Sanofi and MannKind Corp. have entered into a worldwide exclusive licensing agreement for the 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. The companies plan to launch the drug in the U.S. in 1Q15. The transaction is subject to customary closing conditions.
Sanofi will be responsible for global commercial, regulatory and development activities and MannKind will manufacture Afrezza at its facility in Danbury, CT. The companies are also planning to expand global manufacturing capacity as needed.
MannKind will receive an upfront payment of $150 million and potential regulatory and development milestones of as much as $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi will also share the collaboration expenses to a limit of $175 million.
"Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler," said Pierre Chancel, Sanofi senior vice president Diabetes Division. "Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections."
"We are so very pleased and honored that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide," said Alfred Mann, MannKind's chairman and chief executive officer. "Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure. Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs."