Oral biologic drugs like oral Insulin
description
Transcript of Oral biologic drugs like oral Insulin
1© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Oral biologic drugs like oral Insulin
2© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Biologic drugs are growing at a rapid 16% annually Most biologics (like Insulin) must be injected
Easy to administer biologic drugs – Oral Delivery
Opportunity
MarketSituation
Unmet Need
Spark Biotech’s Solution
3© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Market for lead drugs
Therapeutic Protein and biologics market estimated at $50 Billion by 2010*
InsulinGlobal sales forecast in the diabetes
market for Insulin is ~$10.3 B in 2008 with a CAGR of 16.2%1
Human Growth HormoneIn 2001 worldwide Human Growth
Hormone (hGH) sales were ~1.5 B with a CAGR of 8%2
* Source: ”Therapeutic Proteins: Strategic Market Analysis and Forecasts to 2010”, DataMonitor Report #:DMHC18031 Source: ”Drugs of Tomorrow 2001: Diabetes”, DataMonitor Report #:DMHC17382 Source: ”Human Growth Hormone – Delivery Technology Driving Market Growth”, DataMonitor Report #:BFHC0519
4© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Management TeamManagement Team
Dr. PanduRanga Rao Koritala
Chairman & CEO
Over 40 years of experience in biopolymer researchPublished over 160 research papers and in 3 booksDirector (highest level) scientist at Indian National Lab32 PhD. Students completed their doctoral work with his guidance
Entrepreneur with two successful product launches
S. Bobby Koritala COO and President
Former Director of Technology, Blue Cross Blue Shield Grew start-up software firm to over 170employees and $40 Million in revenue before acquisition
Ronald J. Richmeier Business Development
Genentech – Director - Sales and Marketing19 Years Pharma industry experience
Anand Janardhan Clinical Development
Pfizer/Pharmacia – Manager - Clinical DevelopmentCelebrex drug development
Matthew Kenning Mfg Process Development
Manufacturing excellence initiativeBiochemical manufacturing – Senior Mgmnt
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Nanospheres and Microspheres Unmodified drug
molecule Encapsulation
Natural polymer based microspheres and nanoparticles
Mechanism of action Carrier device
containing nano/microspheres
Physiologically natural delivery path
Liver targeted
TranscellularParacellular
Transcytosis M-Cells on Peyer’s patches
Sparkulin™ - Oral delivery WHERE the body needs it
Insulin
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Oral reformulation of Biologic drugs
Spark’s Technology
Spark Platforms- Gelatin- Chitosan- Alginate- Protenoid (P)- Protenoid (A)- PCL-PEG
Drugs Studied- Insulin- BSA- pDNA- Vaccines- Anti-cancer drugs- Contraceptive
Studies - In vitro- In vivo models
Customizable for …- Range of molecular sizes- Release characteristics- Dosage- Targeting- Stimuli sensitive
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Making Insulin Therapy Effective
70 mg/dL
160 mg/dL
Time
High Glucose (Hyperglycemia)
Low Glucose (Hypoglycemia) Blo
od
Glu
cose
Time
High Glucose (Hyperglycemia)
Low Glucose (Hypoglycemia)
Today’s Insulin Therapy Sparkulin™ Therapy
8© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Sparkulin™ - On Demand Insulin ReleaseWHEN the body needs it
Enzymatic Reaction
Glucose DiffusionGlucose
Enzymes
Unmodified Insulin
Swelling
Insulin Release
Normal Glucose Levels
9© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Development Status
Six different oral biologic delivery technologies studied in-vitro and in-vivo
In-vitro and animal studies performed for oral delivery of insulin
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Time (Hours)
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mgs
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Development Status
Patent pending and other patents in process
Proof of concept human study of oral delivery carrier conducted
Partnership discussions with Bharat Biotech – Oral Heparin and in early discussions with Genentech, J&J, Eli Lilly, Takeda, and Novo Nordisk
Completing pre-clinical in-vitro and rat model study of glucose-sensitive, on-demand oral Insulin - Sparkulin™
R&D collaboration with Argonne National Laboratory for nano/microsphere characterization (SEM & TEM)
SEM – Scanning Electron Microscopy, TEM – Tunneling Electron Microscopy
11© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Spark’s Business Model
Initial clinical development and commercialization for sales in India Partnership with large Bio-Pharma company for clinical development
and sales in US Value Propositions
Competitive advantage Product lifecycle management
Market expansion Pricing power
OtherDrugs
OralEPO Oral
hGH
{
Sparkulin™
Spark Biotech
Partnering
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Development Milestones
FDA – Food and Drug Administration of USAIND – Investigational New Drug ApplicationNDA – New Drug Application for marketing drug
2006 2007 2008 2009 2010 2011 2012 2013
CMD
NBE
CMD
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CMD
CMD CMD
CMD
CMD
CMD
CMD
CMD
CMD
CMD
NBE
NBE
NBE
NBE
NBE
NBE
NBE NBE
NBE
NBE
NBE
NBE NBE
NBE NBECommercial Marketed Drug
New Biologic Entity
USA - Insulin
Pre-Clinical Phase I Phase IIIPhase II NDA
$ 20M $ 25M $ 45M Royalty
Pre-Clinical Phase I Phase II Phase III NDA
USA - hGH Royalty$ 5M $ 7.5M $ 15M $ 20M$ 5M
India - InsulinPre-clinical and Clinical
2006 - 2008
13© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Investment Strategy
Several rounds of funding to support pipeline development
Seed/Series A$4.9 M
(2006)
Series B
$15 M
(2008)
Series C
$25 M
(2009)
Exit
>$300 MValuation
(2010)
Seed/Series A – Use of proceeds Complete pre-clinical studies and file IND of Sparkulin™ with
USFDA Complete Phase I and II Clinical development of Sparkulin™
in India Business Development
16x return at exit for Seed/Series A investors in 4-5 years
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Cash Flow and Profit & Loss
Revenues grow significantly upon sales of Sparkulin™ in the USA
Cash flow and balance remains positive
($50.00)
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$50.00
$100.00
$150.00
$200.00
$250.00
2006 2007 2008 2009 2010 2011 2012 2013
Inflow
Outflow
Cash Balance
P&L
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Spark Biotech – Success Factors
Large and growing market - Build up opportunities
Risk reduced path to commercialization Established Biologics Unmodified drug molecule and FDA approved polymers used Speed to market – Fast development and commercialization in India,
which contributes to speed of development in the USA
Broad applicability of technology and flexibility
Business model reduces burn rate
Depth of experience
16© Spark Biotech, Inc., 2004-2005 All Rights Reserved.
Orally delivered biologic drugs - Sparkulin™
Orally delivering Insulin where and when the body needs it