MannKind's ($MNKD) workforce is feeling the effects of the FDA declining to approve their employer's inhaled insulin therapy Afrezza last month. The Valencia, CA-based company is laying off 131 people at its manufacturing facility in Danbury, CT, the Associated Press reported.
The job cuts are part of the 41-percent work force reduction that MannKind announced earlier this month. The company is trimming its expenses after U.S. regulators rejected its application for approval of its inhaled insulin therapy for patients with type 1 and type 2 diabetes in January 2011. Company financial chief Matt Pfeffer told the AP that the two clinical studies that the FDA is asking the firm to conduct in order to gain approval of the inhaled insulin are expected to take a year and a half to complete.
The bid for approval of Afrezza ran into trouble in part because regulators wanted to see more data on the treatment using the company's next-generation inhaler. The company has no products on the market yet, and Afrezza is supposed to be the firm's first product using its Technosphere technology to generate sales revenue.
The technology offers a way to attach drug molecules electrostatically to the surface of particles, which can be prepared in a dry powder form and inhaled into the lungs. This might offer a more convenient alternative to injecting peptide drugs like insulin while also providing a quick way for treatments to be absorbed into the blood stream.
Of course, the inhaled insulin field is littered with letdowns such as Pfizer's Exubera, Alkermes/Eli Lilly's AIR program, and Novo Nordisk's AERx product.
- here's the AP story