According to the 10-year agreement, Cipla will be responsible for the development, manufacturing and supply of the drug product. Akorn will be responsible for the regulatory submission with the FDA and for marketing and distribution of the drug product in the US and Puerto Rico.
Akorn will pay Cipla milestone fees for the development of the drug product and will retain ownership of the FDA dossier. Akorn expects to launch the inhalation drug product in 2010.
Arthur Przybyl, Akorn’s president and CEO, said: “This development agreement represents our first drug product targeted for inhalation therapy. Our business relationship with Cipla continues to expand. Including this transaction, we now have four drug products under development with Cipla. We expect this drug to eventually be an excellent addition to our niche specialty pharmaceutical portfolio.”