French pharmaceutical group Sanofi has signed a worldwide licensing agreement for a new inhaled insulin treatment.
Under the exclusive agreement with MannKind Corporation the two companies will collaborate on development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.
Sanofi will be responsible for commercial, regulatory and development activities in all markets, while MannKind will manufacture Afrezza at its facility in Danbury, Connecticut, Once the product has been launched, the companies intend to collaborate to expand manufacturing capacity as needed to meet global demand.
Afrezza is planned to be made available in the United States in the first quarter of 2015.
The product is a drug-device combination that consists of a dry formulation of human insulin delivered through a small inhaler. Welcoming the addition of Afrezza to Sanofi's portfolio of integrated diabetes solutions, Pierre Chancel, senior vice president of its Diabetes Division, said that it provides patients with another insulin therapy option to manage their diabetes and does not require multiple daily injections.
The terms of the agreement state that MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. These further payments will depend on certain regulatory, development and sales targets. In addition, Sanofi has agreed to pay MannKind its share of the collaboration's expenses up to a limit of $175 million.
Profits and losses associated with Afrezza will be shared by Sanofi and MannKind, with Sanofi retaining 65 percent and MannKind receiving 35 percent.
