Diabetes Innovation in Israel!

As one of the many companies emerging from Israel’s booming biotechnology sector, Oramed is a prime example of what has become the epitome of science in Israel: determination, vision, and innovative problem-solving.

Oramed Pharmaceuticals is a leading innovator of oral delivery solutions for injectable pharmaceutics.

Many wonder why vaccines, insulin, and other important therapeutics are given via injection, and if an oral delivery solution could ever be developed.

Essentially, if given orally, these protein-based formulations would either be destroyed by the acidic environment in the stomach, or fail to traverse the intestinal wall into the bloodstream as a consequence of their large molecular size.

Solving the Puzzle

Dr. Miriam Kidron was a senior researcher in the Diabetes Unit at Hadassah Medical Center in Jerusalem and involved in the project dedicated to solving this puzzle.

Thus, while Oramed is relatively young – founded in 2006 – its base concept began more than 25 years ago by Dr. Kidron and her colleagues in the research laboratories.

Dr. Kidron is a pharmacologist and biochemist with a PhD in Biochemistry from Hebrew University, and one of the leading researchers on oral insulin development in the world today. Nadav Kidron, Oramed’s CEO, founded the company after her team had its breakthrough.

Nadav is a natural entrepreneur having trained as a lawyer and attained an international Master’s degree in Business Administration. He served on the managerial boards of a number of companies before founding Oramed; he also happens to be Dr. Kidron’s son.

Building Worldwide Support

Nadav Kidron notes “Before we formed the company we knew that there is a huge advantage to this technology, and so we thought big and aimed big from the beginning. On top of this, being based on 25 years of research and having support of world renowned scientists and former management of top pharma companies is a big advantage.”

Oramed has garnered worldwide support of prominent scientists for its technology, and those that make up its scientific advisory board are a powerful testament to that: Scientific Board Chairman Dr. Michael Berelowitz, former Senior VP of Pfizer; Prof. Avram Hershko, 2004 Nobel Prize Laureate in Chemistry, and a leader in the field of drug delivery methods; Dr. Derek LeRoith, Chief of Endocrinology, Diabetes and Bone Disease Unit at Mount Sinai School of Medicine; former Senior VP of Merck and Co, Prof. John Amatruda; Prof. Ele Ferrannini, Past President of the European Association for the Study of Diabetes (EASD); and Dr. Nir Barzilai, the Director of the Institute for Aging Research at the Albert Einstein College of Medicine.

The office of the Chief Scientist of Israel has also shown its confidence in Oramed’s technology, having recently awarded Oramed its third consecutive grant to continue its research and development.

Testing Groundbreaking Technology

Nadav Kidron describes his greatest challenge as the CEO of Oramed as “Events happening that are outside of our control as we have to coordinate with many companies for drug development, trials, etc. – so being able to deliver results according to our plans is a challenge.”

He describes his greatest accomplishment as “Successful results of trials, getting tremendous interest from diabetics around the world that follow our development and are waiting to start using our product even at this point in clinical trials. Being in touch with them and sharing the hope around the corner for a better treatment of diabetes gives us great satisfaction.”

Oramed is currently testing its groundbreaking technology on its two primary drug candidates – oral insulin and oral GLP-1 analog – both potent and valuable medications for treating type 2 diabetes.

Treating a Global Crisis

Type 2 diabetes is one of the medical epidemics of our generation. In 1985 the world population of those with the disease or not yet diagnosed was in the range of 30 million; by the year 2000 that amount grew to 170 million. A research article published in 2004 in the Journal Diabetes Care estimated the world population to reach 366 million by the year 2030. With the World Health Organization reporting the current type 2 diabetes population to be hovering in the 346 million range as of 2011– we have a major crisis on our hands; we have seen the population more than double in 10 years and reach the predicted estimation 20 years before its time.

Not unsurprisingly, oral insulin has been hailed as the “holy grail” of the pharmaceutical world. However in addition to noting the incredible value that this medication would provide for diabetic patients worldwide in terms of increased quality of life, comfort, and compliance, there is an element that is just as important to note: Oramed’s oral insulin is not meant to replace injections.

An Earlier Treatment Option

So what it is then, exactly?

Oramed’s oral insulin represents an earlier treatment option, given in the beginning stages of the disease. In this way it has the effect of slowing down the rate of degeneration of the disease by providing additional insulin to the body and allowing the already weak pancreas to rest. In addition, since taking insulin orally mimics the natural route taken by insulin in the body, it allows the liver to regain the role of monitoring release of the hormone into the bloodstream based on demand – leading to fewer or no hypoglycemic episodes, a problematic and sometimes fatal side effect with injectable insulin.

GLP-1 analog is a medication that mimics a naturally-occurring hormone and has an array of benefits – from keeping blood sugar levels regulated and preserving pancreatic cell function to promoting weight loss – all the while with an excellent safety profile. While the list of advantages is long, and the list of disadvantages quite short – namely one, nausea – the short list still seems to take precedence as the side effect is strong enough to cause many patients to stop shortly after beginning treatment with the drug. Oramed hopes to overcome the side effect with its oral GLP-1 analog, and in fact early results have thus far supported this goal.

Dr. Miriam Kidron notes that “Oral insulin is unique because its mimics the physiologic delivery of insulin. With GLP-1/exanatide – the current method is via injection which has a side effect of nausea. Oramed’s oral GLP-1 results up to now have indicated no nausea, which is very exciting.”

In addition, insulin today, given in injection form, is generally administered in the late stages of the disease once other medications have caused the already struggling pancreas to overwork and essentially burn out. By giving insulin earlier, and increasing the likelihood of patient compliance via administration in capsule form, the potential for extending the time frame between diagnosis and late stage complications is greatly increased.

Since patients in later stages of the disease are dependent on insulin injections and at a higher risk for any number of debilitating health complications – such as kidney failure, blindness, and amputation – curbing the rate of deterioration of the disease is a key element to increasing quality of life and independence, and a critical focus in treatment of the disease.

Global Economic Cost of Diabetes

And it isn’t only the individual that benefits – it is the rest of us, as well. According to a 2010 report by the International Diabetes Federation, the global economic cost of diabetes is estimated at $400 billion; the insulin market alone, however, makes up “only” around $14.5 billion. The astounding percentage discrepancy is comprised mostly of compensation for lost productivity, disability payments, and other non-drug related costs that heave a heavy burden on each country’s healthcare system and ultimately its tax-payers.

Moving Forward

There is much exciting news coming out of the company right now. Oramed is gearing up as we speak to file an Investigative New Drug application (IND) later this year with the United States Food and Drug Administration (FDA) for trials in the US on its oral insulin candidate on type 2 diabetics. This trial, set to include 147 patients after a successful smaller trial in South Africa, is an essential milestone in gathering the data necessary to make a clear case for Oramed’s technology.

While clinical trials to date have provided extensive support for Oramed’s drug delivery platform, the results of which have been presented at numerous conferences, the successful results of this FDA-approved trial, together with Oramed’s growing international patent portfolio, will be the catalyst that is required to project Oramed into the vocabulary of every pharmaceutical company large and small, and, most importantly, pave the way to getting its products out to the people who need them.

Dr. Miriam Kidron notes “There are many amazing technologies coming out of Israel. I am happy to be a part of that.”

Aviva Sherman, Oramed Pharmaceuticals
Joseph Sherman, United with Israel

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