July 2012–It is no secret that there is a massive world-wide demand for insulin. In the U.S. alone, there are 18.8 million people diagnosed with diabetes, of which 26% are treated with insulin. Currently, insulin can only be administered by injection. However, there is an obvious appeal to oral insulin–most people would rather get their medicine in pill form than via syringe.
So why isn’t insulin available in pill form? The stomach, intestines, and liver break down insulin and block its absorption, thereby preventing it from reaching the bloodstream. For decades, researchers have been trying to find a way around these obstacles. Scientists from Hadassah University Medical Center in Jerusalem, Israel may have found a solution. In 2005, a medical breakthrough at Hadassah laid the foundation for the creation of Oramed Pharmaceuticals, of which Hadassah owns 8 percent. Oramed’s proprietary technology is used to place insulin into a capsule that protects it from the harsh environment of the stomach and enhances its absorption into the body.
Oramed is likely to be the first company to market insulin pills in the U.S. In 2010, Oramed successfully completed a Phase 2b trial in South Africa. In a recent communication, Oramed’s CEO, Nadav Kidron, affirmed that in Q4 of 2012 the company will be filing an Investigative New Drug application (IND) with the FDA to conduct a phase 2 trial, and that he aims to start the trial in Q1 of 2013. The company was recently awarded a grant of NIS 2 million from the Israeli government, which Kidron will use to help finance the upcoming FDA trial.
Other companies are also working to commercialize oral insulin. Denmark’s Novo Nordisk announced earlier this year that their oral insulin completed the very earliest stage of clinical testing. Biocon, out of India, conducted a Phase 3 trial of its insulin pill in India, but the drug did not meet expectations.In a recent conversation, Dr. Ehud Arbit, Director of Research and Development at Oramed, said it was likely that Oramed would be marketed in the U.S. before Biocon because the unsatisfactory results of Biocon’s phase 3 trial will slow its progress with the pill.
Inhaled insulin may be another alternative to injection. Pfizer marketed an inhaled insulin called Exubera, but the cost of the delivery mechanism and concerns about decreased lung capacity and increased risk for cancer with long-term use led to discontinuation of the drug at a huge financial loss. Eli Lilly has also abandoned its development of inhaled insulin
Mannkind Corporation has developed an inhaled insulin named Afrezza. Mannkind will be conducting a second set of phase 3 trials after a previous phase 3 was deemed insufficient by the FDA. Inhaled insulin sends insulin directly from the lungs into the blood stream, while insulin taken by mouth passes through the gut and liver first, mimicking normal body function. Because of this difference, Dr. Arbit does not feel that Oramed’s pill would compete directly with Afrezza, but rather could be used in a complementary fashion.
Dr. Arbit also suggested that investors may be wary of committing to Afrezza because of lingering concerns about whether inhaling insulin over many years might damage the lungs. The need for a separate delivery mechanism would contribute to the cost of inhaled therapy and might make it less discrete to use, issues which may make it more difficult for people to comply with treatment recommendations. The convenience of oral insulin is likely to result in better adherence to treatment regimens, thereby further increasing the market for the pill while improving patient outcomes.
Oral insulin will be life-changing and of benefit to millions. Oramed’s unique technology and progress to date in getting such a medicine to market makes it a company to watch.
K. Kleinhaus, a new contributor to IsraelStrategist.com, is an Assistant Professor at New York University School of Medicine. She has a particular interest in Israeli innovation in biotechnology and medical devices. Click here to read her full bio.