EZRA Innovations, LLC

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Drug Delivery Platforms Drug Development Expertise Partnering Strategies

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EZRA Innovations, LLC

A Pharmaceutical Research and Development Company

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A UAMS Developed Technology

The Secret Sauce:
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EZRAs Novel Tablet and Formulation designs act as a platform technology enabling EZRA to mimic difficult to engineer branded drugs

Developed over 200 Generic Drugs from concept to finish, following the Abbreviated New Drug Applications (ANDAs) process, (CRO Capabilities) Submitted and approved over 20 New Drug Applications (NDAs) to the FDA

Created strategic partnerships for a number of drug development technologies

Professional experience includes Merck, Teva, Watson, Johnson and Johnson

Cherng-Ju Kim, Ph.D., Pharmaceutics and Drug Delivery Michael Geranen, CEO Dr. Shirish Shah, Ph.D., Drug Program Management (ICON, PLLC) Joe Fix, Ph.D.Manufacturing and Controls, Drug Formulation, Former VP of Fujisawa, JnJ and Merck. Hugh McTavish, Ph.D./J.D.IP Counsel, Jennings Osborne, Ph.D., CRO Joe Bell, MBA/JD

The generic process uses an Abbreviated New Drug Application (ANDA) that is short and tightly defined by the FDA, versus New Drug Applications (NDA) It is NOT a new molecule that requires a long testing process EZRAs technology provides a new drug delivery method for an FDA approved and widely prescribed drug that is no longer on patent ANDAs only require testing in 36 patients to demonstrate a close approximation of blood levels as compared to the originally approved drug

EZRAs novel drug delivery platform is:

An engineered solution rather than a biologic approach to drug delivery systems Can be engineered to precisely control and manipulate the release of the targeted chemical compound Once-a-day designs (sustained-release) Applicable across a broad range of generic or branded drugs

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EZRA ACT Technology

Compared to

Tablet-in-Tablet

asymmetrical

symmetrical

water-insoluble polymer

water-soluble polymer

The symmetric tablet dissolves proportionately, reducing surface size and delivering the drug as a descending distribution (think reduction of surface size like an ice cube) The asymmetric tablet (EZRA technology) has fixed sides with the only exposure being the flat top surface and through the use of polymers, allows the distribution surface to remain constant, allowing for a precise and controlled drug distribution over time

Manipulate drug release rates to any desired profiles Protect the active chemical to improve shelf life Replicate difficult formulations found in other proprietary technologies Non-infringing delivery system

Examples of technologies that EZRA can replicate

Johnson & Johnsons OROS Tablet Technology Concerta Franchise +$1B
C-4

Novartis MicroCapsule Technology Focalin Franchise +400M

CONCERTA (methylphenidate HCl) Extended-Release Tablets

CONCERTA approved Children (6 to 12 yr): Aug 2000 Adolescents (13 to 17 yr): Oct 2004 Methylphenidate approved by FDA in 1955
CONCERTA tablet Drug overcoat Ratecontrolling membrane Push layer Delivery/ exit orifice Drug layer 1 Drug layer 2

GSKs DiffCore System

Lamictal Franchise $600M and growing

EZRA is different: EZRA can mimic multiple technologies with a single technology!

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time = 0
a

t1

t2

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EZRA can design the technology in a variety of ways to achieve unique distribution patterns. For example, coating the pill exterior with drug will cause an instant release followed by a constant release over the next 18 hours (A), or no release until the pill reaches the small intestine (F).

A
b

Enteric pH

Here, the objective is to replicate the distribution pattern of the target drug. By replicating the distribution pattern, EZRA can create a generic version of the drug and qualify for an accelerated FDA pathway for approval (ANDA). Note how the UAMS drug tracks the brand.

Dont think $4.00 Wal-Mart generic prescriptions Think generics with limited competition and premium pricing For example, a brand without competition might sell for $140 for a 30-day supply When the first generic enters the market the price will drop, but should still remain near $100 for a 30-day supply There is a tremendous profit potential in targeting Super Generics

Clinical Timeline Drug 1

Pilot Study 9 Patients 3-Way Crossover 26-36 Fasted/ Fed Clinical Trial Submission of Application to FDA FDA Approval Market Launch

Milestone Payment Month 9-12 Month 14-17 Month 17-20

Milestone Payment Month 40-43

Royalty To EZRA Month 44

Average ANDA FDA review time in 2008 was 21 months.

Ezras objectives in building value for our shareholders

Establish generic drugs with high barriers to entry and low litigation risk Ezra can compete with 80% of the sustained release drugs in the market Ezra will help drive down the cost of medicine The value of Ezra is in the ACT drug delivery system as a platform delivery system Move Ezra into position to be acquired for its technology and ongoing cash flow

The First 12 Months

Upsher-Smith Manufacturing Ezras formulations. Ezra runs Pilot Study optimizing formulation for success in clinical Bio Equivalence study. Ezra runs Bio Equivalent study. Ezras Results: Design of the 1st drug Successful pilot study validation of drug formulation and manufacturing processes Possible license or acquisition target but low valuation

Months 12-24

Bio Equivalence study complete Start drug target 2 Upsher and EZRA submit ANDA and wait for approval Drug Target enters pilot study and subsequent Bio Equivalence trial

Drug situation Two-Three dugs submitted to FDA for Generic approval 505(b)2 selections targeted More Upsher Drug targets managed clinically EZRA can help Upsher clinically manage upcoming pipeline Outlook With two drug in FDA process and another through pilot, $100200M in generic revenue expected

Projected Revenue
Year 1
Drug 1 Revenue Drug 2 Revenue Total Drug Revenues Interest Income UAMS Royalty Developer Royalty Gross Profit

Year 2 1,000,000 1,000,000 0 50,000 950,000

Year 3 0 0 0 0

Year 4 62,000,000 62,000,000 458,472 3,100,000 59,358,472

Year 5

Year 6

0 0 0

80,000,000 80,000,000 200,000,000 200,000,000 280,000,000 280,000,000 2,390,656 4,327,873 14,000,000 14,000,000 20,000,000 20,000,000 228,390,656 230,327,873

Michael Geranen 941-323-6577 mgeranen@ezrainnovations.net

Thank you!