Primary File Info
Will Mannkind’s Dream Come True?
George L. Whaley, Jessica Brown
May 1, 2015
Strategy & General Management, Marketing & Sales
strategic management, entrepreneurship, product marketing, biotechnology, biotechnology management
Journal of Case Studies
The CEO and major stockholder of MannKind, Inc., convinced his firm to develop an inhalable insulin, Afrezza and inhaler, Dreamboat to treat diabetes. The unapproved Dreamboat inhaler with Afrezza instead of the approved Medtone inhaler was used when MannKind filed their application in 2010 with the U.S. Food and Drug Administration (FDA). MannKind used its latest inhaler technology and the inhaler substitution delayed the approval process because FDA wanted proof Dreamboat was as safe as Medtone. The delay triggered external and internal challenges such as stock price fluctuations, stockholder suits and layoffs. MannKind filed another FDA application in 2013 focusing on safety of the inhaler substitution. FDA delays caused the CEO to wonder about the success of his strategic framework. As the CEO awaited FDA approval in April 2014, he reflected on his dream to develop a product that tackled diabetes in spite of his frustration with the FDA process