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Sucampo Announces Japanese Government Funding For Unoprostone Isopropyl Development In Retinitis Pigmentosa

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

Contraindications

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.

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