MannKind Talks Is Anyone Listening?

MannKind Talks Is Anyone Listening?

This morning MannKind (NASDAQ:MNKD) released preliminary data from two phase 3 clinical studies of Afresa™, which they are now calling an ultra rapid acting insulin. The fact that the company is now calling Afresa, an ultra rapid acting insulin rather than an inhaled form of insulin speaks to the issues facing the company. With the dismal failure of Exubera and subsequent decisions by Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO) to abandon their inhaled insulin projects MannKind stands alone in the inhaled insulin space. Realizing that in the eyes of investors and possible partners that inhaled insulin is as dead category, the company is trying to reposition Afersa as better form of insulin that just happens to be inhaled rather than injected.

The question is; is anyone listening to what the company is saying or are they still viewing MannKind as an inhaled insulin company?

Before we answer that question let’s take a look at the data released today. Study 102 compared the efficacy of meal-time Afresa in combination with a long-acting basal insulin versus twice daily injections of pre-mixed insulin in patients with Type 2 diabetes. Over the 52-week period of the study, A1C levels decreased comparably in the two treatment groups, 0.59 in the Afersa group and 0.71 in the pre-mix group.

According to the company patients in the Afresa group gained less weight than patients in the pre-mix group had fewer hypoglycemic events and a comparable percentage reached A1C target levels.

Study 030 compared the pulmonary safety which basically concluded that Afersa had no adverse effect on lung function. It should be noted that the company did state they did not believe Afersa would be approved for use for in smokers or patients with existing pulmonary issues.  

Of the two studies 102 carries more significance as previous studies had already indicated that Afersa was not associated with adverse pulmonary events. Looking at 102 Diabetic Investor doesn’t believe the data is strong enough to compel physicians or patients to switch existing patients or start new ones. Like it or not MannKind has a higher threshold because of the stigma associated with inhaled insulin. Afersa cannot simply do as well as injectable insulin it must do better, much better.

In the real world when inhaled insulin is mentioned to physicians they think of Exubera and more importantly of the Exubera delivery device. Although the delivery device for Afersa is far superior to the Exubera bong, this is what physicians think of when someone mentions inhaled insulin.

Diabetic Investor also does not buy into the theory that physicians or patients prefer inhaled over injectable. As we have been saying since Exubera came along it’s actually more painful for a patient to monitor their glucose levels than it is to inject insulin. With all the issues surrounding many of the oral medications physicians are increasingly prescribing insulin for their type 2 patients. Combine this with the growing popularity of insulin pens and it’s clear that patients are not adverse to injectable therapy options.

Perhaps the most compelling indicator as to how Afersa is doing comes from the company’s statement that they are waiting until the drug goes to the FDA before doing any type of partnership agreement. If Afersa was truly better than existing insulin’s potential partners would be anxious to do a deal given the increasing use of insulin in the type 2 patient population.

The bottom line for MannKind is that potential partners are not only listening but they don’t like what their hearing. They understand that that Pfizer (NYSE:PFE) basically threw away $4 billion with Exubera and the top two insulin companies Lilly and Novo gave up on their projects. They realize that even if approved there are significant marketing hurdles to overcome because of the well publicized failure of Exubera.

Try as they might to position Afersa as a more effective rapid acting insulin that just happens to be inhaled investors and potential partners just aren’t listening. This lack of interest should send a loud and clear signal to anyone who believes Afersa will succeed where so many others have failed.