TDS Tech Presentation 2010

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

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-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

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5.0

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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

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g/m

l)

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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