The Top Four Diabetes Best Sellers and One Oral Insulin Pill That May Threaten Them All

Insulin injections store sugar in fat and muscle, but this is not how the body naturally uses insulin. In healthy non-diabetics, insulin is absorbed through the portal vein and sent directly to the liver where it is used to store sugar into long glycogen chains. Since the liver self-regulates this process, there is no need for different kinds of insulin in healthy people who are not diabetics. Basically, oral insulin has the potential to obviate the need for different forms of insulin, and streamline the whole market. That is, if it works therapeutically, which the Phase IIb has not yet proven.

Another potential advantage is in terms of clinical testing. As we saw with Novo’s relatively quick trial that led to the approval of NovoRapid, oral insulin may be able to shorten its Phase III trial time compared to other insulin trials. As stated earlier, the reason that new insulin trials are generally so long and trial thousands of patients is that modified insulin has the potential to cause cancer, insulin being close to a hormonal growth factor. The insulin in Oramed’s capsule is not modified because it doesn’t need to be, since it goes straight to the liver where it is automatically regulated rather than in the blood where it must have artificially controlled release. This could mean that Phase III trials have the potential to be shorter with less patients over a smaller time frame.

It is still early days, but given the nature of the diabetes market in general and the insulin market in particular, oral insulin has the potential to change the nature of the entire diabetes market, and could threaten some of the biggest pharma companies in the world. It could get patients started on insulin therapy much earlier before diabetes symptoms become too acute, and unlike biosimilars, could threaten any form of injectable insulin available today.

So far, it seems that the big players including Lantus, Novo Nordisk, Eli Lilly and Merck have not taken serious notice. But if and when we start hearing about negotiations with Big Pharma, investors will know that ORMD-0801 is being taken seriously. The next step will be a Phase III, possibly beginning sometime in early 2017, though we have no indication from the company of an exact timeframe. At this point the company is risky, but it is certainly a top Phase III trial to watch in 2017, with enormous implications for one of the biggest disease markets in the world.

Note: This article is written by David Rich and originally published at Market Exclusive.