Sucampo Announces Japanese Government Funding for Unoprostone Isopropyl Development in Retinitis Pigmentosa

  Sucampo Announces Japanese Government Funding for Unoprostone Isopropyl
  Development in Retinitis Pigmentosa

Business Wire

BETHESDA, Md. -- February 4, 2013

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Japan
Science and Technology Agency (JST) has adopted unoprostone isopropyl
ophthalmic solution .15% in the Adaptable and Seamless Technology Transfer
Program. As part of this program, R-Tech Ueno, Sucampo’s development partner,
has signed an agreement for unoprostone isopropyl with the JST in which the
Japanese government shall provide the majority of funding* for Phase 3
clinical development costs for unoprostone isopropyl for retinitis pigmentosa
(RP). Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may
file for FDA approval of the product for retinitis pigmentosa (RP) in the
future assuming the successful trials.

A form of unoprostone isopropyl, trade name RESCULA^®, is currently approved
in the United States for use in patients with open-angle glaucoma or ocular
hypertension. The FDA has granted orphan drug designation to unoprostone
isopropyl for treatment of RP.

Retinitis pigmentosa is a genetic disease characterized by progressive,
irreversible vision loss and decreasing visual acuity. As RP progresses, daily
life becomes increasingly more 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. There are no
drugs or therapeutic procedures currently approved for the treatment of RP

“Sucampo congratulates our partner, R-Tech Ueno, for being the only project of
17 who applied to be selected for this prestigious Technology Transfer
Program. Much like the FDA’s orphan drug designation for unoprostone isopropyl
for retinitis pigmentosa, Sucampo is pleased that the Japan Science and
Technology Agency has recognized the potential unoprostone isopropyl may hold
to be a treatment for RP, an illness with significant impact for so many
patients who currently have no other treatment options,” said Ryuji Ueno,
M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific
Officer of Sucampo. “In addition, we are looking forward to the US launch of
RESCULA for IOP-lowering in glaucoma and ocular hypertension later this

In 2009, Sucampo licensed from R-Tech Ueno the development and
commercialization rights to unoprostone isopropyl for the United States and
Canada, including all associated patents, improvements, and other intellectual
property owned, controlled and developed by R-Tech Ueno. Under this agreement
R-Tech Ueno is the exclusive manufacturer of unoprostone isopropyl for
Sucampo. The agreement also provides Sucampo with a portion of the clinical
data needed to file for an RP indication in the US and Europe, an important
step in extending the role of unoprostone isopropyl in treating other
ophthalmic diseases.

*Note: This program provides a participating institution with a total R&D
funding of up to 2 billion yen (approximately US $22 M) for up to 7 years. If
the development is successful, the participating institution repays the total
amount of the provided funding by paying royalties based on product sales. If
the development is not successful, the participating institution repays 10% of
the provided funding, with no interest payments due.

About Unoprostone Isopropyl

Unoprostone isopropyl is a member of Sucampo’s family of prostones and is a
synthetic docosanoid. Unoprostone isopropyl may have a local effect on BK (Big
Potassium) channels in the eye. BK channels are expressed in contractile
tissues like the trabecular meshwork. RESCULA may reduce elevated intraocular
pressure (IOP) by increasing the outflow of aqueous humor through the
trabecular meshwork. Complete details of the mechanism of action are unknown
at this time.

Important Safety Information


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 a global pharmaceutical company focused on
innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of prostones
was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman,
Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones,
naturally occurring fatty acid metabolites that have emerged as promising
compounds with unique physiological activities, can be targeted for the
treatment of unmet or underserved medical needs. For more information, please

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. We
aim at becoming a “global pharmaceutical company specializing in specific
fields (ophthalmology and dermatology) and developing and selling
pharmaceutical products through the eyes of doctors. We are promoting the
development of new drugs for unmet medical needs for which the government
provides recommendations and assistance, orphan drugs and the drugs in the
field of anti-aging (lifestyle drugs).

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
US and internationally and the exposure to litigation and/or regulatory

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 the Company
incorporates by reference.


Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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