q-ter space project milan, 25 th november 2009 scharper high solutions a spin-off of scharper spa
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Q-TER Space ProjectMilan, 25th November 2009
Scharper High Solutions
a spin-off ofScharper SpA
Company presentation
Scharper SpA
Confidential
(2008, Values)
Int. Med. 45%
Women's health
12%
ENT38%
Derma5%
Group of Pharmaceutical companies,Group of Pharmaceutical companies, Privately owned,Privately owned, European based, European based, Successfully operating in Italy for over 14 years,Successfully operating in Italy for over 14 years, Track record for pioneering the nutraceutical/medical food market in Track record for pioneering the nutraceutical/medical food market in
ItalyItaly
2008 Values
DrugsDrugs 65%65%
Non-DrugsNon-Drugs 35%35%
Q-TER® Space Project
Current Challenges
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• Several unmet medical needs caused by free radicals of oxygens (ROS) or mithocondrial disfunctions already exist (both in space and ground medicine)
• Most of them could be treated by antioxidant agents/metabolism enhancer specific treatments
Natural antioxidants
• need to be dissolved in water before intake
• have often poor solubility and scarse bioavailability
• reduced effectiveness
Q - TER®
Project description
The solution : Q-TER®
Terclatration
CoQ10
Q-TER® (*) multicomposite has proven to be about 200 times more soluble and to retain its antioxidant capacity more than 5 times with
respect to native CoQ10.
• potent lipophilic antioxidant
• involved in mitochondrial oxidative metabolism
• insoluble substance (poor bioavailability & stability problems)
dry co-grinding method which:
• allows the attainment of ternary compositions (active substance, a hydrophilic or hydrophobic carrier, a co- grinding agent)
• confers solubility and dissolution speed desired
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Project description
Q-TER® - IP position
Terclatration process has been covered by the granted patent WO03097012 claiming the process of dry co-grinding of a ternary mixture comprising:
• an active substance• hydrophilic or hydrophobic carrier• co-grinding auxiliary substance required for activating the incorporation of the active substance in the carrier.
Scharper owns the worldwide exclusive rights of commercial and scientific exploitation of Q-TER® up to patent expiry date
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Project description
The solution: Proof of concept
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Proof of concept data already available for mitocondria related diseases:
• Disease A
• Disease B
• Disease C
• Disease D
Confidential info available (NDA required)
(*) free radicals
Project description
Potential market(*)
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Expected number of patients (USA + EU)
(*) epidemiological studies trend
Disease A Disease B Disease C Disease D
2013 1.172.621 11.361.203 13.386.333 13.049.697
2023 1.321.183 12.175.613 17.945.293 14.702.986
Q-TER® Space Project
Competition
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Current solutions do not meet patients’ needs as they:
• are not effective
• are expensive and have heavy side-effects
• have a limited mechanism of action
Q-TER® space project:
• Develop new drug deliveries
• patches
• sublingual tabs
• Gather new proof of concept data
Project description
Q-TER®: current & future applications
Q - TER®
already formulated in
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Mental & physical fatigue Powder in sachet
Dizziness & tinnitus Powder in sachet
dissolved in water after shaking before the intake
Medical needs:• Disease A• Disease B• Disease C• Disease D
Q-TER® Space Project
The investment opportunity
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• solid scientific evidence
• proven business model
• skills to product development already available within organization
• product development (nutraceuticals and medical foods vs drugs)
• lower investments and development risks
• shorter time to market
• finalize spin-off SHS operations among Scharper activities
Project description
Timeline
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Project start Y1 Y2 Y3 Y4
Product (3) (disease C)
Product 4 (disease D)
Technology development phase
Y5
Proof of concept studies (*)
Disease A/B
Disease C
Disease D
Product (2)(disease B)
Product (1)(disease A)
Go/no Go decision (*) Pharmacokinetics – Animal studies
Project description
Financials: Whole sales revenues (€)
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Y1 Y2 Y3 Y4 Y5 Y6 Y7Base case Disease B - - 3.706.146 11.197.011 18.792.643 24.600.680 28.581.836
Disease A - 136.137 344.428 697.121 1.058.230 1.249.417 1.445.040 Disease C - - 3.448.708 9.489.786 18.343.160 25.190.627 33.700.820 Disease D - - - 2.476.059 7.517.316 12.679.206 19.247.035
- 136.137 7.499.281 23.859.978 45.711.349 63.719.931 82.974.731 Total (€)
Funding & financial
Funding requirements and timeline
The objective that SHS intend to reach with funding required is to fully explore prototypes of potential nutraceutical products to launch on the market.
Timing to invest/spend money raised by funding programme.
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T0 T1 T2 T3 T4 T5 T6 T7Technical Study 1 200.000
Study 2 240.000 Preclinical Study 3 60.000
Clinical Study 4 200.000 200.000 200.000 Study 5 200.000 100.000 Study 6 200.000 100.000
Patents Patent 1 5.000 12.000 Patent 2 5.000 12.000 Patent 3 5.000 12.000 Patent 4 5.000 12.000
Management Core 50.000 50.000 50.000 50.000 70.000 70.000 70.000 70.000 Partial 5.000 10.000 10.000 10.000 10.000
G&A 5.000 10.000 10.000 10.000 10.000 2% of Scharper G&A 422.940 484.640 562.120 625.780 669.660 669.660 669.660
Total 972.940 1.154.640 1.060.120 885.780 759.660 759.660 759.660 90.000 Raise funding 972.940 2.127.580 3.187.700 4.073.480 4.833.140 5.592.800 6.352.460 6.442.460
Required step by step following go/no Go decision
Marco Cartolari, MBA
Managing Director
Marco Castelnovo, MBA
New Products & Business Development Manager
Antonella Sblendido
Medical Affairs
Management & Contacts
Scharper S.p.A
Via Milanese 20
20099 – Sesto San Giovanni (MI)
Ph: +39 02 2629161
Confidential