Pantec Biosolutions

P.L.E.A.S.E.®
needle free drug delivery through the skin
Christof Böhler, Drug Delivery Partnerships, Jan 2008
Pantec Biosolutions AG
Founded in November 2005 in Liechtenstein
Joint venture between Pantec Engineering
AG and a big In Vitro Fertilisation Centre
Staff of 6 plus 25 FTE’s in collaborations
ƒ
ƒ
80% engineers
20% biomedical scientists
Collaboration partners Europe and USA
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slide 2
We replace injections with patches
Currently used Injection therapy for
In Vitro Fertilisation (IVF)
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video
P.L.E.A.S.E.® (Painless Laser Epidermal System)
Painless laser microporation of the skin
+ drug containing patch
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slide 3
Large molecule drugs
can only be injected because…..
ƒ when taken orally, they are
ƒ degraded by the gastrointestinal system
ƒ degraded by the liver
ƒ when applied as skin patch
ƒ they do not penetrate the stratum corneum
ƒ they are too big
ƒ they need a selective “opening of the skin”
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slide 4
Why we do it – big market opportunities
First focus market
In Vitro Fertilisation (IVF)
$ 2 billion
Global biopharmaceuticals market1
therapeutic proteins, hormones, antibodies, etc.
$ 60 billion (CAGR 15% !)
40% (=$24billion)
lost patent
protection
Anti inflammation
Immunesuppressants
Multiple sclerosis
Hepatitis C
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Source
1 GEN, vol 27, Nr 9,
May1, 2007
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slide 5
Why we do it – Pharma is in trouble
Genetic Engineering & Biotechnology News, May 01, 2007
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slide 6
How we do it
Active laser poration of the outer skin layers
prior to intraepidermal drug application
P.L.E.A.S.E.®
Painless Laser
Epidermal System
Benefits
• Painless
• Easy to use
• Handheld
• Self application &
• Home use possible
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slide 7
P.L.E.A.S.E.® - the design
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How we do it - P.L.E.A.S.E.® - platform
Pore array on human skin in vivo
Single pore
60 μm depth
200 μm width
200 μm
4 mm
200 μm
Data from human cutaneous tolerability study
Dec 2006
150 pores on a 6 mm circular array
(proDERM GmbH, Hamburg)
Biopsy taken from forearm
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slide 9
How we do it - PBS core competencies
Laser and optical tissue
interactions
Engineering & technology
partnering expertise
Active IP management
Biomedical & regulatory
application know how
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slide 10
How we do it - PBS core competencies
Preclinical data
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slide 11
Diclofenac permeation: effect of P.L.E.A.S.E.®
Cumulative delivery (mcg/cm2)
Experimental Conditions:
Diclofenac sodium dissolved in water (10 mg/ml)
900 pores, Area = 3 cm2; porcine skin in vitro
2500
P.L.E.A.S.E.
2000
Passive
1500
1000
500
0
0
Pantec Biosolutions AG
4
8
12
16
Time (h)
20
24
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slide 12
Lidocaine permeation: effect of P.L.E.A.S.E.®
Cumulative delivery (mcg/cm2)
Experimental Conditions:
Lidocaine HCl dissolved in water (10 mg/ml)
Area = 3 cm2; porcine skin in vitro
2500
Passive
P.L.E.A.S.E. 150
2000
P.L.E.A.S.E. 300
16.9 x Pass.
P.L.E.A.S.E. 450
15.5 x Pass.
P.L.E.A.S.E. 900
1500
13.1 x Pass.
1000
7.2 x Pass.
500
0
0
Pantec Biosolutions AG
4
8
12
Time (h)
16
20
24
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slide 13
Progesterone permeation: effect of P.L.E.A.S.E.®
Cumulative delivery (mcg/cm2)
Experimental Conditions: PHARMA X, PGEL 1%; ACB 6%
400 pores: 60 μm depth, 200 μm diameter
Area = 3 cm2; human abdominal skin in vitro
1200
ACB
1000
PHARMA X
PGEL
800
600
400
200
0
0
Pantec Biosolutions AG
4
8
12
Time (h)
16
20
24
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slide 14
Triptorelin permeation: effect of P.L.E.A.S.E.®
Cumulative delivery (mcg/cm2)
Experimental Conditions:
Triptorelin dissolved in water (3 mM; 3.9 mg/ml)
900 pores: area = 3 cm2; porcine skin in vitro
400
350
300
250
FT
DERM
200
150
100
50
0
After 6 h
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After 24 h
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slide 15
hGH permeation: Effect of P.L.E.A.S.E.
Exptal Conditions:
hGH dissolved in water (3 mg/ml)
Area = 3 cm2; porcine skin in vitro
Cumulative delivery (ug/cm2)
14
12
FT
DERM
10
8
6
4
2
0
3h
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6h
24 h
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slide 16
Overall achieved targets
Controlled micro pores
Painfree
Short healing times
Small pore array
Variable pore depth
Fast treatment (seconds)
Controlled drug delivery
Conventional drug patch
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slide 17
Business model – winning relationships
Pharma, Specialty Pharma,
Biotech
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Device development &
production
IP management
Preclinical development
Regulatory expertise
General project management
Physicians in the team =>
“patient demand in mind”
Pantec Biosolutions AG
Strong in selected therapy
areas
Strong need for innovative drug
delivery solutions
Strong interest in intradermal
drug delivery
Strong in Sales & Marketing
IVFspecialist
Patient
Health
insurances
Pharmacist
Pharmacy
Patch Company
Innovation driven
Willing to take a risk and take
the reward
Strong intradermal protein
formulation expertise
Strong in manufacturing
patches
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slide 18
Strategic considerations
Issue
Pantec BS only tests approved molecules
P.L.E.A.S.E.® - platform developed
Therapeutic amounts of IVF hormones
delivered in vitro
Reputable patch partner under contract
Pantec BS can take over the role of a general
contractor and deliver the entire sales
packages, = device plus patches to licensing
partner
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Benefit for licensing partner
Lower regulatory and clinical cost and risk
No issue for licensing partner
Licensing partner can choose to co-develop
either all three or single hormone patches
No issues with operative project management
for licensing partner
A one stop shop for innovative transdermal
applications
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slide 19
First target market - In Vitro Fertilisation
Infertility affects 20% of all couples!
1 million IVF stimulations globally per annum
2 to 3 months of daily painful self-injections by the patients
$2 billion total IVF hormone market growing at >10%
Inhouse clinical & market intelligence “IVF Institutes” by Prof. Zech
First customer IVF-Institutes (5 private clinics) secured
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slide 20
Patient interviews – In vitro Fertilisation
Spontaneous associations thinking of the hormone treatment
17,7%
2,4%
Negative comments
Positive comments
Neutral comments
Negative Comments
ƒ Painful injections
ƒ Number of injections
ƒ Partner needed
79,8%
Would you decide for the new pain free laser method, should it be
available next time?
Very probable
Probable
It depends
I stick to injections
Don’t know
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slide 21
Summary - achievements
P.L.E.A.S.E.® platform developed and first series produced
Skin and patient tolerance proven by clinical tolerability study
Therapeutic amounts of IVF hormones delivered in vitro
First positive clinical results with IVF hormone
Hormone patch development with reputable patch company initiated
Co-development agreement with Pharma company in place
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slide 22
Team internal and external
Picture taken at Technical
review meeting
September 2006
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slide 23
Acknowledgements
Thomas Bragagna, CTO
Entire PBS team
Dr. Yogeshvar Kalia
Dr. Yogeshwar Bachhav
All outsourcing partners
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slide 24