R-Tech Ueno: Announcement of Approval of sNDA for RESCULA® Ophthalmic Solution and Start of Commercialization

  R-Tech Ueno: Announcement of Approval of sNDA for RESCULA® Ophthalmic
  Solution and Start of Commercialization

Business Wire

TOKYO -- December 19, 2012

R-Tech Ueno (JASDAQ:4573):

Sucampo Pharmaceuticals, Inc. (hereinafter referred to as "Sucampo") announced
that it has received approval by the U.S. Food and Drug Administration (FDA)
of the supplemental new drug application (sNDA) to change to Package Insert
(PI) for RESCULA^® ophthalmic solution. (Please refer to Sucampo press release
as of December 12, 2012)

The approved change to the PI will make it possible to prescribe RESCULA^®
ophthalmic solution as a first-line therapeutic agent for open-angle glaucoma
or ocular hypertension, or to concomitantly administer it with other
intraocular pressure (IOP) lowering agents. Open-angle glaucoma is the most
common form of glaucoma. RESCULA^® is a BK (Big Potassium) channel activator,
and is different from other IOP lowering agents. Following this approval,
Sucampo intends to commercialize RESCULA^® ophthalmic solution on the US
market in the first quarter of 2013.

In April 2009 our company granted Sucampo to market RESCULA^® in the U.S. and
Canada for glaucoma or ocular hypertension, and transferred the sales right.
We also licensed their use of related patents, and reached an exclusive
manufacturing & supply agreement with them.

Please note this event does not change our performance projection for the full
financial year that was published on August 9, 2012.

In regard to the news of approval of RESCULA^® sNDA and its commercialization
in the U.S., our President, Yukihiko Mashima, M.D., PhD, has the following to
say:
"I am extremely glad to hear of the U.S. approval of RESCULA^® as a first-line
agent for open-angle glaucoma or ocular hypertension, and the news of its
expected commercial market launch there. In glaucoma patients, many of whom
are aged persons, the Japanese PI for RESCULA^® carries no contraindications
or precautions against these. That is why I think the said drug will become a
valuable therapy agent in the U.S. because it provides the patients to
balanced efficacy of IOP reduction with management of side effects. RESCULA^®
ophthalmic solution has a history of showing notable activities of
neuroprotection from the basic researches, and increase ocular circulation
from the clinical studies. It has proved its high usefulness as an ophthalmic
solution product.
We intend to continue our partnership with the licensee, Sucampo, extend our
market beyond Japan and the U.S. to the global market, and further increase
RESCULA^® ophthalmic solution's standing."

  *About RESCULA^® ophthalmic solution :

RESCULA^® is a glaucoma/ocular hypertension treatment drug that was the first
in the world to utilize Prostone. RESCULA^® has a pharmacological effect as an
ion channel opener. There are reports that RESCULA^® has not only an ocular
pressure decreasing action but also an optic nerve protective action (in
vitro) and an action to improve ocular blood flow in normal tension glaucoma.
It has been approved in 45 countries all over the world since it was marketed
in Japan in 1994.
RESCULA^® was originally approved by the FDA in 2000. Sucampo had been making
a supplemental New Drug Application about RESCULA^®.

  *About R-Tech Ueno, Ltd.

R-Tech Ueno is a bio venture company established in September 1989 for the
purpose of R&D and marketing of drugs. Under the leadership of the CEO, 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).

  *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,
which occur naturally in the human body as a result of enzymatic, 15-PGDH,
transformation of certain fatty acids, was first identified by Ryuji Ueno,
M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman, Chief Executive Officer
and Chief Scientific Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996
with co-founder.
For more information about Sucampo Pharmaceuticals, please visit
www.sucampo.com.

Contact:

R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business Management Department
info@rtueno.co.jp
 
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