In January 2016, MannKind gave a positive spin to the news that Sanofi was pulling-out of its commercialisation partnership for the inhalable insulin product Afrezza by telling investors at the JP Morgan Healthcare Conference about the opportunities to regain and self-market its lead project, as well as investigate its proprietary Technosphere delivery platform with a number of candidates.
A year on, and CEO Matthew Pfeffer told the same audience that within its pipeline, an epinephrine programme is “the only one that’s still moving forward aggressively,” and the firm had a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA) in early December to discuss clinical pathways for the anaphylaxis candidate.
“That was a major step for us,” Pfeffer told delegates in San Francisco, and while he would not further details of the programme for now, he stressed the need to have “some alternatives in that space.”
Mylan’s EpiPen is the only epinephrine product available in the US, after Sanofi abandoned another marketing deal last year, this time with Kaleo for the Auvi Q injector. And a series of price hikes has led the US government to question the lack of competition and put pressure on the FDA to improve the generic drug review process.
“Most of the technology [in developing] and existing products use auto-injector mechanisms,” Pfeffer said. “All too often, people are reluctant to either stab themselves in the leg with this rather scary looking needle or the cost of at $250 or $300 a pop unless they are really sure they need it, they don’t want to do that.”
MannKind’s candidate will be a single-use disposable, he revealed. “It’s a simple couple of pieces of plastic, relatively affordable as you might imagine and we think it makes a nice alternative [to the EpiPen].”
The handheld inhaler will comprise of the mouthpiece of the Afrezza inhaler with a cartridge built into it.
Like Afrezza, ephinephrine will be delivered using MannKind’s Technosphere platform which uses the excipient fumaryl diketopiperazine (FDKP) – highly soluble at pH 6.0, the prevailing physiological pH in the lungs – in order to avoid both hepatic first pass metabolism and degradation in peripheral circulation in the delivery of an API.