ground flour pharma lecture 8 resources
TRANSCRIPT
This is your brain on fluorine
Team: Kiel Neumann (EL)
Stephen DiMagno (PI)
Allan Green (Mentor)I-Corps 11/15/11
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PET is a non-invasive medical diagnostic
technique for cardiac, brain, and tumor imaging
GFP technology makes imaging agents available
for clinical use, often for the first time.
Initial target indications: pediatric neuroblastoma,
Parkinson’s disease.
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Manufacture
GMP precursor manufacturesGMP cassette manufacturersRadiopharmacies
Clinical Trials
St. Jude Children’s Research HospitalSloan KetteringUCSF
General methodology for
adding fluorine to lead compounds of
interest
The Business Model Canvas
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
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We provide accessibility
Only want GMP precursor in cassettes without development
Could license precursor synthesis for incorporation in cassettes
Require GMP precursor (or cassette) to develop our product with their synthesizer
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GMPPrecursor
GMPCassette
Finished Imaging Agent
$10’s per cassette $300 per cassetteFinished Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging Agent
$1700 per dose~100 doses/cassette
One time setup
$140,000Revenue neutral
thereafter
Licensing fee or nominal
royalty ($50) per cassette
$500 fee per dose at
existing price structure
PatientsHospitals
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GMPPrecursor
GMPCassette
Finished Imaging Agent
$10’s per cassette $300 per cassetteFinished Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging Agent
$1700 per dose~100 doses/cassette
One time setup
$140,000Revenue neutral
thereafter
Licensing fee or nominal
royalty ($50) per cassette
$500 fee per dose at
existing price structure
PatientsHospitals
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GMPPrecursor
GMPCassette
Finished Imaging Agent
$10’s per cassette $300 per cassetteFinished Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging AgentFinished
Imaging Agent
$1700 per dose~100 doses/cassette
One time setup
$140,000Revenue neutral
thereafter
Licensing fee or nominal
royalty ($50) per cassette
$500 fee per dose at
existing price structure
PatientsHospitals
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2.2 million doses per year
%10 of the market is 200,000 doses
$500 per dose = $100 million
Current sales $2 M/year because production is limited and costs are high.
Confidential financial Gannt chart prepared
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1) Radiologists and Nuclear Medicine Physicians2) Radiopharmacy companies (Cardinal Health, Siemens, GE
Healthcare, IBA, AAA)3) Equipment manufacturers (GE, Philips, IBA, Advion)4) cGMP manufacturers
1) Pharmaceutical companies2) Radiologists and Nuclear Medicine Physicians
- Face to face with attending Radiologist at Stanford University
- Face to face with radiopharmacist at UCSF
- Conference call with Nuclear Radiologist at Memorial Sloan Kettering
- Conference call with president of medium size drug company with PET product at the FDA
- Telephone conference with cGMP facility
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- Immediate need for our product
- Currently used SPECT product for neuroblastoma is limited by absence of correlative CT data
- Our lead PET agent would provide more information on existing imaging equipment base
- Two customers offered to participate in clinical trials
- Potential for further development of other tracers identified in interviews
- Actual need for the general procedure
- Allow access to previously unknown tracers
Key meetings with two radiopharmacy companies, one large, one small. Shift in emphasis of the first product to the potentially more profitable application (Parkinson’s imaging).
Small player has only regulatory license to use the compound for clinical imaging, but is currently production limited. Sales are limited by chemistry and by the number of cyclotron facilities. Potential for ~50 fold improvement in sales.
Our IP is being scrutinized seriously by interested parties.
Large player desires interaction with company only (no academic tie in.)
Preferred deliverable from us is a cassette and technical expertise.
Pricing structure is right for lead compound.17
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Face to Face meeting with president of small radiopharmaceutical company
Face to face with a clinician at Memorial Sloan-Kettering
Face to face with Global Production Manager of Molecular imaging for one of world’s largest radiopharmaceutical companies
OncoKinib collaboration between Geurbet, OncoDesign, and Ariana pharmaceuticals
Face to face meeting with head of R & D and International Production Manager from Linz, Austria
Eckert and Zeigler – German PET modular synthesis provider
Face to face meeting with Executive Director and CEO of Scott Tech Center in Omaha, NE
Introductory teleconference to CEO of Innovation Accelerator
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Scott Tech Center and Innovation Accelerator
Willing to offer free advice on startup strategy
Aid in developing two pronged strategy (bottom up – Product Portfolio Manager, and top down - Director of Venture Technology) with one of world’s leading radiopharmaceutical companies
Potential tie in to State economic development resources
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Proprietary compounds for mass distribution
Cassette manufacturers’ pricing strategies for intermediates are appropriate for generics only.
Cassette-based system is mandatory for this market
Lead compound market is potentially large
Current provider is manufacturing limited (~100 doses/day). Our process would increase output dramatically with existing cyclotron infrastructure
European manufacturer/distributor with regulatory approval could incorporate our technology into their production system relatively rapidly
European data could be used by Company to support US FDA regulatory submission for product approval
General methodology for
adding fluorine to lead compounds of
interest
The Business Model Canvas
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
cGMP manufacturerRadiopharmaciesNuclear 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 developers
Pharmaceutical development companies
IPPoP data
Radiologists
Technical assistance
Direct sales of precursor
R&D and clinical studies presented in journals and meetings
Sales of precursor through global finished pharmaceutical distributor
Conference call with top 40 Fortune 500 chemical distribution company Open to cGMP production of our potentially proprietary precursors Interested in developing a general “plug-and-play” cassette
Would allow implementation of our methodology and precursors for any radiochemistry module
Important for FDA compliant production of any drug used in patient diagnostics
Face to face meeting with Director of Business Development of a leading drug discovery outsourcing company Discussed preclinical studies and contract manufacturing of
proprietary intermediates
- Face to face with former Director of Chemistry of major pharmaceutical company- Significant interest in general methodology application to proprietary
compound syntheses
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-Initially seeking to market method technology
-too diffuse, but many opportunities (i.e. product-driven opportunities more than general technology-driven)
-Need to identify specific imaging product opportunities
-Validated hypothesis for immediate need of tracers
-Raised question on identity of lead compound pipeline for Parkinson’s disease
-Recruited two potential partners for clinical trials
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Approximately 2.2 million procedures in the US.
Drug costs range from $700 (on-patent) to ~$150 (generic FDG)
US sales of radiopharmaceuticals for PET and SPECT $1.2 billion
US sales expected to grow to $6 billion by 2018
Global numbers approximately 2x
Source: Bio-Tech Systems Report #330; data for 2010.
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2500 installed PET scannersPET radiopharmacies cover the entire US marketRadiopharmacies have an interest in proprietary agents as a basis of competition in their market.
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Neuroblastoma
Prevalence: about 6000 US cases about 1000 new cases per year
Subjects receive 3-6 images/yearto follow response to therapeutic protocols
World market at U.S. x 2 gives potential of 40,000-70,000 scans/year
Drug costs $500/per gives ~$20 - $35 M
Parkinson’s Disease
DatSCAN sales in Europe ~$100 M
The world's highest recorded prevalence of Parkinson's Disease of any region is in Nebraska, with 329.3 people per 100,000 population
US – 600,000 patients 1 scan per year @ $500 = $300 M