Sanofi And MannKind Enter Licensing Agreement For Afrezza
Sanofi announced that it has entered into a global licensing agreement with MannKind Corporation for the development and marketing of Afrezza (human insulin) inhalation powder.
Under the terms of agreement, Sanofi will make an upfront payment of $150 million. MannKind will also be eligible to receive potential milestone payments of up to $775 million based on the achievement of certain regulatory and development targets and sales thresholds. The collaborators have agreed to share both profits and risks on a global basis with Sanofi retaining 65 percent and MannKind taking the other 35 percent. Sanofi will give MannKind an advance payment of the partnership’s expenses up to $175 million.
Afrezza is a rapid-acting inhaled insulin therapy for the glycemic control of adult patients with diabetes mellitus. The product is comprised of a dry formulation of human insulin which is administered through an inhaler. The U.S. Food and Drug Administration (FDA) approved Afrezza this June to meet the need of those afflicted with diabetes mellitus — a disease affecting 29 million people in the U.S. alone and 347 million around the world. The disease is characterized by the body’s inadequate regulation of blood glucose. The approval of this treatment will help expand treatment options for those who have struggled with current injection-method treatment options.
Pierre Chancel, SVP of Diabetes Division at Sanofi, said, “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.”
Alfred Mann, MannKind’s Chairman and CEO, said, “We are so very pleased and honored that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide… Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization, and manufacturing costs.”
Sanofi recently reported favorable performance and growth in its sales of diabetes treatments, especially by its biotech company Genzyme. MannKind and Sanofi said they will launch Afrezza in the U.S. in the first quarter of 2015.
According to the Los Angeles Times, this drug is following in the footsteps of Pfizer’s Exubera, another inhaled insulin product, which was removed from the market because of poor sales performance. However, MannKind stands by its product, asserting that it is “vastly superior” because the drug is faster-acting than an injection and comes in a much smaller inhaler than Pfizer’s Exubera.
However, there is still some work to be done on MannKind’s part, the LA Times says. The FDA is requiring the company to pay for a study to determine if the drug causes any issues in users’ lungs. The drug label also must possess a warning that the drug is not to be used by those who suffer from asthma or chronic lung disease.