Sanofi’s termination of its licensing agreement with MannKind leaves Afrezza’s future in doubt.
By Kevin Shannon, Analyst
3 August 2016
I am an analyst at Datamonitor Healthcare, currently located in San Diego, California, where I am a member of the cardio...
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The need for a Big Pharma partner with extensive diabetes experience to market Afrezza was clear even before the drug’s approval, and Sanofi’s decision to end its collaboration with MannKind casts doubts over the product’s commercial viability despite MannKind indicating that it plans to continue distribution of the product. Sanofi’s termination of the partnership likely stems from the requirement for further marketing investment despite very weak Afrezza sales. In addition to its diabetes marketing experience and physician relationships, Sanofi’s presence was important to provide expertise and finance for the post-marketing safety studies requested by the FDA when approving Afrezza. With the insulin market dominated by three companies, the likelihood of MannKind finding a commercial partner with the required experience and resources to challenge is slim. However, MannKind intends to continue marketing Afrezza. It believes that a market for its product does exist, and cites Sanofi’s lack of marketing effort and a premium price for Afrezza’s failure.
Mannkind will now be forced to overcome safety concerns surrounding Afrezza which has limited its uptake to date. Even post-approval, apprehensions regarding respiratory function and cancer continue to plague Afrezza. This is evidenced by the inclusion of a number of pulmonary-related limitations on Afrezza’s prescribing information and the requirement for three post-marketing studies to be carried out, including one which assesses the potential risk of pulmonary malignancy. This study will also investigate Afrezza’s long-term impact on cardiovascular outcomes and pulmonary function.
Datamonitor Healthcare’s Type 1 Diabetes: Marketed Drugs provides an in-depth analysis of key marketed drugs for type 1 diabetes across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK), including a comparative evaluation of clinical and commercial drug attributes to determine competitiveness in the marketplace.
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