Sucampo Pharmaceuticals, Inc. ("Sucampo") (NASDAQ: SCMP), a global
biopharmaceutical company, today announced that it has received orphan
drug designation in the European Union for unoprostone isopropyl for the
treatment of retinitis pigmentosa (RP). RP is a genetic disease
characterized by progressive, irreversible vision loss and decreasing
visual acuity, and there are no drugs or therapeutic procedures
currently approved for the treatment of RP today.
To qualify for orphan designation by the European Medicines Agency
(EMA), a medicine must be intended for the treatment, prevention or
diagnosis of a disease that is life-threatening or chronically
debilitating; the prevalence of the condition in the EU must not be more
than 5 in 10,000; and no satisfactory method of diagnosis, prevention or
treatment of the condition concerned can be authorized, or, if such a
method exists, the medicine must be of significant benefit to those
affected by the condition1.
"We are very pleased to receive orphan drug designation by the EMA for
unoprostone isopropyl for the treatment of RP," said Ryuji Ueno, M.D.,
Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific
Officer of Sucampo. "RP is a significant burden to the patients and
caregivers whose lives are affected by the disease. The granting of this
orphan drug designation is yet another important milestone for
unoprostone isopropyl as we continue in our development of the product
to address the unmet needs of patients afflicted with this disease."
As previously announced, in February of this year R-Tech Ueno, Ltd.,
Sucampo's development partner, signed an agreement for unoprostone
isopropyl with the Japan Science and Technology Agency in which the
Japanese government shall provide the majority of funding for phase 3
clinical development costs for unoprostone isopropyl for retinitis
pigmentosa (RP). In the first quarter, R-Tech announced the enrollment
of the first patient in this program. Sucampo is co-developing
unoprostone isopropyl with R-Tech and may file for EMA and U.S. Food and
Drug Administration (FDA) approval of the product for RP in the future
assuming successful trials. A form of unoprostone isopropyl is currently
approved in the United States. In addition, the FDA has granted orphan
drug designation to unoprostone isopropyl for treatment of RP.
RP causes the degeneration of photoreceptor cells in the retina.
Photoreceptor cells capture and process light, helping us to see. As
these cells degenerate and die, patients experience progressive vision
loss2. 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.
About Unoprostone Isopropyl
Unoprostone isopropyl is a member of Sucampo's family of prostones and
is a synthetic docosanoid. It has received orphan drug designation for
RP in Europe by the EMA and in the United States by the FDA.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global biopharmaceutical 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 visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are
registered trademarks of Sucampo AG.
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.
1. European Medicines Agency website: www.emea.europa.eu
Foundation Fighting Blindness website: www.blindness.org
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718