Sanofi Terminates Partnership for MannKind’s Inhaled Insulin, Afrezza

Twitter Summary: @SanofiDiabetes + #MannKind end partnership on #Afrezza, how does this impact patients + why the breakup? 

MannKind recently announced that Sanofi has ended the partnership for the inhaled insulin, Afrezza. All rights to market and sell Afrezza will now be returned to MannKind over the next 90-180 days.

What does this mean for current and new Afrezza users? According to a call that MannKind’s management team did with investors, the near-term goal is to prevent any interruption in access to Afrezza during this transition period over the next three to six months. It didn’t make promises beyond that, but it’s clear MannKind plans to continue making and selling Afrezza, and the hope is to adopt a new marketing and pricing strategy going forward. The company can explore other partnerships for Afrezza’s distribution, though it’s unclear if another company would choose to do this on the terms that MannKind would ask. If MannKind doesn’t find a partner, it has the internal resources to keep Afrezza available into the second half of this year, and perhaps longer. MannKind is expected to share more details at the JP Morgan conference this week. They’ve had the added complexity of a new CEO that did not work out – former Insulet CEO Mr. Duane DeSisto was hired, but later this news was followed by the abrupt announcement that Mr. DeSisto would not continue as CEO. 

Why the breakup? Why the management change? Sanofi ended the partnership after lower-than-expected 2015 sales for Afrezza and uncertainty on how Afrezza could become profitable for Sanofi in the long-term. We have the impression there was not management agreement on how this was economically viable. The companies first teamed up on the rapid-acting insulin Afrezza in August of 2014, and the insulin was launched early in 2015. Word has it, however, that due to the expense of manufacturing the insulin and FDA requirements (on both future trials required, as well as direct-to-consumer marketing), chances for success in the market place were slim, even though the product itself has so many admirers. As for why Mr. Duane DeSisto came on as CEO and did not continue, the company gave the impression that Insulet was suing MannKind because Mr. DeSisto was not allowed to work for another diabetes company.

What are the specific challenges for Afrezza on the market? There are several factors that have potentially contributed to its low success thus far, including:

• Reimbursement for Afrezza has been lacking, which may have made it more costly or inaccessible for patients and harder for doctors to prescribe.

• Afrezza’s label does not include some of the factors that made it a compelling choice compared to other rapid-acting insulins in clinical trials, including reduced hypoglycemia and “ultra rapid-acting” action. This was really a shame for many, and it also limited what the communication with consumers could look like. 

• Afrezza was launched at the same time as Sanofi’s new basal insulin Toujeo, and it’s possible Toujeo’s launch overshadowed that of Afrezza to a certain extent. We’ve heard that awareness for Afrezza is not high among patients and providers, though it’s not clear if (or to what extent) this directly impacted its sales. We did know a number of doctors, nurses, and patients that had an excellent experience with Afrezza, and we liked the degree to which this was available as an alternative given that so many people are not doing as well as they (or their healthcare teams) would like on traditional “multiple daily injections."

• New insulins often take time to reach a large audience (even for now-blockbuster insulins like Lantus), and it’s expected that this would be particularly true for a new form of insulin that is inhaled insulin.

• According to a conversation we had with Sanofi management, nearly two-thirds of Afrezza users who have tried it to date haven’t continued using it after the first-prescription. If that’s true, it’s unclear what exactly is driving the drop-off in use: reimbursement issues? coughing side effects? not enough advantage vs. injectable insulin? The fact that there hasn’t been optimal follow-up is unfortunate, since some of these are addressable.

• The previous failure of the first inhaled insulin, Exubera, may have negatively influenced perceptions of inhaled insulin in general, especially to healthcare providers. Even Sanofi’s marketing slogan for Afrezza – “Surprise – It’s Inhaled Insulin” – perhaps focused too much on its inhaled design, rather than focusing on what inhaled insulin means for people with diabetes: “No needles!” However, the FDA also regulates direct-to-consumer marketing, so there may have been restrictions in place here.

We spoke to diaTribe advisor Dr. Irl Hirsch in December about Afrezza, and he echoed some of these hassles: “In my clinic since Afrezza was launched, out of ten prescribing clinicians … we’ve had three patients try to get the drug, one flunked their pulmonary function test (the mandatory lung-screening test to get Afrezza), two were denied by insurance, and here we are at the end of 2015 and not a single patient of over 3,000 are inhaling their insulin.” In a different world, if endocrinologists had more time and if reimbursement were better, anyone with an A1c over 7% might have been invited to try it. We also point out that in the US, the world has changed – it used to be that doctors and nurses could recommend changes to their patients – or that patients could request certain products. Now, particularly in reimbursement-constrained environments like the Pacific Northwest, the payers are the ones who make the decisions and it’s barely possible for healthcare providers to recommend anything, given the time required and overall difficulty. 

Still, MannKind is no stranger to challenges. Afrezza was initially rejected by the FDA twice, in 2010 and 2011, before finally receiving approval in 2014. While the road ahead will be challenging, we continue to hear from our readers how for many people, Afrezza has made an incredible impact in their diabetes management. As one patient we spoke to last year told us, “I’ve been impressed at how quickly it works. If I take it at the right time then I can keep my blood sugars at a pretty normal range. My goal with Afrezza is to maintain an A1c that is a normal person’s A1c and it looks like I may be able to do that.”

We hope MannKind will find a way to bring this insulin to more people with diabetes – the faster action, lower rate of hypoglycemia, and absence of needles are advantages that could benefit many people. –AB/AJW/KC