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sumitomo dainippon pharma co (4506) Details

Sumitomo Dainippon Pharma Co., Ltd. manufactures and sells pharmaceuticals, food ingredients, food additives, veterinary medicines, diagnostics, and others in Japan, China, North America, and other regions. The company offers pharmaceutical products, such as therapeutic agents for hypertension, angina pectoris, arrhythmia, Parkinson’s disease, systemic fungal infections, and hepatocellular carcinoma; atypical antipsychotics; rapid-acting insulin secretagogues; vasodilators; and biguanide oral hypoglycemic drugs. It also provides products for therapeutic indications, such as Anderson-Fabry disease, gastroprokines, antiepileptic, sedative hypnotics, short-acting and long-acting beta-agonist, corticosteroid nasal spray, inhaled corticosteroid, carbapenem antibiotics, and serotonin-agonist antianxiety drugs. In addition, the company offers food ingredients and additives, such as polysaccharides and seasonings; and chemical product materials, such as cosmetic materials, coatings and industrial chemicals, active pharmaceutical ingredients, and electronic chemicals. Further, it provides veterinary medicines for companion animals, including dogs and cats; and farm animals, such as cattle, swine, poultry, horses, and cultured fish. Additionally, the company develops point-of-care testing diagnostic products for infectious diseases and acute myocardial infarctions, as well as for born and calcium metabolism, and central nervous system disorders; research materials that facilitate research related to medical care; and BBI608 and BBI503 to treat solid tumors. It has a joint development agreement with Healios K.K. to develop iPS cell-derived retinal pigment epithelial cells for age-related macular degeneration and other eye diseases. The company was formerly known as Dainippon Sumitomo Pharma Co., Ltd. and changed its name to Sumitomo Dainippon Pharma Co., Ltd. in June 2014. Sumitomo Dainippon Pharma Co., Ltd. was founded in 1897 and is headquartered in Osaka, Japan.

6,697 Employees
Last Reported Date: 06/23/16
Founded in 1897

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sumitomo dainippon pharma co
Sumitomo Dainippon Pharma Co., Ltd Announces Positive Results from Phase 3 Study Evaluating the Novel Drug Candidate Dasotraline

Sumitomo Dainippon Pharma Co., Ltd. announced positive topline results from a Phase 3 study evaluating the novel drug candidate dasotraline (generic name, code name: SEP-225289), a dopamine norepinephrine reuptake inhibitor, being evaluated in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD). The study met its primary endpoint. The Phase 3 study evaluated the efficacy and safety of dasotraline (4mg/day versus placebo) in children ages 6 to 12 years with ADHD in a laboratory classroom setting. The primary endpoint was change from baseline at Day 15 in ADHD symptoms as measured by mean SKAMP-Combined Score obtained from an average of 7 assessments collected across the 12-hour laboratory classroom day (12-24 hours post-dose). In this Phase 3 study, dasotraline 4 mg/day demonstrated sustained efficacy over the 12-24 hour time period post-dose and was associated with an acceptable safety profile over the 2 week study duration. Based on the results of the study, Sunovion Pharmaceuticals Inc., a U.S. subsidiary of Sumitomo Dainippon Pharma, plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in FY2017 for ADHD in adults and pediatric populations. The company will also continue to develop dasotraline for binge eating disorder (BED) in adults in the United States. Dasotraline 4 mg/day significantly improved mean SKAMP-Combined score versus placebo (p<0.0001, effect size 0.85) with significant effects persisting throughout the day. Mean SKAMP subscores improved significantly for attention (p<0.0001, effect size 0.81) and deportment (p<0.001, effect size 0.70). Treatment-emergent AEs were mild or moderate in severity; most frequent were (dasotraline 4 mg/day; placebo) combined insomnia (19.6%; 3.6%), decreased appetite (10.7%; 3.6%), headache (10.7%; 8.9%), affect lability (8.9%; 7.1%), and irritability (5.4%; 3.6%). Dasotraline is a new chemical entity that is considered to be a dopamine and norepinephrinereuptake inhibitor (DNRI). It has an extended half-life (47-77 hours) that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval at steady state. Dasotraline is currently in development to evaluate its use in treating ADHD in adults and pediatric populations and binge eating disorder (BED) in adults in the United States. The SEP360-305 study conducted in the United States was a Phase 3, two-week, multi-center, randomized, placebo-controlled, double-blind, in children with ADHD. This Phase 3 study evaluated the efficacy and safety of dasotraline in children with ADHD throughout the day in a laboratory classroom setting. 112 children, ages 6 to 12 years, with ADHD were administered of dasotraline or placebo (dosed daily at home at approximately 8 p.m.) for a period of two weeks. The laboratory classroom evaluations took place at baseline and Day 15. The primary endpoint was change from baseline at Day 15 in ADHD symptoms as measured by mean SKAMP-Combined Score obtained from an average of 7 assessments collected across the 12-hour laboratory classroom day (12-24 hours post-dose).

Sumitomo Dainippon Pharma Co., Ltd. Concludes License Agreement with Bukwang Pharmaceutical Co., Ltd

Sumitomo Dainippon Pharma Co., Ltd. announced that the company has concluded a license agreement with Bukwang Pharmaceutical Co., Ltd. relating to the development, sales and so on in Korea of lurasidone hydrochloride. Under the terms of the agreement, Bukwang will have the exclusive license of lurasidone to develop, sell and so on in Korea and Sumitomo Dainippon Pharma will receive upfront, launch milestone and sales milestone payments from Bukwang and supply lurasidone bulk tablets to Bukwang. Bukwang will conduct the bridging phase 3 study of lurasidone for schizophrenia in Korea.

Sumitomo Dainippon Pharma Co., Ltd. Announces Executive Changes

Sumitomo Dainippon Pharma Co., Ltd. announced that at its meeting held on February 24, 2017, the board of directors decided to change the following representative directors and executive officers. With effect from April 1, 2017, the retirement of one of the current representative directors, Hiroshi Noguchi, from executive officer and representative director, a new representative director will be appointed. Hiroshi Nomura appointed as the representative director, executive vice president from member, board of directors, executive vice president of the company. Hiroshi Noguchi appointed as member, board of directors from representative director, senior executive vice president of the company. New executive officers with affect from April 1, 2017: Mitsuyuki Taniguchi (currently deputy executive director, sales & marketing division); Atsuko Higuchi (currently senior communication officer); and Shigeyuki Nishinaka (currently senior director, global business development). Retiring executive officers with effect from March 31, 2017: Hiroshi Noguchi (currently representative director, senior executive vice President); Masaru Ishidahara (currently member, board of directors, senior executive officer) and Yoshinori Oh-e (currently senior executive officer).

 

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Valuation 4506 Industry Range
Price/Earnings 24.7x
Price/Sales 1.9x
Price/Book 1.6x
Price/Cash Flow 20.9x
TEV/Sales 1.5x
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