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The Future of Targeted Drug Delivery

The Future of Targeted Drug Delivery. Lisa Shafer, PhD. Director, CNS Drug Therapy R&D Medtronic Neuromodulation lisa.l.shafer@medtronic.com. DISCLAIMERS This presentation includes the description of devices and therapeutic uses that are in early stages of development.

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The Future of Targeted Drug Delivery

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  1. The Future of Targeted Drug Delivery Lisa Shafer, PhD Director, CNS Drug Therapy R&D Medtronic Neuromodulation lisa.l.shafer@medtronic.com

  2. DISCLAIMERS This presentation includes the description of devices and therapeutic uses that are in early stages of development. The devices and therapeutic uses are not commercially available and have not been approved by regulatory institutions Medtronic does not market its products for unapproved indications and can make no representation regarding the safety and/or efficacy of the devices when used for unapproved claims Before commercialization is possible the devices and therapeutic uses need to obtain regulatory approval

  3. Summary • Dedicated to achieving greater depth in our current therapies • Compelled by the opportunity to expand to disease modifying therapies • Medtronic’s infusion technology, scientific foundation and combination device experience enables success • The complexity of targeted drug delivery requires extraordinary collaboration

  4. The Problem • The incidence of neurodegenerative disease is rapidly increasing as the population ages as previous causes of mortality decline • Unfortunately, neurodegenerative diseases are extremely difficult to address because the blood brain barrier excludes most drugs (and all biologics) from entering brain • Despite a significant number of drug targets and funding, most drugs aimed at neurodegenerative disease have failed due to the inability to deliver enough drug locally or systemic side effects associated with current peripheral delivery methods

  5. Medtronic’s Experience SynchroMed II • Medtronic is the worldwide leader in drug delivery directly to the central nervous system (CNS), bypassing the blood brain barrier for local, continuous delivery • SynchroMed® II is a fully implantable, programmablepump that has been used for over 20 years and 300,000+ patients to treat chronic pain and severe spasticity through direct delivery to the intrathecal space • Medtronic is also the worldwide leader in electrical stimulation directly to the brain for chronic diseases • Deep Brain Stimulation utilizes an implantable pulse generator connected to leads in the brain that has been used for over 10 years and 68,000+ patients to treat Parkinson’s disease, Essential Tremor, and Dystonia Deep Brain Stimulation

  6. The Solution • By combining Medtronic’s significant experience in the local delivery of drugs (SynchroMed® II) with our expertise in targeting discrete structures in the brain (Deep Brain Stimulation)… …Medtronic has created a system that can solve the problem of delivering drugs directly to the brain, bypassing the blood brain barrier, to effectively address neurodegenerative disease. Medtronic’s Investigational Intraparenchymal catheter with SynchroMed II pump

  7. Growing need for delivery of drugs into the CNS beyond the intrathecal space Intracerebroventricular (ICV) Intraparenchymal (IPa) Intrathecal (IT)

  8. SynchroMed® II Implantable Programmable Pump Catheter Access Port • Battery driven, peristaltic drive – up to 7 years implant duration • 20 & 40 ml reservoir volumes • Infusion rates from 0.048 to 20ml/day • Remote programing, capable of multiple dosing paradigms; variable flow rates, intermittent bolus, day/night. Reservoir Refill Port Titanium Housing Spinal Catheter N’vision Programmer SynchroMed® II pump

  9. Enabling Features for Future TDD

  10. Medtronic Infusion System Platforms* Ventricular Catheter Anchor* SynchroMed® II Infusion System Chronic ICVInfusion System* Intraparenchymal Catheter Anchor* SynchroMed® II Infusion System Chronic IPA Infusion System* IT and ICV) Access Port* MANTIS* Implantable* Micro-pump* Acute Infusion Systems* Paradigm® Veo *Products in Development / Investigational Use

  11. _ _ _ _ _ Factors that may influence drug distribution in the CSF Dosing Regimen e.g. Continuous vs Bolus Target Location e.g. Cervical vs Lumbar Infusion Rate e.g. Slow vs Fast Drug Properties e.g. Small vs Large Molecule Infusion Catheter Tip Drug Concentration

  12. Factors that may influence drug distribution in the CNS

  13. Medtronic’s CNS Drug-Device Therapy Portfolio

  14. Complexity of drug delivery therapies requires extraordinary collaboration Drug/Biologic + Therapy Success Biology & Delivery Principles Device

  15. Thank You, Medtronic Neuromodulation’sCNS Drug Therapy R&D Teamlisa.l.shafer@medtronic.com

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