Ground Fluor Pharmaceuticals
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.
Ground Fluor Pharmaceuticals
*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
GFP Team
General methodology for adding fluorine
to lead compounds of
interest
The Business Model Canvas - Initial
Accessibility (RCY)PuritySpeedPET/SPECTMultiplatformSensitivity (nca)Specific compounds
IPPoP dataRegulatory planUnderstanding of the regulatory process
Contract cGMP precursor manufactureSalary, RentsClinical trials
SOPs for precursors and drugsRecruit clinical sitesIn vivo animal studiesDevelop regulatory plan for pre IND meetingID cGMP CROFund-raising
Nuclear Medicine and Radiology departments
Technical Assistance (Image Atlas)FDA regulatory support
Radiopharmacies
Equipment producers
Prescribing physicians
Radiologist who perform studies
Sales of intermediates
Technology license
Product license (royalty)
Drug developersPharmaceutical development companies
IPPoP data
Radiologists
Technical assistance
cGMP manufacturersRadiopharmacies
Direct sales of precursor
Sales of packaged precursor in cassettes
Cassette manufacturers
I-Corps Final Presentation 12/14/11
Distribution Food Chain
5
Reagents
• F-dopa iodonium intermediate• F-dopamine iodonium intermediate
GMP Cassette
Components
•ABX•Eckert & Ziegler•GE MX module for TracerLab•Siemens Explora
GMP
Compliant
Synthesizer
•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
Testing Value Proposition*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
Testing Value Proposition
*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
What We Learned
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)PuritySpeedPET/SPECTMultiplatformSensitivity (nca)Specific compounds
IPPoP dataRegulatory planUnderstanding of the regulatory process
Contract cGMP precursor manufactureSalary, RentsClinical trials
SOPs for precursors and drugsRecruit clinical sitesIn vivo animal studiesDevelop regulatory plan for pre IND meetingID cGMP CROFund-raising
Nuclear Medicine and Radiology departments
Technical Assistance (Image Atlas)FDA regulatory support
Radiopharmacies
Equipment producers
Prescribing physicians
Radiologist who perform studies
Sales of intermediates
Technology license
Product license (royalty)
Drug developersPharmaceutical development companies
IPPoP data
Radiologists
Technical assistancecGMP manufacturersRadiopharmacies
Direct sales of precursor
Sales of packaged precursor in cassettes
Cassette manufacturers
I-Corps Final Presentation 12/14/11
Getting Out of the Building
*Provide infrastructure for commercialization and clinical trials
Academic Partners
GMP ManufacturingABXAlbany Molecular
*Offer large-scale cGMP precursor production
*Met Biologics GMP production facility representatives at UNMC
TracerLab/ GENeptisEckert & ZieglerSiemens ExploraNeoprobeSynthra
*Offer GMP-compliant synthesizers
UCSFMemorial Sloan-KetteringSt. Jude Children’s Research HospitalStanford Medical Center
I-Corps Final Presentation 12/14/11
Market SizeGlobal 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
Target Markets in PET imaging
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
Target Markets in PET imaging
• Neuroblastoma• Childhood cancer
with prevalence comparable to leukemia
• mIBG SPECT imaging now used
• PET agent sought
• Carrier-free F-18 dopamine synthesis shown by GFP
n
GFP F-18 Dopamine
I-Corps Final Presentatio 12/14/11
13
GMPPrecurso
r
Revenue Model
GMPCassette
$10’s/cassette $300 /cassetteFinished
Drug Product
$1700 per dose~100 doses/cassette
One time setup
$140,000
Nominal royalty
($50) per cassette
PatientsHospital
s
Small initial
investment
Small licensing revenue
$500/dose100
doses/preparation
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)PuritySpeedPET/SPECTMultiplatformSensitivity (nca)Specific compounds
Contract cGMP precursor manufactureSalary, RentsClinical trials
SOPs for precursors and drugsRecruit clinical sitesIn vivo animal studiesDevelop regulatory plan for pre IND meetingID cGMP CROFund-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
Lessons Learned
Submitted SBIR Phase 1 proposalPI bought out of teaching commitment in springRented space for GFPNegotiated license agreement with UNLNegotiating technology demonstrationsMet with State representatives for economic development
Top Related