MannKind Partners with Sanofi to Market Afrezza

MannKind will get 35% of the profits while Sanofi is set to get 65% of profits on Afrezza. Afrezza was approved with a black box warning which states, "Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza. Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients." The FDA also required four postmarketing studies as a condition of approval: one to evaluate the pharmacokinetics, safety, and efficacy of Afrezza in pediatric patients; another to assess the potential risk for pulmonary malignancy with Afrezza, along with assessment of cardiovascular risk and long-term effect on pulmonary function; and two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one characterizing dose response, the other within-subject variability. Mannkind Corp