ground flour pharma final nsf i-corps presentation
TRANSCRIPT
Spoke to: firms covering 60%-80% of the global radiopharmaceutical market,
15 clinical PET users, and 7 GMP PET manufacturers, 5 officials of state
economic development (>90 people total)
PET is critical for the diagnosis and
treatment of cancer, neurological disease
(Parkinson’s, Alzheimer’s), and cardiac
disease. F-18 is the imaging isotope of
choice.
The Challenge: Synthesize and inject the drug within two hours.
(F-18 half-life = 110 min).
The Solution: Single step fluorination for PET imaging agents.
GFP does this better than anyone else.
*10X increase in production at same cost
*Pure “carrier-free” product to reduce side effects
*Robust manufacturing reliability
*Simplified regulatory approval
*Accelerate new agents to market
*Global PET market estimated to grow from $6.1 billion in 2010 to $9.8 billion in 2015
*GFP addresses the large unmet clinical demand for imaging agents
This is your brain on fluorine
I-Corps Final Presentation 12/14/11
I-Corps Final Presentation 12/14/11
*Kiel Neumann (Entrepreneurial lead)
*Graduate Student at UNL (PhD in May 2012)
* Thesis project developed technology used by GFP
*Stephen DiMagno PhD (PI)
*University of Nebraska Professor
* Expertise in the synthesis, physical properties, and
medicinal chemistry of fluorinated organic compounds
*Allan Green MD, PhD, JD (Mentor)
* Extensive experience in the pharmaceutical industry,
including the development and launch of imaging
products
* Currently teaches FDA Law at the Boston College Law
School
General
methodology for
adding fluorine to
lead compounds of
interest
The Business Model Canvas - Initial
Accessibility (RCY)
Purity
Speed
PET/SPECT
Multiplatform
Sensitivity (nca)
Specific compounds
IP
PoP data
Regulatory plan
Understanding of
the regulatory
process
Contract cGMP precursor manufacture
Salary, Rents
Clinical trials
SOPs for precursors
and drugs
Recruit clinical sites
In vivo animal studies
Develop regulatory
plan for pre IND
meeting
ID cGMP CRO
Fund-raising
Nuclear Medicine and
Radiology
departments
Technical Assistance
(Image Atlas)
FDA regulatory supportRadiopharmacies
Equipment producers
Prescribing physicians
Radiologist who
perform studies
Sales of intermediates
Technology license
Product license (royalty)
Drug developers
Pharmaceutical
development
companies
IP
PoP data
Radiologists
Technical assistance
cGMP manufacturers
Radiopharmacies
Direct sales of precursor
Sales of packaged
precursor in cassettes
Cassette manufacturers
I-Corps Final Presentation 12/14/11
5
Reagents
• F-dopa iodonium intermediate
• F-dopamine iodonium intermediate
GMP Cassette
Components
•ABX
•Eckert & Ziegler
•GE MX module for TracerLab
•Siemens Explora
GMPCompliantSynthesizer
•TracerLab/ GE
•Eckert & Ziegler
•Siemens Explora
•Neoprobe
•Synthra
PET Drug Distributor
•Siemens PETNet
•GE Amersham
•Cardinal Health
•AAA
•Iason
Precursor Synthesis
Finished product
Precursor in Cassette
Cassette (device)
I-Corps Final Presentation 12/14/11
*Increase manufacturing yields by 10-fold without increase of
the cost of inputs
*Confirmed by European producer of F-18 DOPA. GFP technology
would increase their output 10x
*Cold unlabeled drug in current PET products produces side-
effects that limit clinical use
*Children’s Hospital confirms side-effects of F-18-dopamine are a
problem and would be solved by GFP technology
*Current manufacturing technology limits the clinical
availability of important PET agents
*Discussion with US hospital confirms important agent (F-18 DOPA)
not available due to low yield and unreliability of current
syntheses
I-Corps Final Presentation 12/14/11
*Companies with proposed proprietary PET agents need improved
manufacturing pathways for reliability and economic success
*Detailed discussion with two potential R & D partners (one large
pharma, one small pharma) confirm need
Radiopharmaceutical
Distributors
•Siemens PETNet
•GE Amersham
•Cardinal Health
•AAA
•Iason
•Neoprobe
I-Corps Final Presentation 12/14/11
“Value is in the finished
product”
“Plug & Play”
“We are definitely
interested IF you can
make it work on our
platform”
General
methodology for
adding fluorine to
lead compounds of
interest
The Business Model Canvas - Pivot
Accessibility (RCY)
Purity
Speed
PET/SPECT
Multiplatform
Sensitivity (nca)
Specific compounds
IP
PoP data
Regulatory plan
Understanding of
the regulatory
process
Contract cGMP precursor manufacture
Salary, Rents
Clinical trials
SOPs for precursors
and drugs
Recruit clinical sites
In vivo animal studies
Develop regulatory
plan for pre IND
meeting
ID cGMP CRO
Fund-raising
Nuclear Medicine and
Radiology
departments
Technical Assistance
(Image Atlas)
FDA regulatory supportRadiopharmacies
Equipment producers
Prescribing physicians
Radiologist who
perform studies
Sales of intermediates
Technology license
Product license (royalty)
Drug developers
Pharmaceutical
development
companies
IP
PoP data
Radiologists
Technical assistancecGMP manufacturers
Radiopharmacies
Direct sales of precursor
Sales of packaged
precursor in cassettes
Cassette manufacturers
I-Corps Final Presentation 12/14/11
*Provide infrastructure for commercialization and clinical
trials
ABX
Albany Molecular*Offer large-scale cGMP precursor production
*Met Biologics GMP production facility representatives at UNMCTracerLab/ GE
Neptis
Eckert & Ziegler
Siemens Explora
Neoprobe
Synthra
*Offer GMP-compliant synthesizers
UCSF
Memorial Sloan-Kettering
St. Jude Children’s Research Hospital
Stanford Medical Center
I-Corps Final Presentation 12/14/11
Global PET Market ~ $6.3 billion
I-Corps Final Presentation 12/14/11
Serviceable available market ~ $1 billion
Initial Target Market (first 2
compounds) ~ $100 million
11
Parkinson’s Disease
SPECT DaTScan(GE) sales in Europe
~$100 M
-Current price - $2800/dose
-Medicare reimbursement -
$600/dose
Currently 1.5 million Americans
diagnosed with 60,000 new diagnoses
each year
Expected to rise with effective
imaging
GFP F-18 DOPA addresses this market
with a PET agent
Current SPECT technology
PET imaging
GFP F-18 DOPA
I-Corps Final Presentation 12/14/11
• Neuroblastoma
• Childhood cancer with
prevalence comparable
to leukemia
• mIBG SPECT imaging now
used
• PET agent sought
• Carrier-free F-18 dopamine
synthesis shown by GFPn
GFP F-18 Dopamine
I-Corps Final Presentatio 12/14/11
13
GMP
PrecursorGMP
Cassette
$10’s/cassette $300 /cassetteFinished
Drug
Product
$1700 per dose
~100 doses/cassette
One time
setup
$140,000
Nominal
royalty
($50) per
cassette
Patients
Hospitals
Finished
Drug
ProductFinished
Drug
ProductFinished
Drug
Product
Finished
Drug
ProductFinished
Drug
ProductFinished
Drug
ProductFinished
Drug
Product
I-Corps Final Presentation 12/14/11
The Final Business Model Canvas
Accessibility (RCY)
Purity
Speed
PET/SPECT
Multiplatform
Sensitivity (nca)
Specific compounds
Contract cGMP precursor manufacture
Salary, Rents
Clinical trials
SOPs for precursors
and drugs
Recruit clinical sites
In vivo animal studies
Develop regulatory
plan for pre IND
meeting
ID cGMP CRO
Fund-raising
Nuclear Medicine and
Radiology
departments
FDA regulatory support
Radiopharmacies
Equipment producers
Licensing fees of precursor
Product license (royalty)
Technical assistance
cGMP manufacturers
Sales of packaged
precursor in cassettes
Cassette manufacturers
I-Corps Final Presentation 12/14/11
Intellectual Property
PoP Data
FDA support
Radiopharmacies
*Limitations in current PET chemistry constrain the availability of
clinically important PET drugs
*Low manufacturing yields, unreliability of current procedures, and
manufacturing complexity are addressed by proprietary GFP
technology
*GFP technology addresses attractive markets
*GFP technology provides accessibility
*Proven synthesis of existing tracers with proven clinical use
* Improved manufacturing of third-party proprietary imaging agents
Submitted SBIR Phase 1 proposal
PI bought out of teaching commitment in spring
Rented space for GFP
Negotiated license agreement with UNL
Negotiating technology demonstrations
Met with State representatives for economic development