neuropharmaceuticals commericalization
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1 neur neurpharmaceuticals cmmericalizatin neurnan pharma 11th Annual NanBusiness Cnference Nanmanufacturing Summit September 4-6, 2012 Bstn, MA
2 neur I. Intrductin 2 Alexander Kabanv, C-funder UNC - Chapel Hill, Eshelman Schl f Pharmacy, Center fr Nantechnlgy in Drug Delivery Zagit Gaymalv C-funder and CEO UNC - Chapel Hill, Eshelman Schl f Pharmacy, Center fr Nantechnlgy in Drug Delivery. 1. Prblem: Glbal besity epidemics 2. Unmet need: Safe and effective anti-besity drug 3. Slutin: 4. Capital & time requirement leptipol - intranasal cnjugated leptin frmulatin $15M (up t 20X ROI, 7-10 years)
3 neur II. Our Business Mdel 3 leptipol key activities relatinship key partners key resurces develpment f value prpsitin channels custmer segments patient segments csts revenue streams We are a pharmaceutical cmpany fcused n develpment f leptin based antibesity intranasal frmulatin
4 neur III. Prblem - Glbal Obesity Epidemics 4 Obesity is nt a persnal chice, its a disease. 34% 51% 34% 32% 1 32% 17% 1 Estimated annual besity market size $1.7B. US ppulatin: 313M EU pplatin: 711M healthy verweight bese
5 neur IV. Current Treatment Optins & Limitatins 5 1. Diet & Exercise Lw cmpliance 2. Supplements Unknwn efficacy 3. OTD & Rx Drugs Unwanted side effects 4. Surgery High risks & csts
6 neur V. Obesity Market Unmet Needs 6 1. Immediate efficacy 2. Safety f chrnic use 3. Ease f administratin 4. Lw side effects 5. Independence f diet and exercise 6. Wideness f safe dse range
7 neur VI. Leptin Rle in Obesity 7 Leptin is a hrmne prduced in adipse tissue. It lwers appetite and signals the bdy t burn fat. In healthy persns, leptin transprted t the brain thrught BBB, via leptin receptrs In bese patients, receptr mediated leptin transprt t the brain is impaired (leptin desensitizatin).
8 neur VII. Leptin Hrmne Based Drugs Evlutin 8 First generatin: naked leptin Secnd generatin: PEGylated leptin Third generatin: leptipol 1990s fragile, nn-stable, shrt half-life, lw biavalibility, des nt crss BBB 2000s stable, prlnged half-life lng shelf-life, lw biavalibility, des nt crss BBB 2010s stable, prlnged half-life lng shelf-life, high biavalibility, crss BBB
9 neur VIII. leptipol - a Nvel Leptin-Based Drug 9 leptipol HM advantages: Rapid brain delivery Targeted hypthalamus delivery Immediate effectiveness Independence f diet and exercise Cnvenience f intranasal delivery Safety (verdse, fluctuatin)
10 neur IX. Preclinical Data 10 What? Treatment with leptipol reduces fd intake and bdy weight Hw? LeptiPOL crsses bld brain barrier and reaches brain independent f leptin transprter When? LeptiPOL starts wrking as early as 20 minutes after administratin Other? Intranasal administratin is cnvenient and effective
11 neur X. Intellectual Prperty Prfli 11 Extensive IP prtfli (ver 30 patent and patent applicatins) exclusively licensed t NeurNan Pharma
12 neur X. Intellectual Prperty Psitining 12 IP psitins secured in United States and number f strategically identified cuntries: Eurpe, Japan, Australia, Canada, & Russia Opinins n Freedm t Operate are in prcess Branding strategy and implementatin effrts has been initiated
13 neur XI. Cmmercializatin Pathway 13 Prduct Discvery Candidate Selectin Pre-clinical Research Pre-clinical Develpment Phase 1,2 Indicatins leptipol Obesity Frmal pre-clinical studies pre-ind meeting PRE-CLINICAL DEVELOPMENT Pre-IND Studies CMC Package Pre-IND Studies ADME-tx CLINICAL DEVELOPMENT Phase I Clinical Trials Phase II Clinical Trials Phase Seed up t $2M Phase A up t $5M EXIT $10M/drug (2X ROI) Phase B up t $2M EXIT $50M/drug (5X ROI) Phase C up t $6M EXIT $0.5B/drug $0.3B/cm. (20X ROI) Out-Licensing Out-Licensing, M&A Out-Licensing, M&A, & IPO. Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7
14 neur XII. Why Invest in NeurNan Pharma? Prblem: Glbal besity epidemics 2. Need: Delivery f leptin t the brain 3. Slutin: leptipol HM - intranasal cnjugated leptin frmulatin 4. Secured IP: Over 30 patents and patent applicatins cvering defined reginal markets 5. Up t 20X ROI: With $15M capital requirement up t 20X ROI in 7-10 years
15 neur XII. Thank yu! 15 Questins? Please cntact Z... Zagit Gaymalv, Ph.D
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