Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced it has received a total of $9.5 million from its North America commercialization partner Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP). Sucampo paid CPP $4.5 million in option fees and invested $5.0 million in CPP via a convertible note, all in accordance with the terms of the agreements that Sucampo and CPP entered into in January 2016.
“We continue to be pleased with the clinical progress of CPP-1X/sul to address a disease for which patients have no effective therapies”
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 (FAP). 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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) both granted CPP-1X/sul orphan drug status for treatment of FAP.
“We continue to be pleased with the clinical progress of CPP-1X/sul to address a disease for which patients have no effective therapies,” said Jeff Jacob, Chair and CEO of CPP. “The additional resources and support from Sucampo will help speed our FAP-310 clinical trial to completion and can offer new hope for treating this unmet medical need.”
CPP received $8.0 million 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. $3.0 million of that initial payment was a one-time option fee; the remaining $5.0 million 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 $9.5 million, 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.
For more information on the clinical trial (CPP FAP-310), please visit: https://clinicaltrials.gov/ct2/show/NCT01483144.
About Cancer Prevention Pharmaceuticals, Inc.
Cancer Prevention Pharmaceuticals, Inc. (CPP) 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 (NCI) 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. For more information, please visit www.canprevent.com.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of highly specialized medicines. Sucampo 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 U.S. 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 U.S. 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 U.S. The company has two marketed products – AMITIZA and RESCULA. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
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This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the continued Phase III trial of the CPP-1X/sul therapy. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Cancer Prevention Pharmaceuticals, Inc.
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