Cancer Prevention Pharmaceuticals Receives $9.5 Million in Additional Funding from Sucampo Following Phase 3 Trial Progress
September 11 2017 - 8:30AM
Business Wire
CPP-1X/sul aims to prevent disease
progression in patients with Familial Adenomatous Polyposis
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.
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.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn
(Sucampo Pharmaceuticals).
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170911005171/en/
Cancer Prevention Pharmaceuticals, Inc.Investor
Contact:Chris Richied, +1.520.908.7774CFOorMedia
Contact:Christine Brannen,
+1.520.908.7774press@canprevent.com
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