Sanofi and Mannkind Corporation have launched Afrezza® (insulin human) Inhalation Powder, an inhaled insulin, in the United States. Afrezza is approved by the US Food and Drug Administration to control high blood sugar in adults with Type 1 and Type 2 diabetes. Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler.

Sanofi and MannKind entered into a worldwide exclusive licensing agreement, worth up to $925 million, to develop and commercialize Afrezza in 2014. Under the collaboration agreement, Sanofi is responsible for global commercial, regulatory, and development activities.

Under the terms of the agreement, MannKind received an upfront payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration's expenses up to a limit of $175 million. Sanofi is responsible for global commercial, regulatory, and development activities. Under a separate supply agreement, MannKind is manufacturing Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary.

Source: Sanofi