A UAMS Developed Technology

EZRAs novel tablet and formulation designs act as a platform technology enabling EZRA to mimic difficult to engineer branded drugs.

Ezra Innovations, LLC

Drug Delivery Platforms Drug Development Expertise Partnering Strategies

The EZRA Team

Michael Geranen Chief Executive Officer Joe Fix, Ph.D. Manufacturing and Controls, Drug Formulation, Former VP of Fujisawa, Johnson & Johnson and Merck Cherng-Ju Kim, Ph.D. Pharmaceutics and Drug Delivery Dr. Shirish Shah, Ph.D. Drug Program Management (ICON, PLLC) Hugh McTavish, Ph.D., J.D. IP Counsel Joe Bell MBA, J.D.

Ezra Innovations, LLC

EZRA Innovations, LLC
Arkansas Bioventures University of Arkansas for Medical Sciences 401 S. Cedar Street Little Rock, AR 72205
Arkansas Bioventrues OfficeUAMS Campus

A Pharmaceutical Research and Development Company

Phone: 501-686-6696 Fax: 501-686-8501 E-mail: mgeranen@ezrainnovations.com

How is EZRA Different?

EZRA has a unique opportunity to develop generic versions of branded drugs which face limited generic competition due to difficulties in formulation. EZRAs core business revolves around a unique, mathematically-based drug delivery technology called the Asymmetrically Controlled Tablet (ACT). This technology allows EZRA to develop a number of high barrier-to-entry, generic versions of extended release (once-daily) drugs. EZRA can compete against the pharmaceuticals expensive brand in generic form because of its unique drug delivery technology assessing a large pre-built market. EZRAs drug delivery technology is flexible in design so that it can be engineered to control and manipulate the release of the targeted chemical compound over a 24hour period.

FDA Regulatory Guidance

EZRA follows the generic Abbreviated New Drug Application process. This is a short, well defined process outlined by the FDA which allows for generic drug approval to the brand named drug. The Pioneer brand drug has already completed the difficult clinical trial which may have required 7.5 years time and inordinate amounts of money. EZRA simply has to conduct a blood level study comparing the release of EZRAs drug in the body to the brand (36 patients). For this reason, EZRA can conduct a number of trials for generic drug approval supporting a valuable suite of products.

advantage. Price of manufacturer on a per pill basis is substantially less than other drug delivery technologies. Being able to control and manipulate the release profiles of several sustained release drug delivery technologies utilizing mathematics and geometry, where other technologies are designed from a biological perspective specifically with the delivery of the brands active ingredient in mind.

Competitive Advantages of the ACT Technology

To be approved as an FDA generic substitute, EZRA must demonstrate bioequivalence with the brand drug. Being able to replicate across a spectrum of drug franchises without infringement to the formulation or the brands technology is competitive advantage of the ACT platform; allowing EZRA access to large markets. Being able to provide higher milligram strength dose-loads in a sustained release fashion is a distinct competitive

Ezra Innovations, LLC

Arkansas Bioventures University of Arkansas for Medical Sciences Phone: 501-686-6696 Fax: 501-686-8501 E-mail: mgeranen@ezrainnovations.com