Cyclosporine, marketed as Neoral, is an immunosuppressant developed by Novartis for the prevention of organ rejection following kidney, liver or heart transplantation. In late 2004, Chiron Corporation (now Novartis Vaccines and Diagnostics, Inc.) submitted a new drug application for an aerosolizable form of cyclosporine to the Food and Drug Administration. The FDA issued an approvable letter in June 2005, opening the door for eventual approval of inhalable cyclosporine.
APT specializes in re-purposing existing drugs, with particular interest in developing new treatments for rare diseases and unmet medical needs. If inhalable cyclosporine is approved by the FDA, it is eligible to receive orphan drug designation, giving APT seven years of exclusivity to market the drug.
Under the terms of the agreement, Novartis has licensed patent, know-how and regulatory cross-referral rights to APT for inhalable cyclosporine. Financial terms were not disclosed.