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News Article | February 28, 2017
Site: www.businesswire.com

BEIJING--(BUSINESS WIRE)--Pharmaron, a fully integrated contract research organization offering R&D services to the life sciences industry, today announced that it has signed a definitive agreement under which Pharmaron will acquire a majority stake in Shin Nippon Biomedical Laboratories Clinical Pharmacology Center, Inc. (“SNBL CPC”) in Baltimore, Maryland, USA. This clinical center is a leading provider of moderate and highly complex Phase I/II clinical development services for the life sciences sector. Current shareholder Shin Nippon Biomedical Laboratories, Ltd. (SNBL) (TSE:2395) will retain a minority stake in the business following the transaction. SNBL CPC is a full-service clinical CRO located on the campus of the University of Maryland BioPark. Since its inception in 2005, over 200 studies have been completed in the purpose-built, clinical pharmacology unit. Many of these completed clinical studies have been submitted in support of global regulatory filings for drug approval for marketing of both small and large molecules. This strategic acquisition allows Pharmaron to be one-step closer to offering a full spectrum of R&D services. Addition of this capability to the Pharmaron Group naturally complements and expands Pharmaron’s existing drug R&D services, further consolidating the clinical development capabilities, through synergistic integration with recently acquired radiolabelled science capabilities, including Quotient Bioresearch’s clinical metabolism in the UK and Xceleron’s AMS-based 14C-microtracer technology in the USA. Mr. Larry Lou, President and COO of Pharmaron commented: “We are delighted to have SNBL CPC join the Pharmaron Group. This is an important milestone for Pharmaron. Once integrated and further developed, the new clinical platform will fuel the corporate engine for business growth in a sustainable manner. This is another testimony of our determination to fully realize our mission to support our clients’ success in discovery, development and commercialization of important medicines and fulfill our vision to be a global leading organization in the life sciences service industry.” Dr. Ryoichi Nagata, Chairman and CEO of SNBL commented: “The mission of SNBL CPC has been to offer complex and innovative clinical pharmacology services in close proximity to leading university medical centers. Through this transaction, we look forward to seeing future growth of CPC as part of Pharmaron Group.” The financial terms of the transaction are not being disclosed. Teneo Capital served as financial advisor to Pharmaron; O’Melveny & Myers LLP served as Pharmaron’s legal advisor. SC&H Capital served as financial advisor to SNBL; Miles & Stockbridge P.C. served as legal advisor to SNBL. Pharmaron is a private, premier R&D service provider for the life sciences industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of R&D service capabilities ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology, safety assessment, radiochemistry and radiolabelled metabolism, clinical analytical sciences to chemical & pharmaceutical development. With over 4,000 employees, and operations in China, the United States, and the United Kingdom, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. www.pharmaron.com SNBL CPC is a clinical pharmacology facility located in the University of Maryland BioPark in Baltimore, Maryland, USA. The state of the art facility and equipment is bolstered by a vibrant research community. SNBL CPC specializes in complex Phase I-II trials, including TQT/Phase 1 QT de-risking, first-In-human (FIH), Japanese Bridging and Phase II Proof of Concept (POC) studies in therapeutics areas including immunology/infectious disease, neurology, respiratory, dermatology and more. SNBL CPC conducts clinical trials from multiple sectors, including biopharmaceutical and biotech industry, academia, and the government. SNBL CPC offers full service support of clinical trials through its in-house resources, expert partners from surrounding universities and practices. Proximity and the agreements that SNBL CPC has developed with the University of Maryland, Baltimore and Johns Hopkins University makes this facility best of its kind.


News Article | October 27, 2016
Site: www.chromatographytechniques.com

A major laboratory company that sells primates was sued by the U.S. Department of Agriculture for violations of the Animal Welfare Act. The action against Shin Nippon Biomedical Laboratories USA, filed last month, follows several years of official complaints filed by the group People for the Ethical Treatment of Animals (PETA). The USDA alleges dozens of monkey deaths “willfully violated the Animal Welfare Act,” according to the administrative lawsuit, dated Sept. 22. “The gravity of the violations alleged in this complaint is great and includes 38 deaths of nonhuman primates and repeated instances in which Respondent failed to provide adequate veterinary care to animals and failed to meet the minimum standards for its facilities,” the agency alleges. SNBL was reached by phone Wednesday, but did not respond to Laboratory Equipment’s request for comment. The alleged mistreatment spans five years, from 2011 to May of this year, according to the papers. Among the accusations included are a shipment of 840 long-tailed macaques from Cambodia to Houston in the fall of 2013. Upon their farther travels to Washington and Texas, 25 of them died or were euthanized due to organ failure caused by dehydrations and hypoglycemia, according to the agency. A whistleblower report in 2011 detailed earlier abuse and neglect of monkeys, according to PETA. The USDA has previously stepped in and issued stipulations in 2006, 2008 and 2009. PETA said in a statement it was calling for the National Institutes of Health to block federal funding for the company – and also asking the Food and Drug Administration to investigate potential violations of the Food, Drug, and Cosmetic Act. “SNBL’s incompetence and indifference have killed too many monkeys for too many years,” said Kathy Guillermo, PETA’s senior vice president of laboratory investigations. “PETA is calling for this laboratory to be stripped of its funding and shut down.”


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Imagama T.,Yamaguchi University | Ogino K.,Okayama University | Takemoto K.,Shin Nippon Biomedical Laboratories | Kato Y.,Yamaguchi University | And 6 more authors.
Journal of Clinical Biochemistry and Nutrition | Year: 2012

Recently, arginase is suggested to regulate nitric oxide production by competing with nitric oxide synthase for the same substrate, L-arginine, in experimental asthma. We investigated the role of arginase and its relationship to nitric oxide production after spinal cord injury. Rats were subjected to laminectomy and complete transection of their spinal cords (injury group) or laminectomy only (sham group). In the injury group, arginase I was increased in the macrophages at the transection edge, and the peak was observed 48 h after spinal cord injury. However, nitric oxide production decreased significantly in the injury group despite increased nitric oxide synthase2 mRNA expression compared with the sham group. We also demonstrated the reduction in L-arginine concentrations, which was inversely associated with changes in arginase activity. Therefore, arginase appeared to regulate nitric oxide production by consuming L-arginine. The regulation of arginase activity and L-arginine levels may improve nitroxidative stress and reduce tissue damage in spinal cord injury. ©2012 JCBN.


PubMed | Centers for Disease Control and Prevention, University of Maryland Baltimore County, Baylor College of Medicine, University of Rochester and 5 more.
Type: Clinical Trial, Phase I | Journal: Clinical and vaccine immunology : CVI | Year: 2015

Noroviruses are the leading cause of acute gastroenteritis worldwide, and norovirus vaccine prevention strategies are under evaluation. The immunogenicity of two doses of bivalent genogroup 1 genotype 1 (GI.1)/GII.4 (50 g of virus-like particles [VLPs] of each strain adjuvanted with aluminum hydroxide and 3-O-desacyl-4monophosphoryl lipid A [MPL]) norovirus vaccine administered to healthy adults in a phase 1/2 double-blind placebo-controlled trial was determined using virus-specific serum total antibody enzyme-linked immunosorbent assay (ELISA), IgG, IgA, and histoblood group antigen (HBGA)-blocking assays. Trial participants subsequently received an oral live virus challenge with a GII.4 strain, and the vaccine efficacy results were reported previously (D. I. Bernstein et al., J Infect Dis 211:870-878, 2014, doi:10.1093/infdis/jiu497). This report assesses the impact of prechallenge serum antibody levels on infection and illness outcomes. Serum antibody responses were observed in vaccine recipients by all antibody assays, with first-dose seroresponse frequencies ranging from 88 to 100% for the GI.1 antigen and from 69 to 84% for the GII.4 antigen. There was little increase in antibody levels after the second vaccine dose. Among the subjects receiving the placebo, higher prechallenge serum anti-GII.4 HBGA-blocking and IgA antibody levels, but not IgG or total antibody levels, were associated with a lower frequency of virus infection and associated illness. Notably, some placebo subjects without measurable serum antibody levels prechallenge did not become infected after norovirus challenge. In vaccinees, anti-GII.4 HBGA-blocking antibody levels of >1:500 were associated with a lower frequency of moderate-to-severe vomiting or diarrheal illness. In this study, prechallenge serum HBGA antibody titers correlated with protection in subjects receiving the placebo; however, other factors may impact the likelihood of infection and illness after virus exposure. (This study is registered at ClinicalTrials.gov under registration number NCT1609257.).


Nakagami A.,Japan Women's University | Koyama T.,Japan Women's University | Kawasaki K.,Hoshi University | Negishi T.,Aoyama Gakuin University | And 3 more authors.
Developmental Psychobiology | Year: 2011

Polychlorinated biphenyls (PCBs) are endocrine disrupting chemicals that disturb normal development of embryonic brains. In the present study, we evaluated the relationship between maternal plasma PCB concentration and infant behavioral characteristics in mother-infant interactions. We grouped 20 pregnant cynomolgus monkeys (Macaca fascicularis) into higher and lower PCB exposure groups; monkeys in the higher PCB group had PCB concentrations above 15 pg/g, which is representative of natural exposure levels. Maternal PCB concentration correlated negatively with infant behaviors (approach, look, proximity, locomotion) at the age of 6 months (p < .05), when an increase in these behaviors should normally occur. These results suggest that maternal PCB exposure may affect the development of infant social behavior in cynomolgus monkeys. Furthermore, this study provides primate evidence to support observations of associations between behavioral and learning disabilities and prenatal exposure to PCBs in humans. © 2010 Wiley Periodicals, Inc.


Sawada K.,Tsukuba International University | Fukunishi K.,Shin Nippon Biomedical Laboratories | Kashima M.,Shin Nippon Biomedical Laboratories | Saito S.,Japan National Institute of Radiological Sciences | And 4 more authors.
Anatomical Record | Year: 2012

Our article summarizes a series of studies about fetal gyrification and its relation to cerebral growth in cynomolgus monkeys. Based on the cerebral growth (i.e., brain weight, cerebral volume, and frontooccipital length of the cerebral hemisphere) and the developmental pattern of gyrification in each sulcus of cynomolgus monkeys, we divided the gyrification process into four stages: Stage 1. Demarcation of cerebral lobes and limbic gyri; Stage 2. Demarcation of neocortical gyri; Stage 3. Emergence of secondary and tertiary sulci; and Stage 4. Growth of sulcal length and depth. Each stage of those gyrification processes was influenced by different developmental events, such as the emergence of corticocortical long-associative fiber tracts, cortical maturations, and subcortical white-matter development. This is the first report to systematically propose gyrification processes closely related to the order of phyologenetical development of the cerebral cortex in primates. © 2012 Wiley Periodicals, Inc.


Imai N.,Tokushima University | Imai N.,Shin Nippon Biomedical Laboratories | Sawada K.,Tsukuba International University | Fukunishi K.,Shin Nippon Biomedical Laboratories | And 2 more authors.
Congenital Anomalies | Year: 2011

The present study aimed to quantitatively clarify the gross anatomical asymmetry and sexual dimorphism of the cerebral hemispheres of cynomolgus monkeys. While the fronto-occipital length of the right and left cerebral hemispheres was not different between sexes, a statistically significant rightward asymmetry was detected in the cerebral width at the perisylvian region in females, but not in males (narrower width of the left side in the females). An asymmetry quotient of the sulcal lengths revealed a rightward asymmetry in the inferior occipital sulcus and a leftward asymmetry in the central and intraparietal sulci in both sexes. However, the laterality of the lengths of other sulci was different for males and females. The arcuate sulcus was directed rightward in males but there was no rightward bias in females. Interestingly, the principle sulcus and lateral fissure were left-lateralized in the males, but right-lateralized in the females. The results suggest that lateralization patterns are regionally and sexually different in the cerebrum of cynomolgus monkeys. The present results provide a reference for quantitatively evaluating the normality of the cerebral cortical morphology in cynomolgus monkeys. © 2011 The Authors. Congenital Anomalies © 2011 Japanese Teratology Society.


Iwasaki K.,Shin Nippon Biomedical Laboratories | Murayama N.,Showa Pharmaceutical University | Koizumi R.,Showa Pharmaceutical University | Uno Y.,Shin Nippon Biomedical Laboratories | Yamazaki H.,Showa Pharmaceutical University
Drug Metabolism and Pharmacokinetics | Year: 2010

Drug metabolizing activities of cytochromes P450 (P450s, or CYPs) 3A4 and 3A5 in liver microsomes from the cynomolgus monkey [Macaca fascicularis (mf)] were investigated and compared with those of human P450 3A enzymes. Low activities for dealkylation of ethoxyresorufin and pentoxyresorufin were seen in recombinant monkey mfCYP3A4 and mfCYP3A5 and in recombinant human CYP3A4 and CYP3A5 expressed in bacterial membranes. Hydroxylation activities of mfCYP3A4 and mfCYP3A5 toward coumarin, paclitaxel, diclofenac, flurbiprofen, and S-mephenytoin were below detectable levels, as was also true for CYP3A4 and CYP3A5. Monkey mfCYP3A5 and mfCYP3A4 were highly active in bufuralol 1′-hydroxyl-ation. mfCYP3A5 was efficient at dextromethorphan O-demethylation, although human CYP3A5 was unable to catalyze this reaction. Apparent bufuralol 1′-hydroxylation and dextromethorphan O-demethylation activities of monkey liver microsomes were higher than those of human liver microsomes, possibly because of contributions of mfCYP3A5 to these P450 2D-dependent drug oxidations. mfCYP3A5 and CYP3A5 catalyzed midazolam 1′-hydroxylation at a low substrate concentration more efficiently than the corresponding CYP3A4. mfCYP3A5 had higher testosterone 6β-hydroxylase activity than mfCYP3A4, but the reverse relationship was observed in oxidation of nifedipine and hydroxylation of dexamethasone. These results demonstrate that monkey P450 3A enzymes have similar substrate selectivity to that of human P450 3A enzymes, but exhibit wider substrate selectivity toward P450 2D substrates.


Chowdhury G.,Vanderbilt University | Murayama N.,Showa Pharmaceutical University | Okada Y.,Showa Pharmaceutical University | Uno Y.,Shin Nippon Biomedical Laboratories | And 4 more authors.
Chemical Research in Toxicology | Year: 2010

(R)-Thalidomide was oxidized to 5-hydroxythalidomide and 5′-hydroxythalidomide by NADPH-fortified liver microsomes from humans and monkeys. (R)-Thalidomide was hydroxylated more efficiently than (S)-thalidomide. Recombinant human P450s 3A4, 3A5, and 3A7 and monkey P450s 3A8 and 3A5 (coexpressed with NADPH-P450 reductase in bacterial membranes) also catalyzed (R)-thalidomide 5-hydroxylation. Purified human P450s 2C19, 3A4, and 3A5 mediated (R)-thalidomide 5-hydroxylation at similar rates in reconstituted systems. P450 2C19 showed a rather nonsaturable substrate-velocity curve; however, P450s 3A4 and 3A5 showed sigmoidal curves. P450 also oxidized 5-hydroxythalidomide to an epoxide or dihydroxy compound. Liquid chromatography-mass spectrometry analysis revealed the formation of a glutathione conjugate from (R)- and (S)-5-hydroxythalidomide, catalyzed by liver microsomal P450s 3A4 and 3A5 in the presence of glutathione (assigned as a conjugate of 5-hydroxythalidomide formed on the phenyl ring). These results indicate that human P450s 3A4 and 3A5 mediate thalidomide 5-hydroxylation and further oxidation leading to a glutathione conjugate, which may be of relevance in the pharmacological and toxicological actions of thalidomide. © 2010 American Chemical Society.

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