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UC-II ® Undenatured Type II Collagen for Joint Support OCT 18, 2018
UC-II® Undenatured Type II Collagen for Joint Support
OCT 18, 2018
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Global joint-health supplements market
CONSUMER SEGMENTS
• Main consumer targets : Senior people. Few real innovations.
• New opportunities : Sport-supplements market will be probably a new market for
innovative joint-health products. Complex and qualitative formulation could be an
opportunity for development
Constantly growing market , new consumer segments
GLOBAL MARKET DYNAMICS
• Market size and share : 2,9 billion USD = 5.2 % of global dietary supplement sales in 2017
• Main regions : 1= Asia pacific, 2=North America, 3=Europe
• Growth and CAGR : This market has been constantly growing for 5 years, +3.4% CAGR
• Best seller countries : USA, Japan, China, Australia, UK
• New product launch dynamic : 645 Vitamin and Dietary Supplement products from
2012-2018
Sources: Euromonitor Consumer Health Database, 2017
Mintel Food and Drink Platform, 2017
5.2 %
of
global
VDS
2.9 USD
billion
+3.4%
CAGR
Consumer Health & Nutrition | 15 Oct 2018
High potential consumer segments for joint health
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76% of Boomers and 69% of GenX taking supplements in Germany, Italy and France
would like to use Food Supplements for joint health
SORD UK, 2018, 1000 consumers Consumer Health & Nutrition | 15 Oct 2018
What is UC-II® brand?
K. Kuhn, 1987, in R. Mayne and R. Burgeson, eds., Structure and Function of Collagen Types, Academic Press, p. 2
Vander Rest M et al. FASEB J., 1991, 5:2814. Collagen triple helix
~ 300 nm
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Undenatured (native) type II collagen derived from
chicken sternum cartilage
Trademarked, patented, clinically studied ingredient
for joint health
Manufactured in USA under food GMP conditions
Small dose (40 mg/once per day)
Unique mechanism of action (Oral tolerance)
Backed up by preclinical and clinical science
Consumer Health & Nutrition | 15 Oct 2018
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Making the difference with UC-II® undenatured type II collagen
Commercially available collagen products
Collagen Products
Undenatured
Denatured
Gelatin Collagen hydrolysate
(Hydrolyzed collagen)
Preparation method
No heat
No enzyme
Gentle processing
Partial hydrolysis (heat)
Harsh processing
Complete hydrolysis
(heat + enzyme)
Harsher processing
Triple helical structure Retained Disrupted Disrupted
Structural representation
Product form Intact polypeptides
Active epitopes
Mixture of peptides and
polypeptides
No active epitopes
Amino acids & small
peptides
No active epitopes
Confidential Consumer Health & Nutrition | 15 Oct 2018
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UC-II® undenatured type II collagen delivers clinically studied joint-health benefits
UC-II® brand clinical studies
Consumer Health & Nutrition | 15 Oct 2018
Two pivotal clinicals established the efficacy of UC-II® brand
Study Population Main Outcomes
Lugo et al (2013) Healthy Subjects • Statistically significant improvement in knee joint function
versus placebo
Lugo et al (2016) OA Subjects
• UC-II® supplemented subjects presented with a statistically
significant improvement in all three WOMAC subscales versus
placebo
• Also showed superiority over GC treatment, which was not
statistically significant over placebo
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Interest level regarding the science supporting the benefits of
UC-II® undenatured type II collagen
GC: Glucosamine-Chondroitin ; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index
Consumer Health & Nutrition | 15 Oct 2018
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Randomized, Double-Blind, Placebo-Controlled Study
UC-II® Brand - healthy subject study, 2013
Groups Group 1: UC-II® Brand, 40 mg
Group 2: Placebo
Subjects N=55
Duration 120 Days
Primary
Endpoint Improvement in knee function
Secondary
Endpoints
Time to onset of knee joint pain on
Stepmill
Time to offset of knee joint pain
after stepping off the Stepmill
Time Points
Measured 0, 7, 30, 60, 90 and 120 days
Average Age
of Subjects 46 years
Lugo et al., J Int Soc Sports Nutr. 2013;10:48
Consumer Health & Nutrition | 15 Oct 2018
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Randomized, Double-Blind, Placebo-Controlled Study
UC-II® Brand - healthy subject study, 2013
Lugo et al., J Int Soc Sports Nutr. 2013;10:48
Consumer Health & Nutrition | 15 Oct 2018
UC- II® undenatured type II collagen
significantly increase average knee extension
compared to placebo
UC- II ® undenatured type II collagen
appears to be alleviating joint discomfort
in healthy subjects
17 week supplementation
with UC-II ® undenatured tyype II collagen
was well tolerated
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Randomized, Double-Blind, Placebo-Controlled Study
UC-II® Brand - 2016 OA study
Lugo JP, et al. Nutr J. 2016;15:14.
Confidential
Total WOMAC Score Reduction
UC-II ® brand achieved statistical significance versus placebo and GC
GC failed to achieve significance versus placebo
UC-II ® is safe and effective
Study Design
3 Groups Placebo GC (1500 mg G + 1200 mg C) UC-II® Brand (40 mg)
Subjects N = 186
Primary Endpoint
Change in Total WOMAC at Day 180 vs PBO & GC
Secondary Endpoints
Mean VAS, LFI and WOMAC Subscales at Day 180 vs PBO & GC
Visits Days 0, 7, 30, 60, 90, 120, 150 & 180
Population Osteoarthritic subjects (Moderate to severe)
# Centers 13 clinics participated in study
PBO: Placeobo; GC: Glucosamine, Chondroitin; VAS: Visual Analogue Scale for Pain aid,
Consumer Health & Nutrition | 15 Oct 2018
Key outcomes of the Bagi 2017 study
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Presented at the 8th International Conference of Orthopedic Surgeons and Rheumatology
Preclinical study in meniscus tear OA model supports that a
clinically relevant daily dose of UC-II ® brand maintains joint health
Research results show that UC-II ® brand:
Improves the mechanical function of the injured knee
Prevents joint cartilage deterioration
Preserves bone integrity of the knee joint
A validated dynamic weight bearing system was used to measure the mechanical
function of the knee
Micro Computed Tomography was used to analyze the structural changes of the bone
and cartilage tissue
Consumer Health & Nutrition | 15 Oct 2018
UC-II® brand undenatured type II collagen was administered at clinically relevant dose of 0.66 mg/kg/day by
oral gavage to male Lewis rats, 7 days per week for a period of 8 weeks
A group of 10 rats were allocated into following groups
Naïve Control
Sham Control
PMMT + vehicle
PMMT + UC-II® brand undenatured type II collagen
Assessments:
Weight bearing capacity
Radiography (X-ray, mCT of bone and cartilage)
Histology: H&E, Toluidine Blue, Safranin O and Cathepsin K
Histomorphometry
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Rat Model of OA (Partial Medial Meniscectomy Tear)
UC-II® brand - 2017 study
Transection
Medical
Meniscus
Bagi et al., Osteoarthritis Cartilage
2017; 25:2080-90
Consumer Health & Nutrition | 15 Oct 2018
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Study results (2017)
Confidential
Bagi et al., Osteoarthritis Cartilage 2017; 25:2080-90
DWB – Rear Right Leg (g)
Consumer Health & Nutrition | January 2018
*p < 0.05 vs Naïve; ap < 0.05 vs Sham & UC-II
Research results show that UC-II®:
Improves the mechanical function of the injured knee
Prevents joint cartilage deterioration
Preserves bon integrity of the knee joint
DWB: Dry Weight Basis
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Five published studies
UC-II® Brand - dog & horse studies
Inclusion Criteria
Deparle, et al. J Vet Pharmacol Therap. 2005;28:385-390
Peal, et al. J Vet Pharmacol Therap. 2007;30:275-278
D’Altilio, et al. Toxicol Mech Methods. 2007;17:189-196
Gupta, et al. J Vet Pharmacol Therap. 2009;32:577-584
Gupta, et al. J Anim Physiol Anim Nutr. 2012;96:770-777
GFP: Ground Force Plate
Consumer Health & Nutrition | 15 Oct 2018
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The principle of “Oral Tolerance”
UC-II® brand - Proposed Mechanism of Action
UC-II Undenatured Type-II Collagen may trigger the rebuild of cartilage in your joints
Consumer Health & Nutrition | 15 Oct 2018
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Possible mechanism of action & oral tolerance
UC-II® brand Containing Undenatured Type II Collagen
UC-II
TGF-β
IL-10
Von Boehmer et al. Exp Med. 2007;204:1737-1739
Ramage, et al. Scand J Med Sci Sports. 2009;19:457-69
Tregs, IL-10 and TGF-β helps repair and build new cartilage
• UC-II® ingredient is adsorbed in the gut (Peyer’s patch)
• The type-II collagen initiates a cell-signaling cascade
involving anti-inflammatory cytokines (TGF-B and IL-10)
which then trigger chondrocytes to produce type II
collagen and other extracellular matrix proteins in the
knee
Consumer Health & Nutrition | 15 Oct 2018
Mode Of Action
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Ready to Market Solutions
UC-II® Dosage Form: Bone & Joint Health
40mg UC-II® brand plus Vitamin C & Vit D, Manganese and Copper
Allowing EFSA health claims on bones, muscles, connective tissue and
cartilage formation
EFSA Health Claims are in line with UC-II® benefits:
Vitamin C contributes to normal collagen formation for the normal function of bones and
cartilage (and gums)
Vitamin D contributes to the maintenance of normal bones and muscle function
Manganese contributes to the maintenance of normal bones and the normal formation of
connective tissue
Copper contributes to the normal formation of connective tissue
Consumer Health & Nutrition | 15 Oct 2018
Vcaps® Plus capsule
Small size (size 3)
Easy to swallow
Branding possible
Super-Convenience: one tiny “pill” – once daily
UC-II® brand: dosage form: bone & joint health
Convenience UC-II® Vitamins &
Minerals capsule
Source: NMI SORD Research 2017 Q.23_26
75% of consumers consider easy-to-
swallow as important in their buying
decision of food supplements
1500mg Glucosamin &
1200mg Chondroitin
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31% of sports supplement users have
stopped taking Glucosamine because they
feel it was not effective
Consumer Health & Nutrition | 15 Oct 2018
UC-II® brand
Combination products and DUOCAP® capsules
Other possible combinations: botanical extracts with anti-inflammatory benefits like Omega 3 concentrates /
Krill Oil, Curcumin, Boswellia
UC-II® undenatured
type II collagen +
liquid Curcumin
UC-II® undenatured
type II collagen +
Krill oil
UC-II® undenatured
type II collagen +
fish oil
UC-II® undenatured
type II collagen +
curcumin extract
Consumer Health & Nutrition | 15 Oct 2018 20
Cartilage containing undenatured type II collagen
Small 40mg, once-a-day dosage - Allows for multiple formulations
Unique mechanism of action
9 published studies, incl. healthy adult study
Significantly outperforms glucosamine plus chondroitin across a variety of metrics
Studies in dogs, horses and humans shows that UC-II® brand contributes to joint comfort
UC-II® brand is backed by safety research
Granted & pending patents
Self-affirmed GRAS, FDA new dietary ingredient (NDI) notified and published
UC-II® brand is non-novel in the application of food supplements in the EU
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Take aways
UC-II® Undenatured Type II Collagen
Confidential Consumer Health & Nutrition | 15 Oct 2018
Disclaimer
Review and follow all product safety instructions. The statements made in these materials have not been evaluated by the U.S. Food and Drug Administration or any other regulatory authority. Lonza’s products are not intended for use to diagnose, treat, cure or prevent any disease.] All information in this presentation corresponds to Lonza’s knowledge on the subject at the date of publication, but Lonza makes no warranty as to its accuracy or completeness and Lonza assumes no obligation to update it. All information in this presentation is intended for use by recipients experienced and knowledgeable in the field, who are capable of and responsible for independently determining the suitability and to ensure their compliance with applicable law. Proper use of this information is the sole responsibility of the recipient. Republication of this information or related statements is prohibited. Information provided in this presentation by Lonza is not intended and should not be construed as a license to operate under or a recommendation to infringe any patent or other intellectual property right. All trademarks belong to Lonza or its affiliates or to their respective third parties and are used here only for informational purposes. Copyrighted material has been produced with permissions or under license, all other materials belong to Lonza. © 2016 Lonza
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LONZA(C) , 2018
Consumer Health & Nutrition | 15 Oct 2018
