zappworldwide tm - the dental connection deck-mylan(… · productformats 5formatstosatisfyallend...

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ZAPP Worldwide Allinone product with disruptive breakthrough antimicrobial technology 1 TM

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Page 1: ZAPPWorldwide TM - The Dental Connection Deck-Mylan(… · ProductFormats 5formatstosatisfyallend +users:Patients,Physicians,SurgeonsandConsumers 8 Mouth+Rinse+Gargle+ Anti-viral,

ZAPP  WorldwideAll-­‐in-­‐one  product  with  disruptive  breakthrough  anti-­‐microbial  technology

1

TM

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• ZAPP-­‐ a breakthrough productwith a rangeof effects

• This platform technology will be adapted to regulatoryrequirementsworldwide

• Under development for over 20 years with dramatic effects onpatients tested

What  is  ZAPP:  A  Platform  Technology

2

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Overview  – Rx Formats  

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Rx Topical  Cream

US,  Canada,  Ja

pan

RxMouthwash

US,  Canada,  Ja

pan

RxWound  Irrigation

Worldwide

RxNasal  Spray

Worldwide

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*Excluding  Japan

Overview  – OTC Formats

OTC Mouthwash

Europe,  A

sia,  Latin  Am.*

OTC Topical  Cream  (Small  Tube)  

Europe,  A

sia,  Latin  Am.*

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Competitive  Advantage

Patent  applications  for  worldwide  coverage  have  been  filed  and  additional  applications  are  under  development

IP

Collectively, the executive team brings over 100 years ofexperience in medicine, entrepreneurship, and executiveleadership in the biopharmaceutical industry

Team

Overview  -­ Advantages

The  combined   ingredients   work  in  a  synergy  to  create  a  unique  effectThis  unique  antimicrobial  has  a  broad  spectrum  effect  killing  bacteria,  viruses  and  fungi

Page 6: ZAPPWorldwide TM - The Dental Connection Deck-Mylan(… · ProductFormats 5formatstosatisfyallend +users:Patients,Physicians,SurgeonsandConsumers 8 Mouth+Rinse+Gargle+ Anti-viral,

ProblemFinding  a  One-­Stop  solution  that  does-­it-­all

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They need a single solution that will kill all microbes,and disinfect wounds.Patients

Physicians/Surgeons need a simple and safe solutionto control infectionsPhysicians

Consumers need an everyday broad-­‐spectrum productthat controls infection

Consumers

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üKills  BacteriaüKills  VirusesüKills  Fungi

üEffective  on  resistant  bugs  i.e.  MRSA

The  Solution:  ZAPPA  multi-­benefit,  broad  spectrum,  one-­stop  breakthrough  product  with  predictable  results

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ZAPP ointment can be used onsurgical wounds, burns, acne,animal bites and insect bites

ZAPP antimicrobial rinse or irrigationdisinfects surgical wounds, mouthand lip sores and nasal/sinusinfections in both humans andanimals

ZAPP does not cause bacteria todevelop resistance-­‐ a commonproblem with antibiotics

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Product  Formats5  formats  to  satisfy  all  end-­users:  Patients,  Physicians,  Surgeons  and  Consumers

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Mouth  Rinse  Gargle  Anti-viral, anti-bacterial and anti-fungal mouth rinse for colds, flu, mouth infections, allergies, lesions and ulcerations, post surgical flush/rinse

Nasal  SprayAnti-viral, anti-bacterial and anti-fungal nasal & sinus spray for colds, flu and post surgical flush/rinse

Rx/OTC  Large  &  Small  Topical  Antimicrobial  TubesAnti-viral, anti-bacterial and anti-fungal topical cream for medical, surgical, infected and skin wounds, burns, acne and animal bites

Surgical/Topical  Wound  Irrigating  SolutionAnti-viral, anti-bacterial and anti-fungal wound disinfectant for all surgical procedures with a few exceptions

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MARKET  SIZES  AND  CLINICAL  TRIAL  COSTS

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526$

679$

90$52$

801$838$

0"

100"

200"

300"

400"

500"

600"

700"

800"

900"

US+Canada" Europe" Asia"Pacific" La@n"America"

Comparison"of"Global"Markets"

Market$Size$2013$$M$ Market$Size$2018$$M$

Nasal  Spray  Market  is  Forecast  to  GrowThe  Nasal  Spray  market  is  predicted  to  grow  over  the  next  5  years  in  US+Canadaand  Europe*  

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*  Growth  data  for  AsiaPac.  and  Lat Am  not  available

The  Nasal  Spray  Market  is  valued  at  $1.3  B  in  

2013  and  is  likely  to  cross  $1.8  B  by  2018

Rx Nasal  Spray

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1289%

720%

1889%

41%

1523%

839%

2265%

52%

0"

500"

1000"

1500"

2000"

2500"

US+Canada" Europe"(Big"5)" Asia"Pacific" La>n"America"

Comparison"of"Markets"and"Growth"to"2018"

Market%Size%2013%$M% Market%Size%2018%$M%

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The  mouth  rinse  market  is  valued  at  $3.9  B  in  

2013  and  will  increase  to  $4.7  B  by  2018    

Mouth  Rinse  Market  is  Forecast  to  Grow

OTC  Mouth  RinseRx Mouth  Rinse

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Market  Sizes  in  2018US  +  Canada:  $5.2  BEurope  5  +  PL:  $7  B

ZAPP  Prescription  Topical  Market  is  Forecast  to  GrowThe  prescription  dermatological  market  is  predicted  to  grow  over  the  next  5  years

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Total  Prescription  Dermatological  Market  (US+Canada+Europe)  is  valued  at  $15.7.8  B  in  2013  and  will  reach  $21  

B  in  2018

Effective  CAGRsUS  +  Canada:  6.14%Europe  5  +  PL:  6.2%

RX Large  Tube

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Geographical  Comparison  of  Rx  Surgical/Topical  Wound  Irrigation

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975$867$

296$

28$0"

200"

400"

600"

800"

1000"

1200"

US+Canada" Europe"Big5+1" Asia"Pacific" La?n"America"

Market"Size"Across"Geographies"$M" The  number  of  surgical  procedures  appear  to  remain  fairly  constant  over  the  years,  hence  change  in  market  size  could  not  be  calculated

Total  Market  Size  is  Estimated  at:  $2.1  B

Rx  Wound  Irrigation

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4300$

1600$

5100$

1600$

5540$

2062$

6571$

2062$

0"

1000"

2000"

3000"

4000"

5000"

6000"

7000"

Western"Europe" C&E"Europe" Asia"Pacific" La=n"America"

Market"Size"Comparison:"2013"vs"2018"

2013"Market"Size"$M" 2018"Market"Size"$M"

OTC  Antimicrobial  Market  is  Forecast  to  GrowThe  market  is  set  to  grow  across  all  geographies  over  the  next  4  years

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The  combined  market  size  was  $12.6  B  in  2013  and  will  reach  $16.2  B by  

2018

OTC  Small  Tube

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ZAPP’s  Advantages  Over  Competitors  

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ü All-­‐in-­‐1  anti-­‐microbial  

ü Kills  bacteria,  viruses  and  fungi

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Intellectual  Property

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PCT  Patent  Application

• Already  filed  and  intends  to  file  further  patent  applications  for  worldwide   IP  protection  

• Protection  for  formulations,   formats,  and  uses  (as  topical  antimicrobial,  mouth   rinse,  Rx  Surgical/Topical  Wound   Irrigation  and  nasal  spray)

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History  to  Date

• Proprietary  regional  formulations  have  been  established

• Proof-­‐of-­‐concept  studies  have  been  undertaken

• Overall,  the  founder  and  team  have  spent  twenty  years  developing  this  unique  product  concept

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Business  Model and  Development  PlanThe  company  has  devised  an  organized  approach  to  reach  market

Business  Model

Development  Plan

• ZAPP  will  be  available  in  5  formats  and  sold   to  medical  practitioners  or  directly  to  consumers  either  as  prescription  or  OTC  product

• Payment:• Cash  payments  from  patients/consumers• Building   the  product  cost  into  the  cost  of  the  procedure

• Payment  from  third  party  insurers

• Antimicrobial  application  is  the  most  advanced  and  will  be  quickest  to  market

• Pre-­‐clinical  toxicology and  animal  testing  for  tissue  tolerance  

• Microbial,  Viral,  fungal  panel  testing  and  surrogate  models

• Clinical  testing  in  humans

• CMC  and  stability  studies  will  be  undertaken

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Estimated  Costs  for  Clinical  Studies

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PHASE  1,  PHASE  2,  PHASE  3  CLINICAL  STUDIES   Cost-­‐‑Low  ($)   Cost-­‐‑High  ($)  Clinical  Studies  for  the  following  @  $8,000/subject:  A.   Topical  (Cream/Ointment/Gel/Spray)  B.   Mouth  Rinse  C.   Nasal  Rinse  D.        Surgical-­‐‑Topical  Irrigation  Solution  

   

$9.0M  

   

$14.0M  

Insurance:  Clinical  site;  IRB;  Recruitment  costs;  CRO  

 $4.0M  

 $5.0M  

CMC:  Chemistry,  Formulation,  Manufacturing,  Stability  

 $4.0M  

 $5.0M  

Panels  and  Surrogate  Markers/Endpoints:  Costs  (all  products-­‐‑A,  B,  C,  D)  

 $2.5M  

 $2.5M  

Regulatory/Safety  Reports:  Regulatory,  e-­‐‑subs,  Safety  Reports  

 $5.0M  

 $7.0M  

Pre-­‐‑Clinical:  Costs:  

 $1.25M  

 $1.25M  

FDA  and  Other:  FDA  Meetings,  Clinical  Investigator  Meetings  &  Audits,  Pre-­‐‑FDA  Audits;  Internal  Operations  

   

$5.0M  

   

$6.0M  Rx  Products:  A,  B,  C,  D:  (Rx  costs  only)  

Sub-­‐‑Total:  

   

$30.75M  

   

$40.75M  OTC  Costs:  Costs:  labeling,  EU  Regs,  etc.  

 $1.0M  

 $1.0M  

     Sub-­‐‑Total:   $31.75   $41.75  

          Total:   $31.75M   $41.75M  

 

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Executive  Team

Glenn  Abrahmsohn,  LDS,  RCS  (Eng),  Chief  Executive  Officer  &  Founder• 39  years  experience   in  dentistry• 20  years  working  with  antimicrobial   solutions• Extensive  publications  in  peer-­‐reviewed   journals

Mark  Kirn-­‐Slaboszewicz,  MA,  Chief  Advisor• 32  years  executive   leadership   in  biopharmaceutical   industry• Former  President,  Schering-­‐Plough  Healthcare   Products• Additional  leadership   roles  at  Sterling  Drug  and  American  Cyanamid

Benjamin  Lewis,  PhD,  RPh,  RAC, Regulatory  Affairs  Executive  and  Scientist• 30  years  experience   at  FDA:  Director,  Regulatory  Operations• Developed  and  successfully  submitted  multiple   INDs  and  8  NDAs  • Head  Regulatory  Affairs,  N.  America  at  Mitsubishi;  VP  Regulatory  Affairs  at  Prestwick

Dean  Rodwell,  MS, Research  &  Development  Executive• 40  years  experience   in  toxicology,  GLP,  and  drug  development• Executive  experience   in  roles  such  as  VP  (IIT  Research  Institute),  President  (Huntingdon  

Life  Sciences),  and  COO  (BioDuro)

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IP  Counsel  and  Advisors  1/2

Doug  Nordlinger,  JD,  Corporate  Advisor• 30  years  experience   in  joint  ventures,  M&A,  and  project  financing  • Partner  at  Skadden,  Arps,  Slate,  Meagher  &  Flom• Additional  experience   with  regulatory  agencies

Richard  Dulik,  JD,  Intellectual  Property  Counsel• 18  years  experience   in  IP  law• Expertise   in  patent  prosecution,  counseling  biotechnology  and  internet   start-­‐ups,  technology  

exports,  and  licensing• Adjunct  Professor  of  Law  at  Georgetown  University

Gary  Connell,  J.D.,  Intellectual  Property  Attorney  – Sheridan  Ross  PC• B.S.,  Biology,  1982;  J.D.,  1986• 25+  years  patent  prosecution  experience   in  biotechnology  and  pharmaceuticals  • Former  In-­‐house  Patent  Attorney,  PPG  Industries,  Inc.• Co-­‐President,  Sheridan  Ross  PC

Richard  Stern,  Ph.D., Patent  Agent  – Sheridan  Ross  PC• 14  years  experience   in  IP  law;  patent  agent  since  2002• Former  Manager  of  Intellectual  Property  at  Heska Corporation• Research  background  in  molecular   genetics,  infectious  diseases  and  immunology

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IP  Counsel  and  Advisors  2/2

Robert  Traver,  Ph.D.,  J.D.,  Intellectual  Property  Attorney  – Sheridan  Ross  PC• B.S.,  Pharmacy,  1988;  Ph.D.,  Pharmaceutical  Science,  1997;  J.D.,  2000• 12  years  working  experience   as  a  hospital  and  retail  pharmacist• 15  years  patent  prosecution  experience   in  pharmaceutical   formulation  and  pharmacology  • Teaches  patent  law  in  the  Bioinnovation and  Entrepreneurship  Program  at  the  University  of  

Colorado,  DenverFaith  Charles,  JD,  Corporate  Transactions  and  Securities

• 25  years  of  corporate  transactional  experience• Partner  at  Thompson  Hine• Leads  Thompson  Hine’s  Life  Sciences  group

Matthew  Vaughan,  JD,  Corporate  Transactions  and  Securities• Focus  on  early   stage  and  emerging  companies  at  Thompson  Hine• Experience   in  private  equity  and  venture  capital   transactions• 5  years  experience   in  litigation

Yuxin  Zhang,  PhD,  Statistician• 15  years  in  statistics  for  the  pharmaceutical   industry• 12  years  Former  Head  of  Biometrics  &  Data  Management  at  Shire  Ltd• Outstanding  track  record  of  NDA  approvals

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Contact

Glenn Abrahmsohn, L.D.S., R.C.S., (Eng.)Founder & CEO

The Dental Connection260 Crandon BoulevardKey Biscayne, FL 33149.(305)  361-­0778

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IMPORTANT  CLARIFICATIONS:

THIS  BUSINESS  OVERVIEW  CONTAINS  PROJECTIONS  OF,  AND  ASSUMPTIONS  REGARDING,  FUTURE  EVENTS  REFLECTING  THE  BELIEFS  AND  EXPECTATIONS  OF  THE  COMPANY. SUCH  EVENTS  MAY  OR  MAY  NOT  OCCUR. CONSEQUENTLY,  THESE  PROJECTIONS  AND  ASSUMPTIONS  MUST  NOT  BE  RELIED  ON  TO  INDICATE,  OR  GUARANTEE,  ANY  ACTUAL  RESULTS.

CERTAIN  OF  THE  STATEMENTS  SET  FORTH  IN  THIS  BUSINESS  OVERVIEW  CONSTITUTE  “FORWARD-­‐LOOKING  STATEMENTS”  MADE  PURSUANT  TO  THE  SAFE  HARBOR  PROVISIONS  OF  THE  PRIVATE  SECURITIES  LITIGATION  REFORM  ACT  OF  1995. FORWARD-­‐LOOKING  STATEMENTS  INCLUDE,  WITHOUT  LIMITATION,  ANY  STATEMENT  THAT  MAY  PREDICT,  FORECAST,  INDICATE,  OR  IMPLY  FUTURE  RESULTS,  PERFORMANCE  OR  ACHIEVEMENTS. ALL  SUCH  FORWARD-­‐LOOKING  STATEMENTS  INVOLVE  RISKS  AND  UNCERTAINTIES. THERE  CAN  BE  NO  ASSURANCE   THAT  THE  FORWARD-­‐LOOKING  STATEMENTS  INCLUDED  IN  THIS  BUSINESS  OVERVIEW  WILL  PROVE  TO  BE  ACCURATE. IN  LIGHT  OF  THE  SIGNIFICANT  UNCERTAINTIES  INHERENT  TO  THE  FORWARD-­‐LOOKING  STATEMENTS  INCLUDED  HEREIN,  THE  INCLUSION  OF  SUCH  INFORMATION  SHOULD  NOT  BE  REGARDED  AS  A  REPRESENTATION  OR  WARRANTY  BY  THE  COMPANY  OR  ANY  OTHER  PERSON  THAT  THE  OBJECTIVES  AND  PLANS  OF  THE  COMPANY  WILL  BE  ACHIEVED  IN  ANY  SPECIFIED  TIMEFRAME,  IF  AT  ALL. THE  COMPANY  DOES  NOT  UNDERTAKE  ANY  OBLIGATION  TO  UPDATE  ANY  SUCH  STATEMENTS.

THIS  BUSINESS  OVERVIEW  DOES  NOT  CONSTITUTE  AN  OFFER  TO  SELL  SECURITIES  OR  A  SOLICITATION  OF  AN  OFFER  TO  BUY  SECURITIES. THIS  BUSINESS  OVERVIEW  IS  SUBMITTED  ON  A  CONFIDENTIAL  BASIS  SOLELY  FOR,  AND  SHOULD  BE  USED  ONLY  IN  CONNECTION  WITH,  THE  RECIPIENT’S  CONSIDERATION  OF  A  BUSINESS  RELATIONSHIP  WITH  THE  COMPANY. THE  USE  OF  THIS  BUSINESS  OVERVIEW  FOR  ANY  OTHER  PURPOSE  IS  NOT  AUTHORIZED. THE  REPRODUCTION  OR  DISTRIBUTION  OF  THIS  BUSINESS  OVERVIEW  IN  WHOLE  OR  IN  PART,  OR  THE  DIVULGENCE  OF  ANY  OF  ITS  CONTENTS,  WITHOUT  THE  PRIOR  WRITTEN  CONSENT  OF  THE  COMPANY  IS  PROHIBITED.

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