Cipla, a Rs.14,280 crore plus fourth largest pharma major, has entered into an exclusive marketing and distribution agreement with US-based MannKind Corporation for Afrezza in India. Afrezza is the only US FDA approved inhaled insulin available for patients suffering from diabetes.

Available by prescription, Afrezza (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.

Umang Vohra, MD & global CEO, said, “Cipla is committed to providing access to innovative medicines and newer drug delivery systems to the patients. Afrezza, an inhaled insulin, is a cutting-edge product which will increase patient convenience. The innovative drug delivery system will revolutionize the diabetic care in India. This partnership with MannKind is another step from Cipla to cater to the unmet needs of the patients.”

“Our agreement with Cipla for Afrezza provides us with a long-term partner with a wealth of knowledge and experience in diabetes. Cipla is a leader across therapies in India with an established sales, marketing and distribution network. With this partnership, Cipla will leverage its strength in inhalation and extend it to diabetes therapy, stated Michael Castagna, CEO of MannKind. “The International Diabetes Federation estimates that 425 million people are currently living with diabetes worldwide, including 73 million in India. This agreement with Cipla, our second international partnership agreement for Afrezza, extends the potential opportunity for approximately 1 out of 4 people of the worldwide population with diabetes to manage their disease with our novel mealtime insulin, when combined with our earlier agreement in Brazil and our own efforts in the United States.” Under the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India, including approval from the Drug Controller General of India (DCGI). Cipla will also be responsible for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla.