Cancer Prevention Pharmaceuticals, Inc., a private biotech company developing novel therapeutics to prevent cancer and other diseases, has signed a license agreement with Mallinckrodt Pharmaceuticals, through its Sucampo AG subsidiary, granting Mallinckrodt exclusive North American commercialization rights to Cancer Prevention’s lead drug candidate, CPP-1X/sul.
In April 2018, U.K.-based Mallinckrodt had exercised its option to the license agreement, and paid Cancer Prevention $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 Cancer Prevention a $5 million license fee. In addition, following commercialization of the product, Cancer Prevention and Mallinckrodt will share profits equally on all North American sales of the drug.
Cancer Prevention also is 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.
Cancer Prevention maintains all global rights to CPP-1X/sul outside North America.
In connection with the transaction, Cancer Prevention signed a service agreement with Mallinckrodt to assist with completing the FAP Phase 3 pivotal trial and certain activities supporting the preparation, filing and review of the NDA in the United States. Cancer Prevention expects to be compensated for the services with additional R&D payments of up to approximately $10 million.
The current standard of care for FAP requires patients to undergo the progressive removal of the colon and rectum, ongoing endoscopies of the gastrointestinal tract, and additional surgery throughout life. FAP has been designated an orphan indication in the U.S. and Europe, occurring in about 1 in 10,000 people, with an estimated 30,000 cases in the U.S.
Last year the U.S. Food and Drug Administration granted CPP-1X/sul Fast Track designation, which provides a streamlined path to commercialization if approved.
The randomized, double-blind Phase 3 trial of CPP-1X/sul will determine if the combination of eflornithine plus sulindac is superior to either of the drugs as single agents in delaying time to the first occurrence of an FAP-related event.
(Source: Cancer Prevention Pharmaceuticals, Inc.)
