While Fiasp is now the only ultra fast insulin on the market, it won’t be the new kid for long. At least two other companies are hard at work bringing their own version of ultra fast acting insulin to a pharmacy near you.
Pharmaceutical company Eli Lilly and Company says they are starting the late phases of clinical studies on an ultra fast insulin to go up against Novo Nordisk’s Fiasp, which is on the market in parts of Europe and in Canada. Lilly’s insulin will be for use in syringes, pens, and pumps and they plan to submit in 2019 for regulatory approval to multiple agencies in a global rollout that will include the United States.
French biotechnology company Adocia is also in late stage development of an ultra rapid insulin but how and whether their drug might come to market is unknown since a collaboration between Adocia and Lilly was dissolved in January 2017.
“Development of an ultra rapid insulin has been a priority for Lilly for years,” says Deirdre Ibsen, Platform Leader in the effort to develop and market the company’s ultra-rapid formulation. “We’ve had three efforts in development, including two internal efforts. Obviously we feel strongly that there is a role for ultra-rapid insulin in helping people better manage their diabetes.”
Dr. Thomas Hardy, an endocrinologist and Senior Medical Director at Lilly, says the company has been working for more than six years on ultra rapid insulin formulations. He says Phase III clinical trials are about to begin, which is the last step before results of the trials are submitted to the Food and Drug Administration, the European Medicines Agency, and other regulatory agencies for approval.
Hardy says the new insulin was formulated with two new excipients to speed up its action. One of those includes an agent to speed up blood flow at the site of injection.
So far, test results show that there is a 26 percent reduction in the time it takes for the insulin to start acting, 21 minutes with the new insulin verses 28 minutes with Humalog.
According to the United States National Institutes of Health, Lilly has already completed a large number of clinical trials in Phases I and II on what the company calls LY900014. The formulation has been tested on both people with type 1 and type 2 diabetes and on those using pumps and taking insulin by injection.
Hardy says Lilly will conduct trials with people using open loop insulin delivery systems, in which an insulin pump is combined with a sensor that reads and displays glucose readings so the patient can adjust their insulin accordingly.
He also says that he thinks Lilly’s new insulin will be well suited for use in an artificial pancreas, once one is fully developed and marketed.
“This is an interesting area to be doing research right now,” Hardy says. “The goal is to develop insulin that mimics human insulin as closely as possible. With this new formulation, we’ve come a lot closer.”
Others are also coming closer. Among them is Adocia, which had, then lost an agreement with Lilly to develop and market an ultra-fast insulin. Lilly and Adocia agreed in December 2014 to collaborate on developing an ultra-rapid formulation called BioChaperone Lispro. Successful clinical trials followed and everything seemed to be fine until January 2017 when, on the brink of entering Phase III trails, the collaboration was ended by Lilly for reasons that are still not clear. The rights to the formulation reverted back to the French company from Lilly at no cost.
For its part, Adocia is continuing its efforts to develop BioChaperone Lispro. Analysts speculate that Adocia will need to find another pharmaceutical partner with deep pockets to shoulder the costs of late stage clinical trials and negotiate other regulatory and marketing hurdles.
The quest to develop and sell an ultra-rapid insulin is more than scientifically interesting. It is also potentially very profitable.
Right now Novo Nordisk’s fast acting insulin Novolog is the third best selling diabetes medication in the world, with $3.3 billion in sales two years ago, according to the drug industry watchdog pharmaceutical-technology.com. Lilly’s fast-acting Humalog is close behind as the fourth best selling diabetes medication globally with $2.84 billion in global sales in 2015.
Novo’s Fiasp will naturally compete with its Novolog and could also have overtaken Humalog if Lilly did not have a product to fill the gap.
But, whether the motivation is financial, scientific or a happy mix of the two, the beneficiaries will be anyone taking insulin to control their diabetes.
“This work is rewarding and important,” Ibsen says. “It means making better medications that help people struggling to stay healthy with a very challenging condition. The idea of a more rapid insulin is exciting for a lot of reasons.”