R-Tech Ueno: Announcement of Approval of sNDA for RESCULA Ophthalmic Solution and Start of Commercialization
TOKYO--(BUSINESS WIRE)--Dec 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
Business Management Department
Posted: December 2012