The future of Afrezza inhaled insulin maker MannKind Corp. has been the subject of quite a bit of controversy, with some very vocal naysayers predicting the demise of the California company.

That's not happened, and in fact, new leadership has helped restructure the company and bring it back from the brink. Their future's not yet certain, but things are looking up (as their Feb. 25 earnings call noted), especially with recent news that MannKind has brought on the respected Dr. David Kendall as its new Chief Medical Officer. Kendall started the job on Feb. 12, fresh from Lilly Diabetes where he'd served as CMO since 2011.

We had a chance to chat with Dr. Kendall recently -- about his rich experience, why he decided to make this move, and what he hopes to accomplish in his new role.

 

An Interview with Dr. David Kendall

DM) OK, first the big question: Why did you decide to leave an established Pharma company like Lilly for a relative 'upstart' like MannKind?

DK) I was thrilled to join Lilly when I did seven years ago. Under Enrique Conterero’s leadership, they were starting one of the most impressive runs in diabetes history -- making the insulin franchise relevant, signing a partnership with Beohringer Ingelheim, launching Trulicity (once-weekly GLP-1 injection), and trying to innovate insulin while understanding the biosimilar landscape. I couldn’t have joined at a better time, in launching so many products for the treatment of diabetes across the world.

I looked at where we were, and when (MannKind) came to me with this opportunity, I first and foremost thought I could come here and contribute to make a real difference in a transformative area of diabetes.

So in other words, you wanted to be on the cutting edge?

The big insulin makers are doing what they are in diabetes drugs and insulin, but the true innovation is coming from the small bio-tech space – from those at Bigfoot Biomedical, having real-time glucose information and innovating in a space that’s been tough to innovate in until recently. Afrezza’s already there, and I want to get us into the boxing ring and get the scientific and clinical chatter out there so people can truly see how this asset works.

I remember the launches of Humalog (in 1996) and having individuals come back to me and say, “I don’t know what you’ve done, but I want a refill on that insulin because it changed my meal-time experience.” I think Afrezza can do the same in a way we haven’t seen since then. 

So, yes: I’m incredibly excited that I’ve made this move.

And MannKind’s business uncertainty didn't give you pause?

I have worked in a number of places that went through challenging times organizationally and financially, and overcame those roadblocks and hurdles.

I was at the International Diabetes Center at the University of Minnesota during the 90s and early 2000s and dealt with the clinical care changes there, and the American Diabetes Association's medical group right at the time of financial crisis there.

So, I looked at this as an opportunity to face something that’s of value in the clinical space. It was encouraging to see (MannKind CEO) Mike Castagna’s charge of putting us in a position where we can control our future financially. But for me, I would argue there’s a treasure trove of data available on Afrezza that we can dig into and put back into the clinical space, and in the hands of clinicians to use it and those who live with diabetes to see how it works.

We’ll have to do it with caution and with relatively close attention to budget, but we’ve got plenty of data and clinicians out there who can help raise awareness without needing to spend millions of dollars in investments.

How’s the new role been for you so far? What's exciting?

Well, it’s been 10 days; I started working the day after leaving Lilly. So they got a free week out of me. It’s been a remarkable and delightful transition, and it’s been refreshing and great fun to see just what the opportunities are to really transform the meal-time insulin space for all people with diabetes.

I personally see the opportunities, because there really are no good meal-time therapies, except for never eating a carbohydrate in your life. You’ve got background insulins, but there’s no way to really tackle blood sugar when there is food on board.

At a high-level, I wish at some point in my career I’d trademarked the term “hassle factor,” because that is what this is all about. It’s about living in the moment. There’s a learning curve, just like when you switched from pork insulin to analogues, but it takes one of the hassle factors out of diabetes. That’s how I viewed my role as a clinician and how I’m approaching it at MannKind, to get someone the best tools possible. But it’s your house to build.

How would you describe the differences between MannKind and where you've been previously?

I spent time at biotech in the 'Wild West' days of Amylin before they were bought by Bristol-Myers Squibb, but one of the things that I really appreciate is practical decision-making. When you’re at a big organization, just like with big government, even if decisions get made well they get made very slowly. In a fashion where it seems, for me at Lilly, that everyone of the 44,000 employees had to be informed before a decision was made.

The leadership at MannKind is one where we can sit down and say the first three things we have to do, and we can discuss and move forward on executing at least a couple action items now. The speed of decision-making and being able to execute those actions quickly in a small agile company, that’s a big change. We should all have a sense of urgency, not because it’s about the company but because Afrezza is a tool that’s of immense value for people. If we’re not going to help people and make it available, we’re not fulfilling our personal and moral obligation to the Diabetes Community.

Can you outline your new role as Chief Medical Officer?

The CMO for MannKind is responsible for strategy and execution of all things research, science and medicine-related. I’d say research is the exploration of an idea that science has given you. Eventually, the clinical development and ultimately the medical affairs teams must work in lock-step so you’re producing scientific information that’s valid and meaningful to the regulatory agencies, as well as to anyone who will be an end-user. It’s an experience as much as a therapy.

So all of that exploratory research and those who participate, and the communication of that -- as well as the monitoring of regulatory and safety needs that includes all of the clinical data that went forth to those regulatory agencies -- all falls under the purview of the CMO. Right now, our hallmark product is Afrezza so I am focused on Afrezza. But in the future, I anticipate it’ll be focused on the Technosphere platform in other drug delivery, such as hypertension. All of those areas are what I’ll be doing.

Part of my responsibility in accepting this job is to make sure our research, clinical, medical and safety and regulatory activities are being executed in a coordinated fashion -- one that best serves the end-user, those living with diabetes. We have to provide the clinical evidence supporting Afrezza, and I feel we have the responsibility of improving the insulin-using experience.

With our leadership team at the company, we've re-established priorities around that, which I will be focused on for 2018.

As far as the Afrezza science, what would you say to those who might still be worried about lung risk?

Although there are theoretical concerns on lung impact, the safety data that I’ve been able to review and that the FDA’s reviewed is that Afrezza’s benefits and availability clearly outweigh any theoretical risk. Otherwise, this wouldn’t be an approved product for a chronic condition. I see the lung as our tool, not as a potential danger. From what I’ve seen and heard, it seems the concerns over the pulmonary bed have been largely set aside.

Also, there are a lot of potential advantages of pulmonary insulin delivery that don’t depend on conditions with subcutaneous injections or pump therapy that can vary effects.

Can you walk us through a bit about the clinical research underway on Afrezza?

We have three very specific priorities for the medical group in 2018.

The first is to refine and execute a lean clinical development plan, and enhance the scientific communication platform for clinical support -- to make sure there’s awareness of the scientific data we have and the clinical implications of Afrezza. We’ll then leverage our robust, existing research data set. More than 60 studies have been executed with Technosphere and Afrezza, and execute a comprehensive scientific disclosure plan to share data that can help inform the clinical and patient communities on meal-time insulin control with Afrezza.

We do have studies on using and leveraging technology with Afrezza, and have initiated one using the One Drop app and an ongoing meal-time dosing for T2s, and finally we have an investigator-initiated group at Yale in the pediatric population to bring Afrezza into hybrid closed loop systems.

How are you approaching glucose monitoring technology related to Afrezza and its value for patients?

I've always held that really good insulins will require very good information at the level of the user. We're at that point, now that we have the ability to include glucose monitoring into our Afrezza research -- whether it's through interstitial CGM or through Abbott Libre Flash. We have data that's reliable enough, so that "in-the-moment insulin" can be not just a nice tool, but the tool of choice for people with diabetes. If you have data on what your insulin is going to do and it does that within 60-120 minutes, that's what the body wants for you. That's why I think technology is going to help us make Afrezza an even better tool.

What can you say about pricing, especially with your background at Lilly during a time when insulin prices rose dramatically?

I’ll never claim to be a pricing or negotiating expert. I’ll leave that to the payer reimbursement team’s side. But what is required of anyone in the pharma or device space now is to deliver on value. You can argue what that value is, of course. I used to jokingly say to my managed care colleagues that anyone of us can have a heart attack or stroke without prior authorization, but couldn’t get the therapies needed to prevent that heart attack or stroke.

Part of my work at ADA was during the time of the Affordable Care Act, and love it or hate it, supporting pre-existing conditions and making sure those with chronic conditions had access to the tools necessary for their best care. It is my responsibility as the medical team lead here to make sure we work with payers and providers and systems to demonstrate value. We have to show people are doing better, feeling better and can care for themselves in more effective ways in order to validate Afrezza. In healthcare, we have to stand behind our asset and say here’s the value we can provide.

Has MannKind embraced the “Beyond A1C” message for Afrezza?

This is an area that falls under my purview. My dream is to have an FDA leader who personally lives with type 1 and understands what it’s like to have a blood glucose of 220 versus 110, what it feels like to have an hour’s worth of glucose values in the 50s, how it disrupts your day. All of that isn’t captured in A1C or necessarily in (regular meter monitoring), and recovery from a significant low can take more than an hour out of your day. Those things go into the value, and it’s what we can show being addressed with Afrezza, using technology to show that.

I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers.

 

Thank you for taking the time to talk, Dr. Kendall. As Afrezza users ourselves, we look forward to seeing what's ahead for MannKind with you on board!