Last ¥1,426 JPY
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r-tech ueno ltd (4573) Details

R-Tech Ueno, Ltd. is engaged in the research, development, manufacture, and sale of pharmaceutical products for the treatment of ophthalmology and dermatology worldwide. The company offers Rescula eye drops to treat glaucoma and ocular hypertension. Its product pipeline comprises Rescula/UF-021, which is in Phase IIb clinical trials to treat retinitis pigmentosa; RU-101 which is in Phase IIa clinical trials for the treatment of dry eye; and RK-023 that is in Phase IIa clinical trials to treat alopecia, as well as in Phase I clinical trials to treat hypotrichosis of the eyelashes. The company is also developing RTU-007 for treating diabetic cataract and retinopathy, and age-related macula degeneration; RTU-1096 for the treatment of atopic dermatitis, contact dermatitis, psoriasis, and diabetic neuropathy. In addition, it offers R and D assistance services, including development of synthetic methods; contract manufacturing of pharmaceuticals; characterization studies; formulation studies; and quality tests and stability tests for drug substances and drug products. Further, the company is engaged in contract manufacturing of injections, eye drops, liquid drugs, liquid-filled hard capsules, solid formulations, and ointments. R-Tech Ueno, Ltd. was founded in 1989 and is headquartered in Tokyo, Japan.

75 Employees
Last Reported Date: 06/25/14
Founded in 1989

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r-tech ueno ltd (4573) Key Developments

R-Tech Ueno, Ltd. Announces Non-Consolidated Earnings Results for the Second Quarter and First Half Ended September 30, 2014; Provides Earnings Guidance for the Fiscal Year Ending March 31, 2015; Provides Year End Dividend Guidance for the Fiscal Year Ending March 31, 2015

R-Tech Ueno, Ltd. announced non-consolidated earnings results for the second quarter and first half ended September 30, 2014. For the quarter, net sales were ¥1,581 million, compared to ¥1,275 million a year ago. Operating income was ¥272 million, compared to ¥256 million a year ago. Net income was ¥241 million, compared to ¥181 million a year ago. For the first half, net sales were ¥2,728 million, compared to ¥1,275 million a year ago. Operating income was ¥411 million, compared to ¥713 million a year ago. Net income was ¥356 million or ¥18.36 per diluted share, compared to ¥533 million or ¥27.43 per diluted share a year ago. For the fiscal year ending March 31, 2015, the company expects net sales of ¥5,763 million, operating income of ¥1,431 million, net income of ¥1,003 million or ¥52.01 per share. For the fiscal year 2015, the company expects year end dividend of ¥25 per share.

R-Tech Ueno, Ltd. Announces Completion of a Phase I/II Clinical Study of Recombinant Human Serum Albumin-Containing Ophthalmic Solution

R-Tech Ueno, Ltd. announced the completion of a Phase I/II clinical study of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101) for the treatment of severe dry eye. The design of this study was a placebo (without the active ingredient) controlled, double-masked study in severe dry eyes patients in the United States to confirm the safety and initial efficacy of RU-101 ophthalmic solution in two stages. Using the RU-101 ophthalmic solution of maximum dosage safety of which had been confirmed at Stage I (equivalent to Phase I), the safety and effectiveness were evaluated in the Stage II (equivalent to early Phase II) in 104 patients (RU-101 ophthalmic solution, 52 patients; placebo ophthalmic solution, 52 patients). The corneal staining score after 12-week administration was used as a primary endpoint for the effectiveness. No safety issue was found for RU-101 ophthalmic solution throughout the two stages. Administration of RU-101 ophthalmic solution significantly improved the corneal staining score time-dependently and statistically for 4, 8, and 12 weeks after starting instillation. However, no significant difference between RU-101 and placebo was noticeable in the score after 12 weeks of instillation because the score improved similarly in the placebo group as well. Nevertheless, the RU-101 instillation group tended to show a greater improvement after 4 and 8 weeks than the placebo group, and the improvement was particularly remarkable in patients with more severe dry eyes. In addition, results from evaluation with the conjunctival staining score, a secondary endpoint, were similar to those from corneal staining score-based evaluation.

R-Tech Ueno, Ltd. Announces Initiation of the Phase I Clinical Trial for the Novel VAP-1 Inhibitor RTU-1096

R-Tech Ueno, Ltd. has started the phase one clinical trial for the new molecular entity RTU-1096, which is a vascular adhesion protein-1 (VAP-1) inhibitor having anti-inflammatory and immunomodulatory effects. The descriptions are as follows: the company has developed the anti-inflammatory drug with a new mechanism of action based on the VAP-1 inhibitory effect. At present, the company has started the phase I clinical trial for the oral agent of a new molecular entity (Development Code: RTU-1096) targeted at healthy male adults. This trial is intended to examine the safety, tolerability, and pharmacokinetics of the inhibitor with a single dose. The trial would be conducted as a placebo-controlled, double-blind, dose-escalation study complied with the Good Clinical Practice (GCP). RTU-1096 is a new molecular entity for first-in-human use. After its safety and tolerability with a single dose are confirmed, it would further examine its safety, tolerability, and pharmacokinetics with repeated doses. If its safety and tolerability are confirmed through the phase I clinical trial, RTU-1096 would be one of the promising treatment candidates for diseases with unmet medical needs (medical areas where satisfying treatment is not yet established), which is what the company is focused on. The current candidate diseases for RTU-1096 are dermatological diseases such as atopic dermatitis and psoriasis. These diseases have been treated mainly with ointments such as steroids, and there are concerns regarding side effects due to long-term administration and the burden of daily application. RTU-1096 has a new mechanism of action; therefore, the company believe that it will possibly be effective for patients in whom the existing treatment is not sufficiently effective. In addition, by providing RTU-1096 as an oral agent, the company expects that it would improve the quality of life (QOL) of patients and reduce the burden on the patients' families.


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