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Mo-99 Supply Ira Goldman Project Director, Strategic Supply

Toward a More Secure Future?. Mo-99 Supply Ira Goldman Project Director, Strategic Supply. Lantheus at a Glance. 2. Current Product Portfolio. 3. HFR. The Reactors. BR2. Maria. NRU. Osiris. LVR-15. Safari. RA-3. OPAL. Mo-99 TARGETS. LEU - OPAL, RA-3, SAFARI

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Mo-99 Supply Ira Goldman Project Director, Strategic Supply

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  1. Toward a More Secure Future? Mo-99 SupplyIra GoldmanProject Director, Strategic Supply

  2. Lantheus at a Glance 2

  3. Current Product Portfolio 3

  4. HFR TheReactors BR2 Maria NRU Osiris LVR-15 Safari RA-3 OPAL Mo-99 TARGETS LEU - OPAL, RA-3, SAFARI HEU – BR2, HFR, LVR-15, Maria, NRU, Osiris

  5. Nordion Covidien IRE NTP CNEA ANSTO Health Processors LEU – ANSTO, CNEA, NTP HEU – Covidien, IRE, Nordion

  6. Current U.S. Mo-99 Supply Matrix Reactor Mo-99Extraction Mo-99Purification Tc-99m Generator Manufacturer Maria Reactor Poland HFR Reactor Netherlands Covidien Netherlands BR2 Reactor Belgium Covidien IRE Belgium LVR-15 Reactor Czech Republic OSIRIS Reactor France NTP S. Africa SAFARI Reactor S. Africa Lantheus NRU Reactor Canada AECL Canada Nordion Canada RIAR Reactors Russia Under Development OPAL Reactor Australia ANSTO Australia

  7. Medium and Long term Mo-99 Supply Chain • S.99 American Medical Isotopes Production Act of 2011 • U.S. Domestic Projects • 4 DOE/NNSA cooperative grants (non-HEU projects) • GE Hitachi-Clinton – power reactor, neutron • activation, LSA (Northstar & NuView) • Babcock & Wilcox – MIPS aqueous solution reactor • Morgridge Institute for Research(SHINE) – accelerator-driven fission process • Northstar –Mo-100 accelerator LSA w/Tc-99m separator

  8. Medium and Long term Mo-99 Supply Chain • North American production • Other (potential) projects • Northstar/MURR - Mo-98 NA LSA w/Tc-99m separator • Coqui Radiopharmaceuticals – fission, 2015? • MURR – fission ? • Perma-Fix (with PNNL) – neutron activation? • MiPod - fast fission (238U(n,f)99Mo) • Canada – NISP grant (Non-reactor-based Isotope Supply Contribution Program) • Cyclotron-produced Tc-99m • Photon/accelerator production

  9. Medium and Long term Mo-99 Supply Chain • Europe – New RRs: • FRM II Reactor – 2015 • Jules Horowitz Reactor – 2016 • Pallas Reactor – 2020? • MYRRHA Reactor – 2022? • Processors Conversion to LEU – 2015~? • Australia – Phase 2 , 2015 • South Africa - Safari 2 DIPR, 2020?

  10. Medium and Long term Mo-99 Supply Chain • Russia – Rosatom/Isotope, 2013? • (thru Nordion) • Argentina – CNEA new reactor & processing, 2018 • South Korea – New RR, fission 2017 • India, China – fission 2014, 2015?

  11. Diagnostic RP Reimbursement Advocacy • Separate Medicare payment for dRPs in hospital outpatient (most important setting for using RPs) was discontinued by CMS in 2008 • Separate Medicare payment for dRPs continues in physician offices • Since 2008 LMI, CORAR, and medical societies continued strong advocacy with CMS to restore separate Medicare payment for dRPs in HO setting to maintain patient access to newer and better dRPs. • Increased cost of Mo-99 and Tc-99m is another very important reason for restoring such separate payment for dRPs in HO • CMS/CORAR meeting of 7/26/2011 indicated that Congressional action may be necessary in order to restore separate Medicare payment for dRPs in hospital outpatient setting

  12. LMI Mo-99 Leadership • Secure, reliable, globally diversified supply chain, focused on reactors and processors • NRU, SAFARI, BR2, OSIRIS, HFR, LVR-15 • Nordion, NTP, IRE, ANSTO • Secured FDA approval for new reactor (LVR-10) and LEU Mo-99 • 1st commercial sale of NTP LEU Mo-99 (Dec. 2010) • 1st FDA approval ANSTO LEU Mo-99 processes (June 09, Apr. 11’) • regular commercial shipments from NTP and ANSTO (May-June 2011 and ongoing) • Active engagement with Mo-99 projects • Advocacy to restore separate reimbursement for diagnostic RPs in hospital outpatient

  13. Toward a More Secure Future? Conclusions Impact of reactor outages (2009-10), medical reimbursement pressures, and medical radiation concerns have decreased demand for Tc-99m How will future demand evolve? The Mo-99 production landscape is changing - many new projects, including domestic U.S., on drawing board How many will succeed? When? 2016-2018 situation unclear (post-NRU) LEU-based production will be the future of Mo-99 supply Medicare reimbursement landscape is changing with payments decreased and/or “bundled” with procedures Need for separate Medicare payment for dRPs to compensate for Mo-99/Tc-99m cost increases Lantheus has taken a leadership role in securing future Mo-99 supply

  14. Thank you!

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