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news.CPEX Pharmaceuticals has signed an agreement with DPT Laboratories that provides long-term, manufacturing capacity for Nasulin, its intranasal insulin product candidate. Nasulin is currently in Phase II clinical trials for diabetes.
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Under the contract manufacturing agreement, 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.
According to CPEX Pharmaceuticals, 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.
John Sedor, president and CEO of CPEX, said: “This contract manufacturing relationship marks another important step in our strategic plan for the development of Nasulin. We are currently focused on completing Phase II trials of Nasulin and securing a partner for late-stage Nasulin development.”