You can always tell who the pioneers are because they have arrows in their back and are lying face-down in the dirt.
It looks like an arrow is being aimed at MannKind (NASDAQ:56400P706), which is the last thing that investors in this company want to see right now.
Diabetes powerhouse Novo Nordisk (NYSE:NVO) made news earlier this week as it announced that it has submitted a new type of mealtime insulin to the FDA for approval. This new insulin combines a short-acting insulin with a vitamin and an amino acid, which increases the body's ability to absorb the insulin, leading to blood sugar levels being lowered faster.
That could spell trouble for MannKind as one of the benefits touted of using Afrezza, MannKind's inhaled insulin, is that it offers a very fast insulin absorption rate -- much faster that any of its competitors can currently claim. That speed of action is important as it can help patients better control their after-meal blood glucose spikes, leading to better overall health.
In the clinic, Afrezza was shown to go to work extremely quickly in the body, as it reaches its maximum peak absorption rate after only 12 to 15 minutes. That speed helps give Afrezza an edge over other insulins on the market that have to be injected, and it's a major selling point. By comparison, absorption of Novolog, which is Novo Nordisk's current fastest-acting insulin, starts 40 to 50 minutes after being injected.
We don't yet know how much faster this new insulin will be than Novo's prior insulins -- those details have yet to be released -- but if it manages to find its way to market, it could spell even further trouble for Afrezza.
A tough road
MannKind has already been forced to deal with a number of challenges related to Afrezza's launch. Afrezza's approval came with a black box warning that forces patients to have a lung-function test performed using a spirometer, a device used to test air capacity of the lungs.
Many physicians who treat diabetes didn't have one on hand, which created an additional barrier for patients to get started on Afrezza.
Afrezza also requires patients and providers to follow a complicated dosing chart in order to get the amount of insulin that they need.
See for yourself what I mean:
Thats a tough selling proposition, especially when compared to using an insulin pen that allows for dialing up nearly any dosage with a simple twist.
Finally, MannKind and its marketing partner Sanofi have been having a tough time getting insurers to cover Afrezza, adding yet another barrier. That's a huge uphill battle the company is fighting, especially considering that insulin pens are widely available and enjoy great insurance coverage.
Big pharma fights back
We knew big pharma giants like Novo Nordisk weren't going to make it easy for Afrezza to succeed. Each year, Novo Nordisk generates billions of dollars in revenue and profits from its diabetes franchise, so it had a lot to lose if Afrezza turned out to be popular with patients.
Prescribing Afrezza is a big hassle right now. If Novo Nordisk can get an even faster-acting insulin to market in the next year, providers could become even more reluctant to give Afrezza a try.
Afrezza had better get its act together, and fast, as one of its major selling points might be rendered moot in 2016.