Sucampo paid CPP USD4.5 m in option fees and invested USD 5m in CPP via a convertible note, all in accordance with the terms of the agreements that Sucampo and CPP entered into in January 2016.
The payments were triggered by recent positive results from a planned interim futility analysis of CPP's pivotal Phase 3 trial, CPP FAP-310, evaluating CPP-1X/sul for adults with familial adenomatous polyposis.
An Independent Data Monitoring Committee recently recommended continuation of the Phase 3 trial, which is fully enrolled and expected to be completed in 2018 unless there are extensions.
The US Food and Drug Administration and European Medicines Agency both granted CPP-1X/sul orphan drug status for treatment of FAP.
CPP received USD 8m from Sucampo in January 2016 upon signing a collaboration agreement that grants Sucampo the sole option to acquire an exclusive license to commercialize CPP-1X/sul in North America.
USD 3m of that initial payment was a one-time option fee; the remaining USD 5m was an investment in the form of a convertible note.
In connection with the original agreement, Sucampo, which is headquartered in Rockville, MD, agreed to provide another USD 9.5m, in the form of option payments and a convertible note investment, upon completion of the positive futility analysis milestone.
FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. For most FAP patients, current medical practice recommends a lifetime of periodic monitoring as well as surgeries (FAP-related events).
These FAP-related events include surgical removal of the colon, rectum, surgical pouch, duodenum, and/or high risk adenomas.
The purpose of this randomized, double-blind, Phase 3 trial is to determine if the combination of eflornithine plus sulindac is superior to eflornithine or sulindac as single agents in delaying time to the first occurrence of any FAP-related event.
Cancer Prevention Pharmaceuticals, Inc. is developing therapeutics designed to reduce the risk of cancer and other diseases. CPP's pharmaco-prevention approach has been used with success in other disease categories such as cardiovascular, neurovascular, and infectious disease.
In addition to the CPP FAP-310 trial, CPP is co-sponsoring with the National Cancer Institute and SWOG a large Phase 3 trial in colon cancer survivors. CPP is also working collaboratively with nonprofit groups to support their clinical trials in neuroblastoma, gastric cancer, and early-onset type 1 diabetes. CPP is located in Tucson, Arizona.
Sucampo Pharmaceuticals is a biopharmaceutical company focused on the development and commercialisation of specialised medicines.
The company has a late-stage pipeline of product candidates in clinical development for orphan disease areas, including VTS-270, a mixture of 2-hydroxypropyl-B-cyclodextrins with a specific compositional fingerprint that has been granted orphan designation in the US and Europe and is in a pivotal Phase 2/3 clinical trial for the treatment of Niemann-Pick Disease Type C-1, a rare progressive genetic disorder.
VTS-270 has also been granted breakthrough therapy designation in the US Sucampo has an exclusive option for the North American rights to CPP-1X/sulindac, which is in Phase 3 development for the treatment of familial adenomatous polyposis and has been granted orphan drug designation in the US.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval