Under the banner of Afrezza 2.0, MannKind is moving with all deliberate speed to recover the momentum built around inhalable insulin when it was introduced in 2014.
That momentum dissipated after the company turned worldwide marketing rights over to Sanofi shortly after FDA clearance in June of that year. Sanofi severed ties with Mannkind in 2016 amid slow Afrezza sales. This set in motion a series of complicated transactions to settle mutual obligations between the two companies and return control of the product to Mannkind in early April 2016. Officially, MannKind has been circumspect in commenting on Sanofi’s handling of its product, although CEO Matt Pfeffer allowed in remarks at investor calls that MannKind “would have done things differently” in bringing Afrezza to market.
Now, the company is working to do just that. Mannkind has been filling 55 new sales positions, negotiating arrangements with regional diabetes care practices to conduct patient education, and refocusing its physician education efforts to target specialists in diabetes care. It also is undertaking a series of new clinical trials for Afrezza in an effort to open up the marketplace for the drug.
In June 2016, JDRF and MannKind announced a research and clinical trial collaboration which will focus upon Afrezza’s safety and effectiveness for pediatric use. This will help Mannkind fulfill commitments the company has made to the FDA to do more testing of the product. It also could help Mannkind expand the potential market, according to MannKind’s chief commercial officer Michael Castagna.
“The next big thing that I think is critically important for those of you who know about diabetes is that a lot of Type 1 patients are diagnosed as children, and they continue to go on through their lives needing insulin. So getting our pediatric protocol off the ground and running and getting patients enrolled is one of my top priorities,” Castagna said at a July 12th investor forum.
JDRF’s senior research vice president Dr. Steven Griffen said in a telephone interview that it makes sense that Mannkind would want to do pediatric clinical trials. It was unusual for the FDA to clear a new drug without evidence to establish its effectiveness for pediatric use.
“New therapies typically require a pediatric program,” he said.
The challenge in these studies will come with translating doses from injectible insulin to appropriate inhaled doses, according to Dr. Griffen. With pediatric patients, it will involve strict attention to variables such as mealtime carbohydrate load, timing of meals and snacks, and activity level.
Clinical studies on pediatric use should be underway in the fall of 2016. When Mannkind plans to submit Afrezza for expanded use is not clear at the moment, said Dr. Griffen.
“MannKind owns the timeline, and I’m sure that MannKind intends to take the time necessary to do it right,” Dr. Griffen said.
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