MannKind Corporation and BIOMM SA announced that Afrezza® (insulin human) Inhalation Powder, an ultra rapid-acting mealtime insulin to improve glycemic control in adult patients with diabetes mellitus, has been registered by the Brazilian Health Regulatory Agency (ANVISA). The commercialization of Afrezza in Brazil is expected to begin in the fourth quarter this year, subject to the pricing registration process by Câmara de Regulação do Mercado de Medicamentos (CMED). Afrezza is an ultra rapid-acting orally inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus.

Afrezza consists of a dry powder formulation of human insulin delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza dissolves rapidly upon inhalation to the deep lung and passes quickly into the bloodstream (in less than one minute). Glucose-lowering effects are achieved within minutes of administration, and clinical data with Afrezza demonstrates proven efficacy and safety in the treatment of both type 1 and type 2 diabetes.

Currently, diabetes mellitus affects 425 million adults worldwide, including more than 12 million in Brazil, according to the International Diabetes Federation. Diabetes mellitus is characterized by the body's inability to regulate levels of blood glucose properly. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes mellitus insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces.