Transcript Diapositiva 1 - Consiglio italiano per le Scienze Sociali

Scharper High Solutions
a spin-off of
Scharper SpA
Q-TER Space Project
Milan, 25th November 2009
Company presentation
Scharper SpA
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Group of Pharmaceutical companies,
Privately owned,
European based,
Successfully operating in Italy for over 14 years,
Track record for pioneering the nutraceutical/medical food market in
Italy
(2008, Values)
Int. Med.
45%
Women's
health
12%
Derma
5%
2008 Values
Drugs
65%
Non-Drugs
35%
ENT
38%
Confidential
Q-TER® Space Project
Current Challenges
• 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
Confidential
Project description
The solution : Q-TER®
Q - TER®
Terclatration
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
CoQ10
• potent lipophilic antioxidant
• involved in mitochondrial oxidative metabolism
• insoluble substance (poor bioavailability & stability problems)
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.
Confidential
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
Confidential
Project description
The solution: Proof of concept
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
Confidential
Project description
Potential market(*)
Expected number of patients (USA + EU)
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
(*) epidemiological studies trend
Confidential
Q-TER® Space Project
Competition
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
Confidential
Project description
Q-TER®: current
& future applications
Mental & physical fatigue
Powder in sachet
Q - TER®
already formulated in
Dizziness & tinnitus
Powder in sachet
dissolved in water after shaking before the
intake
Q-TER® space project:
• Develop new drug deliveries
• patches
• sublingual tabs
• Gather new proof of concept data
Medical needs:
• Disease A
• Disease B
• Disease C
• Disease D
Confidential
Q-TER® Space Project
The investment opportunity
• 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
Confidential
Project description
Timeline
Project start
Y1
Y2
Y4
Y3
Y5
Technology
development phase
Proof of concept
studies (*)
Product (1)
(disease A)
Disease A/B
Product (2)
(disease B)
Product (3)
(disease C)
Disease C
Product 4
(disease D)
Disease D
Go/no Go decision
(*) Pharmacokinetics – Animal studies
Confidential
Project description
Financials: Whole sales revenues (€)
Y1
Base case
Disease B
Disease A
Disease C
Disease D
Total (€)
Y2
-
136.137
136.137
Y3
3.706.146
344.428
3.448.708
7.499.281
Y4
11.197.011
697.121
9.489.786
2.476.059
23.859.978
Y5
18.792.643
1.058.230
18.343.160
7.517.316
45.711.349
Y6
24.600.680
1.249.417
25.190.627
12.679.206
63.719.931
Y7
28.581.836
1.445.040
33.700.820
19.247.035
82.974.731
Confidential
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.
Technical
Preclinical
Clinical
Patents
Management
Study 1
Study 2
Study 3
Study 4
Study 5
Study 6
Patent 1
Patent 2
Patent 3
Patent 4
Core
Partial
T0
200.000
240.000
60.000
T1
T2
T3
200.000
100.000
100.000
12.000
12.000
12.000
12.000
50.000
200.000
50.000
200.000
200.000
200.000
5.000
5.000
5.000
5.000
50.000
422.940
972.940
972.940
484.640
1.154.640
2.127.580
562.120
1.060.120
3.187.700
G&A
2% of Scharper G&A
Total
Raise funding
50.000
5.000
5.000
625.780
885.780
4.073.480
T4
70.000
10.000
10.000
669.660
759.660
4.833.140
T5
70.000
10.000
10.000
669.660
759.660
5.592.800
T6
70.000
10.000
10.000
669.660
759.660
6.352.460
T7
70.000
10.000
10.000
90.000
6.442.460
Required step by step following go/no Go decision
Confidential
Management & Contacts
Marco Cartolari, MBA
Managing Director
[email protected]
Scharper S.p.A
Marco Castelnovo, MBA
Via Milanese 20
New Products & Business
Development Manager
20099 – Sesto San Giovanni
(MI)
[email protected]
Ph: +39 02 2629161
Antonella Sblendido
Medical Affairs
[email protected]
Confidential