Inhaled insulin running out of puff?

Analysis

The news that Novo Nordisk is following Pfizer’s lead and calling time on its inhaled insulin treatment, AERx iDMS, places a question mark over the future for this way of treating diabetes.

The Danish group cited lack of commercial opportunity, despite the product reaching phase III without any safety issues. But rather than putting the final nail in the coffin of inhaled insulins, the field could now be open to smaller players who could exploit a diminutive, but ultimately profitable, niche for patients who are averse to using needles.

Californian company Mannkind is leading the charge for the smaller companies with its phase III Technosphere Insulin System, which is forecast to bank royalties of $545m by 2012, according to consensus data from EvaluatePharma.

Alongside being able to boast a smaller and easier device for patients to use, Mannkind has been also talking up the associated weight loss its rapid-acting product produces, as a way of differentiating itself from other products nearing the market.

Nektar Therapeutics, Pfizer’s former development partner for Exubera, is also still in the running after the US group handed back all rights to the product, including a second generation version.

Unveiling its new, pocket-sized delivery device at the JP Morgan healthcare conference last week, Howard Robin, chief executive of the company, said that he was close to signing a licensing deal with another pharmaceutical company to exploit the technology.

The last of the giants

The space has also not been entirely abandoned by companies capable of taking a drug to market on their own. Eli Lilly is still pursuing the goal of developing a profitable, marketed inhaled product and has recently reaffirmed its commitment to the project.

Also rather than closing the door completely on inhaled insulin, Novo Nordisk said that it would continue to look at long-acting inhaled insulin. AERx was a short-acting treatment designed to be taken before meals.

Novo Nordisk’s resolution will result in 300 or so people losing their jobs and leave the company nursing a DKr1.3bn ($260m) in write downs, which will hit 2007 operating profits.

But analysts are increasingly becoming more sceptical about inhaled products and 2012 sales forecasts for Lilly's AIR Insulin, developed jointly with Alkemes, drifted down from $556m in January 2007 to $392m in December.

Alternatives to breathing

The belief that diabetes patients do want alternative treatments to injecting insulin has also spawned other delivery techniques. Emisphere Technologies is currently working on oral treatment for the condition, which is in phase II and being closely pursued by Novo Nordisk’s own phase I oral formulation.

US company Nastech has seen its nasal spray drug enter phase II trials, as has Bentley Pharmaceuticals’. Additionally Generex Biotechnology’s Oral-Lyn, which is taken by dissolving into the cheek, is expected to record sales of $373m by 2012, assuming it receives FDA approval by 2011.

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