Deal secures manufacturing capacity for ongoing Phase II trials as well as further development needs and initial commercialization.
CPEX Pharmaceuticals entered into an agreement DPT Laboratories that provides long-term manufacturing capacity for Nasulin™, its intranasal insulin product candidate. Nasulin is currently in Phase II trials.
Under the contract manufacturing collaboration, DPT Laboratories will provide CPEX with capacity to supply Nasulin clinical materials in volumes sufficient for the remainder of Phase II trials and through Phase III trials. Should Nasulin be registered and approved by the FDA, the agreement also provides for validation of the manufacturing process and the opportunity for manufacturing capacity that CPEX expects will be sufficient for the first years of commercial marketing.
CPEX expects to complete the Phase II Nasulin trials in mid-2010. CPEX is currently seeking a licensing partner to support Phase III trials and ultimately assist in taking Nasulin through regulatory approval and on to commercialization.