Last year, MannKind Corporation had its first regulatory breakthrough since its foundation in 1991 when the US Food and Drug Administration (FDA) approved its inhalable insulin drug Afrezza along with the firm’s pulmonary drug delivery technology, Technosphere.
The platform uses the excipient fumaryl diketopiperazine (FDKP) which is highly soluble at pH 6.0 - the prevailing physiological pH in the lungs - in order to avoid both hepatic first pass metabolism and degradation in peripheral circulation in the delivery of, in the case of Afrezza, mealtime insulin.
But the technology can also be used to increase bioavailability and offer a more convenient administration of other active pharmaceutical ingredients (APIs), and with Afrezza set to launch in the coming weeks, the firm said at last week’s JP Morgan Healthcare Conference it was developing a strategy as to which disease it will target next.
“The question should not be whether there is anything following Afrezza but [which of the] many opportunities to select which opportunities has substantial market potential,” MannKind’s founder Alfred Mann told investors.
“We will focus our limited resources on those which have the greatest and earliest opportunities. A list of drugs is being evaluated and will be reported next week to the Board of Directors at MannKind to select the right opportunities going forward.”
Mann, who founded the company and has led much of the financing behind Afrezza, will not, however, be taking the lead in developing the Technosphere platform further, announcing at the conference he has stepped down from the role as CEO.
“I realise my skills will are not best suited to guide our everyday operations,” Mann said. “Therefore considering all this and my age [89], it seemed appropriate at this time for me to step down as CEO of MannKind and turn over those functions to our President Hakan Edstrom who has effectively been managing the team over the last period.”
In his first address as CEO, Edstrom echoed Mann’s views, saying with inhalable insulin, the firm had “probably started with the hardest area you could consider for a disease,” but the significant investment and FDA approval left the company in good stead for the development of its next Technosphere-based therapy.
Afrezza’s launch and Sanofi’s 65%
Edstrom was insistent Afrezza will launch in this quarter, following the commercialisation agreement made with Sanofi in August which saw the French drug giant pay MannKind $150m (€112m) upfront for a 65% share of the drugs profits.
“We are very proud and happy to be in that partnership,” he told the room, adding the deal sees Sanofi take responsibility for terms of sales, marketing, distribution, clinical development and regulatory issues surrounding Afrezza.
Mannkind will keep its manufacturing operations in Danbury, Connecticut and transfer manufactured products to Sanofi at the cost of goods.
Sanofi has asked for an undisclosed quantity of the product by January 23, ready for launch, but according to MannKind the manufacturing yields were better than expected and the product has been delivered ahead of schedule.