Ground flour pharma final presentation

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


*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


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)


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


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


“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


IPPoP dataRegulatory planUnderstanding of the regulatory process




Technical Assistance (Image Atlas)FDA regulatory support

Radiopharmacies

Equipment producers

Prescribing physicians

Radiologist who perform studies

Sales of intermediates

Technology license


Drug developersPharmaceutical development companies

IPPoP data

Radiologists

Technical assistancecGMP manufacturersRadiopharmacies

Direct sales of precursor




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


Market SizeGlobal PET Market ~ $6.3 billion


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


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


The Final Business Model Canvas





FDA regulatory support

Radiopharmacies

Equipment producers

Licensing fees of precursor


Technical assistance

cGMP manufacturers




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

Ground flour pharma final presentation

Education

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