COG NOVEMBER 4, 2013 GNITIVE E HEALT FASTER LEARNING ENHANCED - - PowerPoint PPT Presentation

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COG NOVEMBER 4, 2013 GNITIVE E HEALT FASTER LEARNING ENHANCED - - PowerPoint PPT Presentation

COG NOVEMBER 4, 2013 GNITIVE E HEALT FASTER LEARNING ENHANCED MEMORY ENHANCED MEMORY H IMPROVED MENTAL PERFORMANCE PERFORMANCE A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS


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SLIDE 1

COG

NOVEMBER 4, 2013

GNITIVE

FASTER LEARNING ENHANCED MEMORY

E HEALT

ENHANCED MEMORY IMPROVED MENTAL PERFORMANCE

H

A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH

PERFORMANCE

A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS SUPPORTING MEMORY, LEARNING AND INTELLECTUAL PERFORMANCE

1

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SLIDE 2

TODAY’S MEETING

Welcome to the brave new world of Synapsa™!

MARKET OPPORTUNITY

  • Cognitive Health

g

  • The information age demographic

ABOUT SYNAPSA™

  • A unique, proprietary ingredient

A unique, proprietary ingredient

DEEP DIVE ON THE RESEARCH

  • 30 years of study
  • Highlights of 4 clinical studies

WE’RE PLEASED TO HAVE THE

Highlights of 4 clinical studies

CLAIMS, IP & MORE DISCUSSION

OPPORTUNITY TO MEET WITH YOU TODAY!

DISCUSSION

2

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SLIDE 3

THE COGNITIVE HEALTH SEGMENT

H ge opport nit for gro th

MAR

CONSUMER CONCERN OVER MENTAL ABILITY GREW 47% OVER THE PAST DECADE – HEALTH

Attention M

Huge opportunity for growth

RKET OP

FOCUS INTERNATIONAL

  • Broad range of the population is concerned about

mental functioning

  • 33% over 65

Memory Language Learning Reasoning

PPORTU

  • 26% 18-29

“COGNITIVE HEALTH SUPPLEMENT SALES ARE POISED TO SKYROCKET” – NBJ

g Problem solving Mood Sleep

UNITY

  • 2011 U.S. cognitive health sales grew 6% to $1.4B
  • Ground floor opportunity: The category accounts for less

than 5% of U.S supplement sales

HUGE MARKET OPPORTUNITY WITH HIGH GROWTH PROSPECTS

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SLIDE 4

PEAK PERFORMANCE

A i ti d i t it

MAR

MOST COGNITIVE HEALTH SUPPORT STUDIES & SUPPLEMENTS FOCUS ON

PEAK PERFORMERS IN THE USA

An existing and growing opportunity

RKET OP

STUDIES & SUPPLEMENTS FOCUS ON ISSUES OF COGNITIVE DECLINE VAST NEED & MARKET OPPORTUNITY

IN THE USA

Knowledge workers Over 100 million in 2014 (Infotrends 2011)

PPORTU

VAST NEED & MARKET OPPORTUNITY FOR SUPPORT IN AREAS OF COGNITIVE PERFORMANCE RELATED TO STUDY & WORK

(Infotrends, 2011) College & University Students 21.8 million in 2013 (US Dept of Education)

UNITY

40% of

WORK

(US Dept. of Education)

40% of US population

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SLIDE 5

ALREADY AN ACTIVE MARKET

C ff i & th “ ti l t ”

MAR

STUDENTS Caffeine & other “stimulants”

RKET OP

Undergraduate Post Graduate Medical Legal

PPORTU

Legal

KNOWLEDGE WORKERS

UNITY

WORKERS

Software Architects Engineers

Nearly 63% of medical students report ‘academic performance’ as

Scientists Financial services Legal Media/Social Media

reason for consuming caffeine (Lee K-H, et al 2009)

Media/Social Media

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SLIDE 6

A PLATFORM FOR ‘PEAK PERFORMANCE’

S ™ N t l M S t

MAR

Safe, natural support

Quality

Synapsa™ Natural Memory Support

RKET OP

, pp for healthy adults looking for ‘peak performance’

Q y Control Cli i l

O

PPORTU

  • Learning
  • Memory
  • Academic

Clinical Support

Ongoing Research

UNITY

performance

  • Workplace

performance

IP

New Product

IP

Product Concepts

6

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SLIDE 7

INGREDIEN

THE FUTURE OF QUALITY

NT QUAL

OF QUALITY

LITY PATENTED EXTRACT SEED-TO-SHELF QUALITY

7

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SLIDE 8

A UNIQUE COMPOSITION

Cli i ll t di d i di t d d b t t d

INGR

MULTI-PATENTED PROCESS

Clinically studied ingredient produced by patented process

REDIEN

The unique method

  • India 185078 (2961/DEL/1996): extraction
  • f a formulations mainly containing

bacosides

NT QUAL

,

The unique method

  • f making Synapsa™

– the clinically- studied ingredient –

LITY

g is patented.

8

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SLIDE 9

SEED-TO-SHELF QUALITY

Ke to reprod cible clinical trial res lts

INGR

Each step can influence th fi l d t’

Synapsa™ is a unique extract of Bacopa monnieri, with a wide range of Seed

Key to reproducible clinical trial results

REDIEN

the final product’s complex phytochemical profile and therapeutic action

p , g active constituents that contribute to its therapeutic properties Result of over 30 years extensive Planting Growing

NT QUAL

Putting farming & manufacturing controls in place across each step allows for consistency of the

y research & development at the Central Drug Research Institute (CDRI) in India Consistent farming & manufacturing Harvesting Extraction

LITY

consistency of the entire product & results in a product that can be clinically studied

g g processes from to ensure a standardized level of quality Production Storage

9

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SLIDE 10

CLINICAL R

THE FUTURE OF COGNITIVE

RESEARC

COGNITIVE RESEARCH

CH A FOCUS ON HEALTHY ADULTS

10

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SLIDE 11

COGNITIVE BENEFIT AREAS

D t f li i l t i l h t ti ti ll i ifi t lt

VALU

FASTER INFORMATION PROCESSING

These studies focus Data from clinical trials show statistically significant results

UE PRO

IMPROVED LEARNING RATE DECREASED FORGETTING RATE ,

These studies focus

  • n healthy adults

from 18 to 65

OPOSITI

IMPROVED MEMORY CONSOLIDATION BETTER MULTI-TASKING ACCURACY

ON

SYNAPSA™ STUDIES SHOW BOTH CHRONIC AND ACUTE EFFICACY

11

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SLIDE 12

COGNITIVE STUDY BACKGROUND

St li i l t

CLIN

  • 7 ‘foundational’ clinical trials

The scientific Strong clinical support

NICAL R

  • 6 ‘targeted’ randomized, double-blind,

placebo-controlled clinical trials

  • Additional clinical trials underway and

,

evidence for the cognitive enhancing effect of S ™ N t l

RESEARC

planned

  • Synapsa™ has been shown to be

safe, well tolerated and devoid of

,

Synapsa™ Natural Memory Support is based on 30 years of research

CH

undesirable side effects in clinical studies

years of research

12

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SLIDE 13

SUMMARY OF CLINICAL PROGRAM

Ch i d t ff t f S ™

CLIN

Chronic Use of Synapsa™ – Key Studies

Stough et al. The chronic effects of an extract of Bacopa monnieri on cognitive function in healthy human subjects Psychopharmacology 2001; 156:481 484

Chronic and acute effects of Synapsa™

NICAL R

human subjects, Psychopharmacology, 2001; 156:481-484. Roodenrys et al. Chronic effects of Brahami on human memory, Neuropsychopharmacology, 2002; 27:279-281. Raghav et al. Randomized controlled trial of standardized Bacopa monnieri extract in age-associated memory impairment Indian Journal of Psychiatry 2006; 48:238 242

RESEARC

memory impairment, Indian Journal of Psychiatry, 2006; 48:238-242. Stough et al. Examining the nootropic effects of a special extract of Bacopa monniera on human cognitive functioning, Phytotherapy Research, 2008; 22:1629-1634.

Acute Use of Synapsa™ – Key Studies

CH

Nathan et al. The acute effects of an extract of Bacopa monniera (Brahmi) on cognitive function in healthy normal subjects, Human Psychopharmacology, 2001; 16:345-351. Downey et al. An Acute, Double-Blind, Placebo-Controlled Crossover Study of 320 mg and 640 mg Doses of a Special Extract of Bacopa monnieri (CDRI 08) on Sustained Cognitive Performance. p p ( ) g Phytotherapy Research 2012; 27:1407-1413. Benson S, Downey LA, Stough C et al. An Acute, Double-Blind, Placebo-Controlled Cross-over Study of 320 mg and 640 mg Doses of Bacopa monnieri (CDRI 08) on Multitasking Stress Reactivity and Mood. Phytotherapy Research 21 Jun 2013 y py 13

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SLIDE 14

STOUGH, ET AL. 2001

Vi l i l i t & lid ti

CLIN

Details Summary of Results

  • Double-blind placebo-controlled,

Significant improvement in:

Visual processing, learning rate & memory consolidation

NICAL R

Double blind placebo controlled,

  • 46 healthy participants, 18-60 yrs
  • 3 months, 300 mg/d Synapsa™
  • Independent-group design

Significant improvement in:

  • Information processing
  • Memory consolidation
  • Reduction in state anxiety

RESEARC

  • t = baseline, 5 & 12 weeks

Maximal effects evident after 12 weeks

CH

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SLIDE 15

ROODENRYS, ET AL. 2002

I f ti t ti

CLIN

Details Summary of Results

  • Double-blind placebo-controlled,

Significant effect on:

Information retention

NICAL R

  • 76 healthy participants, 40-65 yrs
  • 3 months, 300 mg/d Synapsa™,

followed by 6 week post-trial assessment

  • Retention of new information,
  • Verbal and visual short-term

memory.

RESEARC

assessment

  • t = baseline, 90 days & 6 weeks post

treatment

CH

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SLIDE 16

STOUGH, ET AL. 2008

W ki i l i f ti i &

CLIN

Details Summary of Results

Working memory, visual information processing & accuracy

NICAL R

y

  • Double-blind, placebo-controlled
  • 107 healthy participants, 18-60

3 months, 300 mg/d Synapsa™ t b li d 90 d Significant improvements in:

  • Working Memory
  • Visual Information Processing

RESEARC

  • t = baseline and 90 days

CH

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SLIDE 17

DOWNEY, ET AL. 2012

I d f iti l d di t t ( t )

CLIN

Details Summary of Results

Improved performance on cognitively demanding tests (acute)

NICAL R

  • Double-blind, placebo-controlled,

cross-over

  • 24 healthy adults subjects
  • 320mg 640mg acute doses Synapsa™

Improved performance on cognitively demanding tests from 320 mg dose (Cognitive Demand Battery)

RESEARC

  • 320mg, 640mg acute doses Synapsa™

Battery)

THE CDR SYSTEM:

CH

  • Used in worldwide clinical trials since 1984. Over 900 trials.
  • Attention, Concentration, Vigilance
  • Working (Short Term) Memory
  • Working (Short-Term) Memory
  • Episodic (Long-Term) Memory

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SLIDE 18

ON-GOING STUDIES

CLIN

One of the most

NICAL R

Additional indications/targets:

aggressive & comprehensive research programs f iti h lth

RESEARC

  • Inattention
  • Acute dosing
  • Cognition enhancement
  • fMRI
  • f a cognitive health

ingredient in the industry

CH

  • fMRI
  • Dementia/Alzheimer’s
  • Basic pharmacology

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SLIDE 19

MARKET OP

THE FUTURE OF EXCITING NEW

PPORTU

EXCITING NEW PRODUCTS

UNITY NEW INDICATIONS NEW IP NEW CLAIMS

19

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SLIDE 20

ADDRESSING THE AGING POPULATION

S ™ A t li R h C il’ Ch i f B

CLIN

ARCLI (AUSTRALIAN RESEARCH

Aging population h ld t Synapsa™: Australian Research Council’s Choice of Bacopa

NICAL R

COUNCIL LONGEVITY INTERVENTION)

  • 465 cognitively healthy older adults (60-75

years old) are being randomized to receive Synapsa™ (300 mg) Pycnogenol (150 mg)

should want Synapsa™ now… and even more in the future

RESEARC

Synapsa (300 mg), Pycnogenol (150 mg),

  • r placebo daily for 12 months
  • Participants will be evaluated at baseline, 3, 6

and 12 months post-randomization for a

the future

CH

variety of cognitive, cardiovascular, and biochemical parameters

  • Design published in the Nutrition Journal,

2012 2012

20

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SLIDE 21

PATENT PENDING FILING

A t t S ™ f t

MAR

APPLICATION PATENT

Patented support for t t t ki & th A new patent on Synapsa™ for acute use

RKET OP

  • Pending: Methods for acutely

improving/enhancing cognitive performance in a human subject i i d i i t ti f t t

test taking & other peak performance cognitive environments

PPORTU

comprising administration of an extract

  • f Bacopa monnieri.
  • Filing December 2013

environments

UNITY

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SLIDE 22

POTENTIAL PRODUCT CLAIMS

Cli i l t f diff t k t ff i

MAR

  • Clinically shown to improve the speed of

information processing

The scientific

Clinical support for different market offerings

RKET OP

p g

  • Supports the transition of short term memory to

long term memory

  • Aids in the retention of new information

The scientific evidence for the cognitive enhancing effect PPORTU

  • Helps improve learning rate & memory
  • A single ingredient that can support learning,

memory, and mental performance

enhancing effect

  • f Synapsa™ is

based on 30 years of research UNITY

  • One ingredient. Better, faster learning.
  • Better performance on cognitively demanding

tests

years of research

  • Improved mental performance when it counts

*The above claims are intended as suggestions only. Use of claims on product labeling and marketing materials should be vetted and approved by your regulatory and legal departments.

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SLIDE 23

TWO DISTINCT PRODUCT TYPES

D il & P k P f t 320 /d

VALU

Daily

Daily & Peak Performance at 320 mg/d

UE PRO

Supplementation to Improve Learning & Memory Same Day

OPOSITI

Same Day Supplementation for Improved Mental Performance in Cognitively

ON

Cognitively Demanding Environments

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SLIDE 24

COGNITIVE

FASTER LEARNING ENHANCED MEMORY

E HEALT

ENHANCED MEMORY IMPROVED MENTAL PERFORMANCE

H

A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH

PERFORMANCE

A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS SUPPORTING MEMORY, LEARNING AND INTELLECTUAL PERFORMANCE

24

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SLIDE 25

APPENDIX

25

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SLIDE 26

COGNITIVE FUNCTIONING GLOSSARY

CLINICAL R

Learning/Learning rate

Acquisition new information or reinforcement

  • f existing knowledge or skills. May involve

synthesizing different types of information.

RESEARC

synthesizing different types of information.

Working Memory

Process that provides temporary storage and manipulation of the information necessary for complex cognitive tasks such as learning

CH

complex cognitive tasks such as learning, reasoning and language comprehension.

Memory Consolidation

Transition of information from short-term to long-term memory.

Information Retention

The second stage of memory after encoding and before retrieval.

Visual Information Processing

A measure of the ability to sustain attention.

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SLIDE 27

BACOPA MONNIERI ALTERNATIVES

F i & th L k f bli h d d/ t di

COM

Focus on aging & other. Lack of published and/or new studies.

  • Studies focusing on trauma & children

MPETITI BACOPIN™

  • Few published studies
  • No recent studies
  • Website not updated since 2005
  • 3 Studies, 2 focusing on elderly & 1 on

VE ANA BACOMIND™

3 Studies, 2 focusing on elderly & 1 on children with low IQ

  • No ongoing support

BACOGNIZE™

  • No clinical studies actually published

ALYSIS BACOGNIZE™

No clinical studies actually published

  • Borrowed science (from Synapsa™)

Generic

  • No published clinical studies

Generic

p

  • Lack of transparency on sourcing/quality

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