Akorn retains distribution rights in Central, North, and South America.
Akorn and Serum Institute of India finalized a definitive development and exclusive distribution agreement for a rabies Mab. The current market size in North, Central, and South America and Europe for rabies Mabs is approximately $100 million, reports Akorn.
Akorn will help fund product development and will receive exclusive marketing and distribution rights to North, Central, and South America. These milestone payments include the successful completion of Phase I, Phase II, and Phase III trials leading to eventual receipt of CBER approval for a BLA license. BLA approval is targeted to occur in 2012. Akorn will receive 40% of the revenues from product sales in North America and 50% of the revenues from product sales in Central and South America. The term of the agreement is 10 years following the first commercial sale of products.
Serum also granted Akorn the first option to obtain exclusive marketing rights in North, Central, and South America for a second Mab product, anti-D human Mab. The terms for anti-D would be consistent with the terms for the current rabies agreement. Additionally, Serum has granted Akorn the first option to expand the territory to include Europe in exchange for annual product sales requirements in Europe. Akorn says that the current market size in North, Central, and South America and Europe for anti-D Mabs is approximately $500 million.