MannKind’s loss mounts ahead of US Afresa submission

By Gareth Macdonald

- Last updated on GMT

Related tags Inhalable insulin

MannKind, one of the inhaled-insulin market’s only remaining players, has posted higher than expected Q4 losses as costs for development of its lead product candidate Afresa increase ahead of its submission to the US FDA.

The firm reported a loss of $83m (€66m), or 82 cents per share, up 11 per cent on its deficit in the comparable period last year and ahead of the 65 cent per share prediction of analysts surveyed by Thompson Reuters​.

MannKind explained that its manufacturing expenditure increased by $2m, while its income from interest crashed from $5m in the same period in 2007 to $271,000 for the final three months of 2008.

For the full year 2008 the picture was similar. MannKind’s annual shortfall amounted to $303m, up from $293.2 million the pervious year.

Company CEO Alfred Mann was upbeat about the increased loss. He explained that: "Our [Food and Drug Administration application] for Afresa is now almost finished," ​adding that the year ahead would see the firm transition from “the development of Afresa into commercial readiness​.”

MannKind’s positive reaction to the loss can be explained by several factors. Firstly the failure of Pfizer’s Exubera and Lilly’s AIR has left the potentially massive inhaled insulin market relatively free of commercial competition for Afresa.

Even before the competitor products were withdrawn, a 2006 Datamonitor​ report predicted that, if approved, Afresa, then known as Technosphere, could generated revenues of $288m in 2015.

Secondly, in September last year MannKind released trial data showing that Afresa is as effective at controlling the blood-sugar levels in type 1 diabetics as injected insulin and crucially, the two treatments showed no differences in lung-function.

And finally, while the opportunity created by the demand for novel insulin delivery products has not gone unnoticed, most recently by Australia’s Nanotechnology Victoria (NanoVic) which proposed a jewellery-based system, the development of potential Afresa competitors is still at a very early stage.

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