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CO
GNOVEMBER 4, 2013 GN
ITIVE
FASTER LEARNING
ENHANCED MEMORY
E H
EA
LT
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
TODAY’S MEETING
Welcome to the brave new world of Synapsa™!
MARKET OPPORTUNITY • Cognitive Healthg• The information age demographic
ABOUT SYNAPSA™• A unique, proprietary ingredientA 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
THE COGNITIVE HEALTH SEGMENTH ge opport nit for gro th
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CONSUMER CONCERN OVER MENTAL ABILITY GREW 47% OVER THE PAST DECADE – HEALTH Attention
M
Huge opportunity for growth
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FOCUS INTERNATIONAL• Broad range of the population is concerned about
mental functioning• 33% over 65
MemoryLanguage LearningReasoning
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• 26% 18-29
“COGNITIVE HEALTH SUPPLEMENT SALES ARE POISED TO SKYROCKET” – NBJ
gProblem solvingMoodSleep
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• 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 WITHHIGH GROWTH PROSPECTS
3
PEAK PERFORMANCEA i ti d i t it
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MOST COGNITIVE HEALTH SUPPORT STUDIES & SUPPLEMENTS FOCUS ON
PEAK PERFORMERS IN THE USA
An existing and growing opportunity
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PSTUDIES & SUPPLEMENTS FOCUS ON ISSUES OF COGNITIVE DECLINE
VAST NEED & MARKET OPPORTUNITY
IN THE USA
Knowledge workersOver 100 million in 2014(Infotrends 2011)
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VAST NEED & MARKET OPPORTUNITY FOR SUPPORT IN AREAS OF COGNITIVE PERFORMANCE RELATED TO STUDY & WORK
(Infotrends, 2011)
College & University Students21.8 million in 2013 (US Dept of Education)
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40% of
WORK (US Dept. of Education)
40% of US population
4
ALREADY AN ACTIVE MARKETC ff i & th “ ti l t ”
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STUDENTS
Caffeine & other “stimulants”
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UndergraduatePost GraduateMedicalLegal
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OR
TULegal
KNOWLEDGE WORKERS
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WORKERSSoftwareArchitectsEngineers
Nearly 63% of medical students report ‘academic performance’ as
ScientistsFinancial servicesLegalMedia/Social Media
reason for consuming caffeine (Lee K-H, et al 2009)
Media/Social Media
5
A PLATFORM FOR ‘PEAK PERFORMANCE’S ™ N t l M S t
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Safe, natural support Quality
Synapsa™ Natural Memory Support
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P, ppfor healthy adults looking for ‘peak performance’
Q yControl
Cli i lO
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• Learning• Memory• Academic
Clinical Support
Ongoing Research
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performance• Workplace
performanceIP
New Product IPProduct
Concepts
6
ING
RRE
DIE
N
THE FUTURE OF QUALITY
NT Q
UA
L
OF QUALITY
LITY
PATENTED EXTRACTSEED-TO-SHELF QUALITY
7
A UNIQUE COMPOSITIONCli i ll t di d i di t d d b t t d
ING
R
MULTI-PATENTED PROCESS
Clinically studied ingredient produced by patented process
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DIE
N
The unique method• India 185078 (2961/DEL/1996): extraction
of a formulations mainly containing bacosides
NT Q
UA
L
,
The unique method of making Synapsa™ – the clinically-studied ingredient – LITY
gis patented.
8
SEED-TO-SHELF QUALITYKe to reprod cible clinical trial res lts
ING
R
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
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DIE
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the final product’s complex phytochemical profile and therapeutic action
p , gactive constituents that contribute to its therapeutic properties
Result of over 30 years extensive
Planting
Growing
NT Q
UA
L
Putting farming & manufacturing controls in place across each step allows for consistency of the
yresearch & 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 gprocesses from to ensure a standardized level of quality Production
Storage
9
CLINN
ICA
L R
THE FUTURE OF COGNITIVE
RE
SE
AR
CCOGNITIVE RESEARCH
CH
A FOCUS ON HEALTHY ADULTS
10
COGNITIVE BENEFIT AREASD 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
PR
O
IMPROVED LEARNING RATE
DECREASED FORGETTING RATE
,These studies focus on healthy adults from 18 to 65
OP
OS
ITI
IMPROVED MEMORY CONSOLIDATION
BETTER MULTI-TASKING ACCURACY
ON
SYNAPSA™ STUDIES SHOW BOTH CHRONIC AND ACUTE EFFICACY
11
COGNITIVE STUDY BACKGROUNDSt li i l t
CLIN
• 7 ‘foundational’ clinical trials The scientific
Strong clinical support
NIC
AL 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
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SE
AR
C
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
SUMMARY OF CLINICAL PROGRAMCh i d t ff t f S ™
CLIN
Chronic Use of Synapsa™ – Key StudiesStough 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™
NIC
AL 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
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SE
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Cmemory 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 ( ) gPhytotherapy 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 2013y py
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STOUGH, ET AL. 2001Vi 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
NIC
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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
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• t = baseline, 5 & 12 weeksMaximal effects evident after 12 weeks
CH
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ROODENRYS, ET AL. 2002I f ti t ti
CLIN
Details Summary of Results• Double-blind placebo-controlled, Significant effect on:
Information retention
NIC
AL 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.
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SE
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Cassessment• t = baseline, 90 days & 6 weeks post
treatment
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STOUGH, ET AL. 2008W ki i l i f ti i &
CLIN
Details Summary of Results
Working memory, visual information processing & accuracy
NIC
AL 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
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C
• t = baseline and 90 days
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DOWNEY, ET AL. 2012I d f iti l d di t t ( t )
CLIN
Details Summary of Results
Improved performance on cognitively demanding tests (acute)
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• 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)
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C• 320mg, 640mg acute doses Synapsa™ Battery)
THE CDR SYSTEM:
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• 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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ON-GOING STUDIES CLIN
One of the most
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Additional indications/targets:
aggressive & comprehensive research programs
f iti h lth
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• Inattention• Acute dosing• Cognition enhancement• fMRI
of a cognitive health ingredient in the industry
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• fMRI • Dementia/Alzheimer’s• Basic pharmacology
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MA
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THE FUTURE OF EXCITING NEW
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NEW INDICATIONSNEW IPNEW CLAIMS
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ADDRESSING THE AGING POPULATIONS ™ 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
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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
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CSynapsa (300 mg), Pycnogenol (150 mg), or 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, 20122012
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PATENT PENDING FILINGA t t S ™ f t
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APPLICATION PATENT Patented support for t t t ki & th
A new patent on Synapsa™ for acute use
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• 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
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comprising administration of an extract of Bacopa monnieri.
• Filing December 2013
environments
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21
POTENTIAL PRODUCT CLAIMSCli i l t f diff t k t ff i
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• Clinically shown to improve the speed of information processing The scientific
Clinical support for different market offerings
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• 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
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• Helps improve learning rate & memory
• A single ingredient that can support learning, memory, and mental performance
enhancing effect of Synapsa™ is based on 30 years of research
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ITY
• 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.
22
TWO DISTINCT PRODUCT TYPESD il & P k P f t 320 /d
VALU
Daily
Daily & Peak Performance at 320 mg/d UE
PR
O
Supplementation to Improve Learning & Memory Same Day
OP
OS
ITISame Day Supplementation for Improved Mental Performance in Cognitively
ON
Cognitively Demanding Environments
23
CO
GGN
ITIVE
FASTER LEARNING
ENHANCED MEMORY
E H
EA
LT
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
APPENDIX
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COGNITIVE FUNCTIONING GLOSSARY CLINN
ICA
L R
Learning/Learning rate Acquisition new information or reinforcement of existing knowledge or skills. May involve synthesizing different types of information.
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C
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 C
Hcomplex 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.
26
BACOPA MONNIERI ALTERNATIVESF i & th L k f bli h d d/ t di
CO
M
Focus on aging & other. Lack of published and/or new studies.
• Studies focusing on trauma & children
MP
ETITI
BACOPIN™ • Few published studies• No recent studies• Website not updated since 2005• 3 Studies, 2 focusing on elderly & 1 on
VE
AN
A
BACOMIND™3 Studies, 2 focusing on elderly & 1 on children with low IQ
• No ongoing support
BACOGNIZE™ • No clinical studies actually published
ALY
SIS
BACOGNIZE™ No clinical studies actually published • Borrowed science (from Synapsa™)
Generic • No published clinical studiesGeneric p• Lack of transparency on sourcing/quality
27