Mo-99 Supply

Ira GoldmanProject Director, Strategic Supply

Toward a More Secure Future?

Lantheus at a GlanceLantheus Medical Imaging

Headquarters: Billerica, Massachusetts

Offices: Puerto Rico, Canada, Australia

Marketed Products: 9

Products in Development: 3

Global Presence: Over 600 employees• R&D• Clinical and Medical affairs• Sales & Marketing• Manufacturing• Distribution• Rx/unit doses (Australia, Canada, PR)

2

Current Product Portfolio

3

TheReactors

NRU

LVR-15

HFR

Osiris

Safari

MariaBR2

LEU - OPAL, RA-3, SAFARIHEU – BR2, HFR, LVR-15, Maria, NRU, Osiris

Mo-99 TARGETS

RA-3

Processors

NTP

Nordion

IRE

Covidien

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

CNEA

Current U.S. Mo-99 Supply Matrix

HFR ReactorNetherlands

BR2 Reactor Belgium

OSIRIS Reactor France

NRU Reactor Canada

SAFARI Reactor S. Africa

Reactor Mo-99 Extraction

Mo-99 Purification Tc-99m Generator Manufacturer

OPAL Reactor Australia

Maria Reactor Poland

CovidienNetherlands

IREBelgium

NTPS. Africa

AECLCanada

NordionCanada

ANSTOAustralia

Covidien

Lantheus

LVR-15 ReactorCzech Republic

RIAR Reactors Russia Under

Development

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 (238U(n,f)99Mo)

• 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

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

•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

Toward a More Secure Future?Conclusions

Thank you!