DGAP-News: Sucampo Announces Completion of Patient Enrollment in a Phase 3 Clinical Study of Unoprostone Isopropyl for Retinitis

DGAP-News: Sucampo Announces Completion of Patient Enrollment in a Phase 3 
Clinical Study of Unoprostone Isopropyl for Retinitis Pigmentosa

Sucampo Pharmaceuticals, Inc. 

22.10.2013 02:00
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Study Conducted by Development Partner R-Tech Ueno and Majority-Funded by Japan
Science and Technology Agency (JST) 

BETHESDA, Md., 2013-10-22 02:00 CEST (GLOBE NEWSWIRE) --
Sucampo AG, a subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
('Sucampo'), today announced that its development partner, R-Tech Ueno, Ltd.
(R-Tech), completed the enrollment on-time for a Phase 3 study of unoprostone
isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa
(RP). R-Tech is conducting the clinical trial at 38 medical institutions in
Japan. 

The randomized, double-blind, placebo-controlled study will evaluate whether
unoprostone isopropyl ophthalmic solution improves central retinal sensitivity
as determined by Humphrey Field Analyzer (HFA) in patients with RP. The study's
primary endpoint is the value of mean retinal sensitivity at four central
points at one year, and the target sample size is 180 patients. 

'There are no drugs currently approved for the treatment of RP anywhere in the
world, and we believe that unoprostone isopropyl may be a promising candidate
for this indication,' said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief
Executive Officer and Chief Scientific Officer of Sucampo. 'With the completion
of the Phase 3 trial enrollment, R-Tech expects to complete this study by the
end of 2014 with top-line results available in early 2015. Upon successful
results, Sucampo intends to work with regulatory authorities in the United
States and the European Union to determine the incremental data that will be
necessary to form application packages for each region, and we look forward to
the possibility of helping to meet the unmet needs of patients suffering from
RP in these countries.' 

This study is being funded through an agreement established in February 2013
between R-Tech and the Japan Science and Technology Agency (JST), the
governmental agency responsible for the implementation of science and
technology policy in Japan (News Release - Feb. 4, 2013). Sucampo licensed from
R-Tech the exclusive development and commercialization rights to unoprostone
isopropyl globally except for Japan, Peoples Republic of China, Taiwan, and
Korea. Both the U.S. Food and Drug Administration and the European Medicines
Agency have granted orphan drug designation to unoprostone isopropyl for
treatment of RP. Sucampo is not responsible for any development costs for the
Phase 3 RP trial in Japan. 

Retinitis pigmentosa is a genetic disease characterized by progressive,
irreversible vision loss and decreasing visual acuity. As RP progresses, daily
life becomes increasingly difficult. Blindness from all causes is among the
most significant injuries to a patient's qualify of life and is a major driver
of patient-based cost of care and lifestyle maintenance. 

Further details of the study can be found at www.clinicaltrials.gov using the
identifier NCT01786395. 

About Unoprostone Isopropyl

Unoprostone isopropyl, a member of Sucampo's family of ion channel activators
knows as prostones, is a synthetic docosanoid that may have a local effect on
BK (Big Potassium) channels in the eye. BK channels are expressed in neural and
contractile tissues like retina and vascular smooth muscle. A form of
unoprostone isopropyl, with a trade name RESCULA(r), is currently approved in 
the
U.S. for use in patients with open-angle glaucoma or ocular hypertension. 

Important Safety Information

Contraindications

RESCULA is contraindicated in patients with hypersensitivity to unoprostone
isopropyl or any other ingredient in this product. 

Warnings and precautions

Unoprostone isopropyl ophthalmic solution may gradually increase the
pigmentation of the iris. The pigmentation change is believed to be due to
increased melanin content in the melanocytes rather than to an increase in the
number of melanocytes. The long term effects of increased pigmentation are not
known. Iris color changes seen with administration of unoprostone isopropyl
ophthalmic solution may not be noticeable for several months to years.
Treatment with RESCULA solution can be continued in patients who develop
noticeably increased iris pigmentation. Patients who receive treatment with
RESCULA should be informed of the possibility of increased pigmentation which
is likely to be permanent. 

Unoprostone isopropyl has been reported to cause pigment changes (darkening) to
periorbital pigmented tissues and eyelashes. The pigmentation is expected to
increase as long as unoprostone isopropyl is administered, but has been
reported to be reversible upon discontinuation of unoprostone isopropyl
ophthalmic solution in most patients. 

RESCULA should be used with caution in patients with active intraocular
inflammation (e.g., uveitis) because the inflammation may be exacerbated. 

Macular edema, including cystoid macular edema, has been reported. RESCULA
should be used with caution in aphakic patients, in pseudophakic patients with
a torn posterior lens capsule, or in patients with known risk factors for
macular edema. 

To minimize contaminating the dropper tip and solution, care should be taken
not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle
tightly closed when not in use. There have been reports of bacterial keratitis
associated with the use of multiple-dose containers of topical ophthalmic
products. 

RESCULA contains benzalkonium chloride, which may be absorbed by soft contact
lenses. Contact lenses should be removed prior to application of solution and
may be reinserted 15 minutes following its administration. 

Adverse reactions

In clinical studies, ocular adverse events above 5% with use of RESCULA were
burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%),
itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation
(9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid disorder
(5.8%). Approximately 10-14% of patients were observed to have an increase in
the length of eyelashes (>= 1mm) at 12 months, while 7% of patients were
observed to have a decrease in the length of eyelashes. Corneal lesions were
reported in 2.3% of patients. 

The most frequently reported nonocular adverse event associated with the use of
RESCULA in the clinical trials was flu-like syndrome, observed in approximately
6% of patients. 

Use in specific populations

Pregnancy Category C - There are no adequate and well-controlled studies in
pregnant women. Because animal studies are not always predictive of human
response, RESCULA should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. 

Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have
not been established. 

It is not known whether RESCULA is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when RESCULA is
administered to a nursing woman. 

No overall differences in safety or effectiveness of RESCULA have been observed
between elderly and other adult populations. 

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., is focused on the discovery, development and
commercialization of drugs based on ion channel activators knows as prostones.
Discovered by the company's scientific founder, prostones are naturally
occurring fatty acid metabolites with unique physiological activities. Sucampo
has two marketed products - AMITIZA(r) and RESCULA - and a pipeline of
prostone-based product candidates in clinical development. A global company,
Sucampo is headquartered in Bethesda, Maryland, and has operations in the
United Kingdom, Switzerland and Japan. For more information, please visit
www.sucampo.com. 

The Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno,
Ltd, and has been licensed to Sucampo AG. 

About R-Tech Ueno, Ltd.

R-Tech Ueno is a publicly traded company listed on the JASDAQ exchange. It is a
bio-venture company established in September 1989 for the purpose of R&D and
marketing of drugs. Under the leadership of CEO Yukihiko Mashima, M.D., Ph.D.,
also a medical doctor, the company is developing new drugs on the theme
'Physician-Oriented New Drug Innovation,' targeting ophthalmologic and
dermatologic diseases that previously had no effective therapeutic agent. 

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; Sucampo's ability to
accurately predict future market conditions; dependence on the effectiveness of
Sucampo's patents and other protections for innovative products; the risk of
new and changing regulation and health policies in the U.S. and internationally
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 8-K and 10-K, which Sucampo incorporates by
reference. 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals). 

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         CONTACT: Silvia Taylor
         Senior Vice President, IR, PR, and Corporate Communications
         1-240-223-3718
         staylor@sucampo.com
News Source: NASDAQ OMX



22.10.2013 Dissemination of a Corporate News, transmitted by DGAP - 
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Language:     English
Company:      Sucampo Pharmaceuticals, Inc.
              
               
              Switzerland
Phone:        
Fax:          
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ISIN:         US8649091068
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