Sanofi, MannKind Sign $925 Million Deal for Inhaled InsulinBy
Sanofi and MannKind Corporation, a Valencia, California biopharmaceutical company, have entered into a worldwide exclusive licensing agreement for 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 in a deal worth up to $925 million. The companies plan to launch Afrezza in the United States in the first quarter of 2015.
Under the terms of the agreement, MannKind Corporation will receive 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 will be responsible for global commercial, regulatory, and development activities. Under a separate supply agreement, MannKind will manufacture 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.
MannKind received approval of Afrezza from the US Food and Drug Administration n in June 2014 to improve glycemic control in adult patients with diabetes mellitus.The product consists of Afrezza inhalation powder delivered using a small inhaler. Administered at the start of a meal, the drug dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration and decline to baseline by approximately 180 minutes.
The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation.