EXAMPLES OF FORWARD-LOOKING STATEMENTS INCLUDE, AMONG OTHERS, STATEMENTS REGARDING OR WHICH MAKE ASSUMPTIONS IN RESPECT OF THE DEVELOPMENT OF ALPHARADIN AND ALGETA'S OTHER PRODUCTS, THE ONGOING EXPANSION OF THE ALPHARADIN PRODUCTION FACILITY AT IFE, THE QUANTITIES OF RADIUM-223 THAT THE IFE FACILITY WILL BE ABLE TO PRODUCE ONCE THE EXPANSION IS COMPLETED, THE ANTICIPATED MARKET DEMANDS FOR ALPHARADIN AND ALGETA'S OTHER PRODUCTS, THE RESULTS OF ONGOING CLINICAL TRIALS AND ALGETA'S STATED KEY ACTIVITIES AND MILESTONES FOR THE NEXT 12 MONTHS, INCLUDING REGULATORY FILINGS, AS WELL AS REGULATORY APPROVALS OF ALPHARADIN AND ALGETA'S OTHER PRODUCTS. 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A New Class of Targeted Cancer Therapeutics Alpha-pharmaceuticals – Potent tumor cell killing – No known resistance – Highly localized activity of alpha emission – Minimal damage to surrounding normal tissue Alpharadin: Success in phase III – Overall survival increased by 44% – Significant SRE benefits, incl. spinal cord compression – Well tolerated – Filing target mid 2012 USA and EU – Expanded Access Program initiated in the USA Alpharadin injection every 4 weeks Thorium TTCs * : Preclinical progress Radium-223 (Alpharadin) Thorium-227 (TTCs) Naturally targets bone metastases Conjugated to tumor-targeting molecules First in new class of Alpha-pharmaceuticals Potential for multiple cancer indications * Targeted Thorium Conjugates 3
Bone Metastases: A Significant Unmet Medical Need Develop in up to 90% of CRPC 1 and up to 80% of breast cancer patients Bone metastases represent a significant unmet medical need: – Ultimately lead to patient death in CRPC* – Cause pathological fractures and spinal cord compression – Patients will continue to progress, despite earlier-stage therapies – No survival benefit from current bone-targeted agents 1 CRPC – Castration Resistant Prostate Cancer 4 * Refs: Mundy, Nat Rev Cancer (2002) 2:584-593; NEJM editorial May 2011; Halabi, Journal of Clinical Oncology (2003) 21: 1232-1237
Alpharadin: Highly Targeted to Bone Metastases Alpharadin is a new class Alpha-pharmaceutical Bone marrow Tumor cells Osteoblast Alpha particle Newly radiation formed bone Osteoclast Radium-223 deposition Targets new bone in metastases Highly localized tumor cell killing Alpharadin (radium-223 in solution) acts as a calcium mimic – Naturally targets new bone growth in and around bone metastases Alpha particles induce double-strand DNA breaks in adjacent tumor cells – Short penetration of alpha emitters (2-10 cell diameters) means highly localized tumor cell killing & minimal damage to surrounding normal tissue Alpharadin is cleared rapidly into small intestine 5
Alpharadin: Easy and Convenient to Administer • Ready to use vials • Long shelf life (4 wks) • Easy to handle • Total 6 i.v. injections • One injection every 4 weeks • Out-patient treatment 6
Successful Phase III Data from 2011 EMCC 1 In CRPC patients with bone metastases: Alpharadin significantly prolonged overall survival – P value = 0.00185; HR = 0.695; 95% CI, 0.552-0.875 Alpharadin significantly prolonged time to first SRE 2 – P value = 0.00046; HR = 0.610; 95% CI, 0.461-0.807 Alpharadin was very well tolerated Radium-223 [Alpharadin], a novel Alpha-pharmaceutical, may provide a new standard of care for the treatment of CRPC patients with bone metastases 1 As presented by Dr Chris Parker, 24 th September 2011 at the Presidential Session featuring Best and Late-Breaking 7 Abstracts at 2011 European Multidisciplinary Cancer Congress, Abstract No.1LBA 2 SREs: Skeletal Related Event
Updated ALSYMPCA Survival Analysis The updated analysis (n=921) confirmed the overall efficacy results of the pre-planned interim analysis from June 2011 Increase in median overall survival of 3.6 months 14.9 months Alpharadin vs. 11.3 months placebo The hazard ratio was unchanged; p-value improved Further, detailed data will be presented at upcoming medical meetings 8
Spinal Cord Compression is an Oncological Emergency Radiation for bone pain Pathological fracture Spinal cord compression Surgery to bone Image adapted from Quraishi & Esler BMJ 2011;342:d2402 Spinal cord compression can be devastating for patients as it can cause paralysis, as well as bladder and bowel dysfunction 9
ALSYMPCA Time to First SRE Component Time to First Event No. (%) of Patients (Radium-223 vs. Placebo) Radium- 223 Placebo HR SRE Component (n=541) (n=268) P value * (95%CI) External Beam 122 (23%) 72 (27%) 0.0038 0.65 Radiotherapy (0.48-0.87) Spinal Cord 17 (3%) 16 (6%) 0.016 0.44 Compression (0.22-0.88) Pathologic 20 (4%) 18 (7%) 0.013 0.45 Bone Fracture (0.24-0.86) Surgical 9 (2%) 5 (2%) 0.69 0.80 Intervention (0.27-2.4) * Not adjusted for multiplicity. 10 Sartor, ASCO GU 2012 Poster Presentation. Abstract 9
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