MannKind Corporation (NASDAQ:MNKD) has finally found a partner to market its diabetes drug Afrezza worldwide. French drugmaker Sanofi SA (ADR) (NYSE:SNY) (EPA:SAN) announced Monday that it would pay MannKind as much as $925 million for worldwide licensing rights of Afrezza. The drug won the U.S. FDA approval just seven weeks ago after being rejected in the past. Following the announcement, MannKind shares soared a whopping 32.84% to $10.80 in pre-market trading Monday.
MannKind and Sanofi to launch Afrezza in the U.S. in early 2015
Sanofi has been exploring deals and novel ways of treating diabetes. The company sees diabetes market as its key growth area, but its top-selling insulin Lantus is set to lose patent protection next year. In June, Sanofi said it would work with Medtronic, Inc. (NYSE:MDT) on devices to simplify insulin use. Now the French company is betting on the inhaled insulin to emerge as a strong alternative to daily diabetes injections.
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Under the terms of the deal, Sanofi will have the rights to develop and market Afrezza for adults with Type-1 and Type-2 diabetes. MannKind Corporation (NASDAQ:MNKD) will receive $150 million of upfront payment. The remaining $775 million will be paid in various milestones depending on the commercial success of the drug. MannKind and Sanofi plan to launch Afrezza in the U.S. in the first quarter of 2015. Sanofi will retain 65% of the profits or losses while MannKind will get the remaining 35%.
MannKind gets a partner despite boxed warning
The Valencia, California-based company’s insulin treatment won FDA approval in June. But there were concerns around the company getting a partner to market the drug. That’s because regulators have said that Afrezza will carry a boxed warning of the risk of bronchospasm in patients of asthma or other pulmonary diseases. Patients with chronic lung diseases can’t use Afrezza. Doctors will have to conduct various tests to identify potential lung disease before prescribing Afrezza. Even people who smoke or have stopped smoking only recently should not use the product.
Brinson Patrick analyst Christopher James expects Afrezza sales to surpass $3.65 billion by 2025. MannKind Corporation (NASDAQ:MNKD) is scheduled to report its fiscal Q2, 2014 results on Monday, August 11 after the market closes.