MannKind’s AFREZZA vs. Pfizer’s Exubera: Will Inhaled Insulin Be Different This Time?

With an FDA decision pending on Mannkind Corporation’s AFREZZA (TM)  (insulin human (rDNA origin) Inhalation Powder – formerly named AFRESA ) and the recent failure of the first inhaled insulin to receive FDA approval, we thought it would be helpful to provide an analytical approach to this emerging health technology.

For those who are unfamiliar with the Exubera story, Pfizer received approval for Exubera(R)(insulin human (rDNA origin) Inhalation Powder) in January 2006.  As the first approved alternative to injectable insulin,  many thought this would represent a milestone in diabetes care destined to take a prominent  place in the diabetes therapeutic armamentarium.  Things did not turn out this way at all. In October of 2007 Pfizer announced that it was ending production, citing Exubera’s failure to gain acceptance with physicians and patients. 

It would be easy to dismiss any inhaled insulin product in the wake of a  failure  of this magnitude (apparently Pfizer took a 2.8 billion dollar charge as a result of the discontinued Exubera progam). However, developing a sound analytical approach to AFREZZA(TM) should be very informative and allow for an objective assessment of its chances for success. 

At BioHorizon, we are emerging health technology-focused. What follows is a list of questions that we have put together that could help to inform your analytical approach to this drug:

1. Does AFREZZA represent true innovation?  Is it a first in class therapy, a me-too drug, or something in between? 

2. Does it work?  In this case we are talking about glycemic control – do patients who take AFREZZA experience better, worse, or similar control of their blood glucose compared to insulin injection? 

3. What is the epidemiology of diabetes? In other words, how many new cases,  and how many exisiting cases are there in North America? This helps us to understand demand for diabetes treatment.  What about the clinical epidemiology?  The clinical epidemiology sheds light on how diabetics are treated and tells us about outcomes.  This information helps us to establish whether or not there is an unmet medical need and gives us an idea as to where would AFREZZA fit in diabetes treatment protocols. 

We ask these three very important questions because we believe that innovative drugs that meet unmet medical needs for highly prevalent conditions change the practice of medicine for the diseases they target. So-called ‘copycat’ therapies that offer incremental or no benefit seldom have the same impact.  Answering these questions will give you much needed insight into where AFREZZA sits along this spectrum.

There are two other questions that come to light specifically after examining the Exubera(R) experience. 

4. Will patients be required to commit to ongoing pulmonary (lung) function tests once AFREZZA therapy is started?  This was the case with Exubera and is felt by some to have been a disincentive to both patients and physicians. 

5. Will cost, dosing and inhaler use be acceptable to insurers, patients and physicians?  Cost and coverage questions dominate the discussion around medical innovation in this day and age, so having some sense of where insurers stand concerning AFREZZA is important.  With Exubera the inhaler was considered large and cumbersome by certain standards and patient and physician feedback indicated that dosing may have been too complicated.  Cost, ease of administration and simplicity of dosing changes are important to diabetic patients and physicians contemplating  a change in insulin regimens. Do not underestimate these factors in your analysis. 

Of course some of these questions will remain unanswered, but we believe that the use of  this approach will allow you  to establish some important objective parameters and in doing so,  help you make better decisions concerning this emerging health technology.

Let us know what you think, and how this approach helped or didn’t help your analysis.  Thanks.

BioHorizon