Abbreviated TECHNOLOGY OVERVIEW
Winter, 2010
Agenda
• Who are we?• What is our science?• Why is it important?• How does it work?• What are examples of success?• How can we collaborate?• Next steps
Corporate Overview
TransDermal Technologies is a company focused on the development and propagation of unique drug delivery technologies
The Company has developed TDS, a transdermal drug delivery platform with a strong intellectual property position.
TDS has the ability to be adapted to deliver molecules of up to 10,000 Daltons
TransDermal Key Development Partners
St. Bartholomew’s & Royal London School of Medicine & Dentistry
The William Harvey Institute, Department of Experimental Pathology, St. Bart’s and the London
Queen Mary and Westfield College, University of London
TransDermal Technologies Management
Management Team
Ken Kirby President and Founder
Chandan Alam, MD Chief Scientific Officer
Annis Arasim Vice President, Chief Financial Officer
Bruce Crawford Vice President Commercial Operations
John Hannon Business and Financial Advisor
Arthur C. Tucker, Ph.D. Clinical Trials Manager
Business Advisors
Don Rosenkoetter
Myron Holubiak
Tim Duffy
Al Forcella
TransDermal Technologies ManagementScientific Advisory Board
Chandan Alam, M.D. Director, Wm. Harvey Research Limited, Pre-Clinical & Clinical Research Advisor
Gustav Born, M.D., Ph.D., F.R.S. Research and Development Advisor, WHRI
Shern L. Chew, MD, P.D, Professor of Endocrinology, Barts and the London
Atholl Johnston, Ph.D., MRCPath, Clinical Pharmacology, WHRI
Richard Langford, MD, MRCS, FCRA, Deputy Director of Research ,Professor of Anesthesiology, Laboratory and Director of Pain Clinic Barts and the London
Arthur C. Tucker, Ph.D., Director of the Ernest G Cook Microvascular Unit and Chairman of the East London and City Ethics Committee
Elizabeth G. Handel, Ph.D., Director, Biotechnology Institute at Palm Beach State College
Lawrence G. Wylie, Ph.D., CIH, CSP, Director Environmental Health and Safety ,The Scripps Research Institute
CV’s are available by request
TransDermal’s Innovative Solution:The TDS Platform
TDS enables companies to:• Accelerate product development for new
chemical entities (NCE’s) in a range of therapeutic areas
• Improve the speed of delivery, compliance, safety and efficacy of current and future drugs
• Provide line extensions of currently marketed products
• Extend the lifecycle of products
The Attributes of TDS Technology
• Efficient, safe, across-the-skin drug delivery system
• Formulated using a proprietary patented approach
• Drug-specific
• Dose-specific
• Short formulae development time
• Unique in concept and performance
Composition of Typical TDS Application
A standard TDS® formulation consists of the following:
• Active ingredient
• Solute modifiers
• Solvent with solvent modifiers
• Energy donors
• Skin stabilizers
All Ingredients are Generally Regarded As Safe, with one exception, which is sold in the U.S. as a food supplement.
The TDS® Formulation Process
TDS® Formulation
Beyond FormulationTransDermal Manufacturing Relationships
• Formulation chemistry is
not complex• Orders of addition and
temperature deltas
must be observed• Any FDA-licensed GMP
facility can fill (subject
to DEA license
requirements
TDS formulations easily scale up
Cost per dose is competitive with Tablets
Intellectual Property
• U.S. Pat. 6,444,234 issued 9/3/02• U.S. Pat. 6,787,152 issued 9/7/04• New patent filed October, 2004 –
First office action 8/08• U.S. Pat. App. 7,267,829 Issued
9/11/07 • Patent Office defined 38 other
inventions• Latest is “product-by-process” patent,
Claims allowed June ‘07• 18 EU Patents issued• No similar drug delivery patents• A-rated IP quality• Additional new art will further protect
the franchise
-2.0
-1.5
-1.0
-0.5
0.0
0.5
1.0
-2 0 2 4 6 8 10 12
Time (h)
Mea
n [T
esto
ster
one]
,Cha
nge
from
ba
selin
e: (n
g/m
L)
TDS®-Placebo TDS®-Testosterone Androgel®
Demethyl Diazepam Levels From Diastat(R) and TDS(R) Diazepam
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Time Points (Zero to 72 Hours)
Mic
rog
ram
s /
Lit
er
Diastat
TDS Diazepam
TDS Trial Results
0
10
20
30
40
50
0 2 4 6 8
Full GLP Trial - Ibuprofen
Time (Hours) After Ibuprofen Treatment
Ser
um
Ibu
pro
fen
(u
g/m
l)
0
10
20
30
40
50
60
1 2 3 4 5
Verbal Rating Score Category
Perc
enta
ge
Active
PlaceboHuman Lidocaine Trial
TO-DATE 18 TRIALS WITH 15 DIFFERENT MOLECULES HAVE BEEN CONDUCTED. . . INCLUDING A PEPTIDE AND 5 HUMAN TRIALS
. . . . ALL HAVE BEEN A SUCCESS
• Anti-Histamine: Hydroxyzine TDS® Pre-clinical
• Anti-NeovascularCystamine Pre-clinical
• Anti-Infective: Acyclovir TDS® Pre-Clinical
• Pain Management: Morphine Sulphate TDS® Pre-Clinical Ibuprofen TDS® Pre-Clinical & Therapeutic Outcome Lidocaine TDS® Clinical Therapeutic Outcome Acetaminophen – Pre-clinical
• Hormone Replacement Therapy: Testagen™ Pre-Clinical and Preliminary Clinical Progesterone TDS® Pre-Clinical a - Melanocyte Stimulating Hormone Analogue - Pre- Clinical and Preliminary Clinical
TDS Success Summary
Publications and Posters
TDS Posters
TDS Posters
Product Development Opportunities
There are several fairly well-advanced “low hanging applies including:
• Testosterone TDS• Progesterone TDS• Lidocaine Tetracaine TDS• Alpha Melanocyte Stimulating Hormone (Melanotan)• Diazepam
Testosterone and Progesterone
A two-pronged attack and takes advantage of our big head start on these applications which makes them the "lowest hanging apples" with the least time and cost to a license deal. Topical gel T is a $700 Million per year market:
• We have already completed three trials of TDS® T• In each case, exceeded AndroGel ®, in safety,
efficacy and ease of use• Dermal Toxicity comparison to AndroGel ®
showed us 5X safer• We have received one peer-reviewed
publication and expect more• The trial can be quickly organized • Progesterone believed to be as large
or larger market
Testosterone Next Steps
• Finalize protocol• Pre-Phase III meetings with MHRA• Revise protocol with regulatory input• Perform trials
- Dose Range Study
- 150 Ss, 12 Weeks
- Transference Study
Progesterone
• We learned that compounded natural Progesterone in a gel or oral suspension is a very common prescription in FP and Ob/Gyn practices
• Opinion formers at the ENDO meeting believe it to be a bigger market than T
• Inherent safety of progesterone and difficulties with Progestin should insure a natural progesterone TDS would get quick approval
Bensacaine/Tetracaine
• Rapid-onset skin anesthesia has multiple applications including needle-stick anesthesia and dermatological procedures
• Market for pediatric practice is estimated at $200 Million a year
• Dermatology, cosmetic surgery and hospital market could be as large or larger
• Approval could be OTC that is,it may have approval
• If desired Phase III trials easy to do, small N
Diazepam
• Indication: Breakthrough Seizure Disorder• Compared against Diastat® Rectube 10 mg• 10 Mg D TDS accomplished therapeutic levels of
active Desmethyl Diazepam at the 15 minute draw vs. 2 hours post dose for Diastat
• Diastat sales are $70 Million – we believe D TDS would be picked up by hospitals growing sales well past this number.
Diazepam Development
• Completed trial is a “proof of concept” showing that the drug can be delivered across intact skin, be very effectively metabolized and achieve a curve similar to oral or IV dose, albeit faster to therapeutic level
• Next trial should be a Phase II dose range trial – 30 Ss
• Then a Phase III trial for approval – 60 Ss• Diastat was approved with similar numbers
How Can We Collaborate
Once a business relationship is made we can:• Provide ethics and Reg. Compliance work• Provide pre-clinical through phase III trials
including assays, statistics and publications• Assist in development of CMC file
OR• We can provide a formula
What are your needs?
How can we help?
Innovative Delivery Solutions
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