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very capital intensive industry. In addition, EZRA transfers much of the financial and legal risk to a competent and established market partner with strong distribution capabilities. The EZRA technology is a platform with which many generic drugs will be developed. It can also be used for branded drugs for which the delivery profile is difficult, in addition to being used with newly formulated drug compounds.
EZRA relies upon the Food and Drug Administrations (FDA), expedited approval process referred to as the Abbreviated New Drug Application. Approximate EZRA development and FDA approval time is 39 months versus the Brands New Drug Application of 7.5 years.
Within 3-4 Years, EZRA will have built a generic drug pipeline in excess of $150M, proven its unique drug delivery technology, and ideally achieved its target of possible exit valuation in excess of $250M.
Strategic Partners/Competitors
There are three types of competitors that can also be classified as potential partners for EZRA within the generic market. The following are the three types of competitors: A partnership can be formed with any of the following classes of competitors, for example the first class would be illustrative of the Anchen-Teva partnership. Large, well-established generic companies such as, Teva, Watson, and Sandoz Mid-size generic companies such as, Par Laboratories, Impaxx Labs, Prasco Large pharmaceutical companies looking for generic opportunities such as, Pfizer and many others
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81,938 0 81,938
and second, EZRAs specialized delivery system can protect the active molecule against the degrading elements.
EZRAs Technology
EZRAs drug delivery technology allows EZRA to target difficult formulations. Not all drug delivery technologies work in the same fashion. For example, several independent technologies have been developed specifically for each franchise. Each franchise has its own particular technological hurdles to deliver the active chemical compound at the right time and location in the body. EZRAs single technology can replicating all three drug franchises, and mimic 90% of the sustained release, once-daily drugs in the market. In total, these three franchises sell $2B a year. The outer core is a water-insoluble shell, with a top layer, or cap which may, or may not contain drug chemical (see Figure 1). The core within the shell is a layered matrix of active drug. This matrix provides sustained release properties (see Figure 1). Utilizing the mathematics of the constant exposed surface area of the matrix, manipulation of FDA approved polymers, and
mathematical asymmetrical design properties, the ACT system is able to control and manipulate release rates of the drug, and location of release in the body (see Figure 2 and Figure 3).
Cross-Sectional
Asymmetrical
Symmetrical
Water-insoluble polymer
Water-soluble polymer
As demonstrated below in Figure 4, the EZRA simulations track the brand drugs release, demonstrate bioequlivancy, and fall within the FDA parameters for generic approval. This invitro testing needs to be replicated in human clinical trials to satisfy FDA ANDA (Abbreviated New Drug Application) guidelines. Please note that the ANDA guidelines do not require a demonstration of either drug safety or efficacy, EZRA needs to only demonstrate bio equivalence.
Operations Summary
EZRA, in an effort to control both startup costs and maintain complex industry levels of excellence and compliance, will initially outsource testing, compliance, and marketing functions. By implementing an effective outsource strategy, EZRA is capitalizing on top industry experts and reducing select industry risks. EZRA recreates the expertise of a Large Pharmaceutical company in a lean and nimble small organization. EZRA core drug development experts have developed over 200 drugs from start to finish. The advisory board careers span years at Merck, Johnson & Johnson, Teva, Watson and Perrigo Company.
Clinical Manufacturing
EZRA will outsource all clinical batch manufacturing to a designated Contract Manufacturing Organization (CMO). The CMO that has been selected has an outstanding reputation with the Food and Drug Administration and has 5 of the top 10 pharmaceutical companies as clients. ACT can be commercially manufactured by a three-step or one-step processes at their location.
Clinical Trials
The drugs targeted by EZRA have already been FDA approved for their original indications (efficacy and safety). Because the underlying drug compounds have already been approved by the FDA, EZRA will be filing a generic ANDA which requires only a truncated approval process, of which a Pivotal Fasting Study 36 subjects without food, and a pivotal fed with food, 24 subjects in order to demonstrate bioequivalence. The human clinical trials would cover a period of approximately 12-15 months. EZRA has identified a leading Contract Research Organization.
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Management
Dr. Cherng-ju Kim, Ph.D. Inventor and Drug Delivery Consultant
Dr. Kim is a Professor in the Department of Pharmaceutical Sciences at the College of Pharmacy, University of Arkansas for Medical Sciences (UAMS). Dr. Kim holds a Ph.D. in Chemical Engineering (1984) from McMaster University, Hamilton, Ontario, Canada with a Major in Polymer Reaction Engineering. A Masters in Engineering (Environmental) (1979) from Environmental Science and Engineering Department at Manhattan College, Riverside, N.Y. and a Bachelors in Engineering in Chemical Engineering (1974) from Korea University, Seoul, Korea. In 1986, he founded Khimm Chemical Co., Toronto, Ontario, Canada to develop and market reverse osmosis membranes for home drinking water systems. He later sold his interest in 1988. From 1984 to 1986 Dr. Kim was a research Scientist, Membrane Research and Development with Zenon Environmental, Inc., Burlington, Ontario, Canada where he worked on developing synthetic ultra-filtration membrane for treating food processing wastewater. Dr. Kim currently holds six patents, and has written three books and 71 academic papers, all addressing pharmaceutics.
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President & COO, CyDex, Inc Exec VP & COO, Elan NanoSystems President and CTO, Yamanouchi Pharma Assoc Dir, Biopharmaceutics, Alza Assoc Dir, Biopharmaceutics, Merck
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biopharmaceutics. Directed the new product development program., Filed six ANDAs, one of which was a transmucosal dosage form of pain medication with complex design and technology that was developed and filed on a very short timeline. Expedited the manufacture of a proprietary Controlled Release pain product for Phase II Clinical Studies. Dr. Shahs notable responsibilities at Perrigo Company include leading a group of up to 18 scientists and technicians to develop 30-35 new Generic products per year, Dr. Shah successfully developed many first to market generics, including common household names such as Tylenol extra strength. Dr. Shah served as technical / scientific key team member of the Pharmaceutical Business Development group responsible for the acquisition, licensing, contract development and manufacture of special technology based products.
Robert H. Lake Executive Vice President, (Consulting) Sales & Marketing /Director
Rob graduated from the University of Mississippi in 1981 with a Bachelor of Arts degree in Biology. He began his pharmaceutical career in 1984 with Wyeth Laboratories where he served as a Hospital Representative. Rob then joined Fisons Corporation as a National Accounts Manager, working in areas such as National Account coverage, Marketing, Sales, Finance, Customer Service, and Distribution. He has held executive level positions with Capellon Pharmaceuticals, Primus Pharmaceuticals and most recently with Adamis Laboratories. Rob has over 25 years experience in launching Rx products and distributing those products to wholesale and pharmacy retail outlets. He is a member of several important pharmaceutical organizations, which includes the National Association of Chain Drug Stores, Healthcare Distributors Marketing Association, and the Food and Marketing Institute. He was a nominee for the prestigious 1994 Diana Award for outstanding trade practices in the pharmaceutical industry. .
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quality of care their employees receive. Tery has been very active in pharmacy associations on both a state and national level, serving as President of the Arkansas Pharmacists Association and also on the Board of Trustees of the American Pharmacists Association. He also served on the APhA Foundation Board of directors for six years including one as President. He has made numerous presentations across the U.S. and abroad on the subject of The Pharmacist Role in Managed Care and the Future of Pharmacy. His presentations include the U.S. Senate Committee on Aging and Hillary Clintons Task Force on Health Care Reform.
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pharmaceutical development company. From 1994 to 1998 he was the Chief Executive Officer and Chairman of the Board of Sigma Diagnostics, a multinational clinical diagnostics company. Prior this he held various university faculty positions in North Carolina and Texas. He served as Professor and Chairman of Biochemistry and Biophysics and in the Curriculum in Genetics and Molecular Biology and Biotechnology at the University of North Carolina Medical School, Chapel Hill, North Carolina from 1989 to 1994. Prior to this he advanced through the academic faculty ranks at the University of Texas Medical Schools in San Antonio and Dallas. Dr Douglas continues his research interests and has authored numerous peer reviewed scientific articles and is an elected member of different scientific and professional societies. He maintains active positions on various civic, corporate, academic and scientific advisory boards in the Midwest and abroad. He received his BS degree in Chemistry and Biology from Southwestern University and his PhD from Saint Louis University. He is decorated veteran of the Vietnam conflict. He is married to Joanne and has three grown children, Hannah, Peter and Sarah.
This overview is for informational purposes and is not an offer to sell or a solicitation of an offer to buy any securities in EZRA Innovations, LLC, or any of its subsidiaries, and may not be relied upon in connection with the purchase or sale of any security.
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