Sucampo Enters Into Exclusive Option and Collaboration Agreement With Cancer Prevention Pharmaceuticals for Development of La...
January 11 2016 - 6:45AM
Addresses Significant Patient Need
Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global
biopharmaceutical company, today announced an option and
collaboration agreement under which Cancer Prevention
Pharmaceuticals, Inc. (CPP) has granted Sucampo the sole option to
acquire an exclusive license to commercialize CPP-1X/sulindac
combination product in North America. This product is
currently in a Phase 3 clinical trial for the treatment of familial
adenomatous polyposis (FAP).
“We are very excited to enter into this
agreement with Cancer Prevention Pharmaceuticals, as it aligns with
our vision to acquire late-stage programs with the potential to
have a significant impact on patient lives,” said Peter Greenleaf,
Chairman and Chief Executive Officer of Sucampo. “We believe
that this product represents a substantial market opportunity and,
given clinical results to date, could be a valuable asset for
Sucampo that leverages our gastrointestinal expertise and strategic
focus.”
There are currently no approved treatments for
FAP and no other products in late-stage development. A
genetic disease, FAP typically develops into colon cancer if left
untreated. Current treatment paradigms require patients to
undergo the progressive removal of colon and rectum, ongoing
endoscopies of the GI tract, and additional surgery throughout
life. As a result, patients with FAP experience poor quality
of life, inconvenience and significant cost. FAP has been
designated an orphan indication in the U.S. and Europe, with a
prevalence of about 1 in 10,000, and approximately 30,000 cases
currently in the United States.
CPP-1X/sulindac oral combination product has
demonstrated robust Phase 2 data in sporadic colon adenoma,
additional evidence of efficacy in FAP with CPP-1X combinations,
and has shown to be well-tolerated. The ongoing Phase 3 study
is a 150-patient, three-arm, double-blind, randomized trial of the
combination agent and the single agent comparators.
Enrollment in the study is expected to be complete in the first
half of 2016 and the trial is expected to conclude in 2018, with
potential for approval in 2019. In addition, co-formulation
activities are ongoing. The product also has additional
opportunities in sporadic colon adenoma therapy (CAT), which is
currently in a Phase 3 clinical trial with the National Cancer
Institute and SWOG (formerly Southwest Oncology Group), as well as
other potential GI and oncology indications.
Under the terms of the agreement, Sucampo will
invest $5.0 million in CPP in the form of a convertible note, with
a planned additional $5.0 million equity investment in CPP’s next
qualified financing, which will be either an IPO or a private
financing as defined by the agreement. In addition, Sucampo
will pay CPP an option fee of up to $7.5 million, payable in two
tranches. CPP will complete the ongoing Phase 3 trial under
the oversight of a joint steering committee. Upon exercise of
its exclusive option, Sucampo would acquire an exclusive license to
the product and would be obligated to pay CPP up to an aggregate of
$190 million in license fees and milestone payments upon the
achievement of specified clinical development and sales milestones.
Under the terms of the license, Sucampo and CPP would share
equally in profits from the sale of approved products.
About FAP
Familial Adenomatous Polyposis
(FAP) is a rare hereditary disease characterized by cancer of the
colon and rectum. Patients with the classic presentation of FAP
begin to develop multiple benign polyps in the colon in their early
teenage years. Eventually, the colon becomes covered with
hundreds to thousands of polyps that typically become cancerous if
left untreated. Current medical practice recommends the removal of
the colon and sometimes the rectum in the formative years for the
typical FAP patient. CPP’s lead product candidate,
CPP-1X/sulindac, is being developed to minimize the occurrence
and/or recurrence of polyps and tumors associated with FAP and
offers the potential of a non-surgical pharmacopreventive therapy
across the spectrum of FAP patients.
About Sucampo Pharmaceuticals,
Inc.
Sucampo Pharmaceuticals, Inc. is focused on the
development and commercialization of medicines that meet major
unmet medical needs of patients worldwide. Sucampo has one
marketed product – AMITIZA – and a pipeline of product candidates
in clinical development. A global company, Sucampo is headquartered
in Rockville, Maryland, and has operations in Japan, Switzerland
and the U.K. 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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About Cancer Prevention Pharmaceuticals,
Inc. (CPP)
CPP is developing therapeutics designed to
reduce the risk of cancer. CPP’s approach has been used with great
success in other disease categories such as cardiovascular,
neurovascular and infectious disease. CPP is co-sponsoring a
large Phase 3 trial in colon cancer survivors (with NCI and SWOG)
and a Phase 3 clinical trial in patients with Familial Adenomatous
Polyposis (FAP). CPP is also working collaboratively with
non-profit groups to support their clinical trials in neuroblastoma
(childhood cancer) for the prevention of relapse, in gastric
cancer, and in early-onset type 1 diabetes.
Sucampo Forward-Looking
Statement
This press release contains "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and
uncertainties, which may cause results to differ materially from
those set forth in the statements. The forward-looking statements
include statements regarding Sucampo’s option agreement with CPP,
including financial terms of a potential license agreement, and the
expected timing of clinical trials. The following factors, among
others, could cause actual results to differ from those set forth
in the forward-looking statements: the impact of pharmaceutical
industry regulation and health care legislation; the ability of
Sucampo to successfully develop and commercialize product
candidates; Sucampo's ability to accurately predict future market
conditions; and the exposure to litigation and/or regulatory
actions.
No forward-looking statement can be guaranteed
and actual results may differ materially from those projected.
Sucampo undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this
press release should be evaluated together with the many
uncertainties that affect Sucampo's business, particularly those
mentioned in the risk factors and cautionary statements in
Sucampo's most recent Form 10-K as filed with the Securities and
Exchange Commission on March 9, 2015 as well as its filings with
the Securities and Exchange Commission on Forms 8-K and 10-Q since
the filing of the Form 10-K, all of which Sucampo incorporates by
reference.
Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
staylor@sucampo.com
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