CPEX Pharmaceuticals Signs Contract Manufacturing Agreement for Intranasal Insulin

PharmaManufacturing.com
08/13/2008

CPEX Pharmaceuticals, Inc. today announced that it has signed an agreement that provides long-term, manufacturing capacity for Nasulin, its intranasal insulin product candidate. Nasulin is currently in Phase II clinical trials for diabetes.

Under the contract manufacturing agreement announced today, 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 Food and Drug Administration, 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.

“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,” said CPEX President and Chief Executive Officer John A. Sedor. “Forming a relationship with a well regarded contract manufacturer like DPT will benefit CPEX in a number of ways. In the near term, securing manufacturing capacity for Nasulin provides us with an uninterrupted supply of product to complete our Phase II clinical activities and for subsequent Phase III trials. Longer term, by assuring that there needn’t be a gap between the supply of clinical materials and the supply of product for commercialization, the agreement potentially eliminates manufacturing delays that could affect bringing Nasulin to market. We believe this significantly enhances the value of Nasulin for potential partners.”