In June, the US Food and Drug Administration (FDA) approved Mannkind’s inhalable human insulin drug Afrezza for the treatment of patients with Type I and II diabetes.
The insulin API is supplied to Mannkind through a long-term agreement inked with French firm Amphastar France Pharmaceuticals on July 31 2014 and according to a recent SEC filing, Mannkind “has agreed to purchase annual minimum quantities of Insulin under the Supply Agreement of an aggregate of approximately €120.1 million in calendar years 2015 through 2019.”
Talking at the Morgan Stanley Global Healthcare Conference last week, CFO Matthew Pfeffer said the firm is looking to expand its insulin suppliers, hoping to strike a deal with French pharma giant Sanofi which manufactures the best-selling recombinant human insulin product Lantus and, in August, signed an Afrezza commercialisation deal worth potentially $775m.
“It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors (transcript here). “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.”
However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “It is not terribly complex, but it takes some time.”
Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner.
Commercial production of Afrezza from its facility in Danbury, Connecticut, is set to begin in November.
Technosphere formulation technology
Afrezza uses the firm’s Technosphere formulation technology - encompassing the excipient fumaryl diketopiperazine (FDKP) which is highly soluble at pH 6.0, the prevailing physiological pH in the lungs - in order to deliver the API to the lungs.
However, Mannkind’s ambition goes past inhalable insulin, Pfeffer told investors, as the firm is now looking to use the platform for the pulmonary delivery of other drugs.
“Our technology platform certainly has a lot of applications even beyond diabetes,” he said, adding one such area could be pain management because of the PK/PD profile of Technosphere and of the Dreamboat inhaler used to deliver the API.
“We are putting kind of significant effort into right now to determine what the next opportunities are where we can leverage this platform,” he continued. However, a number of product development opportunities were passed up on as Mannkind had “been so much starved for cash” as it brought Afrezza to commercialisation.
“Other companies have brought us API and said, can you formulate this into something in Technosphere to the extent they are willing to reimburse us for that. We’ve been happy to do that and that could potentially lead to a product opportunity to a collaboration but it would be premature to announce something like that until something like that is in place.”