Small step for MannKind resurrects inhaled insulin

16-Sep-2008 - Last updated on 17-Sep-2008 at 11:26 GMT

Related tags Inhaled insulin Inhalable insulin Pfizer

MannKind’s inhaled insulin treatment, Technosphere, has met its study goal in the first of three Phase III trials, leading to Pfizer transferring its remaining Exubera patients to the treatment.

The trial showed that Technosphere is as effective in controlling the blood-sugar levels of type 1 diabetics as injected insulin and crucially, the two treatments showed no differences in lung-function measures.

Changes to Exubera’s US product label to include a warning about an increased risk of developing lung cancer was the final blow for Pfizer’s product, with many analysts believing it was also the death knell for inhaled insulin.

Many investors evidently still believe this to be the case, as despite the positive Phase III results MannKind’s shares fell by 14 per cent upon publication of the trial data. MannKind’s share price has fallen by 54 per cent since April 1.

However, Pfizer has shown enough faith in Technosphere’s safety to transfer its remaining Exubera patients onto MannKind’s treatment. This will allow Pfizer to cease production of Exubera.

Dr Peter Richardson, MannKind's chief scientific officer, said: "For some Exubera patients, continued treatment with inhaled insulin is needed. These patients generally fall into two categories: Those with severe needle-phobia or a very poor response to subcutaneous insulin.

“This small number of patients represents a group with particularly high medical need who will benefit from using an inhaled insulin such as Technosphere Insulin."

Pfizer is reimbursing MannKind for the treatment of the patients and the deal does not mean it is to be the big pharma partner for Technosphere.

Negotiations with potential partners are believed to have been delayed until the end of the year. MannKind suspended its search in April as it did not feel it would get an appropriate valuation given the cynicism towards inhaled insulin that was generated by Exubera.

The response of MannKind’s share price to the Phase III results suggests that this cynicism is still prevalent in financial markets. However, if MannKind can bring the product to market it may have a blockbuster on its hands.

Alfred Mann, founder of MannKind, told the LA Times that Technosphere could be a blockbuster even if the US Food and Drug Administration (FDA) warned of an increased risk of lung cancer.

Prior to Exubera’s failure many believed the inhaled insulin market was big enough for a blockbuster treatment.

However, a word of caution was sounded in 2006 report by Datamonitor, which predicted annual sales of $207m for Exubera in 2015. The same report predicted Technosphere would generate sales of $288m in 2015.