Radiohalogen Molecular Imaging and Therapy Agents at MDS Nordion

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1 Radiohalogen Molecular Imaging and Therapy Agents at MDS Nordion 6 th International Symposium on Radiohalogens Dennis W. Wester, Director, Applied Research Vancouver Operations Sep 6-11, 2008

2 Our Global R&D and Manufacturing Sites Vancouver, BC Kanata, ON Fleurus, Belgium

3 Fleurus, Belgium Main radiohalogen products: [ 18 F]-FDG I-123

4 Current [ 18 F]-FDG Production Collaboration with University of Liege IBA 18-MEV Cyclotron Product for Belgian and French markets

5 Future [ 18 F]-FDG Production MDS Nordion facility IBA 30 MeV Cyclotron

6 Future [ 18 F]-FDG Production Coming soon!

7 Fleurus, Belgium Main radiohalogen products: [ 18 F]-FDG I-123

8 I-123 Production in Fleurus Several productions per week 3-4 Ci at EOB Target and purification system from MDSN VanOps Customers in Nordic countries, UK, Poland MIBG production halted in 2004

9 Vancouver, BC Xe-124 targetry I-123 radiochemical Oral I-123 Zemiva Altropane

10 Xe-124 Targetry Three cyclotrons: CP-42, TR-30-1, TR-30-2

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13 Vancouver, BC Xe-124 targetry I-123 radiochemical Oral I-123 Zemiva Altropane

14 I-123 Radiochemical Supplied in 0.1 N NaOH No carrier added 99.8% 123 I 0.2% other radionuclides Available Monday Thursday

15 Vancouver, BC Xe-124 targetry I-123 radiochemical Oral I-123 Zemiva Altropane

16 Oral I-123 Sodium Iodide I-123 Oral Solution Supplied as a solution (0.1 N NaOH) for oral administration Available in MBq quantities requested by the customer at time of calibration >99.8% I-123 (<0.2% other radionuclides, I-125 and Te-121)

17 Vancouver, BC Xe-124 targetry I-123 radiochemical Oral I-123 Zemiva Altropane

18 Zemiva Iodinated phenyl fatty acid Contract manufacturing for Molecular Insight Pharmaceuticals Clinical-stage molecular imaging pharmaceutical product candidate Several other indications relating to the future development for Zemiva have been identified, such as diabetes, chronic kidney disease and heart failure CH 3 I (CH 2 ) 12 CH CH 2 COOH 15-(p-Iodo-phenyl)-3-R,S-methylpentadecanoic acid (BMIPP)

19 Vancouver, BC Xe-124 targetry I-123 radiochemical Oral I-123 Zemiva Altropane

20 Altropane 123 I-labeled small molecule with high selectivity for the Dopamine Transporter (DAT), as an aid in the diagnosis of Parkinson s Disease Contract manufacturing for Alseres Pharmaceuticals

21 Altropane Five clinical studies testing nearly 500 individuals using Altropane as a molecular imaging agent Normal human SPECT brain scan using Altropane Image Source: Boston University Medical Center Human Parkinson's Disease SPECT brain scan using Altropane Image Source: Hospital of the University of Pennsylvania

22 Kanata, ON I-131 radiochemical Neuradiab Bexxar Azedra Iotrex

23 I-131 Radiochemical Fission product from IRE (Belgium) and NTP (South Africa) o (50-60 Ci/mg) Neutron-capture from Te-130 o (~20 Ci/mg, no carrier added) Used mainly for I-131 capsules o e.g., Curicap is a soluble gel capsule filled with [I-131]-NaI

24 Kanata, ON I-131 radiochemical Neuradiab Bexxar Azedra Iotrex

25 Neuradiab Contract manufacturing for Bradmer Pharmaceuticals Anti-tenascin monoclonal antibody (81C6) radiolabeled with I-131 Used for glioblastoma multiforme (GBM) intracavity treatment after resection

26 Kanata, ON I-131 radiochemical Neuradiab Bexxar Azedra Iotrex

27 Bexxar Contract manufacturing for GlaxoSmithKline IgG Anti CD 20, MW: 160,000 Da Treatment of refractory B-cell Non-Hogkins Lymphoma Activity: mci Antibody concentration: 1.1 mg/ml (Tx) Shelf life: C (U.S. Patent 5,961,955)

28 Kanata, ON I-131 radiochemical Neuradiab Bexxar Azedra Iotrex

29 131 I-MIBG (meta-iodobenzylguanine) Neuroblastoma: Bone scan and MIBG exam. Diffuse skeletal metastases are evident on bone scan, but are more clearly revealed on the MIBG exam. Uptake within the patients primary lesion can also be seen on the MIBG exam. A plain film skeletal survey demonstrated a very subtle periosteal reaction within the distal left femoral metaphysis, but was otherwise normal

30 Azedra Iodine-labeled MIBG either diagnostically for imaging disease or therapeutically to deliver targeted radiation to the tumor site Contract manufacturing for Molecular Insight Pharmaceuticals Cold contaminants are avoided using proprietary Ultratrace technology Received Orphan Drug status and a Fast Track designation by the US FDA

31 Kanata, ON I-131 radiochemical Neuradiab Bexxar Azedra Iotrex

32 Iotrex TM Contract manufacturing for Hologic (was Cytyc and Proxima) Component of GliaSite Radiation Therapy System Treatment of Glioblastoma multiforme (GBM) Activity: 195 mci ( 125 I) Shelf life : C

33 Summary All three MDS Nordion sites (Fleurus, Vancouver, Kanata) are involved with radiohalogens Both diagnostic and therapeutic isotopes are used Products range from radiochemicals to radiopharmaceuticals Thanks for your attention (and business)