May 27, 2013 Issue
The Most Powerful Name In Corporate News and Information
Now developing their PREvent Multiple Biomarker Blood Test to go along with their current position in the market as a Leading Protein and Antibody Solutions Provider, GenWay Biotech is well positioned for Growth
About GenWay Biotech
GenWay Biotech is a leading protein and antibody solutions provider.
Since 1998, we have provided
the research community with proteomic solutions and applications by offering
a comprehensive catalog of products and services. To date, GenWay scientists
have produced thousands of proteins and antibodies in our San Diego
Previously serving as President and CEO of APP Pharmaceuticals, Mr. Silberg lead the company to become the second largest US provider of generic injectables in only four years. At GenWay, Mr. Silberg is utilizing his expertise to implement similar strategies to foster the growth of GenWay’s diagnostic division offering diagnostic testing solutions.
Mr. Silberg also leads the catalog and custom service divisions with the goal of continuing the steady growth realized over recent years.
Mr. Silberg graduated in 1972 from the University of Minnesota with a Bachelor’s of Science Degree in Marketing and Advertising.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 27, 2013
Mr. Silberg: GenWay is a company that was initiated back in the late nineties. We started out as a custom protein and antibody lab where we manufacture proteins and antibodies and ELISA kits. We also have a catalogue business which buys and sells custom proteins and antibodies some of which we also manufacture. The unique part about GenWay is sometime around 2008 to 2009 the company made a major strategic decision to initiate a diagnostic business. We formed a partnership with MedStar, which is the commercial arm of Georgetown University and Emory University, in looking at a cardiovascular diagnostic test which is a simple blood test that measures different biomarkers. The concept was developed by Dr. Steven Epstein back in the nineties. If people had plaque in their coronary arteries and for the most part people over sixty years of age do have plaque in their coronary arteries as do younger people as well. If you have plaque in your arteries it is not the amount of plaque that is the main cause of heart attacks. There is a great deal of data that shows it does not matter how much plaque is in your arteries if it is stable. If that plaque is unstable and if it has been destabilized for whatever reason that is when people start getting into trouble because the plaque has a tendency to slough off and ultimately cause a clot in the coronary artery and a heart attack and sometimes death. Steve’s concept was to measure biomarkers of different pathways that would cause inflammation and destabilize plaque in the coronary artery. Steve came to GenWay back then and we worked with not only Steve but the people at Emory University and we have constructed a multiple biomarker blood test which we call PREvent in our FirstMark diagnostic division where we measured three different biomarkers in people that have coronary artery disease or are suspected of having coronary artery disease. We can predict with some pretty powerful statistics those people who are at highest risk for an impending heart attack and/or death from a heart attack. The exciting part of GenWay is not just our custom and catalogue business that we have been involved with for years but this new, very exciting diagnostic test that can help physicians treat coronary artery disease patients the way they should be treated.
CEOCFO: Are you measuring actual plaque that is disengaged or are you measuring the potential for it to float?
Mr. Silberg: We do not measure plaque that is disengaged. What we are measuring are three different biomarkers that are reflective of inflammatory pathways and autoimmune pathways that when present can cause plaque to become unstable. We measure the traditional high sensitivity CRP which is available on the market from a variety of cardiology labs. We also measure heat shock protein 70 and we measure a fibrin and fibrinogen degradation product biomarker. These three biomarkers each measure a different unique pathway and the concept that if you have plaque in your arteries and if it is stable, you may have shortness of breath from time to time and you need to be careful and take your aspirin and that type of medication but you are not in immediate danger of that plaque breaking away. When that plaque is subjected to inflammation activity what happens is plaque tends to loosen up and become unstable and it is unstable plaque that has the risk of breaking or sloughing off and traveling into a coronary artery and causing a heart attack. With that concept in mind we did a proof of concept study with 1500 patients from Emory University and followed that up with 2300 more patient samples to validate the data. Our hopes were that we could demonstrate some interesting statistics. Many of cardiology tests are based on hazard ratios and annualized death rates. Most of the tests available on the market today can predict people who are at higher risk of having a heart attack with the hazard ratio of 1.7 to 2.3 meaning they are 1.7 to 2.3 times more likely to have a heart attack than other coronary patients within a seven to nine-year period of time. Our blood test is able to increase that hazard ratio to five so we can identify patients who have five times greater risk of having a heart attack and/or death from a heart attack within a two to three year period, so the risk is imminent and the ratio is incredibly high. The statistical package that was developed by the Emory University cardiology statistical group is able to predict a host of other risks from this simple blood test. Essentially, we can combine a patient’s risk factors with the number of elevated biomarkers and show a patient and their physician where they fall on a survival curve over the next three to four year. Our test is designed not to predict how much plaque is in the artery but what kind of plaque is in the artery. Quite frankly a very large percent of the people who have heart attacks have less than 10% stenosis in the coronary artery. Recent statistics have shown that it is not the amount of plaque but the type and what our test will do is help predict what type of plaque is there and therefore how much at risk these patients actually are.
CEOCFO: Is the medical community aware at this point or is it too early?
Mr. Silberg: It is a little too early although that is changing rather rapidly. We recently submitted our manuscript for publication in the Journal of the American College of Cardiology (JACC) and it was accepted and has recently been published. We did a press release on the publication and by the time I got to work this morning I was already getting emails from people who are interested in finding out more information and labs that want to know how they should gear up for this, what they should do and how to draw the blood and so forth. It is gaining traction as we speak but we have not had the capital to take the test out commercially. We are talking to several potential partners as well as people who are interested in licensing and perhaps investing in the diagnostic division of GenWay. We are also in the process of a second study which is called Bari-2D which is a study that was done with diabetic patients putting patients into an aggressive treatment protocol and a less aggressive treatment protocol. We are hoping our data will be able to predict which patients should have been put into the most aggressive therapy and beyond that what type of outcomes occurred. The next step is obviously to say ok now that you can identify the people who are at high risk for having a heart attack what more can you do to avoid that happening.
We expect the study to be completed here at First Mark sometime in the next month and a half and the data will then be sent to the University of Pittsburgh to be analyzed. I would anticipate by the end of the summer we would have our second major study which is an outcome study completed and a manuscript written and ready to submit for publication.
CEOCFO: Will you continue to operate First Mark as a division of GenWay? What is the business plan?
Mr. Silberg: Our business plan is to spin out First Mark. It will be a wholly-owned subsidiary of GenWay but it will be its own independent company with its own board and its own shareholders. A small company like GenWay would have to look for a partner, someone who is well versed in the operations of the diagnostic business, and has the infrastructure to commercialize the test.
CEOCFO: You have over thirty years experience in the industry; what have you learned in previous companies that you find most helpful in GenWay?
Mr. Silberg: I have been in the big pharma, biotech and the sterile injectable business for over forty years. When I came to GenWay I came as a board member and shortly after becoming a board member the management team and the board asked me if I would step in as CEO, so I have been CEO of the company now since November of 2010. The reason they asked me to step in is my experience in how you commercialize a product in the healthcare industry. I have seen it from the big pharma side, from biotech and from the sterile inject able side and now I am seeing it from the diagnostic side. While the product is different, and the regulations are somewhat different, the customers are still the same. We are still talking to primary care physicians and internal medicine physicians. I know what we need to do in terms of building a promotional response model. We have to determine how to get out test reimbursed through the regulatory agencies both Medicare as well as the private sector. I am not a scientist. I have been a commercial guy all my professional life. I believe what I bring to a small company is the knowledge of what it takes to commercialize a product to the healthcare community. There is a very strong need in this diagnostic business to have a good solid clinical data behind us and be able to sit down face to face with a physician and walk them through how this test will help them treat their patients better and then show them the clinical proof.
CEOCFO: Why should the business and investment community pay attention to GenWay Biotech? What is special about GenWay?
I think what makes it special is that we are a very small company and we
have something that is very powerful and not so unique that it cannot be
understood by everybody or by the practicing population of physicians. The
fact of the matter is that the cardiovascular market for diagnostic tests is
absolutely huge. We look at data for example on the cardiovascular disease
diagnostic market and we anticipate that by 2014 this next year, we expect
it to reach $8.3 billion in the US. Here we are, a small company entering
into a huge marketplace. I would think as an early-stage investor that would
be the most attractive thing to me. A very quick growth is right around the
corner for this company if this product is launched appropriately.
“We have constructed a multiple biomarker blood test which we call PREvent in our FirstMark diagnostic division where we measured three different biomarkers in people that have coronary artery disease or are suspected of having coronary artery disease. We can predict with some pretty powerful statistics those people who are at highest risk for an impending heart attack and/or death from a heart attack. The exciting part of GenWay is not just our custom and catalogue business that we have been involved with for years but this new, very exciting diagnostic test that can help physicians treat coronary artery disease patients the way they should be treated.”- Thomas Silberg
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