PARIS and VALENCIA, Calif.—Sanofi and MannKind Corp. announced Aug. 11 that they have entered into a worldwide exclusive licensing agreement to develop and commercialize Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.
Under this collaboration and licensing deal, 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, Conn. The companies plan to collaborate to expand manufacturing capacity as necessary to meet global demand.
According to current plans, the pair plan to launch Afrezza in the United States in the first quarter of 2015.
“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’s senior vice president of the 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.”
MannKind will receive an upfront payment of $150 million and potential milestone payments of as much as $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 percent and MannKind receiving 35 percent. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of $175 million.
“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 CEO. “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.”
Sanofi’s diabetes solutions portfolio includes medications as well as drug delivery systems and blood glucose monitoring devices. As a leader in diabetes management, the company says the addition of Afrezza “represents the latest opportunity for the company to bring another insulin option to people with diabetes around the globe.”
The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation.
While the two collaborators are upbeat, not all the opinions are positive. As John Carroll of Fierce Biotech wrote the day of the announcement: “MannKind has finally nailed down the major league pharma player it always wanted to roll out its inhaled insulin product Afrezza. But after going it alone to nail down an FDA approval on a new therapy that continues to generate heavy skepticism about its marketing potential, the numbers involved so far are still strictly minor league.”
However, he did add that if any company can make the product successful on the market, Sanofi is the favorite to do so, adding that the company’s diabetes franchise is built around Lantus, an $8-billion-a-year sales powerhouse.
However, Lantus loses patent protection next year, and Sanofi is looking for innovative ways to fend off competitors, notably Novo Nordisk. Not surprisingly, then, the MannKind deal isn’t the only one Sanofi has made recently, nor likely the last it will be looking to make soon. In June, Sanofi also reported that it would work with Medtronic on devices to simplify insulin administration.
“It is not going to be in competition” with existing products, said Sanofi’s Chancel in a call with analysts Aug. 11 about the Afrezza deal, “it’s going to be a nice complement and upgrade to our portfolio,” adding that the inhaled insulin product will be marketed to patients who are struggling to start insulin because of problems or fears with giving themselves injections.