After already taking several steps back from diabetes in recent years, Bristol-Myers Squibb ($BMY) has pulled out of its deal with Biocon to develop oral insulin, the next big thing in diabetes.
India’s biggest biotech Biocon had a deal with BMS, struck back in 2012, for the U.S. drugmaker to take an option on the worldwide rights to the potential next-gen product, outside of Biocon’s native India.
But today BMS told The Economic Times that it won’t be taking up that option. Under the original deal, Biocon agreed to handle development of its prandial oral insulin candidate, IN-105/Tregopil, through to Phase II studies. If everything went well, BMS was set to take control of the drug outside of India.
In January, Biocon released top-line Phase I data for the drug, undertaken in the U.S., saying the dosing studies conducted with meals “show that there is a clear linear relationship between the dose of administered insulin tregopil and the decrease in postprandial [reduction in blood sugar after a meal] glucose excursion rates.”
When compared to Novo Nordisk’s ($NOVO) injectable insulin NovoLog (insulin aspart), the study also showed that Tregopil “occurs considerably more rapidly than insulin aspart, and is significantly shorter in duration of action than Insulin Aspart.” More detailed data were not given.
Biocon added at the time that it planned to take the drug into the next phase of testing in a larger patient cohort. ET said it will likely need a new partner for this stage, given the expense of conducting further trials on its own.
This comes as BMS has taken a step away from diabetes, selling its portfolio of diabetes drugs to AstraZeneca ($AZN) three years’ ago as it looked to focus more on cancer (notably its new checkpoint inhibitor Opdivo) and virology--especially in hepatitis C.
Oral insulin is the dream of many in pharma and biotech, as it would eliminate the need for injections--something that many patients struggle with and would therefore likely become a major blockbuster if it could produce similar safety and efficacy rates as injectable insulin.
But many companies’ pipelines are littered with failed attempts. Insulin and GLP-1s (which are used in some new classes of insulin) when taken orally are attacked by digestive enzymes in the gastrointestinal tract whose job it is to break down proteins--which is useful for food uptake, but damaging if the protein is a drug that needs to stay intact.
And even if they were to somehow survive in the stomach, these large molecules would then have difficulty passing through the wall of the intestine and entering the bloodstream. Getting around this problem it was have proven so difficult.
But the world’s largest diabetes drugmaker Novo Nordisk appears to be the closest to getting it right.
Last year it released top-line data for a Phase II study that showed positive results for an oral version of its long-acting GLP-1 drug--the same as mechanism used in its once daily type II insulin shot Victoza.
Sydbank analyst Soren Lontoft believes the type II oral insulin market could be worth up to $15 billion, with Novo seemingly leading the race. It’s expected to file for its drug in 2020.
-see the Economic Times’ story