This inhaler is designed to be used with Mannkind’s inhaled insulin Afrezza
MannKind’s search for a partner for its recently approved inhaled insulin therapy Afrezza has ended with a global licensing deal with diabetes powerhouse Sanofi.
MannKind said throughout Afrezza’s development that it would need a strong commercial alliance for the new product, and with the Sanofi partnership it gains a partner whose diabetes franchise – led by long-acting injectable insulin Lantus (insulin glargine) – saw sales rise almost 15 per cent in the first half of the year to almost €3.5bn ($4.7bn).
The deal clears the way for a launch of Afrezza in the US in the first quarter of 2015, with Sanofi responsible for commercial, regulatory and development activities and MannKind focusing on manufacturing the product at its facility in Danbury, Connecticut.
Under the terms of the deal, MannKind gets an upfront payment of $150m, as well as potential development regulatory and commercial milestone payments of up to $775m, and will get a 35 per cent share in profits (or losses) from the product.
The US company is confident that Afrezza will be profitable and – given the size of the diabetes market – believes it can secure blockbuster sales for the drug with a fairly small market share, according to chief financial officer Matt Pfeffer.
“We need better insulins; doctors universally agree we need them that work faster and have less risk of hypoglycaemia,” he told investors just ahead of Afrezza’s US approval in June.
MannKind describes Afrezza as an ultra-rapid-acting insulin – to differentiate it from so called rapid-acting injectable insulin analogues – and says it acts in the body in a way that more closely mimics natural insulin release.
The new drug-device combination “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, head of Sanofi’s diabetes division.
Sanofi also needs new products to bolster its diabetes franchise as it faces the prospect of biosimilar competition to Lantus, which accounted for more than €3bn of sales in the first half of the year. In June the first biosimilar Lantus – Boehringer Ingelheim and Lilly’s Abasria – was recommended for approval in the EU.
The French company will be hoping Afrezza fares better than Pfizer’s ill-fated inhaled insulin Exubera, which was taken off the market in 2008 after poor sales, but it does not rely on Afrezza alone. Sanofi is also developing a new version of Lantus, called Toujeo, which has a reduced risk of hypoglycaemia and could be approved in early 2015.