When will everyone learn?
This morning MannKind (NASDAQ:MNKD) released findings from a 16-week trial for their inhaled insulin Afrezza™. According to a company issued press release; “AFREZZA(TM) (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes. In addition, patients treated with AFREZZA had statistically significant lower rates of hypoglycemia, post-prandial glucose (PPG) levels when measured at 30, 60, 90 and 120 minutes, and fasting blood glucose (FBG) levels when compared to subcutaneously injected insulin lispro.”
The release goes onto state; “In the intent-to-treat population, AFREZZA lowered HbA1c by -0.10% (mean change from baseline HbA1c) as compared to -0.03% in the lispro group.” (Highlighting added by Diabetic Investor)
After a series of setbacks for company shares of MannKind are rallying today up over 7%.
While this news is encouraging Diabetic Investor would hardly classify it as earth-shattering. What everyone seems to forget is that the problem with Afrezza isn’t whether it works or not, the problem with Afrezza is that it’s INHALED INSULIN. No matter how hard the company tries to play up their study results the fact remains that even if the FDA finally approves Afrezza it faces an enormous commercialization hurdles.
Try as they might MannKind cannot separate the worlds inhaled insulin and Exubera. The fact is the Exubera disaster has done for inhaled insulin what BP has done for greater interest in offshore oil drilling. But being compared to Exubera is only a part of the problem. Afrezza is targeted at patients with type 2 diabetes who are not achieving adequate control under their existing therapy regimen. These are the same patients targeted by Victoza and Bydureon.
Let’s assume for just a moment that the FDA finally approves Afrezza, here’s what a physician will look at when deciding which of these three drugs to use for their type 2 patients. Afrezza’s main advantage is that unlike Victoza or Bydureon there are no injections, unfortunately for Afrezza its insulin which means that in order to properly dose the product patients will need to monitor their glucose levels, something not needed with Victoza or Bydureon. While the risk of hypoglycemia may be low with Afrezza, it is virtually non-existent with Victoza or Bydureon. At best Afrezza is weight-neutral, while Victoza and Bydureon produce weight loss. Afrezza is dosed at every meal while Victoza is taken once a day and Bydureon once a week. Although Afrezza has shown some solid results based on all available data Victoza and Bydureon do a better job of controlling glucose levels and both have shown superior results at lowering A1C levels. Afrezza may have fewer possible adverse events assuming patients are properly trained how to use it. Frankly the jury is still out on the long term effects Afrezza may have on lung function.
So even if Afrezza can withstand the comparison to Exubera, a high hurdle by itself, the next question is can it withstand the comparison to competing therapy options. This is why Diabetic Investor has never understood the fascination with Afrezza, when you consider all the facts and get away from the fact that there are no injections, the reality is Afrezza is just another form of insulin. While it may have some attributes over existing injectable short-acting insulin’s, it’s still insulin.
For the all investors out there who are enjoying the ride that MannKind is on today, be advised it won’t last so better to take profits when you can. We’ve said it before and we’ll say it again, the time for inhaled insulin has come and gone.
