Poor patient uptake coupled with safety concerns effectively closed the door on inhalable insulin in 2007 when Pfizer dumped its FDA approved product Exubera at a cost of $2.8bn, and others – including Eli Lilly – turned their backs on similar insulin delivery projects.
MannKind Corporation picked up the pieces and last year received regulatory approval for its product Afrezza, followed by a commercialisation deal with French Pharma Giant Sanofi which launched the inhalable insulin in February.
Sanofi recently reported Q1 2015 sales of just $1m for Afrezza, and while it paid MannKind $7.1m in product shipments as deferred product sales from the collaboration, the launch was described last week as “getting off to a slower start than had been hoped,” by Executive Chairman Alfred Mann.
MannKind’s CFO Matthew Pfeffer, was confident the uptake of Afrezza would accelerate over time, telling in-Pharmatechnologist.com the factors behind the poor uptake “are all related to delay, not to ultimate demand for the product.”
Regulatory Requirements
One such factor is the drug’s label warning that it should not be used by people with existing lung disease or serious asthma. This has led to a requirement that a potential patient must have a spirometry test to measure lung function before being prescribed Afrezza to rule out any undiagnosed conditions.
“Because endocrinologists, who have been the primary prescribers so far, don't typically have this equipment, they need to refer the patient outside for the test,” Pfeffer said.
“Once done, the patient can come back and get their prescription. But this can add many weeks to the process.”
Marketing Drive
Afrezza uptake has been further stifled by the, medical reimbursement climate which is yet to have finalised formulary placement for the new diabetes offering, he continued.
Furthermore, many physicians are still unaware of the product, due in part to Sanofi “going for depth rather than breadth” in its marketing drive.
“We hear frequent reports of patients visiting their doctor to ask about Afrezza, only to find that their doctors don't yet know much about it. Sanofi is actively marketing the product, but there are literally hundreds of thousands of target physicians and it takes time to reach them all with a finite sales force.”
Afrezza’s uptake has also been hit because pharma companies do not do direct to consumer advertising in the first six months following a product's launch.
“This is important in our case, because it implies that such advertising would not start until July or August this year. Because this is a product that would likely benefit greatly from patient demand, we are hampered by this practice.”
Despite these issues, MannKind and Sanofi just need to be patient, Pfeffer said.
“I strongly believe they will be overcome and the product will be every bit as successful as we have always said it would be.”