In part I of our comprehensive report on the type II diabetes market, we broke down the top 4 best selling diabetes drugs, their prospects and the companies behind them. Most of the biggest drugs in this market are peaking or close to peaking in terms of top line revenue, making potential room for new entrants provided they are of better quality. Here are four new diabetes drugs in the pipeline, how they work, their prospects for approval and market potential.
FIAsp by Novo Nordisk A/S (ADR) (NYSE:NVO)
FIAsp, for Faster-acting Insulin Aspart, is a reformulation of a drug we covered in Part I, Novo Nordisk’s insulin aspart branded NovoRapid. NovoRapid is marketed as fast-acting insulin delivery, but this one will be marketed as a faster acting insulin delivery. So how has Novo improved on the delivery speed? The company has combined the insulin aspart that serves as the active ingredient in NovoRapid with the two excipients arginine and nicotinamide. Arginine is an amino acid and Novo believes that through the addition of this amino acid, the stability of the insulin uptake can be improved.
This improved stability affords the drug an opportunity to also include an element that allows for increased delivery speed. Without the stability element, the increased speed might compromise delivery. This is where nicotinamide comes in to play. Nicotinamide is a vitamin that is closely related to niacin, the vitamin B compound used in oncology, dermatology, and used to fortify breakfast cereals. Niacin gets converted into nicotinamide in vivo, and apparently improves the speed of uptake. Not even Novo knows exactly how this works, only that it does.
This one targets both diabetes type 1 and type 2, and will likely serve as a complimentary therapy to NovoRapid and expanding its customer base. It’s primarily targeted for use at or around meal times, when faster acting insulin can decrease the chances of hypoglycemia immediately post-meal. NovoRapid generates about $3.2 billion annually, and FIAsp, if approved, will likely not add too much to this, but should help Novo to maintain its leadership position in fast-acting insulin.
Novo Nordisk A/S (ADR) (NYSE:NVO) submitted an NDA to the FDA in December 2015, and as yet we don’t have a PDUFA date, but chances are the review will come at some point towards the end of 2016, perhaps as late as first quarter 2017. The submission is based on four different Phase III studies, all but one of which compared FIAsp to NovoRapid. The trials have already established increased uptake speed, so assuming Novo can emulate this increased uptake speed in all trials, all the company has to do is demonstrate equivalency to the comparable NovoRapid.
The latest trial and the biggest was called ONSET 1, and this reported to-line results in October 2015. The data met its primary endpoint of equivalence, and with safety and tolerability for each of the active ingredients already well established, there looks to be little reason why the FDA won’t give FIAsp the green light come review.