Sucampo Pharmaceuticals Achieves Orphan Designation for Unoprostone Isopropyl for Treatment of Retin
Sucampo Pharmaceuticals Achieves Orphan Designation for Unoprostone Isopropyl for Treatment of Retinitis Pigmentosa by European Medicines Agency
BETHESDA, Md.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. ("Sucampo") (NAS: 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.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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