Good News for MannKind - Analyst Blog


MannKind Corporation
(MNKD) received a boost when the US Food and Drug Administration (FDA) accepted MannKind’s response to the complete response letter (CRL) issued by the agency on its inhaled insulin candidate, Afrezza. The candidate is being developed for treating type I and type II diabetes.

The agency informed the company that the resubmission will be treated as a class II review. Consequently, a decision from the FDA should be out within 6 months (target date: December 29, 2010). The resubmission included safety and efficacy data from recently completed studies on the candidate.

We remind investors that the FDA had issued a CRL earlier in the year to MannKind in response to the New Drug Application (NDA) submitted in 2009 for Afrezza. The FDA asked MannKind for certain additional information and clinical data. The agency asked for information about the commercial version of the company’s MedTone inhaler, which is different from the one used during clinical trials. Furthermore, the FDA requested for updated safety data.

Afrezza utilizes MannKind’s proprietary dry powder Technosphere formulation of insulin. It is inhaled deep into the lungs using the company’s MedTone inhaler. Once inside the lungs, the insulin is rapidly absorbed into the bloodstream.

Lucrative Diabetes Market

The diabetes market provides one of the largest opportunities in pharmaceuticals. In the US alone, the disease affects 23.6 million people.  The market has a huge unmet need with high incidence of diabetes. A study published by Diabetes Care in 2006 projected that about 48.3 million people would be diagnosed with diabetes in the United States by 2050.

Our Take & Recommendation

We believe that the approval of Afrezza is crucial for MannKind. However, although Afrezza offers distinct advantages over the traditional needle-based insulin therapy that currently dominates the market, the path to approval is not easy.

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