With positive data results from phase III trials announced last August , and a nod of recommendation by a US Food and Drug Administration (FDA) review panel in April , all that is keeping Mannkind Corporation’s inhaled insulin drug Afrezza from being launched is its Prescription Drug User Fee Act (PDUFA) date set for July 15.
Though this date has already been pushed back three months, the company is gearing up for commercial operations at its Danbury, Connecticut facility, according to CFO Matt Pfeffer, who discussed Mannkind’s manufacturing strategy at a recent investor conference.
“We didn’t fully build [Danbury] out because it's quite expensive to do so, pre-approval, but the facility is scaled to do up to two billion cartridges per year fully built out,” he said at the Jefferies Global Healthcare Conference earlier this month. However, the biggest bottleneck to scale-up is fill finish capacity, he added.
“At launch, we expect to have three of those fill finish lines in place, which should give us about 375 million per year capacity.”
He continued: “We can add capacity in a very nice relatively rapid modular way, which is one of the advantages of having built this very nice expensive facility with all the clean rooms and things in place, just waiting to drop the machines in.”
Afrezza is based on Mannkind's Technosphere technology, which uses the excipient fumaryl diketopiperazine (FDKP) as the particle matrix to carry recombinant human insulin to the lungs. The product is inhaled from the cartridge using a device described by Pfeffer as looking a "little bit like a whistle in use," powered by inhalation alone.
Breath of fresh air?
Pfeffer reiterated the site’s anticipated capacity at the Goldman Sachs Healthcare Conference last week, saying demand for orally administered insulin comes from type 1 diabetes patients on both rapid-acting prandial insulin, and longer acting insulin products such as Sanofi’s lantus, as well as type 2 oral patients who are expected to be transitioned onto insulin.
“Afrezza has a very fast rise time to peak concentration in the blood within really 15 minutes of inhalation as compared to say 45 minutes to an hour for rapid-acting analogs,” he said.
He added the drug’s administration leads to an avoidance of big swings in blood sugar associated with other delivery forms, as well as aiding compliance due to its discrete and convenient use.
If approved next month, Afrezza will become the only inhalable insulin drug currently on the market. Disappointing sales and warnings that it could lead to lung cancer caused Pfizer to pull its product Exubera off the market in 2007 , at a cost of $2.8bn (€2bn).
“Certainly the Exubera experience has left its mark in maybe the waters a bit,” Pfeffer said at Goldman Sachs, but “[Afrezza] does happen to share the trade of being an inhaled insulin, but Exubera was an inhaled insulin who had inhalation as its really only advantage.
“Tthe connect profile was essentially the same, maybe not even quite as good as rapid-acting analog injected where as our connect profile is quite different and really fundamentally different from, and better than an injected insulin.”