The search for a practical inhaled insulin option for those living with diabetes has been a difficult one. Many tried with little long term commercial success, but MannKind Corp. has been confident that wide scale adoption of its product is just around the corner. Its Afrezza (insulin human) Inhallation Powder is delivered using a small device about the size of an asthma inhaler. Having been approved by the FDA back in 2014, the folks at MannKind have been working to convince physicians of Afrezza’s benefits and to increase its adoption by patients. We had the opportunity to ask Michael Castagna, PharmD, Chief Commercial Officer of MannKind Corp., a few questions about the potentially revolutionary product, how it came about, and the challenges of getting it into the marketplace.
Medgadget: Afrezza took a lot of effort by MannKind Corporation to develop, but it’s not the first inhaled insulin. Pfizer, Eli Lilly, and Novo Nordisk have gotten their attempts to different stages of development, including Pfizer’s famous failure with Exubera after bringing it to market. How is Afrezza different and what will spur its adoption by doctors, nurses, and patients?
Michael Castagna, CCO, MannKind: Afrezza was designed to have a very different PK/PD profile than other mealtime insulins which allows patients to inhale our brand and know it will be in and out of their body within 2-3 hours where injectable insulin stays around 4-6 hours. This causes patients to have to guess where they are going to land with their sugars when they give themselves an injection. Because Afrezza starts working in 10-15 minutes it takes a lot of the guessing out of your daily life and provides patients with flexibility. We are focused on Endocrinologist and primary care doctors who prescribe insulin as opposed to primary care doctors who treat a lot of type 2 patients and treat patients with oral medications. We know Endos will put in the work with insurance companies to overcome any reimbursement challenges. We are also focused on leveraging our positive patient stories in social media to ensure they spread the word regarding their experience as patients are paying a lot of money for their healthcare.
Medgadget: Tell us about how MannKind was able to get the inhaler to be as small as it is and what was required in terms of formulating the drug for such delivery.
Castagna: The current device is our second generation device and if you look back at the company we invested over $2 billion dollars bringing this product to market. We have created some blue tooth enabled IP around our device portfolio and are looking at ways to integrate this into our future development programs. As for the drug delivery this is a great technology platform to deliver drugs through your lungs and we are looking to apply this technology to other products such as Epinephrine to compete with brands like the Epipen.
Medgadget: Who are the target users of Afrezza and what kind of folks do you expect to want to adopt it as their insulin of choice?
Castagna: Our target users are currently Type 1 and Type 2 patients who have diabetes and are using mealtime insulin. We know many of them are using insulin pumps and others are using Continuous Glucose Monitoring products (CGM) like Dexcom. There are about 4-7M patients using either basal insulin or basal+mealtime insulin in the US.
Medgadget: Tell us about the R&D and regulatory challenges that had to be overcome to get Afrezza approved.
Castagna: There were several that had to be overcome. The biggest one is the fact that it is a drug and device combo and on top of this it is inhaled. There were many changes over the years in the device as well as the development programs which created several challenges along the development pathway and unfortunately delayed the launch of Afrezza by at least a few years.
Medgadget: It is our understanding that MannKind corporation recently took over the selling function of Afrezaa. How are your sales? Can you give us prescription counts?
Castagna: We launched our sales force the first week of July and New Prescriptions are up almost 100% in the first 10 weeks and our Total Prescriptions have stabilized and are now growing after going through an 12 month decline. Diabetes is a difficult and costly disease to treat and we know there are 22M people in treatment and over 4.5M Total prescriptions in a quarter for mealtime insulin on top of the 18M+ Total prescriptions in a quarter for their once a day basal insulin. We just got the product back in Q2 and launched our commercial resources in Q3 and the early indicators are positive. We need to help doctors understand the benefits of this product go beyond inhalation and that is why we are focused on the science behind our technology.
Medgadget: In a recent stock report, an analyst states (Is Mannkind Near The End?): “Spirometry testing is still going to be holding Afrezza back from widespread adoption. Many of the doctors are not going to have to want to perform additional testing, which is inconvenient for the doctors and takes up patient time. Doctors are also likely to be skeptical of taking patients who are well controlled on other insulin treatments and take the risk of giving them Afrezza. If a patient is not clamoring for the drug, a doctor is unlikely to switch them off without prompting.” How do you respond to such critics?
Castagna: We have done research in this area and have created an offering with a company called MedGraphics who will sell a doctor’s office a spirometry machine for under $400. We know 1/3 of our targets have one already, 1/3 have a referral source that exists and the last 1/3 we are working on. This is a simple test that is not extremely time consuming and we have talked with doctors who see 50+ patients in a day and they do spirometry without any issues. It may take some education for some and others we need to help put it in perspective of how much work and energy they put into starting a patient on an insulin pump or CGM and when you think about how much time & energy they spend getting patients to start on all these tools just to get control of their disease versus taking 1 injection of a basal insulin and our product at mealtime it is a very different patient experience. Think about the 15 minutes every three days a patient spends on inserting their pump set and the cost of all their supplies etc…you see the stories everyday on FB and Twitter of patients having their life back and telling others of their success. We understand this brand very well and will ensure we find solutions for the obstacles patients and providers face in treating their patients to help them get to their individual target goals.
Medgadget: Do you see artificial pancreas technologies as posing considerable competition to your product?
Castagna: No, we don’t. You still need to have a device attached to you and have to change sets and pay for insulin on top of the supplies for the AP. If anything we see it is an opportunity because we know how fast our product starts to work and we have had some people doing AP research tell us we are the solution to these spikes their patients are experiencing in the research. We believe anything that can help patients gain better control of their disease is a win-win. AP won’t be for everybody as we only see 35-50% of type 1 patients taking a pump and the rest are self-injecting their mealtime insulin. We hear about people who have stopped using their insulin pump altogether and simplified their life with a basal injection once a day and using our inhaled insulin at mealtimes.
Medgadget: Do you expect to see further advancements in inhaled insulin technology in the not too distant future?
Castagna: It is an expensive investment for any company to build the platform, IP landscape and manufacturing experience that we have learned over the last two decades. I believe we will see new innovations with delivering drugs through the lungs given the surface area that exists and the PK/PD dynamics that can be created by delivering drugs this way. We know we treat Asthma, COPD, Migraine, Flu and many other conditions through inhalation technology.
Link: AFREZZA info page…