Print“Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler, says Pierre Chancel, Sanofi senior vice president of the diabetes division. ”
MannKind has landed Sanofi as a partner for Afrezza just one month after it gained U.S. Food and Drug Administration approval to market the inhaled insulin product Afrezza. Sanofi will pay MannKind $150 million upfront and up to $775 million in potential milestone payments in return for sharing exclusive global rights to develop and commercialize the rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015.
Sanofi could be a great partner for MannKind as it has deep experience in diabetes, built around Lantus, which had $8 billion in annual sales and loses patent protection next year. Sanofi’s next-generation Lantus, called Toujeo, is a new and improved version of its best selling insulin currently under regulatory review.
“Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure, says Alfred Mann, MannKind’s Chairman and CEO. Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs.”
Under their licensing agreement, 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. The companies are also planning to collaborate to expand manufacturing capacity to meet global demand as necessary.
Sanofi will pay MannKind $150 million upfront and potential milestone payments of up to $125 million contingent on specific regulatory and development targets, as well as $650 million in sales milestones. The drugmakers 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.
“Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler,” says Pierre Chancel, Sanofi 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.”
Sanofi's diabetes solutions portfolio includes drugs as well as drug delivery systems and blood glucose monitoring devices. Afrezza is taken at mealtime along with long-acting insulin to control blood sugar.
Afrezza’s approval in late June capped almost ten years of effort by MannKind as it struggled to get its inhaled insulin on the market and the third time that it had applied to the FDA for marketing approval. Over the years, CEO and billionaire Mann pumped more than $900 million into the company and continually reassured shareholders that it was a partnering deal was imminent. Now it has secured both an FDA approval and a partner. But MannKind’s success, though more likely, is not yet assured. Analysts estimate that Afrezza needs to generate $3 billion in peak sales to justify MannKind’s valuation. Sanofi might just be the best partner to get it there.
August 12, 2014
http://www.burrillreport.com/article-sanofi_licenses_rights_to_mannkind%e2%80%99s_afrezza_for_up_to_925m.html
