The rapidly growing diabetes population is expected to increase from current estimates of 370 million patients globally to over 550 million by 2030. Present estimates put diabetes-related healthcare costs in the region of $470 billion, a figure that is expected to grow in line with the increasing diabetic population. As a result, the diabetes market offers drug companies a major opportunity for growth and innovation.

One such innovation surrounds non-injectable forms of insulin. The biotech company Oramed has recently applied to the FDA for approval for a Phase II trial of its orally ingestible insulin capsule. The FDA has requested that Oramed complete a sub-study first, which is expected to begin in the next few weeks, with the Phase II trial to follow later this year. Novo Nordisk has also recently successfully completed a Phase I study of their oral formulation.

The attempts by Oramed and Novo Nordisk are not the first to try to bring a non-injectable insulin to market. In 2008, Pfizer/Nektar Therapeutic's inhalable insulin Exubera was withdrawn from the market after increases in the rates of lung cancer were seen among patients who smoked. This had a major effect on the development of inhalable insulins, with Eli Lilly and Novo Nordisk both terminating projects in Phase III development. MannKind Technosphere's Afrezza remains at present the only inhaled insulin still in late stage development, and MannKind is expected to submit their trial results to the FDA later this year.

The difficulties surrounding non-injectable insulins are not exclusive to the inhaled insulins. For either Oramed or Novo Nordisk's product to be viable, the oral formulation will have to demonstrate that their products have consistent levels of bioavailability. This becomes increasingly difficult with oral administration; bioavailability can vary greatly due to the influences of the digestive tract on the capsule itself. Similarly, the eating and drinking habits of the individual in question will have an impact on the rate and level of absorption of the oral formulation.

Despite these difficulties that must be overcome, most opinions expressed regarding an oral formulation of insulin are positive. The oral formulation provides an obvious benefit regarding administration and potential compliance. The ability to remove the social stigma surrounding injecting insulin should ensure that patient demand for the product will be huge. This is not the only advantage an oral formulation offers; oral delivery also means potential improvements in hepatic glucose control. Orally administered insulin would enter the liver via the portal vein following absorption from the GI tract, which would regulate its release into the bloodstream, mimicking the natural trafficking pattern of endogenous insulin. However, Oramed's chief executive Nadav Kidron has been quick to extol the potential cost reductions that their oral insulin could offer as the major benefit of this therapy. But it is difficult to discern where these cost savings may accrue.

Should either Oramed or Novo Nordisk's oral formulations come to market, as a new therapy, they would be expected to command a considerable price premium over existing therapies. As a point of reference, the recently approved canagliflozin (Johnson & Johnson's Invokana) will carry a wholesale price of $8.77 per pill; putting the retail cost without co-pays or coverage at approximately $300 per month. The most commonly used injectable insulin, insulin glargine, carries a wholesale price of $8.40 per day, while regular human insulin has an approximate cost of $3.00 per day. No savings here then.

However, Oramed state that their oral capsule will not eliminate the eventual need for injections; rather, it is thought that it will allow for earlier treatment of their disease, slow the progression of the disease, and delay the need for needles. Earlier treatment and slower progression could potentially reduce costs associated with diabetes-related complications. However, earlier treatment with oral insulin would be expected to either replace, or be in addition to, standard therapies such as metformin. Since metformin is available for as little as 25 cents per day, replacing metformin with an expensive branded option is something that payers are likely to resist, unless it can be demonstrated that earlier treatment with the new oral formulations result in better long-term outcomes.

Reducing the costs of treating diabetes will be a major concern for health providers, payers, and governments alike as the diabetic population continues to grow. However, cost reductions shouldn't come at the cost of restricting innovation, such as Oramed or Novo Nordisk's oral formulations. Results from future clinical trials and cost-benefit analyses of these products will eventually determine whether Mr. Kidron's assertions prove correct or not. These oral agents will have to demonstrate significant improvements over existing treatments to result in the type of savings needed to make a significant impact in the ever-escalating costs of diabetes treatment.

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