Dharma Therapeutics
Corporate Overview
January 19, 2010
Seattle, WA
January 19, 2010 1
Overview
Corporate Overview
Why work with Dharma? Our internal and
external transdermal and iontophoretic expertise
Iontophoresis
Why iontophoretic products have not seen real
commercial success
Dharma’s Approach
Dharma’s Pipeline
January 19, 2010 2
Corporate Overview
Transcu Ltd – Singapore
Corporate headquarters
Dharma Therapeutics, Inc – Seattle, Washington USA
Innovative, non-invasive delivery of drugs through
the skin
Development of state-of-the-art iontophoretic
transdermal delivery systems from pre-clinical
through approval
TTI ellebeau, Inc – Tokyo, Japan
R&D, passive delivery and iontophoretic electrode
technology
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Business Model
Internally develop novel pipeline products
License pipeline products to pharmaceutical and non-
pharmaceutical partners for commercialization
Establish relationships with pharmaceutical and non-
pharmaceutical companies to work on early stage
product opportunities
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Dharma’s Internal Expertise
17 employees with broad industry experience
Regulatory, Quality Assurance, Quality Control, Clinical Trials
Executive Management, Project Management
GMP Manufacturing for early stage products
R&D capable of both in vitro and in vivo studies
Established quality system that is compliant with FDA
regulations for drugs and devices.
Proven track record of moving products from early stage
development through successful Phase 2 clinical trials, with
on-going Phase 3 development
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Dharma R&D
Evaluation of drug targets in vitro and in vivo allowing
go/no go decisions to be made quickly
Onsite vivarium for small animals, access to larger animals
via collaboration
Access to human skin for model confirmation
Experienced team of scientists
Head of Engineering with over 15 yrs direct experience in
drug delivery science and technology (primarily
iontophoresis)
Three additional scientists with over 16 years combined
experience in iontophoresis and passive transdermal
delivery
Additional scientific expertise at TTI’s Tokyo laboratories
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Hardware & Analytical Support
State-of-the-art Permeation Systems
Two 8-channel galvanostat/potentiostats
One frequency response analyzer
One 9-channel and one 3-channel in vitro permeation
systems for iontophoresis and one 8-channel passive
permeation system
Three automated HPLC systems
One MS system
Radio-label tracer experience
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Dharma’s External Expertise
Established networks with broad capabilities
Commercial transdermal patch manufacturing
State-of-the-art print technology for electrodes
Electronic development and design
Microprocessor control (hardware and software)
PCB layout and related component design
Electronic manufacturing capability meeting FDA
requirements
Access to proprietary state-of-the-art battery, ASIC and
printed circuit technology
Analytical labs with expertise in transdermal method
development and validation
Clinical, regulatory, compliance and product development
expertise
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Iontophoresis
Uses an electric field to transport charged molecules
across the skin
Advantages of Iontophoretic Delivery
Precise control
Rapid delivery
Avoids first pass metabolism
Versatile
Patient friendly
Proven safe and efficient
Track record of FDA approval
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Why Have Iontophoretic Products
Not Been Successful?
Initial products (from Iomed, Empi, Life-Tech) were
medical devices only
Device and drug not designed to work in combination or
for specific application
Formulations not optimized
“Generic” electrode configuration not designed for specific
drug, application site or therapeutic indication
Inadequate clinical data to demonstrate efficacy
Bulky desktop/handheld controllers requiring tethering to
electrodes
User filling required
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Why Have Iontophoretic Products
Not Been Successful?
Next generation products (from Vyteris and ALZA)
were drug/device combinations, but failed because of
one or more of the following:
Cost
Complexity
Manufacturability at commercial scale
Stability
Marketing and reimbursement strategy
Corporate financial status
Ease of use, size
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Dharma’s IDDS Solution
Device and drug designed to work in
combination for specific application
Formulations optimized
Specialized electrode configuration designed
for specific drug, application site and
therapeutic indication
Products designed with the end user in mind
Prefilled patch
Small controller that easily attaches to the patch
Products designed to for commercial scale
manufacturing with a low cost of goods
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Local Anesthesia
Market Opportunity
Well documented opportunity for a product that induces local
anesthesia rapidly, in a cost effective manner
Opportunities to reduce pain during a variety of procedures
Blood draw, blood gas, IV cannulation, minor dermatological
procedures, chemotherapy administration
Opportunities to reduce pain for numerous patient populations
Pediatrics, those who are needle phobic or pain averse
Existing product use is limited by undesirable characteristics
such as long onset time, high cost, or ineffectiveness
EMLA cream claims local anesthesia 60 minutes after
application and represents a >$90MM market
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The Dharma Solution→
Transdermal Lidocaine
Advantages of local lidocaine product
Reduction in pain and anxiety for pain/needle-
phobic patients
Faster throughput of patients reduces overhead cost
to healthcare providers
Easier to place needle post treatment
Reduction in children’s pain and anxiety
Reduce need for lidocaine injections in
dermatological surgeries
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The Dharma Solution→
Lidocaine IDDS
Our product has been designed to meet the
market demand for a low cost, fast onset local
anesthesia product
Lidocaine IDDS will be highly competitive on price
and onset time → provides large share of the
existing local anesthesia market
Lidocaine IDDS’s fast onset time (8 min) →
creates new markets within needle stick,
dermatology and other areas
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Lidocaine IDDS
Product Configuration
Small controller easily attaches to prefilled patch
via magnetic interconnect
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Lidocaine IDDS
Key Benefits
It's Quick.
After just an 8-minute application, provides local anesthesia
It's Easy.
Single-use patch is pre-filled with Lidocaine & Epinephrine
Multi-use power-supply is pre-programmed for ease of use with no dials to set or
current to adjust, provides visual feedback, attaches to patch with magnet
It's Effective.
Proven iontophoresis technology delivers Lidocaine at the injection site
Long duration anesthetic effect
It’s Safe.
Both Lidocaine and Epinephrine have established safety profiles
Drug products based on iontophoretic technology have been approved by the FDA
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Lidocaine IDDS
Clinical Trial Summary
Phase 2A: Phase 2B:
A Double-Blind Randomized, A Multicenter Double-Blind Randomized
Placebo-Controlled, Two-Arm Study Placebo Controlled Two-Arm Study
Evaluating the Safety and Efficacy of Evaluating the Safety and Efficacy of the
the Iontophoretic Administration of Iontophoretic Administration of Lidocaine
Lidocaine and Epinephrine Versus and Epinephrine Using Lidocaine
Placebo Using the DTI/TTI IDDS to Iontophoretic Drug Delivery System
Induce Local Anesthesia Prior to (IDDS) to Provide Local Anesthesia for
Venipuncture in Healthy Adult Venipuncture in Healthy Adult Volunteer
Volunteer Subjects Subjects
70 Subjects Treated 89 Subjects Treated
36 Active 57 Active
34 Placebo 32 Placebo
Age 18-57 years Age 18-66 years
No SAEs No SAEs
3 AEs in 3 subjects – 2 mild, 8 AEs in 5 subjects – 6 mild, 2
1 moderate moderate
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Lido IDDS Pain Scores
Median VAS Scores
25.0
20.0
VAS Score, mm
15.0
10.0
5.0
0.0
Placebo Active Placebo Active
Phase 2B Phase 2A
Phase 2B p= 0.0235, Phase 2A p <= 0.01
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Device Was Well Accepted
Was Your Pain Eliminated? Would You Use IDDS Again?
100.00% 100%
90.00% 90%
80.00% 80%
70.00% 70%
60.00% 60%
50.00% 50%
40.00% 40%
30.00% 30%
20.00% 20%
10.00% 10%
0.00% 0%
Phase 2B Active Phase 2A Active Phase 2B Active Phase 2A Active
% Answering YES % Answering YES
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Pipeline
Partnering Opportunities
Seeking partners to support clinical development
and commercialization of pipeline projects
Seeking partner for regional or world-wide
marketing, distribution and sales
Lidocaine/ Epinephrine for local anesthesia (Phase 2
studies completed)
Anti-inflammatory (pre-IND meeting completed)
Anti-nausea (pre-clinical)
Other targets under evaluation in pain, Alzheimer's and
Parkinson’s diseases
January 19, 2010 21
Contact Us Today To Learn More
About Pain Free Drug Delivery
Paul Sleath, PhD – President & CEO
206-330-2591
psleath@dharmatherapeutics.com
Dharma Therapeutics
1124 Columbia Street, Suite 450
Seattle, WA 98104
www.dharmatherapeutics.com
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