Some people diagnosed with Type 2 diabetes can manage their disease with diet and exercise. Others must turn to insulin injections and other medical interventions to control their blood sugar levels. But diabetes is a progressive disease — even if medication isn’t needed at first, it may be needed over time, according to the American Diabetes Association (ADA).
And while most people with Type 2 diabetes would like to avoid insulin shots, they are a daily reality for many diabetics.
That’s where the promise of a new insulin pill comes in. Israeli company Oramed Pharmaceuticals Inc. just received an Israeli patent for an oral insulin capsule — what researchers have called “the holy grail” of diabetes treatment.
Diabetes is a metabolic disorder in which a person has high blood sugar, either due to the body not producing enough insulin (Type 1) or because the cells have developed a resistance to the body’s own insulin (Type 2). (Some women develop gestational diabetes during pregnancy and are at risk for Type 2 diabetes.) Left untreated, diabetes can damage nerves and blood vessels, and lead to complications such as heart disease and stroke. Other health problems can include kidney failure and vision loss.
By 2030, there will be 366 million people worldwide affected by diabetes, the World Health Organization estimates. More than 25 million Americans currently have diabetes, and by 2034, this number could increase to 44 million, the ADA reports. Americans’ increasing obesity, sugar-laden diets and lack of exercise don’t help.
Injectable insulin was first given to people in 1922. Over the years, there have been numerous attempts to find a needle alternative, including an inhalable version. But various problems — including possible lung cancer and low profitability — forced inhalable insulin off the market, while research continues. Diabetics are hopeful the Food and Drug Administration (FDA) will approve Generex’s Oral-lyn inhalable, which uses a mist spray.
There are two main obstacles to creating an insulin pill: One is that insulin is a protein and, in a pill form, it would be broken down by enzymes in the stomach, much the way protein in food is, so insulin would never reach the bloodstream. The second is that the insulin molecule is too big to pass through the stomach or intestine wall.
“Imagine the intestine wall is a tennis net, and when you take a Tylenol, it’s like a small ball that passes through the net and reaches the bloodstream,” Oramed CEO Nadav Kidron said. “But if the ball is bigger than the hole in the wall, it will never reach the circulation and will have no effect,” he said.
He should know. His mother, Miriam Kidron, studied the disease for 35 years at Hadassah University Medical Center in Jerusalem. At 70, Kidron is a unique woman: the great-niece of Rabbi Abraham Kook, Israel’s first Ashkenazi chief rabbi, she went into the army and then got a master’s degree in pharmacology and a doctorate in biochemistry at Hebrew University. She researched diabetes at Hadassah while raising four children in Jerusalem (she now has 13 grandchildren).
In 2006, she went to her son and said, “We have a breakthrough.”
Their new capsule has both an enteric coating, which prevents it from being dissolved in the stomach, and an anti-protease that prevents the pill from being dissolved by enzymes.
The technology, which received Israeli patent approval in May, has the potential to be used for flu vaccines, among other injectable medications.
A lawyer and MBA who worked with Israeli startups and the nonprofit world, Nadav Kidron, 38, and Miriam Kidron founded Oramed in 2006; Hadassah is a partner. The drug is entering phase 2 of its FDA trials, and Oramed hopes to have the capsule on the market by 2015 in the United States, and earlier in countries such as China and Russia.
Oramed is one of several companies in the race for the cure. Danish pharmaceutical giant Novo Nordisk is spending $2 billion on a pill, but its research in the United States is only at phase 1 of FDA trials. A handful of smaller companies searching for an insulin pill include Philadelphia’s Diasome Pharmaceuticals and Diabetology Ltd. in the United Kingdom.
But competition doesn’t bother Miriam Kidron. “Personally, at the end of the day, I am not afraid,” she said, noting that there will probably be a few options. “There is no one medication good for 100 percent of the population.”
Analysts believe the market for a successful pill is from $5 billion to $10 billion.
But it’s not the money that excites her. “Money is not my motivation. My children are all married [except Nadav], and I have what I need. Maybe if it was 50 years ago,” she mused.
What really drives the Jerusalem grandmother is simple: “I will be happy when people will have oral insulin.”