EZRA Innovations, LLC

Drug Development Expertise

Partnering Strategies

EZRA Innovations, LLC

A Pharmaceutical Research and Development Company

EZRAs novel tablet and formulation designs is a product of UAMS and acts as a platform technology enabling EZRA to mimic difficult to engineer branded drugs.

EZRA Team Highlights

Completed concept to finish, following the Abbreviated New Drug Applications (ANDAs) process Submitted and approved over 20 New Drug Applications (NDAs) to the FDA Created strategic partnerships for a number of drug development technologies

The EZRA Team

Cherng-Ju Kim, Ph.D. Inventor and Drug Delivery Consultant Michael Geranen Chairman, Chief Executive Officer Dr. Shirish Shah, Ph.D. Regulatory Affairs Joe Fix, Ph.D. Chief Operations Officer Hugh McTavish, Ph.D., J.D. IP Counsel Joe Bell MBA, J.D. Delivery Consultant

What is a Generic Drug?

A Fast Track Route Through the FDA
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

The 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

How is EZRA Different?

EZRAs ACT Technology compared to Tablet in Tablet

Asymmetrical

Symmetrical

Water-insoluble polymer

Water-soluble polymer

How is EZRA Different? (continued)

The symmetric tablet dissolves proportionately, reducing surface size and delivering the drug as a descending distribution The asymmetric tablet (EZRA technology) allows the distribution surface to remain constant, allowing for a precise and controlled drug distribution over time

Benefits of the ACT Technology

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

Controlling the Release Profile

Time = 0 A T1 T2 T

EZRA can design the technology in a variety of ways to achieve unique distribution patterns.

Enteric pH

Premium Priced Generic Opportunities

Dont think $4.00 Wal-Mart generic prescriptions, think generics with limited competition and premium pricing When the first generic enters the market the price will drop, but should remain near $100.00 for a 30day supply There is tremendous profit potential in targeting Super Generics

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

Thank you!