Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Japan Science and Technology Agency (JST) has adopted unoprostone isopropyl ophthalmic solution .15% in the Adaptable and Seamless Technology Transfer Program. As part of this program, R-Tech Ueno, Sucampo’s development partner, has signed an agreement for unoprostone isopropyl with the JST in which the Japanese government shall provide the majority of funding* for Phase 3 clinical development costs for unoprostone isopropyl for retinitis pigmentosa (RP). Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval of the product for retinitis pigmentosa (RP) in the future assuming the successful trials. A form of unoprostone isopropyl, trade name RESCULA ®, is currently approved in the United States for use in patients with open-angle glaucoma or ocular hypertension. The FDA has granted orphan drug designation to unoprostone isopropyl for treatment of RP. Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly more difficult. 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. There are no drugs or therapeutic procedures currently approved for the treatment of RP today. “Sucampo congratulates our partner, R-Tech Ueno, for being the only project of 17 who applied to be selected for this prestigious Technology Transfer Program. Much like the FDA’s orphan drug designation for unoprostone isopropyl for retinitis pigmentosa, Sucampo is pleased that the Japan Science and Technology Agency has recognized the potential unoprostone isopropyl may hold to be a treatment for RP, an illness with significant impact for so many patients who currently have no other treatment options,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. “In addition, we are looking forward to the US launch of RESCULA for IOP-lowering in glaucoma and ocular hypertension later this quarter.”
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.
Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.RESCULA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. Macular edema, including cystoid macular edema, has been reported. RESCULA should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. RESCULA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration. Adverse reactions In clinical studies, ocular adverse events above 5% with use of RESCULA were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid disorder (5.8%). Approximately 10-14% of patients were observed to have an increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Corneal lesions were reported in 2.3% of patients. The most frequently reported nonocular adverse event associated with the use of RESCULA in the clinical trials was flu-like syndrome, observed in approximately 6% of patients. Use in specific populations Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, RESCULA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have not been established.It is not known whether RESCULA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RESCULA is administered to a nursing woman. No overall differences in safety or effectiveness of RESCULA have been observed between elderly and other adult populations. 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 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. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG. About R-Tech Ueno, Ltd. R-Tech Ueno is a publicly traded company listed on the JASDAQ exchange. It is a bio venture company established in September 1989 for the purpose of R&D and marketing of drugs. Under the leadership of CEO Yukihiko Mashima, M.D., Ph.D., 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). 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 US 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 the Company incorporates by reference.