FlexNow with 100% SheaFlex70TM

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FlexNowwith 100 SheaFlex70TM
brought to you by BSP Pharma Inc.
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Table of Contents

• Value Proposition
• Testimonials
• Clinical Review
• Destructive Inflammation Cascade
• Alternative Interventions
• Selected Clinical Trial Review
• Safe / All Natural / Sustainable
• Summary

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The Next Generation of Joint CareQuadruple
Action Joint Solution

• Proven Over 30 clinical trials and studies
  prove FlexNow with 100 SheaFlex70
• Reduces inflammation by 9 times
• Improves cartilage retention by 44
• Increases bone retention by 10
• Alleviates pain by 45

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The Next Generation of Joint Care FlexNow with
100 SheaFlex70

• New, Unique and Incremental
• Not a building block (like GS), Not a lubricant
  (like HA), Not a COX-inhibitor
• Single ingredient product, Not a compound formula
• Exclusive, Patented and available only through
  BSP Pharma
• Safe and All Natural
• No contraindications, No side effects, No
  allergies
• Active material High Triterpene Shea Nut
  Extract HTSNE
• Source material Shea Nuts
• not a nut, but the pit of the shea fruit
• used to make shea butter, common in cosmetics
• Shea butter contains less than 6 shea
  triterpenes FlexNow with 100 SheaFlex70
  contains 70 shea triterpenes
• Sustainable
• Wild-crafted/harvested
• Processed in concert with the UN Development
  Programme

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Target Consumers

• Target Market Joint Health
• 60mm joint care consumers
• 45mm Osteo-Arthritis sufferers
• 30mm GS users
• FlexNow with 100 SheaFlex70 is effective for
  individuals who experience or are experiencing
  joint discomfort or pain, stiffness, loss of
  flexibility or mobility anyone who may not be
  as active as they would like, due to joint
  issues
• Arthritis sufferers
• Athletes Professional, amateur and occasional
• Menopause
• Accident prone consumers
• Genetic predisposition to joint issues
• GS/CS and other joint care product users who have
  not realized complete relief Add FlexNow to
  existing regimen (not a replacement solution)

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Dose Regimen FlexNow with 100 SheaFlex70

• Take one dose of 3 softgels per day, with or
  without food
• Effective with or without other joint care
  products. Recommended with building block
  products (eg, GS/CS)
• 4-6 week dosing cycle required for clinical
  benefits

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Table of Contents

• Value Proposition
• Testimonials
• Clinical Review
• Destructive Inflammation Cascade
• Alternative Interventions
• Selected Clinical Trial Review
• Safe / All Natural / Sustainable
• Summary

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Testimonials FlexNow with 100 SheaFlex70

• Hundreds of consumers have contacted us and
  shared stories of how FlexNow has changed their
  lives
• Arthritis Hands, Knees, Shoulders, Feet, Neck,
  Elbows, Spine
• Chronic and Acute Pain
• Bone repair
• Endurance
• Representative testimonials may be found at
  www.PowerOfShea.com/testimonials

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Testimonials FlexNow with 100 SheaFlex70

• The Skeptic
• Being an RN with over 30 years experience...
• I decided to try it for the horrible inflammatory
  arthritic condition I was experiencing in my
  hands.
• I had tried all the over the counter and
  prescription NSAIDs and nothing worked to relieve
  the pain and swelling. I was desperate for help,
  and I could no longer turn the key to start my
  car, open a jar, turn a door knob, or hold a hair
  dryer.
• After 7 days the swelling had improved, and I was
  close to making a fist again. Now, after taking
  FlexNow with 100 SheaFlex70 for 3 months, my
  hands are pain free and I can wear my rings
  again. I am so glad I tried FlexNow with 100
  SheaFlex70
• Maridel - AL
• Joint Replacement/Replacement
• My left knee was rebuilt twice. My last surgery
  was in 1999.
• When I blew out my good knee in 2007, I
  realized it was time to put away my bike for
  good. Very depressing but I figured its just
  part of getting old.
• My health food store talked me into trying
  FlexNow with 100 SheaFlex70.
• In two weeks I felt good enough to try my
  stationary bike. By the end of March, I could
  ride my bike outdoors again. Without PAIN.
• Both of my knees are pain-free. I have built up
  muscle tone, finally. My limp is gone, finally.
  Ive lost almost 20 pounds due to the exercise. I
  FEEL GOOD. Your product is fantastic. At age 50,
  I feel like I have a new lease on life. I feel
  healthy
• Sharon - PA
• Relapse
• I once ran out of your product, and had trouble
  finding it. By the time I got re-supplied, I had
  slipped back into agony.
• Kathy - FL

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Table of Contents

• Value Proposition
• Testimonials
• Clinical Review
• Destructive Inflammation Cascade
• Alternative Interventions
• Selected Clinical Trial Review
• Safe / All Natural / Sustainable
• Summary

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Inflammation the root of disease

• Diseases of the heartblood vessel inflammation
• Malignant neoplasmsinflammation proven to
  contribute to oncogenesis
• Cerebrovascular diseaseblood vessel inflammation
• Chronic lower respiratory diseasebronchi chronic
  inflammation
• Diabetesespecially Type II, excessive
  inflammation impacts blood sugar metabolism
• Influenza and pneumoniaover-expression of
  inflammation at immune system trigger
• Alzheimers Diseaseinflammation predisposes
  neurofibrilary plaques and tangles
• Nephritis and nephroseschronic kidney
  inflammation
• Chronic liver disease/cirrhosischronic liver
  inflammation
• Source National Vital Statistics Report, Volume
  53, Number 5 (October 2004)

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Joint Structure
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Stages of Osteoarthritis
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Destructive Inflammation Cascade

• When the body is injured or infected with a
  pathogen, the immune system releases cytokines
• Cytokines target the area of concern, increase
  vascularity (allowing the body access to fight
  and repair) and drive inflammation
• Joint stress (eg, wear and tear micro cartilage
  tear or bone fissure) often results in a
  destructive inflammation cascade
• Cytokines released vascularity increases
• Inflammation builds in the affected area
• Pain, tenderness and discomfort are evident
• Cytokines strip cartilage and erode bone tissue
• Body sends bone tissue and cartilage repair
  elements to affected area
• Inflammation impedes proper repair
• bone spurs and/or hard/dense bone build up,
  further damaging already weakened and inflamed
  cartilage
• Inflamed cartilage is challenging to repair
  properly raw material may be challenging to
  deliver to the inflamed areas, increasing
  likelihood of additional bone damage
• incremental damage occurs through use of poorly
  repaired site
• More cytokines are released -- cytokine
  production can multiply 1000 fold when activated
• Inflammation builds further, and the destructive
  inflammation cascade continues

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Cytokines drive inflammation in the body, can
ramp up 1,000 fold when activated, often
resulting in a destructive inflammation cascade
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How it works FlexNow with 100 SheaFlex70TM

• Managing cytokines and the destructive
  inflammation cascade is key to reducing pain and
  effectively repairing the affected areas.
• FlexNow with 100 SheaFlex70 modulates the
  production of cytokines and controls the
  destructive inflammation cascade
• Cytokine management FlexNow with 100
  SheaFlex70 reduces cytokine production IL-6 by
  31 and TNF-a by 24, resulting in
• Inflammation reduction Reduces inflammation by
  9X
• Cartilage retention Decreases breakdown in
  collagen / cartilage by 44
• Bone regulation Reduces Osteocalcin (a measure
  of bone destruction) by 10
• Pain management Alleviates pain by 45

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Joint Structure
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Composition of Joint Cartilage

• The least abundant part of cartilage is
  proteoglycans, representing 30
• The shock absorbing part of the cartilage matrix
• Glucosamine/chondroitin impacts proteoglycans
• The most abundant part of cartilage
• is collagen, representing 70
• The meshwork that holds proteoglycans in place in
  cartilage
• FlexNow with 100 SheaFlex70 High Triterepene
  Shea Nut Extract impacts the collagen portion of
  the cartilage matrix

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Healthy Joint Cartilage

• Healthy Cartilage structure
• Collagen Golden bands
• 70 of cartilage
• Impacted by FlexNow with 100 SheaFlex70 High
  Triterepene Shea Nut Extract
• Proteoglycans Turquoise
• 30 of cartilage
• Impacted by GS/CS

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Damaged Joint Cartilage

• When joint injury occurs
• Collagen meshwork (golden bands) breaks and
  shreds
• Proteoglycans (turquoise) leak out, reducing
  joint lubrication / shock absorbing qualities
• Destructive inflammation cascade
• Cytokines are released
• Inflammation increases
• Proper repair of the joint is challenged
• Additional damage occurs, and the cycle continues
• FlexNow with 100 SheaFlex70 High Triterepene
  Shea Nut Extract has been proven to reduce
  cytokine production, resulting in
• Inflammation reduction Reduces inflammation by
  9X
• Cartilage retention Decreases breakdown in
  collagen / cartilage by 44
• Bone regulation Reduces Osteocalcin (a measure
  of bone destruction) by 10
• Pain management Alleviates pain by 45

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Inflammation Categories of Allopathic
Intervention

• Non-steroidal anti-inflammatory drugs
  (NSAIDS)--COX 1 and 2 blockade ibuprofen
  (Motrin), naproxen (Aleve), ketoprofen (Orudis)
• Steroidsbroad spectrum suppression of immune and
  inflammation response prednisone, dexamethasone
  (Decadron), hydrocortisone
• COX 2 Inhibitors celecoxib (Celebrex)

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FlexNow vs Alternatives

• Relative to other remedies, FlexNow with 100
  SheaFlex70 offers more relief and is better for
  the body than
• Steroids Clinical benefits are similar, without
  the side effects
• Analgesics Taken every day, FlexNow
  joint-specific pain management exceeds the
  benefits of analgesics, without the side effects
• Glucosamine
• 48 better than GS even better with GS.
• GS targets 30 of the cartilage matrix
  (proteoglycan) FlexNow impacts the other 70
  (collagen)

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Over 30 Clinical Trials and studies prove
FlexNow with 100 SheaFlex70

• Reduces inflammation by 9 times
• Improves cartilage retention by 44
• Increases bone retention by 10
• Alleviates pain by 45

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ACCMER Trial Parameters

• Randomized Placebo Controlled Trial on the Safety
  and Efficacy of BSP-201 in Osteoarthritis.
  ACCMER. Cheras PA, Myers SP, Outerbridge K,
  Nielsen G. Sept. 4 2007.
• A randomized, double-blind, placebo-controlled
  single center study.
• Active FlexNow with 100 SheaFlex70
• Subjects
• 117 participants, 58 active, 59 placebo
• Radiologic and clinical evidence of
  osteoarthritis of the knee and/or hip
• Measures
• WOMAC (Western Ontario and McMaster Universities
  OA index)
• COAT Scores (Comprehensive Osteoarthritis Test)
• Duration 15 weeks
• Note At the end of the study, scores were not
  at plateau, trending downward. Longer studies in
  the future may yield even more optimal results.
• Australian Centre for Complementary Medicine
  Education Research

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ACCMER Overall Trial Results

• Cytokine Reduction
• 17.9 TNF-a overall reduction 23.9 reduction in
  group with elevated TNF-a
• IL-6 fell by 30.9
• CRP was reduced by 20.6
• Cartilage retention CTX-II cartilage marker
• Reduction of 28.7 in subjects with elevated
  levels,
• Placebo group increased 17.6
• 46.3 reduction in cartilage destruction
• Bone retention Osteocalcin (marker of bone
  destruction) 9.2 reduction in elevated group
• Pain management statistically significant pain
  reduction for both men and women

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HTSNE and Dexamethasone (steroid) produce similar
Arthritis Clinical ScoresControls Arthritis

• High Triterpene Shea Nut Extract Screening for
  Effect on Rat Type II Collagen Arthritis.
  Jorgensen JD, Weidner MS. Unpublished
  pharmacological report. April 10, 2003
• Level of statistical significance plt0.0001,
  Mann-Whitney U test

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HTSNE and Dexamethasone (steroid) exhibit similar
infammation reduction properties Reduces
inflammation
Level of statistical significance plt0.0001,
Mann-Whitney U test HTSNE High Triterpene Shea
Nut Extract
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HTSNE and Dexamethasone (steroid) exhibit similar
infammation reduction propertiesReduces
inflammation by 9-times
Level of statistical significance
plt0.0001, Mann-Whitney U test
BSP 201 Screening for Antiinflammatory effect in
the Rat-carrageenin induced paw edema assay.
Jorgensen JD, Weidner MS. Unpublished
pharmacological report. Dec. 20, 2002
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HTSNE and Ibuprofen produce similar inflammation
controlReduces inflammation

• BSP 201 Screening for Antiinflammatory effect in
  the Rat-carrageenin induced paw edema assay.
  Jorgensen JD, Weidner MS. Unpublished
  pharmacological report. Dec. 20, 2002
• Levels of statistical significance
  plt0.001, Mann-Whitney U test
• 
  plt0.0001, Mann-Whitney U test

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HTSNE and Ibuprofen produce differentiated
Stomach and Intestinal Ulcers/Damage profilesNo
gastrointestinal damage
Level of statistical significance plt0.0001,
Mann-Whitney U test HTSNE High Triterpene Shea
Nut Extract
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HTSNE Exercise Induced Pain and Inflammation
Trialwith Visual Analog Scale (VAS)
Significantly reduces pain and inflammation
A Double-Blind Randomized Placebo Controlled
Parallel Group Study Demonstrates Analgesic
Effects of Sheanut Oil Extract BSP-201 in
Exercise Induced Muscle Tenderness.
Srendt-Nielsen L, Rosetzsky A, Weidner MS. Sept
15, 2003 HTSNE High Triterpene Shea Nut
Extract
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HTSNE Better than Analgesics and GS
Significantly reduces pain and inflammation
A Double-Blind Randomized Placebo Controlled
Parallel Group Study Demonstrates Analgesic
Effects of Sheanut Oil Extract BSP-201 in
Exercise Induced Muscle Tenderness.
Srendt-Nielsen L, Rosetzsky A, Weidner MS. Sept
15, 2003 HTSNE High Triterpene Shea Nut
Extract
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FlexNow with 100 SheaFlex70TM The Next
Generation of Joint Care

• Over 30 clinical trials and studies
• Reduces cytokine production 24-31, producing
  breakthrough results
• 1) Reduce inflammation by 9 times
• 2) Improve cartilage retention by 44
• 3) Increase bone retention by 10
• 4) Alleviate pain by 45
• Safe and Natural substitute for Steroids and
  Analgesics
• Better than GS even better with GS

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Table of Contents

• Value Proposition
• Testimonials
• Clinical Review
• Destructive Inflammation Cascade
• Alternative Interventions
• Selected Clinical Trial Review
• Safe / All Natural / Sustainable
• Summary

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Safe All Natural

• Clinically proven FlexNow with 100
  SheaFlex70 has been the subject of over 30
  clinical trials and studies, and has been
  commercially available for a few years. Over the
  course of hundreds of clinical trial subjects and
  tens of thousands of consumers, just like you,
  there have been
• no adverse effects (no side effects)
• no allergies (the shea nut is not a nut, but the
  pit of the shea fruit)
• no contraindications (no interactions with
  pharmaceutical or OTC products)
• FDA-approved FlexNow with 100 SheaFlex70 is
  accepted by the FDA as having met every safety
  and toxicological requirement for a dietary
  supplement. FlexNow with 100 SheaFlex70 was
  one of only seven dietary supplements accepted by
  the FDA in 2004, given the overwhelming evidence
  supporting the products efficacy and safety.
• Centuries of use All natural shea oil and shea
  butter, the raw materials used to produce
  FlexNow with 100 SheaFlex70 have been used as
  a food and food ingredient in Africa and Europe,
  for hundreds of years shea oil and shea butter
  are common ingredients in both baked goods and
  chocolate production.
• Et al FlexNow with 100 SheaFlex70 contains
  no added sugars (sucrose, fructose, or lactose),
  no salt (sodium chloride), no nuts, yeast, wheat
  (gluten-free), corn, fish, or milk, and no
  artificial colors or preservatives.

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Sustainable/Green

• Good for the plant/Green farming
• Shea trees grow wild in West Africa, where all of
  our shea nuts are grown. The shea nuts (actually
  the pit of the shea fruit) used in the
  manufacture of FlexNow with 100 SheaFlex70 are
  wild-crafted/harvested and processed in concert
  with the UN Development Programme. 
• Wild-crafted plants are carefully gathered from
  their natural, wild habitat, where they have not
  been sprayed with pesticides or fertilized with
  synthetic fertilizers.
• Wild-crafting is a sustainable agricultural
  process that respects the living plant. Only the
  shea fruit is taken during harvest the tree is
  left unharmed. 
• Good for the community
• Local villagers collect ripe shea fruit which has
  fallen to the ground, process a portion for local
  use and sell the bulk of the shea nuts to our
  company, food companies and skin care companies.
• The UN Development Programme has established
  education and training programs to support the
  commercialization and management of the
  wild-craft farming, harvesting, processing and
  sale of shea fruit and shea nuts. 
• The UN Development Programme has helped tens of
  thousands of villagers, particularly West African
  women, to become independent and improve their
  economic position.

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Shea nut harvesting in Burkina Faso, Ghana, and
the Ivory Coast
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Table of Contents

• Value Proposition
• Testimonials
• Clinical Review
• Destructive Inflammation Cascade
• Alternative Interventions
• Selected Clinical Trial Review
• Safe / All Natural / Sustainable
• Summary

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FlexNow with 100 SheaFlex70 Quadruple Action
Joint Solution

• Proven Over 30 clinical trials and studies
  prove FlexNow
• Reduces inflammation by 9 times
• Improves cartilage retention by 44
• Increases bone retention by 10
• Alleviates pain by 45
• Safe and Natural substitute for Steroids and
  Analgesics
• Better than GS even better with GS
• New, Unique and Incremental
• Single ingredient product, Not a compound formula
• Exclusive, Patented and available only through
  BSP Pharma
• Acts uniquely, and synergistically, with other
  joint care
• Safe and All Natural
• No contraindications, No side effects, No
  allergies
• Source material Shea Nuts (not a nut, but the
  pit of the shea fruit)

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Table of Contents

• Back-Up

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BSP Pharma Inc.

• BSP Pharma Inc. is a North American
  pharmaceutical, OTC and dietary supplement
  developer/marketer, focused on identifying and
  commercializing novel, natural substances with
  the following characteristics
• Clinically proven to have substantial and
  meaningful clinical benefits
• Safe and approved by the FDA
• Derived from nature and naturally occurring
  materials
• BSP Pharma Inc. is
• incorporated in Delaware,
• a subsidiary of BSP Pharma A/S
• conducts business in Europe, Asia and North
  America
• owned by Innoventure, a private equity firm,
  based in Denmark.
• BSP is an acronym for ButyrSpermum Parkii, the
  latin name for shea butter, the source material
  for our first commercial product, FlexNow with
  100 SheaFlex70, the subject of over 30 clinical
  trials and studies.

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Contact
If you have any questions/issues or would like to
order, please contact
BSP Pharma Inc. 500 Scarborough Drive Suite
301 Egg Harbor Twp., NJ 08234 Office
1-877-778-1212 CustomerService_at_BSPPharmaInc.com

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Clinical Dossier

• The efficacy of FlexNow on Rheumatoid Arthritis
  Full Trial Dr. K, University Hospital, Japan
  2010 Study in development.
• The efficacy of FlexNow on Rheumatoid Arthritis
  Pilot Study Dr. K, University Hospital,
  Japan 2009 Pilot trial/in progress, 3 month
  duration, positive trend required and confirmed.
• FlexNow and Glucosamine Synergism in
  Osteo-Arthritis Duke University, Durham, NC,
  USA 2009 Study in development. 10-month,
  guinea pig OA animal model. 4 study arms
  placebo, FlexNow, Glucosamine and FlexNow
  Glucosamine. Outcome measures inflammatory,
  bone and cartilage biomarkers together with
  histological examination.
• Safety and Efficacy on Japanese Osteo-Arthritis
  Patients Dr. K, University Hospital, Japan
  2009 Safety parameters, plus pain and stiffness
  measures. Results pending.
• Meta Analysis of BSPPEMS GIBPEMS Tonny
  Jorgensen, CSO BSP Pharma A/S 2009
  Preliminary results show the pain level in the
  glucosamine group is 73 higher than in the
  FlexNow group.
• Randomised placebo controlled trial on the
  safety and efficacy of BSP-201 in
  Osteo-Arthritis, Dr. Phillip Cheras ACCMER,
  University of Queensland, Brisbane, Australia
  2007 Substantial and statistically significant
  anti-inflammatory effect in humans, plus
  chondroprotective and bone remodelling effects.
• 7) GIB Evaluation of Glucosamine Sulphate and
  Ibuprofen versus Placebo Dr. Allan Rosetzsky
  Klifo, A/S, Copenhagen, Denmark 2005
  Treatments revealed no significant effect except
  from Glucosamine Sulphate which had a higher VAS
  pain score compared to placebo, which is the
  opposite of what was expected.

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Clinical Dossier

• Evaluation of The Efficacy and Safety of a
  Sheabutter Extract on Cold Sores (Acute and
  Prophylactic) Dr. Phillip A. Cheras ACCMER,
  Brisbane, Australia 2005 The product was able
  to significantly reduce the reoccurrence of cold
  sores.
• A Randomized Double-Blinded Placebo Controlled
  Study of BSP-103 for the Treatment of Patients
  With Moderate To Severe Plaque Psoriasis Dr.
  Frederic Boudjema Pharmascan, Villeurbanne,
  France 2004 Post hoc data analysis revealed
  that the subgroup with initial PASIgt20 achieved a
  statistical reduction of gt30 after 3 months.
• A Double-Blind Randomized Placebo Controlled
  Parallel Group Study Demonstrates Analgesic
  Effects of Sheanut Oil Extract BSP-201 in
  Exercise Induced Muscle Tenderness (BSPPEMS)
  Lars Arendt-Nielsen, DmedSci, Ph.D. Aalborg
  University, Denmark Journal of Musculoskeletal
  Pain, Vol. 17, Issue 1, February 2009, pages
  8-14 2003 Study found a significant 49 pain
  reduction in the active group compared to
  placebo. Product was found to be safe.
• Mouse Micronucleus Karin Kaaber, DVM ScanTox
  2003 No genotoxicity observed.
• Ames Test Karin Kaaber, DVM ScanTox,
  Denmark 2003 No genotoxicity observed.
• 13) "Acute Oral Toxicity" Karin Kaaber, DVM
  ScanTox, Denmark, 2003 LD50 gt2000mg/kg

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Clinical Dossier

• "Ulcerogenic Effect Karin Damm Jorgensen, DVM,
  Study Director BioAdvice, Vedbaek, Denmark
  2003 This ulcerogenic safety study confirmed
  that BSP201 caused no gastrointestinal lesions in
  contrast to Ibuprofen, which was used as the
  control.
• Determination of Anti-Inflammatory Properties of
  Topical Formulations Containing Shea Butter
  Extract on Lesional Skin of Patients With Atopic
  Dermatitis J. Gassmüller, MD BioSkin Institute
  for Dermatological Research, Hamburg, Germany
  2003.
• Evaluation of the irritating and sensitizing
  potential by repeated 48-hours epicutaneous
  applications under patch-tests (Marzulli
  Maibach method) Dr. Yvette Weltert,
  dermatologist Pharmascan, Villeurbanne, France
  2003 The product can be considered
  hypoallergenic. The product was not associated
  with any clinically significant photo allergenic
  response.
• Cutaneous Irritancy by MTT Assay on Human Skin
  Biopsies Alain Deguercy Laboratoire Dermscan,
  Villeurbanne, France 2003 The product is
  non-irritant in this model.
• Evaluation of Ocular Irritancy. (HET-CAM
  Assay) Alain Deguercy Laboratoire Dermscan,
  Villeurbanne, France 2003 The product is
  non-irritant in this model.
• 19) Topical Safety Study Photosensibility Dr.
  Marlena Nowakowska, MD Group Dermscan, France
  2003 The product is non-photosensitising.

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Clinical Dossier

• Evaluation of The Acute Cutaneous Tolerance.
  48h Occlusive Patch Test Under Dermatological
  Control Dr. Yvette Weltert Palmer
  Research-Dermscan Group St. Etienne, France
  2003 Product is non-irritant.
• Screening of Anti-Inflammatory Effect in The
  Repeated Oxazolone Mouse Ear Oedema Assay
  Morten Sloth Weidner, Ph.D. Department of
  Dermatology, Bispebjerg Hospital, Copenhagen,
  Denmark 2003 This model simulates chronic
  inflammatory conditions. When administered
  systemically, the product demonstrated a dose
  dependent anti-inflammatory response. The
  highest concentration was approximately twice the
  response as the positive control 10/mg methyl
  prednisolone.
• Screening For Anti-Iinflammatory Effect in The
  TPA Subchronic Mouse Ear Oedema Assay Hans
  Christian Wulf, Dr. Med. Morten Sloth Weidner,
  Ph.D. Department of Dermatology, Bispebjerg
  Hospital, Copenhagen, Denmark 2003 This model
  simulates chronic inflammatory conditions. The
  product had a statistical significant inhibitory
  effect on repeated TPA induced oedema (very
  strong inflammation) (x4) formulation
  optimisation tests.
• 23) Screening of Anti-Iinflammatory Effect in
  The Oxazolone Mouse Ear Oedema Assay Hans
  Christian Wulf, Dr. Med. Morten Sloth Weidner,
  Ph.D. Department of Dermatology, Bispebjerg
  Hospital, Copenhagen, Denmark 2003 Confirmed
  topical anti-inflammatory effect as well as a
  significant dose dependent systemic
  anti-inflammatory effect equal in the highest
  dose to 30mg/kg methyl prednisolone.

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Clinical Dossier

• Screening For Anti-inflammatory Effect in The
  Arachidonic Acid Mouse Ear Edema Assay Hans
  Christian Wolf, Dr. Med. Morten Sloth Weidner,
  Ph.D. Department of Dermatology, Bispebjerg
  Hospital, Copenhagen, Denmark 2003 Product
  provided anti-inflammatory effect.
• Collagen II Rat Arthritis Assay Karin Damm
  Jorgensen, DVM, Study Director BioAdvice,
  Vedbaek, Denmark 2003 This chronic joint
  inflammation model confirmed the alleviation of
  joint specific chronic inflammation to a level
  equal to dexamethasone.
• Carrageenin Induced Rat Paw Oedema assay Karin
  Damm Jorgensen, DVM, Study Director BioAdvice,
  Vedbaek, Denmark 2002 This acute inflammatory
  model confirmed the dose dependent
  anti-inflammatory effect of BSP201. The effect
  of a daily dose was comparable to a moderate dose
  of Ibuprofen. (x3)
• The Effect of Sheanut Oil on Serum Lipids and
  Lipoproteins in Normocholesterolemic and Mildly
  Hypercholesterolemic Humans Eric Berg Schmidt
  Department of Medicine, Hjorring/Bronderslev
  Hospital Journal of the American College of
  Cardiology, Abstract 2894, May 1, 2002, Vol. 39,
  Issue 9, Suppl. B 2001 LDL cholesterol
  decreased 8 in active group. Product was found
  to be safe.
• 28) Screening For Anti-Inflammatory Effect in
  The Mouse Ear Oedema Assay (TPA) Karin Damm
  Jorgensen, DVM Panum Institute, Copenhagen,
  Denmark 2001 All versions of the product
  demonstrated a statistically significant dose
  dependent anti-inflammatory effect. A dosage of
  1mg demonstrated the same inhibition as 0.2mg
  hydrocortisone-17-butyrate. (x2)

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Clinical Dossier

• TNF-a/IL-6 Study Morten Weidner Astion A/S,
  Copenhagen, Denmark 2001 This test showed a
  strong reduction of pro-inflammatory cytokines
  TNF-a and IL-6 equal to the effect obtain with a
  comparable dosage of methyl prednisolone. (x2)
• NF-?B Mechanistic Study PanLabs Taiwan Ltd.,
  Taipei, Taiwan 2000 FlexNow was shown to
  inhibit NF-?B dependent transcription response.
• Receptor Binding PanLabs Taiwan Ltd., Taipei,
  Taiwan 2000 Confirmed safety. FlexNow did not
  bind to the glucocorticoid receptors suggesting a
  different mode of action and side effect profile
  than steroids.
• 32) Evaluation of Anti-Viral Effect James H.
  Gilbert, Ph.D., MDS PanLabs Biosafety, Bothell,
  WA, USA 1999 Product demonstrated antiviral
  activity against herpes simplex and to a lesser
  extent Influenza A. It did not show an effect
  against rhinovirus.

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ACCMER Highest Risk Group Results

• Cytokine Reduction
• 24 reduction in TNF-a
• IL-6 fell by 22
• CRP was reduced by 22
• Cartilage retention CTX-II cartilage marker
• Reduction of 39
• Placebo group increased 31
• 70 reduction in cartilage destruction
• Bone retention Osteocalcin (marker of bone
  destruction) 7.8 reduction in elevated group
• Pain management statistically significant pain
  reduction for both men and women