Cipla enters into exclusive pact with US-based MannKind to sell inhaled insulin in India

Drug maker Cipla on Thursday said it has entered into an exclusive pact with US-based MannKind Corporation to market and distribute the latter’s inhaled insulin Afrezza in India.

Under the agreement, Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India, including approval from the Drug Controller General of India (DCGI), while MannKind will manufacture and supply the drug.

The California-headquartered drug maker will receive USD 2.2 million upfront payment from Cipla within 30 days of entering the agreement, with the potential to receive additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India.

Afrezza is the only USFDA-approved inhaled insulin product available in the market. The drug, that comes in powdered form, is delivered using a portable inhaler into the lungs where it is rapidly absorbed.

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.

For Cipla, which is a market leader in India for inhalation-based products mainly targeted at asthma and bronchitis, the addition of Afrezza is expected to give some muscle in the ever-growing chronic therapeutic segment like diabetes. India's insulin market, estimated at Rs 2,200 crore with an annual growth rate of 15-17 per cent, is led by Danish drug maker Novo Nordisk that has around 60 per cent market share.

The agreement with Cipla is Mannkind’s second international partnership agreement for Afrezza; it had a similar agreement with Brazilian partner to distribute the drug in the South American country.

“Our agreement with Cipla for Afrezza provides us with a long-term partner with a wealth of knowledge and experience in diabetes. With this partnership, Cipla will leverage its strength in inhalation and extend it to diabetes therapy,” said Michael Castagna, Chief Executive Officer of MannKind.

Mannkind said the deal with Cipla will help it to reach out to 1 out of 4 people of the worldwide population with diabetes, when combined with the earlier agreement in Brazil and their own efforts in the United States.

The International Diabetes Federation estimates that 425 million people are currently living with diabetes worldwide, including 73 million in India.

Inhaled insulin is a needle-free option for diabetics who otherwise have to inject insulin.

MannKind is trying to resurrect Afrezza after its partner Sanofi, a diabetes powerhouse, tried and failed to make a market for the product in US. Sanofi's failure is attributed to unaffordable pricing and concerns of certain side-effects associated with the drug.