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MannKind celebrates as inhaled insulin clears pivotal trials

Closing in on approval of Afrezza

Mannkind Dreamboat inhaler

Positive results from two phase III trials suggest MannKind is finally closing in on approval of its inhaled insulin product Afrezza after years of struggle.

The pharma company said the results indicate that the powdered insulin product - which is delivered via an inhaler and does away with the need for injections - improved control of blood sugar in people with diabetes when added on top of oral drugs.

Shares in MannKind leaped more than 20 per cent yesterday on rising expectation that Afrezza could now reach the market as early as next year. MannKind is planning to re-file an application for the product in the US in the autumn, having withdrawn its first attempt after an FDA request for more clinical data.

The first study (175) in patients with type II diabetes showed that Afrezza provided superior reductions in haemoglobin A1c levels - a market of blood glucose control over time - and helped more people reach their blood sugar targets when added on top of oral therapy.

After 24 weeks of treatment, around 38 per cent of patients in the Afrezza plus oral therapy group achieved A1c levels below 7 per cent, compared to 19 per cent of patients on oral therapy alone. Similarly, 16 per cent of Afrezza-treated patients had A1c levels below 6.5 per cent, versus 4.2 per cent of the control group.

The second trial (171) in people with type 1 diabetes showed that Afrezza was equally as effective as the fast-acting injectable insulin aspart - sold by Novo Nordisk as NovoLog or NovoRapid - in controlling blood glucose levels, but was less likely to cause hypoglycaemic episodes and weight gain, according to MannKind.

MannKind is hoping to achieve with Afrezza what Pfizer spectacularly failed to do with its ill-fated Exubera brand of inhaled insulin, which was launched to great expectation in 2006 but was withdrawn from the market a year later on lacklustre sales and concern about the risk of dosing errors.

Pfizer took a $2.8bn pretax hit on the product, and its demise also prompted other companies developing inhaled insulin - Lilly/Alkermes and Novo Nordisk/Aradigm - to drop their own programmes.

MannKind will be hoping that the sophisticated Dreamboat inhaler used in Afrezza will help alleviate dosing concerns, although it remains to be seen how the FDA will respond to the new data. Meanwhile, the company is still seeking a commercial partner for the product, and it is likely this will gain pace now that the phase III data is out.

Article by
Phil Taylor

15th August 2013

From: Research



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