Shionogi and Co.

Fukushima-shi, Japan

Shionogi and Co.

Fukushima-shi, Japan

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Shimizu S.,Shionogi and Co. | Ueki T.,Shionogi and Co.
Organic Process Research and Development | Year: 2017

In 1988, Whiting et al. reported the first differential scanning calorimetry measurement in a glass capillary crucible, providing general information about the crucible and the holder as well as the advantages of using this system. However, the glass capillary crucible and the holder are not yet commercially available. Here we introduce a glass capillary crucible developed with our know-how to encourage its wider adoption in order to reduce costs by obviating the need for commercial gold-plated crucibles. © 2017 American Chemical Society.

BURTON-ON-TRENT, England--(BUSINESS WIRE)--The fifth paragraph of release dated June 21, 2017 07:00 AM BST should read: "Under this new agreement, Idis GA will supply and distribute argatroban on an exclusive, unlicensed, on demand basis in all countries where there is no Marketing Authorisation or where MTPE has no direct presence." CLINIGEN SIGNS EXCLUSIVE SUPPLY AGREEMENTS IN GLOBAL ACCESS WITH MITSUBISHI TANABE, SHIONOGI AND ROMARK Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that its Idis Global Access (‘Idis GA’) division, has signed three further exclusive agreements to manage the supply and distribution of critical medicines on demand. The three agreements and relevant territories are: The new agreement with MTPE builds on the current relationship with Clinigen’s Idis Managed Access division to provide early access to argatroban where the product has no regulatory approval. Argatroban is indicated for anticoagulation in adult patients with heparin-induced thrombocytopenia type II (‘HIT’) who require parenteral antithrombotic therapy. Under this new agreement, Idis GA will supply and distribute argatroban on an exclusive, unlicensed, on demand basis in all countries where there is no Marketing Authorisation or where MTPE has no direct presence. The agreement with Shionogi is to provide healthcare professional’s access to Senshio® in Germany. Senshio, prescribed in tablet form, is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (‘VVA’) in post-menopausal women who are not candidates for local vaginal oestrogen therapy. Idis GA will make Senshio available on an on demand basis to physicians and pharmacists in Germany where the product is approved but not commercially available, and in the UK where the product is approved and has been commercially launched. Idis GA signed a two year extension for the exclusive supply and distribution of Romark’s Alinia® into all territories outside of the US and Latin America. Alinia is indicated for the treatment of diarrhoea in children caused by intestinal infection by the parasites, Cryptosporidium parvum or Giardia lamblia. Idis GA is the market leader in providing hospital pharmacists with compliant on demand access to medicines. Healthcare professionals can obtain details about any of the products mentioned above by emailing Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said: “These exclusive agreements demonstrate Idis Global Access’ ability to support international pharma companies, such as Mitsubishi, Shionogi and Romark, to meet on demand access for their medicines. These three varied contracts, including the conversion of a Managed Access programme, demonstrate the positive steps we are taking in building this business to become the go-to leader in ethical access to unlicensed or unavailable medicine.”

Clotet B.,University of Vic | Feinberg J.,University of Cincinnati | Van Lunzen J.,Universitatsklinikum Hamburg Eppendorf | Khuong-Josses M.-A.,Hopital Delafontaine | And 10 more authors.
The Lancet | Year: 2014

Background Dolutegravir has been shown to be non-inferior to an integrase inhibitor and superior to a non-nucleoside reverse transcriptase inhibitor (NNRTI). In FLAMINGO, we compared dolutegravir with darunavir plus ritonavir in individuals naive for antiretroviral therapy. Methods In this multicentre, open-label, phase 3b, non-inferiority study, HIV-1-infected antiretroviral therapy-naive adults with HIV-1 RNA concentration of 1000 copies per mL or more and no resistance at screening were randomly assigned (1:1) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus ritonavir 100 mg once daily, with investigator-selected tenofovir.emtricitabine or abacavir.lamivudine. Randomisation was stratifi ed by screening HIV-1 RNA (.100 000 or >100 000 copies per mL) and nucleoside reverse transcriptase inhibitor (NRTI) selection. The primary endpoint was the proportion of patients with HIV-1 RNA concentration lower than 50 copies per mL (Food and Drug Administration [FDA] snapshot algorithm) at week 48 with a 12% non-inferiority margin. This trial is registered with, NCT01449929. Findings Recruitment began on Oct 31, 2011, and was completed on May 24, 2012, in 64 research centres in nine countries worldwide. Of 595 patients screened, 484 patients were included in the analysis (242 in each group). At week 48, 217 (90%) patients receiving dolutegravir and 200 (83%) patients receiving darunavir plus ritonavir had HIV-1 RNA of less than 50 copies per mL (adjusted diff erence 7E1%, 95% CI 0E9.13E2), non-inferiority and on pre-specifi ed secondary analysis dolutegravir was superior (p=0E025). Confi rmed virological failure occurred in two (<1%) patients in each group; we recorded no treatment-emergent resistance in either group. Discontinuation due to adverse events or stopping criteria was less frequent for dolutegravir (four [2%] patients) than for darunavir plus ritonavir (ten [4%] patients) and contributed to the diff erence in response rates. The most commonly reported (.10%) adverse events were diarrhoea (dolutegravir 41 [17%] patients vs darunavir plus ritonavir 70 [29%] patients), nausea (39 [16%] vs 43 [18%]), and headache (37 [15%] vs 24 [10%]). Patients receiving dolutegravir had signifi cantly fewer low-density lipoprotein values of grade 2 or higher (11 [2%] vs 36 [7%]; p=0E0001). Interpretation Once-daily dolutegravir was superior to once-daily darunavir plus ritonavir. Once-daily dolutegravir in combination with fixed-dose NRTIs represents an effective new treatment option for HIV-1-infected, treatment-naive patients. Funding ViiV Healthcare and Shionogi & Co. © Chataway et al. Open Access article distributed under the terms of CC BY.

Kido Y.,University of California at San Francisco | Kido Y.,Shionogi and Co. | Matsson P.,University of California at San Francisco | Matsson P.,Uppsala University
Journal of Medicinal Chemistry | Year: 2011

Drug-drug interactions (DDIs) are major causes of serious adverse drug reactions. Most DDIs have a pharmacokinetic basis in which one drug reduces the elimination of a second drug, leading to potentially toxic drug levels. As a major organ of drug elimination, the kidney represents an important site for DDIs. Here, we screened a prescription drug library against the renal organic cation transporter OCT2/SLC22A2, which mediates the first step in the renal secretion of many cationic drugs. Of the 910 compounds screened, 244 inhibited OCT2. Computational analyses revealed key properties of inhibitors versus noninhibitors, which included overall molecular charge. Four of six potential clinical inhibitors were transporter-selective in follow-up screens against additional transporters: OCT1/SLC22A1, MATE1/SLC47A1, and MATE2-K/SLC47A2. Two compounds showed different kinetics of interaction with the common polymorphism OCT2-A270S, suggesting a role of genetics in modulating renal DDIs. © 2011 American Chemical Society.

Osato H.,Shionogi and Co. | Jones I.L.,Institute of Chemical and Engineering Sciences, Singapore | Chen A.,Institute of Chemical and Engineering Sciences, Singapore | Chai C.L.L.,Institute of Chemical and Engineering Sciences, Singapore
Organic Letters | Year: 2010

"Chemical Equation Presented" An efficient formal synthesis of oseltamivir phosphate (Tamiflu) has been achieved in 12 steps with use of the inexpensive and highly abundant D-ribose as the starting material. This concise alternative route does not utilize protecting groups and features the introduction of 3-pentylidene ketal as the latent 3-pentyl ether, the use of a highly efficient RCM reaction to form the Tamiflu skeleton, and selective functional group manipulations. © 2010 American Chemical Society.

Sugaya N.,Keiyu Hospital | Kohno S.,Nagasaki University | Ishibashi T.,Shionogi and Co. | Wajima T.,Shionogi and Co. | Takahashi T.,Keio University
Antimicrobial Agents and Chemotherapy | Year: 2012

Peramivir is a new neuraminidase inhibitor for intravenous administration that was first introduced in clinical practice in Japan. We conducted a multicenter, open-label, uncontrolled study in children with influenza virus infection ranging in age from ≥28 days to < 16 years during the 2009 pandemic A (H1N1) influenza epidemic to evaluate the efficacy, safety, and pharmacokinetics of peramivir in children after intravenous infusion of 10 mg/kg (600 mg maximum) once daily. Among the 106 children (125 days to 15 years old) confirmed to have been infected with the pH1N1 virus by the PCR who were treated with peramivir, the median time to alleviation of symptoms was 29.1 h (95% confidence interval = 22.1 to 32.4), and the proportion of the 106 children who were virus positive was 78.2% on day 2 after the start of treatment and had decreased to 7.1% on day 6. The results of the safety evaluation among 117 patients enrolled in this study showed that adverse events and adverse drug reactions were reported in 62.4 and 29.1%, respectively, of the patients. All of the adverse events and adverse drug reactions resolved or improved rapidly. A population pharmacokinetic analysis was performed on the basis of 297 observed plasma concentration data obtained from 115 children with influenza virus infection. Peramivir exposure in children was within the range of levels within which the efficacy and safety was confirmed in adults, and it is considered that peramivir is clinically and virologically effective and safe in children with pH1N1 virus infection. Copyright © 2012, American Society for Microbiology. All Rights Reserved.

Wang M.,Sanford Burnham Institute for Medical Research | Hayakawa J.,Sanford Burnham Institute for Medical Research | Hayakawa J.,Shionogi and Co. | Yang K.,University of Washington | Han X.,Sanford Burnham Institute for Medical Research
Analytical Chemistry | Year: 2014

Diacylglycerols (DAGs) are important intermediates of lipid metabolism and cellular signaling. It is well-known that the mass levels of DAG are altered under disease states. Therefore, quantitative analysis of DAGs in biological samples can provide critical information to uncover underlying mechanisms of various cellular functional disorders. Although great efforts on the analysis of individual DAG species have recently been made by utilizing mass spectrometry with or without derivatization, cost-effective and high throughput methodologies for identification and quantification of all DAG species including regioisomers, particularly in an approach of shotgun lipidomics, are still missing. Herein, we described a novel method for directly identifying and quantifying DAG species including regioisomers present in lipid extracts of biological samples after facile one-step derivatization with dimethylglycine based on the principles of multidimensional mass spectrometry-based shotgun lipidomics. The established method provided substantial sensitivity (low limit of quantification at amol/μL), high specificity, and broad linear dynamics range (2500-fold) without matrix effects. By exploiting this novel method, we revealed a 16-fold increase of total DAG mass in the livers of ob/ob mice compared to their wild type controls at 4 months of age (an insulin-resistant state) versus a 5-fold difference between 3 month old mice (with normal insulin). These results demonstrated the importance and power of the method for studying biochemical mechanisms underpinning disease states. © 2014 American Chemical Society.

In recent years, immunological science has evolved, and cancer vaccines are available for treating existing cancers. Because cancer vaccines require time to elicit an immune response, a delayed treatment effect is expected. Accordingly, the use of weighted log-rank tests with the Fleming-Harrington class of weights is proposed for evaluation of survival endpoints. We present a method for calculating the sample size under assumption of a piecewise exponential distribution for the cancer vaccine group and an exponential distribution for the placebo group as the survival model. The impact of delayed effect timing on both the choice of the Fleming-Harrington's weights and the increment in the required number of events is discussed. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

Matsui T.,Hokkaido University | Yamane J.,Hokkaido University | Yamane J.,Shionogi and Co. | Mogi N.,Hokkaido University | And 4 more authors.
Acta Crystallographica Section D: Biological Crystallography | Year: 2012

FtsZ is a key molecule in bacterial cell division. In the presence of GTP, it polymerizes into tubulin-like proto-filaments by head-to-tail association. Protofilaments of FtsZ seem to adopt a straight or a curved conformation in relation to the bound nucleotide. However, although several bacterial and archaeal FtsZ structures have been determined, all of the structures reported previously are considered to have a curved conformation. In this study, structures of FtsZ from Staphylo-coccus aureus (SaFtsZ) were determined in apo, GDP-bound and inhibitor-complex forms and it was found that SaFtsZ undergoes marked conformational changes. The accumulated evidence suggests that the GDP-bound structure has the features of the straight form. The structural change between the curved and straight forms shows intriguing similarity to the eukaryotic cytoskeletal protein tubulin. Furthermore, the structure of the apo form showed an unexpectedly large conformational change in the core region. FtsZ has also been recognized as a novel target for antibacterial drugs. The structure of the complex with the inhibitor PC190723, which has potent and selective antistaphylococcal activity, indicated that the inhibitor binds at the cleft between the two subdomains. © 2012 International Union of Crystallography Printed in Singapore - all rights reserved.

Takai N.,Shionogi and Co. | Tanaka Y.,Shionogi and Co.
Bioanalysis | Year: 2015

Analysis of drug and metabolite distribution is essential for understanding of the mechanisms underlying the pharmacological or toxicological effects. MS imaging (MSI) can visualize the distribution of drugs or biological molecules in tissue sections without radiolabeling, and distinguish between the distribution of a drug and that of its metabolites in tissue sections. Therefore, it is expected to be a potent imaging technique for drug distribution studies. This article includes cases in which MSI was used to analyze drug and metabolite distribution, and discusses the impact of data obtained by MSI in drug discovery and development. © 2015 Future Science Ltd.

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