Setback for MannKind - Analyst Blog

MannKind Corp. (MNKD) suffered a major setback with respect to its lead product, Afrezza, inhaled insulin for treating type I and type II diabetes. The company received a complete response letter (CRL) from the US Food & Drug Administration (FDA) recently.
 
The FDA has asked MannKind for certain additional information and clinical data that has been submitted along with the New Drug Application (NDA). The agency has also asked for information about the commercial version of the company’s MedTone inhaler, which is different from the one used during clinical trials.
 
Although additional clinical studies are not required at present, the FDA has asked for updated safety data. Changes to the proposed labeling of the cartridges, foil pouches and cartons used in the device have been requested. To sort out the issues, MannKind will request a meeting with the FDA.

The approval of Afrezza is crucial for MannKind. While the original Prescription Drug User Fee Act (PDUFA) date was January 16, 2010, the FDA could not review the application within the time frame as the inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind could not be completed.

Although we believe that Afrezza offers distinct advantages over the traditional needle-based insulin therapy that currently dominates the market, the path to approval is not easy. Many large pharmaceutical companies in the past have made unsuccessful attempts to launch such a product.

The delay in FDA approval will further hinder any possibility of striking a partnership deal. While the company is in discussions with prospective partner players, we believe a concrete agreement is unlikely before approval. We have a Neutral recommendation on the stock.

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