MannKind Corp. (MNKD)

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$MNKD Sanofi/MannKind might be facing a major flop with Afrezza inhaled insulin

By Nicole Gray | July 1, 2015

Dive Brief:

According to IMS data, doctors are writing less than 500 scripts per week for MannKind/Sanofi's inhaled insulin product Afrezza.

As TheStreet notes, Afrezza is even underperforming Pfizer's Exubera at this point, which was launched in 2006 and taken off the market in just one year.

MannKind has asserted that Afrezza is superior to Exubera in every way, and Sanofi executives have insisted—including to this publication—that a turnaround is in the cards.

Dive Insight:

Although MannKind has asserted that Afrezza is superior to Exubera in every way, the numbers tell a different story. While Afrezza only launched in the first quarter of this year, uptake has been anemic, based on the available data.

It helps, however, to look back at all of the commentary surrounding the failure of Pfizer's Exubera.

In 2008, Lutz Heinemann, PhD, published an article deconstructing that product flop and landed on two important factors—the large size of the Exubera device, which made it indiscreet (a no-no in the diabetes marketplace) and challenging dosing.

But despite the fact that MannKind addressed those problems with a smaller delivery device and an easier calculation methodology, there are still challenges, including the fact that patients must undergo a lung function test before being eligible to use Afrezza—a speedbump to be sure.

When BioPharma Dive reached out to a prescribing physician, who preferred to speak anonymously, the physician said, "I would not write it for two reasons:

1) The Exubera problem with the lungs and Afrezza's boxed warning regarding the same issue, and

2) What a pain it is trying to change a patient from the needle-based insulin to inhaled insulin because of dosing. A mistake in equivalency can mean hypoglycemia. I imagine that's why most doctors will not switch patients. The only time I would consider prescribing Afrezza would be for a new patient that I can get used to it slowly, or someone who is very scared of needles."

At this early stage, MannKind and Sanofi have obviously not declared Afrezza a failure. In fact, in a recent exclusive interview with BioPharma Dive, Sanofi's head of U.S. pharmaceuticals told us that Afrezza was off to a "solid start" despite the numbers.

"[T]he strategy here is targeted and focused, and that's important because we need to educate the specialists and high-prescribing physicians for appropriate usage of their medicine," said Jez Moulding. "In terms of access, we've secured third-tier benefit in a number of plans. We'll be launching print and direct-to-consumer promotion in the next few weeks, and we'll be launching a 12-unit cartridge later in Q3."

The companies have yet to throw in the towel on the product (publicly, anyways) and are ramping up DTC marketing efforts. But it seems like it may be an uphill battle at this point.

UPDATE: We have been receiving some very impassioned feedback regarding this post. To be clear: We do not hold any stakes in any companies that we cover. Furthermore, BioPharma Dive recognizes that it is entirely possible that Afrezza sales will pick up in the wake of DTC marketing efforts, as Sanofi's Moulding predicted to us in our interview. But only time will tell, and at this juncture, we are reporting on the few data that are available.

Recommended Reading
thestreet.com: MannKind's Afrezza Lags Behind Biggest Failure in Inhaled Insulin

http://www.biopharmadive.com/news/sanofimannkind-might-be-facing-a-major-flop-with-afrezza-inhaled-insulin/401602/