Under the terms of the ten-year agreement, Cipla will be responsible for the manufacturing and supply of the drug using Akorn’s formulation, and Akorn will be responsible for the abbreviated new drug application (ANDA) regulatory submission and clinical development, and for the purchase of specialized manufacturing equipment.
Akorn will own the ANDA in the US, and will pay Cipla milestone fees for its assistance. The total market size for the oral ANDA anti-infective drug product is approximately $100 million.
“Together with Cipla, we are strongly committed to expediting the clinical development activities necessary to introduce this product to the market. The commercialization of this ANDA drug product is a top priority,” stated Arthur Przybyl, Akorn’s president and CEO.