MannKind Corporation and Sanofi have terminated their license and collaboration agreement for the development and commercialization of an inhaled insulin, Afrezza (insulin human) inhalation powder.

Sanofi and Mannkind Corporation launched Afrezza(insulin human) inhalation powder, in the United States in February 2015.. Afrezza was 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.

In 2014, the companies had formed a worldwide exclusive licensing agreement, worth up to $925 million, to develop and commercialize Afrezza. Under the now terminated collaboration agreement, Sanofi was responsible for global commercial, regulatory, and development activities. MannKind received an upfront payment of $150 million with potential milestone payments of up to $775 million. Under a separate supply agreement, MannKind is manufacturing Afrezza at its manufacturing facility in Danbury, Connecticut.

In a press statement, MannKind said Sanofi and the company will begin transition discussions in order to effect a smooth and orderly transition in the development and commercialization of Afrezza from Sanofi to MannKind over the next 90 to 180 days. In any event, termination of the license agreement in its entirety will be effective no later than six months from the effective date of Sanofi’s notice of termination, or July 4, 2016.

MannKind is reviewing its strategic options for Afrezza as a result of the termination of the collaboration with Sanofi.

Source: MannKind Corporation