ADA: MannKind Has Evolved Rapidly To Accommodate Confident Afrezza Relaunch

Six months ago it seemed as though the sky was falling for small drug developer MannKind, when its big pharma licensing partner, Sanofi, pulled out of their deal for the manufacture and distribution of approved inhaled insulin therapy, Afrezza. However, MannKind Corp. made rapid changes to evolve its business into a specialty pharmaceutical company and took back the drug to market on its own – a feat it had never performed before.

Inhaler
Afrezza Inhaled Diabetes Therapy

During the recent American Diabetes Association annual meeting, held in New Orleans, June 11-14, MannKind Corp.'s chief medical officer, Raymond Urbanski, sat down with Scrip's Lucie Ellis to discuss what went wrong with its Sanofi partnership, why MannKind decided to go it alone and what is next for the newly transitioned specialty pharma.

A History Of Afrezza

MannKind has remained optimistic about the prospects for Afrezza since its distribution deal with Sanofi collapsed in January this year. However, many have been skeptical as the drug previously faced a lengthy approval process in the US and didn't see a strong uptake following its first launch.

Most people bet against the drug, an inhaled insulin for the treatment of type 1 and 2 diabetics, from the start – but not Alfred Mann, the founder of the company, who put down more than $1bn of his own cash to move the product forward. Yet, Afrezza has been overshadowed in the past. Pfizer had a similar product, Exubera, which it pulled from the market after only a few short months because it failed to gain market traction. The big pharma also later discovered that its inhaled insulin was linked to lung cancer. But living in the shadow of the Exubera failure wasn't the only thing bringing down Afrezza. MannKind went back and forth with the US FDA regarding approval of the drug for almost a decade. After several rejections, it finally gained approval in June 2014 – but the drug wasn't launched until the start of 2015.

Alfred Mann, a physicist by training, died in February this year. (Also see "Al Mann Dies, Leaves Legacy Beyond MannKind" - Scrip, 27 February, 2016.)

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