Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
pharmaceutical company, today announced that it entered into an
exclusive license, development, commercialization and supply
agreement with Harbin Gloria Pharmaceuticals Co., Ltd. (Gloria),
for AMITIZA® (lubiprostone) in the People's Republic of China.
Through this agreement, Sucampo has granted Gloria the rights to
develop and commercialize AMITIZA in China, subject to regulatory
approval of the product by the China Food and Drug Administration
(CFDA).
"We are committed to making AMITIZA available to patients
worldwide, and our agreement with Gloria now enables us to access
this important market," said Peter Greenleaf, Chief Executive
Officer of Sucampo. "Current treatment options for constipation are
not effective for all patients, and Gloria's local expertise and
established commercial infrastructure may provide the patient
population in China with a new alternative. We are pleased to
partner with Gloria to expand access to AMITIZA to even more
patients."
Hongbing Yang, Chief Executive Office of Gloria said, "We are
very delighted to partner with Sucampo to bring AMITIZA into the
Chinese market to provide a novel and differentiated therapy for
Chinese patients. Licensing is a cornerstone of Gloria's long-term
strategy in new drug research and development. The collaboration
with Sucampo also reflects Gloria's vision in global partnering and
open innovation."
Under the terms of the agreement, Sucampo will receive an
upfront payment of $1.5 million and a milestone payment from
Gloria. The upfront payment will consist of $1 million within 30
days of signing the agreement and $500,000 within 30 days of
investigational new drug application approval in China. Sucampo
will also be eligible for an additional milestone payment upon the
occurrence of a regulatory or alternatively a commercial milestone
event. Sucampo will be the exclusive supplier of AMITIZA to Gloria
at an agreed-upon supply price. The term of this agreement is 13
years with renewal terms.
Gloria will be responsible for all development activities and
costs. In addition, Gloria will be responsible for all
commercialization and regulatory activities in China.
About lubiprostone (AMITIZA®)
AMITIZA (lubiprostone) is a chloride channel activator that acts
locally in the small intestine to restore motility and to address
the underlying pathophysiology and secondary symptoms of
constipation. AMITIZA (24 mcg twice daily) is indicated in the U.S.
for the treatment of adults with CIC and OIC with chronic,
non-cancer pain. AMITIZA (8 mcg twice daily) is also approved in
the U.S. for IBS-C in women 18 years of age and older. In Japan,
AMITIZA (24 mcg twice daily) is indicated for the treatment of
chronic constipation (excluding constipation caused by organic
diseases). In the U.K., AMITIZA (24 mcg twice daily) is indicated
for the treatment of CIC and associated symptoms in adults, when
response to diet and other non-pharmacological measures (e.g.
educational measures, physical activity) are inappropriate. In
Switzerland, AMITIZA (24 mcg twice daily) is indicated for the
treatment of CIC in adults and for the treatment of OIC and
associated signs and symptoms such as stool consistency, straining,
constipation severity, abdominal discomfort, and abdominal bloating
in adults with chronic, non-cancer pain. The efficacy of AMITIZA
for the treatment of OIC in patients taking opioids of the
diphenylheptane class, such as methadone, has not been
established.
Important Safety Information
- AMITIZA (lubiprostone) is contraindicated in patients with
known or suspected mechanical gastrointestinal obstruction.
Patients with symptoms suggestive of mechanical gastrointestinal
obstruction should be thoroughly evaluated by the treating
healthcare provider (HCP) to confirm the absence of such an
obstruction prior to initiating AMITIZA treatment.
- Patients taking AMITIZA may experience nausea. If this occurs,
concomitant administration of food with AMITIZA may reduce symptoms
of nausea. Patients who experience severe nausea should inform
their HCP.
- AMITIZA should not be prescribed to patients that have severe
diarrhea. Patients should be aware of the possible occurrence of
diarrhea during treatment. Patients should be instructed to
discontinue AMITIZA and inform their HCP if severe diarrhea occurs.
- Patients taking AMITIZA may experience dyspnea within an hour
of first dose. This symptom generally resolves within three hours,
but may recur with repeat dosing. Patients who experience dyspnea
should inform their HCP. Some patients have discontinued therapy
because of dyspnea.
- In clinical trials of AMITIZA (24 mcg twice daily vs placebo;
N=1113 vs N=316, respectively) in patients with CIC, the most
common adverse reactions (incidence > 4%) were nausea (29% vs
3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8%
vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).
- In clinical trials of AMITIZA (24 mcg twice daily vs placebo;
N=860 vs N=632, respectively) in patients with OIC, the most common
adverse reactions (incidence >4%) were nausea (11% vs 5%) and
diarrhea (8% vs 2%).
- In clinical trials of AMITIZA (8 mcg twice daily vs placebo;
N=1011 vs N=435, respectively) in patients with IBS-C the most
common adverse reactions (incidence > 4%) were nausea (8% vs
4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
- Concomitant use of diphenylheptane opioids (e.g., methadone)
may interfere with the efficacy of AMITIZA.
- The safety of AMITIZA in pregnancy has not been evaluated in
humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. Caution should be
exercised when AMITIZA is administered to a nursing woman. Advise
nursing women to monitor infants for diarrhea.
- Reduce the dosage in CIC and OIC patients with moderate and
severe hepatic impairment. Reduce the dosage in IBS-C patients with
severe hepatic impairment.
Please see the Full Prescribing Information here. For further
information on AMITIZA, please visit www.sucampo.com/products.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is a global biopharmaceutical
company that is built on the ongoing pursuit of scientific
innovation to improve the lives of patients. Sucampo has a marketed
product – AMITIZA – and a pipeline including lifecycle management
and clinical development programs. Sucampo is headquartered in
Bethesda, 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 Harbin Gloria Pharmaceuticals Co.,
Ltd.
Harbin Gloria Pharmaceuticals Co., Ltd. is a leading healthcare
group company in China. The Company focuses on the research,
development, and commercialization of a variety of categories
including small molecule medicines, Traditional Chinese medicines,
OTCs and nutritional supplements spanning antibiotics, medical
nutrition, orthopedics, rheumatology, oncology, gastroenterology
and cardiovascular therapeutics areas. Established in 2000, the
Company is headquartered in Beijing, China, and has nine
manufacturing sites, three R&D centers and four GSP companies
nationwide. The Company primarily sells its products throughout
China's hospital market. For more information, please visit
www.gloria.cc.
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 may include statements
regarding product development, product potential, future financial
and operating results, and other statements that are not historical
facts. 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 continue to
develop the market for AMITIZA; the ability of Sucampo to develop,
commercialize or license existing pipeline products or compounds or
license or acquire non-prostone products or drug candidates;
Sucampo's ability to accurately predict future market conditions;
dependence on the effectiveness of Sucampo's patents and other
protections for innovative products; the effects of competitive
products on Sucampo's products; 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 presentation
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 Communications
1-240-223-3718
staylor@sucampo.com
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