Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced the signing of a license agreement with Mallinckrodt Pharmaceuticals, through its Sucampo AG subsidiary (“Mallinckrodt”), wherein Mallinckrodt obtained exclusive North American commercialization rights to CPP’s lead drug candidate, CPP-1X/sul.
In April 2018, UK-based Mallinckrodt had exercised its option to the license agreement and paid CPP $10 million to support the pivotal Phase 3 clinical trial of CPP-1X/sul in patients with the orphan disease familial adenomatous polyposis (FAP). Results from the FAP Phase 3 clinical trial are expected in the first half of 2019. FAP is a genetic disease that typically develops into colon cancer. There are no approved pharmaceutical treatments and no other drugs in late-stage clinical development.
Under the terms of the license agreement, Mallinckrodt paid CPP a $5 million license fee. In addition, following commercialization of the product, CPP and Mallinckrodt will share profits equally on all North American sales of the drug. CPP is also eligible to receive up to an aggregate of $185 million from Mallinckrodt, dependent upon achievement of other clinical development and sales milestones, subject to a reduction of up to $15 million related to amounts provided by the company in advance of entering into this agreement. Each party will be reimbursed for its R&D expenses from future product profits. CPP maintains all global rights to CPP-1X/sul outside North America.