neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s...

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11th Annual NanoBusiness Conference Nanomanufacturing Summit September 4-6, 2012 Boston, MA © 2012 NeuroNano Pharma, Inc. All rights reserved. neuronano pharma -9 o neuro TM neuropharmaceuticals commericalization

Transcript of neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s...

Page 1: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

11th Annual NanoBusiness ConferenceNanomanufacturing Summit September 4-6, 2012 Boston, MA

© 2012 NeuroNano Pharma, Inc. All rights reserved.

neuronano pharma

-9oneuro TM

neuropharmaceuticals commericalization

Page 2: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

I. Introduction

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1. Problem: Global obesity epidemics

2. Unmet need: Safe and effective anti-obesity drug

3. Solution: leptiPOL™ - intranasal conjugated leptin formulation

4. Capital & time requirement $15M (up to 20X ROI, 7-10 years)

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Alexander Kabanov, Co-founder

UNC - Chapel Hill,Eshelman School of Pharmacy,Center for Nanotechnology in Drug Delivery

Zagit GaymalovCo-founder and CEO

UNC - Chapel Hill,Eshelman School of Pharmacy,Center for Nanotechnology in Drug Delivery.

Page 3: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

II. Our Business Model

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leptiPOL™

customersegments

relationship

channels

keyactivities

keyresources

key partners

costs revenue streams

development of value proposition

innovation value - rightleft - innovation competence

patientsegments

We are a pharmaceutical company focused on development of leptin based anti-obesity intranasal formulation

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 4: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

0%

17.5%

35.0%

52.5%

70.0%

19801984

19881992

19962000

20042008

0%

15.0%

30.0%

45.0%

60.0%

19801984

19881992

19962000

20042008

34%

34%

32%

51%

32%17%

Po

pul

atio

n P

erce

ntag

e P

op

ulat

ion

Per

cent

age

III. Problem - Global Obesity Epidemics

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0%

17.5%

35.0%

52.5%

70.0%

19801984

19881992

19962000

20042008

0%

15.0%

30.0%

45.0%

60.0%

19801984

19881992

19962000

20042008

34%

34%

32%

51%

32%17%

Po

pul

atio

n P

erce

ntag

e P

op

ulat

ion

Per

cent

age

obeseoverweighthealthy

4

Obesity is not a personal choice, its a disease.

© 2012 NeuroNano Pharma, Inc. All rights reserved.

•Estimated annual obesity market size $1.7B.

•US population: 313M•EU popolation: 711M

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IV. Current Treatment Options & Limitations

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1. Diet & Exercise Low compliance

2. Supplements Unknownefficacy

3. OTD & Rx Drugs Unwanted side effects

4. Surgery High risks & costs

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 6: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

V. Obesity Market Unmet Needs

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1.Immediateefficacy

2. Safety of chronic use

3. Ease of administration

4. Low side effects

5. Independence of diet and exercise

6. Wideness of safe dose range

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 7: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

VI. Leptin Role in Obesity

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Leptin is a hormone produced in adipose tissue. It lowers appetite and signals the body to burn fat.

In obese patients, receptor mediated leptin transport to the brain is impaired (leptin desensitization).

In healthy persons, leptin transported to the brain throught BBB, via leptin receptors

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 8: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

VII. Leptin Hormone Based Drugs Evolution

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1990s

2000s

2010s

First generation:naked leptin

Second generation:PEGylated leptin

Third generation:leptiPOL™

fragile, non-stable,

short half-life,low bioavalibility,

does not cross BBB

stable, prolonged half-life

long shelf-life,low bioavalibility,

does not cross BBB

stable, prolonged half-life

long shelf-life,high bioavalibility,

cross BBB

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 9: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

VIII. leptiPOL™ - a Novel Leptin-Based Drug

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leptiPOL™ HM advantages:

•Rapid brain delivery•Targeted hypothalamus delivery•Immediate effectiveness•Independence of diet and

exercise•Convenience of intranasal

delivery•Safety(overdose,fluctuation)

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 10: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

IX. Preclinical Data

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Treatment with leptiPOL reduces food intake and body weight

LeptiPOL crosses blood brain barrier and reaches brain independent of leptin transporter

Intranasal administration is convenient and effective

LeptiPOL starts working as early as 20 minutes after administration

What?

How?

When?

Other?

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 11: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

X. Intellectual Property Porfolio

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Extensive IP portfolio (over 30 patent and patent applications) exclusively licensed to NeuroNano Pharma

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 12: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

X. Intellectual Property Positioning

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IP positions secured in United States and numberofstrategicallyidentifiedcountries:Europe, Japan, Australia, Canada, & Russia

Opinions on Freedom to Operate are in process

Branding strategy and implementation efforts has been initiated

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 13: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

XI. Commercialization Pathway

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PRE-CLINICAL DEVELOPMENT CLINICAL DEVELOPMENT

Formalpre-clinical

studies

Pre-IND Studies

CMC Package

Pre-IND Studies

ADME-tox

Phase IClinical

Trials

Phase IIClinicalTrials

Phase “Seed”up to $2M

Phase Aup to $5M

pre-INDmeeting

up to $2MPhase B Phase C

up to $6M

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

leptiPOL™ Obesity

Discovery CandidateSelection

Pre-clinicalResearch

Pre-clinical Development

Phase 1,2Product Indications

Out-Licensing Out-Licensing,M&A

Out-Licensing,M&A, & IPO.

EXIT$10M/drug(2X ROI)

EXIT$50M/drug

(5X ROI)

EXIT$0.5B/drug$0.3B/com.(20X ROI)

13

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 14: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

XII. Why Invest in NeuroNano Pharma?

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1. Problem: Global obesity epidemics

2. Need: Delivery of leptin to the brain

3. Solution:leptiPOL™ HM - intranasal conjugated leptin formulation

4. Secured IP:Over 30 patents and patent applications covering definedregionalmarkets

5. Up to 20X ROI:With $15M capital requirement up to 20X ROI in 7-10 years

© 2012 NeuroNano Pharma, Inc. All rights reserved.

Page 15: neuro - core.ac.uk · VII. Leptin Hormone Based Drugs Evolution o-9 neuro TM 8 1990s 2000s 2010s First generation: naked leptin Second generation: PEGylated leptin Third generation:

XII. Thank you!

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© 2012 NeuroNano Pharma, Inc. All rights reserved.

Questions?Please contact Z...

Zagit Gaymalov, Ph.D.

[email protected]+1.402.957.4290www.neuro10-9.com