TransTech Pharma, Inc.

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December 10, 2012 Issue

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Addressing areas of Unmet Medical Needs such as Alzheimer’s disease, Diabetes, Obesity and Cancer, TransTech Pharma, Inc. is advancing Molecules Discovered through their Translational Technology® that Translates the Functional Modulation of Human Proteins into Safe and Effective Medicines

About TransTech Pharma:

www.ttpharma.com

TransTech Pharma is a privately held, clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The Company’s high-throughput drug discovery platform, Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. TransTech Pharma has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, diabetes, obesity, cardiovascular disease, inflammation and cancer.

Adnan M. M. Mjalli, Ph.D.
Chairman, President and CEO

Dr. Mjalli is an internationally recognized expert in drug discovery and development of new medicines in the pharmaceutical and biotechnology industry. Dr. Mjalli is the founder, Chairman of the Board, President, and CEO of TransTech Pharma, Inc. and High Point Pharmaceuticals LLC., both of which are drug discovery and development companies of novel medicines. Dr. Mjalli is also a founder and Chairman of High Point Clinical Trials Center (HPCTC) Inc., a clinical trials research center that conducts human clinical trials. In addition, Dr. Mjalli is the founder and Chairman of the Board and former President and CEO of PharmaCore Inc., a drug manufacturing company. Dr. Mjalli obtained his Ph.D. in Medicinal Chemistry in 1989 from the University of Exeter, UK. His postdoctoral work was carried out at the University of Rochester. Dr. Mjalli has held various positions of increasing responsibility in research and senior management at several pharmaceutical and biotechnology companies including Merck & Co., Inc. and Ontogen Corporation. He is the author of more than 40 scientific papers, four book chapters and an inventor on more than 700 patents and patent applications. Dr. Mjalli served on the Board of Directors of Siga Technologies, the North Carolina Biotechnology Center, Guilford Technology Community College (GTCC) Board, and High Point Economic Development Corporation. Currently, Dr. Mjalli serves on the High Point University Board, The Foundation Board of GTCC, High Point Chamber of Commerce, the Arab American University, the American Task Force on Palestine, America-Mideast Educational and Training Service, Inc. (AMIDEAST), and is a member of the American Chemical Society.

 

Dr. Mjalli has been the recipient of several awards and honors including: the 2012 “Circle of Excellence Award”, the 2011 “Palestine Presidential Merit and Excellence Award”, the 2010 “#1 Top Palestinian Personalities Award”, the 2009, 2011 & 2012 “Triad’s Most Influential People” from the Triad Business Journal, the 2008 “Palestine Diaspora Figure Award” from the Palestine International Award for Excellence & Creativity, the 2008 “Leading Palestinian-American Award in Business & Science” from the American Task Force on Palestine, the ”Fast 50 Award” honoring the Triad’s 50 fastest growing private companies and their CEO’s, Carolinas regional “Finalist for Ernst & Young 2008 Entrepreneur of the Year”, the 2007 “Fast 50 Award”, Carolinas regional “Finalist for Ernst & Young 2007 Entrepreneur of the Year”, the “Health Care Heroes Innovator Award” and the “North Carolina Biotechnology Economic Development Award” from the North Carolina Biotechnology Center. He has been named among the “Triad’s Most Influential People”, was issued the “City of High Point North Carolina Key Award” and awarded the “Science Award in Recognition and Appreciation of Excellence in Innovation and Creativity” by Helios Pharmaceuticals. As a student, he was the recipient of academic awards such as the Glaxo Group Research Scholarship for Ph.D. degree, the Lovis Rydon Memorial Research Prize for Outstanding Research from the University of Exeter and the European Economic Community Scholarship for M.S. degree.


Healthcare

Pharma/Biotech


TransTech Pharma, Inc.
4170 Mendenhall Oaks Pkwy.
High Point, NC 27265

336-841-0300 Ext. 101

www.ttpharma.com


 

Interview conducted by: Lynn Fosse, Senior Editor CEOCFO Magazine, Published – December 10, 2012

 

CEOCFO: Mr. Mjalli, what is the overall vision at TransTech? 

Dr. Mjalli: Our mission is to advance molecules discovered with our platform technologies to address unmet medical needs in diseases like Alzheimer’s, diabetes, obesity and cancer.

 

CEOCFO: What is the basic technology and what have you figured out?

Dr. Mjalli: TTP Translational Technology allows us to intelligently interrogate a protein target of interest to determine whether it’s a viable target in a disease pathway and if so allows us to discover and develop very specific molecules that have the potential to become drugs to treat the disease. The key advantages are speed and efficiency. It takes us on average two years to go from a biological target translation to the IND stage to something the industry typically takes five to seven years to accomplish, and the ability to tackle targets and diseases the industry has found hard to handle with traditional methods.

 

CEOCFO: Can you tell us how the technology works? How are you able to do what other people cannot?

Dr. Mjalli: We rely on innovative tools in biology and chemistry. We have coupled computational biology and computational chemistry with proprietary software and molecules that we call TTProbes. These probes are highly specialized molecules that are proprietary to us. They allow us to verify, on the fly, the gene confirmation, the binding site by which the drug would interact that gives us a desired functional outcome in the lab, in animals and in humans.

 

CEOCFO: Could you tell us a little about your strategy?

Dr. Mjalli: Because of our size and because we have a prolific discovery engine and a number of therapeutic areas with more than sixteen molecules in development, we cannot advance all of them to the market. We rely on key strategic partnerships. We are very selective. We have been doing one partnership every one to two years. With that, we gain many things. We gain whatever survives the risk, obviously. This big partner brings in a lot of muscle and expertise in development as well as marketing. They provide the company with cash that will help us advance other programs that we still carry forward, internally. These strategic partnerships are tied to milestone payments as the drug progresses to the marketplace as well as royalties throughout the patent life. That has been our strategy. Ten to fifteen percent of our pipeline is in partnerships. This allows us to sustain the growth and advancement of our programs without having to rely on public funding solutions.

 

CEOCFO: Is it easier with each one you do? Do the companies you partner with look at your other partnerships? Does that put you a couple of steps ahead or is each situation separate unto itself?

Dr. Mjalli: Each partner is different. These drugs are different from each other. What “partner A” is looking for is not necessarily the same as what “partner B” is looking for. There is a very unique situation to each partnership including what drives it and what is behind it and why we decide to go and work with “partner A” not “partner B”. There are a number of factors that we take into account. If we have a drug in Alzheimer’s disease that we want to license, we make sure the partner has resources and will progress this molecule, taking into account their own pipeline, because sometimes the partners tend to give priority to their own pipeline. We look at the champions, the scientists and clinicians who are championing our programs. That is also a key feature in sustaining a successful partnership.

 

CEOCFO: How have you chosen the areas for your attention? What are one or two of the key programs?

Dr. Mjalli: We have a very unique strategy; we look at therapeutic areas and diseases where no cures yet exist and where huge unmet medical needs persist. These are the factors that determine which therapeutic area, which disease and what drug that we really need to go after. Diabetes and Alzheimer’s disease are two major areas of focus for us. For example, despite all available antidiabetic therapies on the market, a large percentage of diabetics fail to achieve glucose control. Despite all of the billions of dollars spent every year over the past twenty years on diabetes research, in the private sector as well as the government sector; we still have a ways to go. Other than these factors we consider if there is a market for it and if there is a population that needs it. That has been our strategy.

 

We do not go after “me too” type of drugs. It is not like there is a drug on the market and we want to have another one similar to it. Instead, we focus on novel mechanisms and discover molecules with unique profiles that target huge unmet medical needs. For example, in Alzheimer’s disease, with our TTP488 dosing for eighteen months, we were able to clearly demonstrate improvement in cognition. This drug is hindering these Alzheimer’s patients from getting worse. In fact, we have situations where if we stop the treatment the patients still continue to improve. Also, there is a link where the drug normalizes glucose in a separate trial as well as the HbA1c. The whole idea behind Type III Diabetes, which is basically “brain” diabetes, linked to Alzheimer’s disease; TTP488 could really shed light on how Alzheimer’s and diabetes are linked. It is the first Alzheimer’s drug and the first clinical study where a molecule works centrally in the brain to control diabetes as well as Alzheimer’s disease. Some have hypothesized for a long time about a link between diabetes and Alzheimer’s disease, but no one knew exactly how it worked. We believe we have solved that puzzle here. That is a clear breakthrough in science and on a clinical end yielding unprecedented benefits to the patient.

 

Another example is our Glucokinase Activator program, TTP399. The Glucokinase enzyme is in the liver as well as throughout the body. With Type II diabetes, the patients’ post meal glucose goes up and usually the organs and cells in the body consume glucose they don’t need and the extra glucose signals the pancreas to produce the required amount of insulin to normalize it. In diabetics, especially with Type II, the pancreas is not able to keep up with the demand from the extra glucose in the body. That is why the pancreas becomes ill, the cells get weaker and their ability to produce insulin becomes even worse. At TransTech, we discovered that if you target the Glucokinase enzyme locally only in the liver and activate that enzyme, it does two things. First, if it senses that the glucose is at higher than a normal level, then it activates the whole entire machinery to absorb the excess glucose that the body does not need back into the liver, and second, the glucose gets burned off that way without having to signal to the pancreas to produce insulin. That is really very important. Our animal studies show that two or three months of treatment leads to the pancreatic cells growing back and the morphology is improving and the pancreas’ ability to produce insulin is restored, which could really have a big impact on chronic treatment. What would happen with Type II diabetics with about six months to one year of treatments? Would the diabetes go away? Will the pancreas now start functioning fully? That is the question that we are answering in the clinic right now. This could be huge! By us controlling glucose, through this unique mechanism and this drug, TTP399, without having to put pressure on the pancreas, we call it pancreas on holiday. That will lead to pressure relief of the pancreas and lead to improvement at the organ level and the cell level. That is really the discovery we have partnered with Forest Labs and is now in Phase II clinical development.        

 

CEOCFO: Is the overall medical drug development community aware of your concept or is it still very selective?

Dr. Mjalli: We have been very conservative. The company is careful not to oversell our achievements. However, the programs now are very advanced and the medical community is becoming more familiar with these medical advances. We enjoy the wealth of information provided by our technology and the clinical success we are seeing.

 

CEOCFO: Why should TransTech stand out for investors and people in the business community?

Dr. Mjalli: It stands out because this is a new paradigm that we have shown to work very effectively. It is a new paradigm in research and discovery where you do not really have to spend billions and billions of dollars and many years before you arrive at a drug. The average cost is billions of dollars and a timeframe of twelve to fourteen years for a drug to go from idea to market. We have been able to do this, at least the preclinical and early clinical work for a fraction of the cost and a third of the time it usually takes enabling us to translate ideas into clinical candidates. We have a pipeline that is competitive with many companies; medium sized or large pharma companies who spend billions and billions of dollars. Therefore, what we have is a new paradigm that relies on innovation and technology all the way.

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“The Company’s high-throughput drug discovery platform, Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. Our mission is to advance molecules discovered with our platform technologies to address unmet medical needs in diseases like Alzheimer’s, diabetes, obesity and cancer.”- Adnan M. M. Mjalli, Ph.D.

 

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