Mannkind has partnered Sanofi for the marketing and commercialisation of its inhaled insulin drug Afrezza, recently approved by the US FDA.
Mannkind’s Afrezza was approved by the US Food and Drug Administration (FDA) in June as a fast-acting meal time insulin for those with Type 1 and Type 2 diabetes. CEO Alfred Mann has spoken in the past about a potential partner coming on board following this approval and today the firm announced it has selected Sanofi.
French Pharma giant Sanofi is paying Mannkind $150m (€112m) up front, with potential milestone payments of up to $775m, and will be responsible for global commercial, regulatory and development activities.
“Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections,” said Pierre Chancel, Sanofi Senior Vice President Diabetes Division.
The rapid-acting inhaled insulin therapy will form part of Sanofi’s diabetes portfolio, which includes its long-acting basal insulin analogue Lantus. Last year, Lantus clocked in sales of €5.7bn ($7.6m) but its US patent is set to expire next February.
Afrezza works using the firm’s Technosphere platform, which consists of the excipient fumaryl diketopiperazine (FDKP) which is highly soluble in the lungs and thus allows the insulin to be rapidly absorbed when inhaled.
FDKP is sourced from an unnamed major supplier, according to Mannkind, but the actual manufacture of the product is done from its own Danbury, Connecticut, facility. This plant will supply Sanofi with Afrezza under a separate supply agreement announced today, details of which were not disclosed.
Mannkind expects to manufacture between 375 and 400 million cartridges from Danbury at the launch, Mann said at the Wells Fargo healthcare Conference in June, increasing fill and finish lines and therefore capacity as demand takes off. “Ultimately we can do 2 billion cartridges a year out of that facility,” he told investors.
The Technosphere powder is administered through a palm sized inhalation device made by a third-party using Mannkind’s molds. “Designing the devices and the cartridges was very complicated, but making them is not, it’s pretty standard,” said Mann.