First Inhalable Insulin Comes to the US

Sanofi announced on Feb. 3, 2015 that it launched FDA-approved Afrezza (insulin human) Inhalation Powder, which is now available for prescription in US retail pharmacies for the treatment of type 1 and type 2 diabetes. Afrezza is a rapidly absorbed, short-acting dry formulation of human insulin delivered from a small and portable inhaler to control blood sugar in diabetes patients. Administered at the beginning of a meal, Afrezza can help control high blood sugar, but should not be used in patients with chronic lung disease such as COPD or asthma.

Mannkind Corporation developed Afrezza and can expect an upfront payment of $150 million, with potential milestone payments up to $775 million, with 35% of future profits. The inhalable version will be available for $7.54 per daily dose for 12 units, which is $4.40 (per dose or per unit?) more expensive than Sanofi’s injectable equivalent, Apidra (insulin glulisine [rDNA origin] injection), according to Reuters. The company’s press release lists one of the “limitations of use” as the need to continue long-acting insulin in combination with Afrezza for patients with type 1 diabetes, meaning the inhalable product cannot replace other forms of insulin for some patients.

Sanofi’s diabetes division is responsible for $7 billion in sales annually. In 2014, Sanofi noticed a drop in sales for its diabetes treatment Lantus, contributing to CEO Chris Viehbacher’s termination, according to Forbes. To make matters worse, Reuters reports that the Lantus insulin patent is due to expire this year, meaning Sanofi expects little to no sales growth through 2018. Introducing the first FDA-approved inhalable insulin may up the game for Sanofi, securing its hold on the diabetes market. However, Reuters continues by mentioning that industry analysts expect sales of only approximately $182 million per year by 2019 given previous inhalable insulin commercialization attempts by Pfizer that were unsuccessful.

Sources:
SanofiReuters