In 2011, it was estimated that 8.3% of Americans—25.8 million children and adults in all—have diabetes. A great number of them use insulin to regulate their condition, through either syringes or insulin pumps because insulin is a peptide hormone which breaks up when swallowed. But a new holy grail for insulin patients is on the way: a swallowable insulin pill. Two biopharma companies—a large multinational and a small Israeli firm—are racing to create the first insulin pills; it is likely that within 15 years, diabetics will be able to get rid of their needles entirely.
Nadav Kidron is excited about his product's progress. The Israeli pharmaceutical executive heads up Oramed, which received a patent in the European Union less than two weeks ago for oral ingestion of insulin. "We want to make sure oral insulin isn't a last resort," Kidron told Fast Company in a telephone interview. "We want to complement the body's insulin output and make it a primary solution alongside exercise and not a last resort like injection. Billions of dollars are spent each year on diabetes, and we cannot spend that much as a society. There is no other choice."
Oramed and global healthcare giant Novo Nordisk are in a race to produce the first ingested insulin pill. Both companies are working on products that use protective coatings to prevent insulin—which notoriously does not make it through the digestive tract when swallowed—from dissolving. New development in peptide research means that researchers have found techniques, involving protein blockers and other solutions, to allow oral ingestion of insulin.
While Novo and Oramed race to release oral insulin pills, another diabetes treatment that doesn't involve needles is much further along. Pharma firm MannKind is working on an inhalable insulin powder called Afrezzal, which is already in late-stage clinical trials. Afrezza uses a proprietary inhaler and is expected to be easier to use than earlier attempts at inhalable insulin, which were out of the financial reach of most customers. For pharmaceutical companies, insulin pills are a sort of "magic bullet" that help them bypass the use issues associated with inhalers.
Kidron said that a key problem his company is tackling is oral insulin's inability to go through the intestinal wall. When Reuters' Bill Berkrot asked Novo head of diabetes research Peter Kurtzhals about the company's research into oral insulin, Berkrot said "We've built technologies and we've seen from studies in animals and early human trials that this may not be as impossible as decades of research had indicated previously."
Both companies currently have their products in different stages of testing. Due to the experimental nature of oral insulin, the FDA and their European counterparts are being rightfully cautious with the advance. Oramed is currently in Phase II testing for their oral pill for Type 2 diabetes and gearing up for a Phase II study of their Type 1 oral pill. Meanwhile, Novo Nordisk recently completed their Phase I trial for a Type 2 diabetes pill. Both Novo and Oramed are interested in the American market as the primary market for their insulin pills—which says a lot about American diet and exercise habits, and the potential money they could make selling stateside.
Over the phone, Kidron was frank about his company's hopes to find a corporate partner to help with funding and bring the product worldwide. Although Novo has a far better market footing than the much smaller Oramed, they're entering a crowded field. Now that the basics of delivering oral insulin have more or less been figured out, scientists are focusing on increasing the safety and minimizing the risk of side effects. This means that many other industry players are getting in the game. Indian life sciences firm Biocon is researching oral insulin and recently entered into an agreement with another major multinational, Bristol-Myers Squibb. Google's venture capital arm, Google Ventures, also senses world-changing potential in oral insulin: They recently invested $10 million in early-stage peptide delivery firm Rani Therapeutics.
In the meantime, patients with diabetes have a glimpse of big changes on the horizon. Even though both the Novo and Oramed products have to go through years of testing, biochemists have found the essential steps to deliver insulin orally. Doctors and patients are both well aware of the stigma of injecting insulin, and the discomfort and awkwardness that accompanies it. Although the scientific and bureaucratic obstacles to bringing oral insulin products to market are massive, it's now doable—something which wasn't the case before.