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Drug Delivery: Overview and Emerging Trends Kurt R. Sedo
Vice President, Operations PharmaCircle LLC
Encinitas, CA
3rd Annual Drug Development Networking Summit 2018
Drug Delivery: Overview and Emerging Trends
• Products/Pipeline Overview
• Recent Innovator Approvals
• Current State and Trends – Injection, Oral, Inhalation, Ophthalmic, Nasal, Topical, Transdermal
• Review DD Technology Trends
• Venture Capital Investments
• Conclusions
Overview: Products and Pipeline
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Route: Marketed vs Pipeline
Marketed
Pipeline
DD 38% Non-DD
62%
Marketed Products
DD 37%
Non-DD 63%
Pipeline Programs
Overview: Innovator Drug Approvals Since 2012
0 20 40 60 80
100 120 140 160
Innovator DD Approvals by Route
DD 44%
Non-DD
56%
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Innovator Approvals by Route
Overview/Trends: Injectables
• Injectables Taking Over Pipeline
• Devices, Devices, Devices… – Multiple device strategies
incorporated into first approvals (i.e. Repatha)
• Delivery of High Volume and/or Viscous Biologics
• Trending Formulation Approaches – Controlled Release SC/IM (i.e. Depot)
– Controlled Release IV (i.e. PEG)
– Targeted (ADC, nanoparticles)
– Nucleic Acid Delivery
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Device Based Approvals Since 2012
Overview/Trends: Oral
• Mature Space – Generic companies have capability to develop complex formulations
– Product development transitioning to CDMO’s
• Area Growth/Interest – Rapidly Disintegrating Formulations (ODT/ODF)
• Pediatric and geriatric patients
– Oral Macromolecule
• Moving beyond insulin
Oral Modified Release
46%
Rapidly Disintegratin
g Formulations
18%
Oral Enhanced BA
15%
Chewable 6%
Abuse Resistant
5%
Dispersible 4% Taste
Masking 4%
Other 2%
Oral DD Approvals Since 2012
Overview/Trends: Inhalation • Approvals since 2012 With Same Platform
– GSK Ellipta (DPI): Anoro (2013), Breo (2013), Arnuity (2014), Incruse (2014), Trelegy (2017)
– Novartis Breezehaler (DPI): Seebri (2012),
Ultibro (2013), other prior to 2012
– Almirall Genuair (DPI): Eklira (2012), Brimica/ Duaklir (2014), others prior to 2012
– BI Respimat (Nebulizer): Striverdi (2013), Stiolta (2015), others prior to 2012
– Pari eFlow (Nebulizer): Quinsair (2015), Vantobra (2015), other prior to 2012
– Teva RespiClick/Spiromax (DPI): Biresp (2014),
ProAir (2015), AirDuo (2016), ArmonAir (2017)
• Inhaled combination products especially difficult to develop as a generic
DPI 54%
MDI 19%
Nebulizer 27%
Inhalation Approvals Since 2012 by Technology Category
Overview/Trends: Ophthalmic
• Topical Most Common
• Expanded Interest – Program/technology advancement
– Funding, deals…
• Unmet Needs – Back of the eye delivery
– Convenient administration
• Easy to use application device
• Reduced dosing frequency
Topical 86%
Device/Dispenser 8%
Implants/Rods 5% Photodynamic
1%
Iontophoresis <1%
Products/Pipeline by Technology Category
Overview/Trends: Nasal, Topical, Transdermal
• Nasal – Applicable to fast acting (i.e. migraine, overdose) and macromolecules
– Recent device/product approvals
– Revived interest in route for right application/indication
• Topical – Slow and steady as there is always a need for these products
– Used when it makes sense
• Transdermal – Limited NDA approvals since 2012
– Modest progress in technologies such as microneedles, macromolecule…
Overview/Trends: Drug Delivery Technologies
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Technology Count by DD Category
0
200
400
600
800
1000
1200
1400
Drug Delivery Related Deals by DD Category
DD Venture Capital Funding Since 2012
INJECTION 38%
ORAL 16%
SKIN 11%
OPHTHALMIC 8%
OTHER CATEGORIES 9%
TRANSMUCOSAL 7%
MEDICAL DEVICES 6%
INHALATION 5%
Venture Capital Funding by DD Category
Closing Observations/Comments • Drug Delivery Applied Across Products/Pipeline
– ~40% apply DD technology (> trend)
• Injectables becoming majority of pipeline/focus – Injection based devices and delivery of biologics
• CDMO’s Becoming Centers for Technology/Product Development
• Drug Delivery and Compliance Devices – Continued development of devices across routes not just injection
• Needs Based Approach to DD Technology/Product Development – Right technology/route for right product
– Opportunities exist outside biologics!!!
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