Toward a More Secure Future?

Mo-99 Supply

Ira Goldman Project Director, Strategic Supply

Lantheus at a Glance

Lantheus Medical Imaging Headquarters: Offices: Marketed Products: Products in Development: Global Presence: Billerica, Massachusetts Puerto Rico, Canada, Australia 9 3 Over 600 employees

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R&D

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Clinical and Medical affairs

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Sales & Marketing

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Manufacturing

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Distribution

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Rx/unit doses (Australia, Canada, PR)

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Current Product Portfolio

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NRU HFR Osiris BR2 Maria LVR-15 Safari

The Reactors

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

Nordion Covidien IRE

Processors

CNEA NTP LEU – ANSTO, CNEA, NTP HEU – Covidien, IRE, Nordion

Current U.S. Mo-99 Supply Matrix

Reactor Maria Reactor Poland HFR Reactor Netherlands BR2 Reactor Belgium LVR-15 Reactor Czech Republic OSIRIS Reactor France SAFARI Reactor S. Africa NRU Reactor Canada RIAR Reactors Russia OPAL Reactor Australia Mo-99 Extraction AECL Canada

Under Development

Mo-99 Purification Covidien Netherlands IRE Belgium NTP S. Africa Nordion Canada ANSTO Australia Tc-99m Generator Manufacturer Covidien Lantheus

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

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 ( 238 U(n,f) 99 Mo) • Canada – NISP grant (Non-reactor-based Isotope

Supply Contribution Program)

• Cyclotron-produced Tc-99m • Photon/accelerator production

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?

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?

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

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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  1 st commercial sale of NTP LEU Mo-99 (Dec. 2010)  1 st 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

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

Thank you!