Firm already has rights to the oral dosage form.
Akorn signed an exclusive drug development and supply agreement with Cipla for an injectable drug product for the prevention of organ transplant rejection. In June, Akorn announced an exclusive agreement for the oral dosage form of this drug product. The addition of the injectable format expands the breadth of Akorn’s offerings for this indication.
Under terms of the 10-year deal, Cipla will be responsible for the development, manufacturing, and supply of the drug product. Akorn will be responsible for the ANDA regulatory submission as well as marketing and distribution in the U.S. and Puerto Rico. Cipla will receive milestone fees for assistance with the ANDA development.
Akorn will own the ANDA in the U.S. The drug will be purchased from Cipla on an exclusive basis. Akorn expects to launch the product in late 2009.
