- We should be scared because MannKind is running a study to clear Afrezza for use on people with Mild Obstructive Pulmonary Disease
- A 2008 study had a high drop-out rate
- Afrezza caused depressed lung function over a two year period
Let's balance that out:
1) Afrezza could be cleared for people with Mild Obstructive Pulmonary Disease, good! The current studies are for people who do not have "History of COPD, asthma, or any other clinically important pulmonary disease," this could open Afrezza up to these people.
2) In 2008 everyone was scared of inhalable insulin because of Exubera. CEO Alfred Mann at the January JP Morgan Healthcare conference:
One of the greatest drug failures in history was the Pfizer attempt to do this some years ago with Exubera. After that failure, when they asked the question in 2008 to the physicians at the American Diabetes Association meeting only 28% of the people felt they would ever use an inhaled insulin. A year later, when people began to learn that we are not just an inhaled insulin but a new form of insulin that has tremendous physiologic benefits, the number had risen to 48%, and then in 2010 they asked the question again, and by now people were beginning to understand the significance of Afrezza, and now 95% of the physicians said they would use Afrezza in their practice. They stopped asking that question since it was so overwhelming after that.
If your own doctor would not even consider inhalable insulin in the wake of Exubera are we supposed to be surprised that patients dropped out?
3) Dr. Mann at that same conference:
We also see a very tiny reduction in pulmonary function, you know like a, maybe a 1.5% reduction. That reduction, by the way, is comparable to what you see in the other cohort, the conventional cohort. It's the reduction you get in about 4 months of life, so it's hardly significant. The FDA set as a goal that we don't include patients who have below standard pulmonary function of 30%, we're talking 1.5%, it's a not a big deal, the FDA is not concerned, nobody seems to be concerned. And by the way it's probably just a reaction to the inhalation of the powder before you do the test because once you stop taking Afrezza the 1.5% is restored, so it's really not an issue.
There will almost certainly be more "scary" articles about Afrezza. It is important to realize that institutions do not pay people to write glowing articles about a stock before they buy it. They do the opposite.
Disclosure: I am long MNKD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.