For MannKind Corporation, 2014 was a busy year with the US Food and Drug Administration (FDA) approving its drug-device combination inhaled insulin Afrezza, and inking a deal with Sanofi to commercialise the product.
And yesterday Afrezza became available by prescription in the US with Janet McGill - a clinical trial investigator in the development of the product - describing the launch as bringing “another option to administer insulin that is not an injection,” to patients with type 1 and type 2 diabetes.
Afrezza uses the excipient fumaryl diketopiperazine (FDKP) to increase the solubility human insulin delivered to the lungs when a patient inhales the dry formulation contained in pre-filled cartridges using a small, disposable device.
Sam Finta, who was a trial patient for Afrezza and has become an independent online advocate for the drug, told in-Pharmatechnologist.com that the product is being well received among diabetics that he has spoken to, and chat across a number of patient forums suggest similarly.
“While there are critics and opponents of the drug, many [of these have] other agendas,” he told us. “Afrezza is a disruptor in a multi-billion dollar business.”
Sanofi and MannKind now control the inhaled insulin market as though such products have been investigated by drug companies in the past, the most advanced was Pfizer’s Exubera, a drug-device combination approved by the FDA in 2006 and pulled a year later at a cost of $2.8bn after it failed to gain the acceptance of patients or physicians.
While Exubera suffered from an unwieldy delivery device and questionable effects on lung function, its failure saw both Eli Lilly and Novo Nordisk discontinue development of rival products. When Pfizer warned its drug could increase the risk of lung cancer among users, the concept seemed doomed to fail.
We contacted the companies previously involved in inhaled insulin R&D to see if the launch and user interest would see them reassessing the market opportunity.
“Although we always remain flexible, our near term plan does not include inhaled insulin,” a spokesperson from Eli Lilly – which took the product AIR insulin, developed with Alkermes, into Phase III clinical trials before dropping it in 2008 – told us.
Novo Nordisk also confirmed it had no plans to re-enter the space following the discontinuing of its AERx project with Aradigm in 2008.
“Our focus is on developing simple and user-friendly injection devices, such as FlexTouch, our latest prefilled insulin delivery system,” spokesman Mike Rulis said. “In parallel, we are pursuing oral delivery of insulin and currently have one compound OI338GT in phase 1 development.”
As for Pfizer, spokesman Dean Mastrojohn said the firm “continues to explore inhaled formulations in respiratory diseases, specifically asthma and COPD,” but did not comment further as to whether it would look to revisit inhaled insulin.
Currently, Dance Biopharm has an investigational pocket-sized inhaler device and insulin container in Phase II trials. The candidate, Dance-501, uses vibrating mesh micropump technology to deliver a liquid formulation of insulin in order to lower manufacturing costs, and facilitate ease-of-use.
The firm did not respond to a request for comment on either its product or the launch of Afrezza when contacted by this publication.