In 2014, the US Food and Drug Administration (FDA) approved MannKind Corporation’s inhaled insulin product Afrezza for patients with type 1 and type 2 diabetes, along with its Technosphere delivery technology, and months later the product was picked up by Sanofi in a $150m commercialisation agreement.
But this week, the French Pharma Giant has told MannKind it is ending the partnership.
From its launch in February 2015 to the end of September, sales of the drug had been “disappointing,” clocking in around €5m ($5.4m), and with MannKind’s share price falling to its historical low yesterday there are questions over the futures of both Afrezza and MannKind itself.
The news brings back memories of Pfizer’s failure in the inhaled insulin sector. In 2007, Exubera was pulled from the market a year after launch after failing to win over patients and physicians, and led to the Big Pharma firm taking a $2.8bn hit.
'Opportunity, not obstacle'
Sanofi was able to terminate the partnership any time on or after January 1 2016 upon 90 days’ written notice, but MannKind’s CFO Matthew Pfeffer said in a conference call yesterday such a break-up had never been anticipated when the partnership commenced.
Despite this, he told stakeholders Sanofi’s exit is an “opportunity rather than an obstacle to correct the commercial trajectory of Afrezza,” and the firm is now able to explore alternative distribution and licensing arrangements domestically and internationally.
He added that “it became clear as 2015 progressed that sales forecasts were not met and that change would be required if Afrezza would achieve the market success we believed - and still believe - should be possible.”
Marketing delays, direct-to-consumer advertising which never arrived, and an alleged hiring freeze on Afrezza sales reps haunted the product during the year, and Pfeffer said MannKind has already begun “a process of independent research to validate that different sales efforts and pricing strategy is required” to take Afrezza forward.
“Future marketing plans must centre on educating patients and doctors on Afrezza… [while] positive marketing depends on redefining pricing and contract tactics to improve reimbursements and patient access with commercial and government payers.”
Supply and Demand
Pfeffer was also confident there would be no rupture in supply for current users of the drug.
“Immediate next steps include discussion with Sanofi about a smooth and orderly transition of development and commercialisation activities related to Afrezza… to ensure that no interruption of therapy or coverage with patients.
“Our conversations with Sanofi yesterday [Monday] indicate our partner fully intends to honour that obligation. Sanofi will continue to sell Afrezza during the notice period so long as they have inventory.”
He also referred to “the pool of loyal Afrezza advocates which continues to grow daily” which he said helps reinforce real world experience of the product.
One such follower is Sam Finta who was a trial patient for Afrezza and has become an online independent advocate of the drug. He said Afrezza continues to be a disrupter in a multi-billion dollar business and while he is concerned about the drug’s future he told in-Pharmatechnologist Sanofi’s exit is “not the end of Afrezza, no matter what happens.”
Enter the Technosphere
As for MannKind, Pfeffer was resolute “this is not the end of the line” and said the firm was looking forward “to enter the New year now with a clean slate and the freedom to pursue a new approach.”
The addition of a new CEO this week - Duane DeSisto, former CEO of medical device company Insulet – will help champion this effort, he continued, but Pfeffer added it would be the firm’s Technosphere platform which “continues to be the foundation which MannKind’s future will be built.”
The core of the technology is the excipient fumaryl diketopiperazine (FDKP). In Afrezza, FDKP, water and the non-ionic surfactant polysorbate 80 are mixed and crystallised into uniform particles of 2 microns in diameter in combination with recombinant human insulin.
FDKP is highly soluble at pH 6.0 – the prevailing physiological pH in the lungs – meaning that when the Afrezza particles have reached their destination the excipient dissolves and allows the insulin to be rapidly absorbed.
The firm is looking at using the technology with other APIs and - according to Pfeffer – is currently “working on several potential out licensing transactions for additional products opportunities.”