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Lifestyle & Food
               Voorkomen is het nieuwe genezen


               Health Valley Event
Luc Sterkman   13 maart 2013
Nelissen Pluimvee
Globus ei BV
Prijsvorming

                 1,4
Prijs per kilo
                 1,2




                  1




                 0,8
                                                                                                                                                      2003
                                                                                                                                                      2004
                                                                                                                                                      2005
                 0,6




                 0,4




                 0,2




                  0
                       2   4   6   8   10   12   14   16   18   20   22   24   26   28   30   32   34   36   38   40   42   44   46    48   50   52




                                                                                                                                      Week
Zoektocht naar toegevoegde waarde
Begin van nieuw leven!
Preventie

         Genetica




            Voeding


                      Leefstijl



    Gezondheidszorg
Health Valley 2013




Health Valley, make health & innovation work!
Innovatie
Innovatie 2.0
Medication

       Nutraceutical

Food
Ontwikkelprogramma’s


NWT-02



           Bioactive peptides
NWT-03     Behoud van cardiovasculaire
           gezondheid




OBESITAS
Pharmaceutical approach


 Aangepast op regelgeving

 Senior farma medewerkers

 Klinische studies

 Product ontwikkeling

 Kwaliteits standaard

  – Good Clinical Practice
  – Good Laboratory Practice
  – Good Manufacturing Practice
New regulation (2006/1924/EC)

Voedingsclaims                   Gezondheidsclaims

                             Art. 13                    Art. 14
                 Art. 13.1        Art. 13.5        Art. 14
Bijv. Nutriënt
samenstelling    Algemeen         Claim op basis   - Risico reductie
                 geaccepteerd     van ‘nieuw’      - Kinderen
                 wetenschap-      bewijs
                 pelijk bewijs
Business model
Egg yolk is the superior carrier for lutein




          Chung, HY, et al, J. Nutr. 134:1887-1893, 2004
NWT-02 status


              2007                                                      2012                         2014

                                                          PCT
                                                                               National
 Patents     EU filing             PCT filing            grant
                                                                            authorizations
                                                           ed

                                                                                                    EFSA/
Regulatory      Lab       Volunteers                    People “at risk’’
                                                                                                     FDA


Production   Lab scale                 Pilot scale                                     Industrial



              Market
Marketing    definition
                          Product definition         Preparations                     Partnering            Sales
Clinical trial program
  Human 1 - pivotal study on visual function
  12 months | 100 subjects with early stage AMD

  Human 2 - study on cholesterol & AMD
   3 months | 120 healthy volunteers

  Human 3 - study on bioavailability of ‘EyePowder’
  formulations vs NWT-02
   2 months | 100 healthy volunteers

  Human 4 - pivotal study on visual function
   12 months | 120 subjects - early stage AMD
NWT-02 results – pilot study

                                    Blood lutein level                                                       Total Cholesterol


                        2,00                                                                     1,04
                                                                                                 1,03
                        1,80
                                                                                                 1,02




                                                                           Change vs base line
  Change vs base line




                                                          Normal egg                                                               Normal egg
                        1,60                                                                     1,01
                                                          NWT-02                                                                   NWT-02
                                                                                                 1,00
                        1,40
                                                          NWT-01 (lutein                         0,99                              NWT-01 (lutein
                                                          egg)                                                                     egg)
                        1,20                              Control                                0,98                              Control
                                                                                                 0,97
                        1,00
                                                                                                 0,96
                        0,80                                                                     0,95
                               0w      6,5 w   13 weeks                                                 0w      6,5 w   13 weeks
                                       Time                                                                     Time
Results
  NWT-02 does very efficiently bring lutein and other valuable
  nutrients in the blood stream and into the macula.

  This leads to stabilization (often even improvement) of eye
  functions such as visual acuity and light- dark adaptation.

  Although egg yolk is used, there is no or little effect on
  blood cholesterol.
NWT-03: “the new approach
for maintaining (vascular) health”

Development of bioactive peptides as functional food or nutraceutical for
the prevention of vascular damage and related disorders
NWT-03 Project

 Hydrolysate – produced via enzymatic treatment of lysozyme, an egg-
 derived protein

 Designed based on bioinformatics-model of the University Wageningen;
 aiming for a beneficial effect on the arterial vascular wall

 First tested in pharmacology models to confirm the effect and elucidate
 the mechanisms

 Subsequently tested in animal experiments:

  – Confirming reduction in bloodpressure in Hypertensive rats

  – Demonstrating maintenance of the flexibility of the vascular wall in
     ZDF-rats, which suffer from Diabetes melllitus; model for ageing
NWT-03 status

              2006                                                       2012                       2015



  Patents                                       PCT             National
              EU filing    PCT filing
                                              granted        authorizations



 Regulatory      Lab              Animals                  Volunteers           Patients          EFSA/ FDA



 Production   Lab scale                      Pilot scale                                     Industrial



               Market
 Marketing    definition
                                    Product definition                  Preparations       Partnering     Sales
Acute effects of NWT-03 in SHR-rats
Kidney – anatomy and histology




                             Histology (PAS) of a
                             healthy glomerulus
Renal morphology in ZDF-rats
Glomerulosclerosis and Albuminuria
                           60



                           50
glomerulosclerosis-score




                           40
                                                         9
                                                             controls
                           30                            8   diabetes
                                Albuminurie (mg/24uur)   7
                                                             diabetes + NWT-03
                           20
                                                         6

                                                                                 controles
                           10                            5
                                                                                 diabetes
                                                         4                       diabetes + NWT-03
                           0
                                                         3

                                                         2

                                                         1

                                                         0
Sector overschrijdende aanpak

         Genetica
                                   Wetenschap


                                Innovatieve bedrijven
            Voeding


                                  Leefstijl
              Overheid


    Gezondheidszorg
Preventieve aanpak
                         Diagnostiek
         Genetica
                                   Wetenschap


                                Innovatieve bedrijven
             Voeding
    Speciale voeding

                                  Leefstijl
              Overheid
                                  Preventiemanagement


     Gezondheidszorg
    Zorgverzekeraars
Secundaire preventie
  Vroege diagnostiek         Medische technologie
  – Kan leiden tot
                             – Kan leiden tot
  Vroege behandeling         Diagnostische apparatuur
  – Met als doel
                             – Met als doel
  Secundaire preventie       Vroege diagnostiek
  – Gebruik makend van
                             – Gebruik makend van
  Food                       Scanning Laser Optics
  – Milde effecten
                             – Milde methode
  – Zonder neven effecten
                             – Zonder neven effecten
  – Op professionele wijze
                             – Op professionele wijze
    ontwikkeld (farma)
                               ontwikkeld (Qserve)
Rol Newtricious
Samenwerken
Samenwerken en verbinden
Virtual company
Newtricious “Network”




                        Nateland consultancy




                    Coppelmans VOF
BrandRep




Aroma Uden
Strategische investeerders
Luc Sterkman
Luc Sterkman
Luc Sterkman

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Luc Sterkman

  • 1. Lifestyle & Food Voorkomen is het nieuwe genezen Health Valley Event Luc Sterkman 13 maart 2013
  • 4. Prijsvorming 1,4 Prijs per kilo 1,2 1 0,8 2003 2004 2005 0,6 0,4 0,2 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Week
  • 7.
  • 8. Preventie Genetica Voeding Leefstijl Gezondheidszorg
  • 9. Health Valley 2013 Health Valley, make health & innovation work!
  • 12.
  • 13. Medication Nutraceutical Food
  • 14.
  • 15. Ontwikkelprogramma’s NWT-02 Bioactive peptides NWT-03 Behoud van cardiovasculaire gezondheid OBESITAS
  • 16. Pharmaceutical approach Aangepast op regelgeving Senior farma medewerkers Klinische studies Product ontwikkeling Kwaliteits standaard – Good Clinical Practice – Good Laboratory Practice – Good Manufacturing Practice
  • 17.
  • 18. New regulation (2006/1924/EC) Voedingsclaims Gezondheidsclaims Art. 13 Art. 14 Art. 13.1 Art. 13.5 Art. 14 Bijv. Nutriënt samenstelling Algemeen Claim op basis - Risico reductie geaccepteerd van ‘nieuw’ - Kinderen wetenschap- bewijs pelijk bewijs
  • 20. Egg yolk is the superior carrier for lutein Chung, HY, et al, J. Nutr. 134:1887-1893, 2004
  • 21. NWT-02 status 2007 2012 2014 PCT National Patents EU filing PCT filing grant authorizations ed EFSA/ Regulatory Lab Volunteers People “at risk’’ FDA Production Lab scale Pilot scale Industrial Market Marketing definition Product definition Preparations Partnering Sales
  • 22. Clinical trial program Human 1 - pivotal study on visual function 12 months | 100 subjects with early stage AMD Human 2 - study on cholesterol & AMD 3 months | 120 healthy volunteers Human 3 - study on bioavailability of ‘EyePowder’ formulations vs NWT-02 2 months | 100 healthy volunteers Human 4 - pivotal study on visual function 12 months | 120 subjects - early stage AMD
  • 23.
  • 24. NWT-02 results – pilot study Blood lutein level Total Cholesterol 2,00 1,04 1,03 1,80 1,02 Change vs base line Change vs base line Normal egg Normal egg 1,60 1,01 NWT-02 NWT-02 1,00 1,40 NWT-01 (lutein 0,99 NWT-01 (lutein egg) egg) 1,20 Control 0,98 Control 0,97 1,00 0,96 0,80 0,95 0w 6,5 w 13 weeks 0w 6,5 w 13 weeks Time Time
  • 25.
  • 26. Results NWT-02 does very efficiently bring lutein and other valuable nutrients in the blood stream and into the macula. This leads to stabilization (often even improvement) of eye functions such as visual acuity and light- dark adaptation. Although egg yolk is used, there is no or little effect on blood cholesterol.
  • 27. NWT-03: “the new approach for maintaining (vascular) health” Development of bioactive peptides as functional food or nutraceutical for the prevention of vascular damage and related disorders
  • 28. NWT-03 Project Hydrolysate – produced via enzymatic treatment of lysozyme, an egg- derived protein Designed based on bioinformatics-model of the University Wageningen; aiming for a beneficial effect on the arterial vascular wall First tested in pharmacology models to confirm the effect and elucidate the mechanisms Subsequently tested in animal experiments: – Confirming reduction in bloodpressure in Hypertensive rats – Demonstrating maintenance of the flexibility of the vascular wall in ZDF-rats, which suffer from Diabetes melllitus; model for ageing
  • 29. NWT-03 status 2006 2012 2015 Patents PCT National EU filing PCT filing granted authorizations Regulatory Lab Animals Volunteers Patients EFSA/ FDA Production Lab scale Pilot scale Industrial Market Marketing definition Product definition Preparations Partnering Sales
  • 30. Acute effects of NWT-03 in SHR-rats
  • 31. Kidney – anatomy and histology Histology (PAS) of a healthy glomerulus
  • 33. Glomerulosclerosis and Albuminuria 60 50 glomerulosclerosis-score 40 9 controls 30 8 diabetes Albuminurie (mg/24uur) 7 diabetes + NWT-03 20 6 controles 10 5 diabetes 4 diabetes + NWT-03 0 3 2 1 0
  • 34.
  • 35. Sector overschrijdende aanpak Genetica Wetenschap Innovatieve bedrijven Voeding Leefstijl Overheid Gezondheidszorg
  • 36. Preventieve aanpak Diagnostiek Genetica Wetenschap Innovatieve bedrijven Voeding Speciale voeding Leefstijl Overheid Preventiemanagement Gezondheidszorg Zorgverzekeraars
  • 37. Secundaire preventie Vroege diagnostiek Medische technologie – Kan leiden tot – Kan leiden tot Vroege behandeling Diagnostische apparatuur – Met als doel – Met als doel Secundaire preventie Vroege diagnostiek – Gebruik makend van – Gebruik makend van Food Scanning Laser Optics – Milde effecten – Milde methode – Zonder neven effecten – Zonder neven effecten – Op professionele wijze – Op professionele wijze ontwikkeld (farma) ontwikkeld (Qserve)
  • 42. Newtricious “Network” Nateland consultancy Coppelmans VOF