Nadav Kidron, Esq., chief executive officer of Oramed Pharmaceuticals Inc. (OTCBB: ORMP), talks with the Opportunist’s Managing Editor Leslie Stone about why he believes his company’s oral insulin capsule has the potential to revolutionize the management of diabetes.
More than 300 million people worldwide have diabetes. That number is expected to escalate in the coming years—so much so, in fact, that the World Health Organization has identified diabetes as one of the four priority non-communicable diseases along with cancer, cardiovascular disease and chronic respiratory illness. There is no cure for Type 1 diabetes, which destroys the insulin producing cells of the pancreas. It can occur at any age but typically strikes in childhood, and its victims remain dependent on daily insulin injection for survival. Type 2 is reversible —in the early stages—with changes in diet and exercise.
Oramed Pharmaceuticals has developed a proprietary platform technology that allows for the oral delivery of drugs such as insulin that are now only available via injection. The company’s current drug candidate, a patented oral insulin capsule, is about to enter FDA-approved Phase II clinical trials in the United States for the treatment of individuals with diabetes. “It is game-changing technology,” says Nadav Kidron. “We had successful trials at [Jerusalem’s] Hadassah Medical Center as well as in South Africa, so that gave us the proof of concept that the technology works.”
Opportunist: How did you become involved with Oramed?
Kidron: My mother, Dr. Miriam Kidron, was a senior researcher in the Diabetes Unit at Hadassah Medical Center in Jerusalem. She and her colleagues spent more than 25 years developing the concept and I became involved after she told me they had a breakthrough. Oramed took its idea from Hadassah, where an equity position is still maintained today. We listed the company publicly to allow more investors to become involved and, in an effort to advance the product, we have raised $20 million to date.
Opportunist: What does your work entail?
Kidron: Establishing the company, getting initial funding and recruiting the top people from the business, financial, technical and strategic worlds.
Opportunist: We understand your team includes a Nobel Prize winner, as well as several other top people from the scientific world.
Kidron: Yes. We realized from the get-go that it was important to recruit the top names. The No. 3 person at Merck and the senior vice president of Pfizer are also involved. We showed them our technology and they all agreed that it was game-changing and wanted to be part of it. No one came in for the financial aspect; they wanted to contribute to bettering the lives of hundreds of millions of people.
Opportunist: How old is the company and where are your operations?
Kidron: We were incorporated in 2006. Over the past seven years, we have been testing the product and we are now in Phase II trials.
Our headquarters is in Jerusalem, but there are several employees based in the United States. I am here in New York City at the moment to present at several conferences and business- related meetings.
Opportunist: Tell us about your products.
Kidron: Our current pipeline includes an oral insulin capsule called ORMD-0801, now in Phase II clinical trials, and an oral GLP-1 Analog capsule called ORMD-0901, which is entering Phase II trials. We are also in pre-clinical trials on a combination therapy using these two products.
Opportunist: How do they work?
Kidron: Today a lot of people receive medicines made out of peptides that cannot be delivered orally. Our platform allows us to do so. There are two obstacles to overcome to make it work. The first is degradation by enzymes and stomach acid and the second is the size of the peptide, which is too large to enter the bloodstream. We overcome these two obstacles by protecting the proteins and polypeptides from degradation and by allowing for absorption across the gastrointestinal wall and into the blood. This mechanism is particularly important with insulin: with today’s injection, insulin is delivered directly into the bloodstream; when given orally the hormone passes via the liver prior to reaching the bloodstream, which gives the body more control over the insulin as this is one of the liver’s normal functions. There is much less worry of insulin overdose and hypoglycemia because distribution and secretion into the body is then more accurate. Plus you don’t have to keep it refrigerated—there are many advantages to that. It is also important to note that this technology is not limited to insulin.
Opportunist: What other medicines can be delivered this way?
Kidron: We can use it for many other drugs as well as vaccines. One example is the flu vaccine. If people could buy it orally, so many more people would take it. This would definitely save on the time and expense of lost work days — both to individuals as well as the market as a whole. That is just one example of how our technology can really make a big difference in the world.
Opportunist: How has your product been received by your peers?
Kidron: Over the last few years we have presented at the forefront of conferences in America and Europe and our concept has been very well received. We have published several scientific papers, which are fully accessible on our website. We have been getting much more visibility in the scientific rather than the business world, though I believe we are in the process of being discovered more and more every day.
Opportunist: Was it difficult to get approvals for your patents and clinical trials?
Kidron: What’s important to note is that we are introducing a new delivery method as opposed to a new drug. Therefore, we are not trying to prove whether the insulin works or not. That makes it much easier. We are able to show that you can deliver the insulin orally; therefore, the risk is much lower and much more limited when compared to innovative drugs that have yet to be tested on large numbers of people.
On a safety note, there are no severe side effects. So we can demonstrate our technology with the faith that giving it orally can get the desired effects and we can sleep at night knowing that it’s safe.
Opportunist: What do you enjoy most about your work?
Kidron: It has been very rewarding to see how much people really want to be a part of something that can help others—regardless of any monetary benefit. It’s amazing to work with people who truly want to do good. That’s been a real eye-opener—on a global scale.
Opportunist: Have you been personally affected by diabetes?
Kidron: I have no immediate family members who are diabetic, but some of my close friends and relatives suffer from the disease. So I am very familiar with its effects.
Opportunist: Have you encountered any obstacles in moving the company forward?
Kidron: Early on, a potential partner offered a proposal that we debated about taking. We obviously turned it down—and I don’t know if that was a mistake or not—but many times I wonder if we would be in a much different market cap today if we had accepted that proposal. Only time will tell.
Kidron: No one else has done what we have done up to now. Some others are working on it but, to the best of our knowledge, we are at the forefront in terms of the level of progress that we’ve made.
We have been in touch with other big players in the field and at the end of the day we would probably partner with one of them. I can say that we are in some level of discussions with several companies, but I cannot say more than that.
Opportunist: What makes Oramed a good prospect for investors?
Kidron: The fact that we have a technology for which we’ve already shown proof of concept. We are a well-funded company with no debt. Plus, the strength of the profile of the people who are part of this company and support its technology. When you take all of that into consideration and look at the upside of the product and the fact that this is the most interesting time in the history of Oramed—with our clinical trial about to start in the United States—and given the fact that we have kept a relatively low profile to date—all of that positions Oramed as a very attractive investment opportunity. I would encourage potential investors to visit our website and see what they can learn.
Opportunist: Where do you see the company in the coming years?
Kidron: Well, in the short term I would like to successfully complete our Phase II trials with oral insulin. We are also looking forward to more clinical trials toward the end of next year. Later on, we hope to work with partners to expand the pipeline to include more drugs that could potentially be delivered orally rather than through injection. I think it’s all about timing. There have been trials and the world is progressing. So much of it is about being in the right place at the right time in order to get it right. We look forward to sharing more good news in the coming years.
Leslie Stone is an award-winning writer/editor with more than two decades of experience covering business, finance and lifestyle issues for newspapers, magazines and online publications. Originally from Virginia, she currently resides in the Orlando area.
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