Sanofi terminated its licensing agreement related to the development and commercialisation of MannKind's inhaled insulin therapy Afrezza, MannKind said Tuesday. MannKind noted that the deal will be terminated no later than six months from the effective date of Sanofi's notice or July 4. Shares in MannKind plunged as much as 40 percent on the news.
Afrezza was cleared by the FDA for use in improving glycaemic control in adults with diabetes in June 2014. Sanofi and MannKind entered into a global licensing agreement worth up to $925 million in August 2014 to market the drug for adults with type 1 and type 2 diabetes, with the product launching in February last year.
However, the uptake of Afrezza was slow, with Sanofi reporting sales of 5 million euros ($5.4 million) for the product in the first nine months of 2015. A spokesman for the French drugmaker said Afrezza continued to suffer from a low level of prescriptions, despite substantial sales efforts. "The product never met even modest expectations and we do not project Afrezza reaching even the lowest patient levels anticipated at the time of entering the license and collaboration agreement, while costs are projected to remain very high for a significant period of time," the spokesman explained.
MannKind stated that the drugmakers will soon initiate discussions to ensure a smooth transition in the development and commercialisation of Afrezza from Sanofi within the next 90 to 180 days. MannKind added that it "is reviewing its strategic options for Afrezza as a result of the termination."
For related analysis, see ViewPoints: Sanofi's Afrezza gamble proves short-lived.
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