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Lung cancer remains the leading cause of cancer deaths, with an annual estimated 12.9 percent of all new cancer cases and nearly 1.6 million deaths worldwide. NSCLC accounts for approximately 85 percent of all lung cancer cases.4 During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.5 The VENTANA PD-L1 (SP263) Assay is the only fully automated PD-L1 assay for KEYTRUDA to launch on Roche's BenchMark series of instruments. The launch should significantly increase patient access to PD-L1 testing given Roche's extensive global diagnostic instrument base. "Roche first launched the VENTANA PD-L1 (SP263) Assay in September 2016 as a diagnostic test for previously treated metastatic NSCLC patients in countries accepting the CE mark. We are very pleased to expand its application to include patients being considered for KEYTRUDA immunotherapy as the first line of treatment," said Ann Costello, Head of Roche Tissue Diagnostics. "The assay provides new insights into possible treatment options for this potentially deadly disease." Roche will continue to pursue regulatory approval for the VENTANA PD-L1 (SP263) Assay in other cancer indications and in other geographies. For more information, go to PDL1ihc.com. 1This product is intended for in vitro diagnostic (IVD) use. 2The VENTANA PD-L1 (SP263) Assay has demonstrated equivalence to the CE marked PD-L1 IHC 22C3 pharmDx assay, which has previously demonstrated clinical utility through data from KEYNOTE-024 and KEYNOTE-010. KEYNOTE-024 was a phase 3, randomized, open-label, active-controlled, multicenter trial of 305 patients with metastatic NSCLC who were treatment naïve and whose tumors had high PD-L1 expression based on a tumor PD-L1 expression ≥50% and without EGFR or ALK genomic tumor aberrations. Outcome data showed superior progression free survival and overall survival in first-line treatment of mNSCLC with PD-L1 expression ≥50%. KEYNOTE-010 was an open-label, randomized, active-controlled, multicenter, phase 2/3 trial of 1,033 patients with mNSCLC that had progressed following platinum-containing chemotherapy, and if appropriate, targeted therapy for EGFR or ALK genomic tumor aberrations. Superior overall survival vs docetaxel at PD-L1 expression ≥1% was observed. For a CE mark, Roche relied on a method comparison study carried out by AstraZeneca, which compares data from currently available PD-L1 assays, DAKO pharmDx 22C3 (used in the clinical studies of KEYTRUDA), DAKO pharmDx 28-8 (used in the clinical studies of OPDIVO), and SP263. 3Please consult your local representative for availability and restrictions. 4Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. http://globocan.iarc.fr. Published 2013-12-12. Updated 2014-01-09. Accessed 2016-02-08. VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the Programmed Death Ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark series automated staining instrument. PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with KEYTRUDA® (pembrolizumab). PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. VENTANA, BENCHMARK and OPTIVIEW are trademarks of Roche. Other product names and trademarks are the property of their respective owners.


LONDON--(BUSINESS WIRE)--Roche Diagnostics UK and Ireland launches the next generation of INR patient self-monitoring meter for patients on warfarin anticoagulant therapy. The new CoaguChek INRange meter allows patients to send their results to their clinic via an App on their phone using wireless connectivity. This innovation helps to empower patients to take control of their therapy and reduce the number of clinic visits that they have to make, saving both time and money. Today’s launch of the new CoaguChek INRange meter coincides with the publication of a new patient survey carried out by the Atrial Fibrillation Association. Results showed that of those patients currently on warfarin surveyed, 86% of patients agreed that they would consider patient self-monitoring to give them a life free from frequent clinic visits as they could quickly and easily send results to their healthcare professional. With the CoaguChek INRange meter, important reminders can be set up for events such as when to test or when to take medication. Comments can be added to specific results and these can be displayed in graphs, allowing patients to see how many of their results fall within their target therapeutic range. Trudie Lobban MBE, Founder and CEO of the Atrial Fibrillation Association, said, “The AF Assoc. welcomes the launch of the INRange meter that can be a future-proof solution to the needs of patients on warfarin. The results of the survey showed that nearly 80% of patients would want to self-monitor giving them independence when travelling for work or pleasure”. Pierre Hazlewood, Director of Point of Care, commented, “Our new meter further supports patient self-monitoring by encouraging healthcare professionals and patient dialogue via digital connectivity and App options. It also meets the needs of patients with new features and improved functionality including adding comments to a result, setting reminders and plotting results in graphs.” Anticoagulation drugs affect the blood’s ability to clot, it is important that the right dose is maintained to reduce the risk of severe bleeding or complications. The new CoaguChek INRange meter will help monitor these doses, reducing clinic visits. It is estimated that just a 5% improvement in TTR across UK anticoagulation clinics would prevent 400 – 500 strokes per year1. Furthermore if 10% of the current 950,000 patients switched to point of care devices, the NHS could save over £11.2million per year2 The purpose of the survey was to help discover patient needs about INR self-monitoring versus clinic visits. The benefits are reinforced in the 2014 NICE guidance on INR self-monitoring3. The development and distribution of the AF Assoc survey was funded by Roche. Roche have not been involved in creating the content of the survey. B-roll and images are available from: coaguchek@theprnetwork.co.uk Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, anti-malarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. CoaguChek and INRange are trademarks of Roche. All other product names and trademarks are the property of their respective owners. Copyright 2017 Roche Diagnostics Limited, All rights reserved.


News Article | February 21, 2017
Site: www.eurekalert.org

Osaka University and Otsuka Pharmaceutical Co., Ltd. (Otsuka) signed a comprehensive collaboration agreement for advanced research in immunology between the Osaka University Immunology Frontier Research Center (IFReC) and Otsuka. This agreement allows researchers at IFReC to focus on original basic research areas and, with Otsuka, to develop innovative new treatments therefore contributing back to society with the results of their advanced immunology research. IFReC was selected for the World Premier International Research Center (WPI) Initiative Program initiated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) in 2007 and launched at Osaka University in October of the same year as a research center in immunology. Led by Director Shizuo Akira, an eminent immunologist, IFReC brings together around 170 of the world's leading investigators in the fields of immunology, live imaging and bioinformatics from Japan and across the world to conduct innovative immunological research. The center provides an international environment coupled with excellent research facilities, making it possible to pursue leading-edge research. IFReC researchers publish in internationally renowned academic journals to high acclaim including the award of several prestigious international prizes. Guided by our corporate philosophy, Otsuka-people creating new products for better health worldwide, Otsuka is committed to improving the health and well-being of patients and consumers through "treating diseases" and "promoting daily health". As a total healthcare company, Otsuka continues to focus on creating creative and innovative products. In order to address unmet needs in medicine, we focus our research on central nervous system disorders and oncology, and also develop treatments in cardiovascular, infectious, ophthalmological, and dermatological disease fields. According to the agreement, Otsuka will have access to information regarding results of independent basic research projects at IFReC. Although Chugai Pharmaceutical Co., Ltd., which signed a prior agreement has the right of first refusal on joint research projects and intellectual property. Otsuka can discuss future joint research with IFReC, and receive disclosure about future patent rights in immunology from Osaka University. As part of this agreement, Otsuka will contribute to the research activity expenses of IFReC for a period of 10 years.


News Article | February 27, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for the anti-cancer agent, alectinib hydrochloride (brand name: Alecensa®) for the treatment of people with “anaplastic lymphoma kinase (ALK) positive, advanced non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib.” “We believe that the approval of Alecensa by the TFDA would bring the great news to Taiwanese patients who are fighting against this disease,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “We are pleased that Alecensa created by Chugai will contribute to the treatment of ALK-positive NSCLC.” Taiwan’s approval was based on two clinical phase I/II studies, as summarised below: - The NP28761 study is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: January 22, 2016) - The NP28673 study is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: February 1, 2016) - People in the phase II studies received 600 mg of Alecensa orally twice daily. In both trials, the primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1), and evaluated by an Independent Review Committee (IRC). Secondary endpoints included duration of response (DOR) and safety. - Alecensa demonstrated a safety profile consistent with that observed in previous studies. - The most common Grade 3 or higher adverse events were an increase in muscle enzymes (increased blood levels of creatine phosphokinase; five percent), increased liver enzymes (alanine aminotransferase; 4.8 percent, and aspartate aminotransferase; 3.6 percent) and shortness of breath (dyspnoea; 3.6 percent). Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases. Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, the EU and Taiwan for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib. In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis). Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.


News Article | February 21, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha annunciato che F. Hoffmann-La Roche Ltd. ha ottenuto l’autorizzazione all'immissione in commercio condizionata da parte della Commissione europea (CE), di agenti anti-tumorali, alectinib cloridrato (nome del marchio: Alecensa®) per il trattamento di pazienti adulti con “ALK (anaplastic lymphoma kinase, chinasi del linfoma anaplastico) positivo, carcinoma polmonare non a piccole cellule (non-small cell lung cancer, NSCLC) diffuso o per pazienti intolleranti al crizotinib.”


News Article | February 24, 2017
Site: www.businesswire.com

TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha comunicado que F. Hoffmann-La Roche Ltd. ha conseguido la aprobación de comercialización condicional de la Comisión Europea (CE) , para el agente anticancerígeno, clorhidrato del alectinib (nombre de marca: Alecensa®) para el tratamiento de los pacientes adultos con “cáncer de pulmón de células no pequeñas metastásico (CPCNP) ALK positivo, en aquellos pacientes que han avanzado en la enfermedad o que son intolerantes a crizotinib.”


Patent
The General Hospital Corporation and Chugai Pharmaceutical Co. | Date: 2013-10-16

The present invention relates to a polypeptide, or pharmaceutically acceptable salt thereof, comprising the formula PTH(1-X)/PTHrP(Y-36). Further, the present invention refers to a polypeptide which binds the PTH receptor and has a high affinity for the R^(0) form of the PTH receptor and to a polypeptide having affinity for PTH RG and a low affinity for PTH R^(0). Moreover, the present invention includes to a pharmaceutical composition comprising such polypeptide. The present invention further relates to a polypeptide or a pharmaceutical composition of the present invention for use in a method for treating a disease or condition. Moreover, the present invention refers to a nucleic acid comprising a sequence encoding a polypeptide of the present invention, a vector comprising said nucleic acid, a cell comprising said vector and a method of making a polypeptide of the present invention. Finally, the present invention further relates to a method for determining whether a candidate compound is a long-acting agonist of a G protein coupled receptor (GPCR).


Patent
Chugai Pharmaceutical Co. and The General Hospital Corporation | Date: 2013-09-25

The present invention provides screening methods for GPCRs based on the discovery that the affinity of a receptor agonist for a GPCR (such as the parathyroid hormone receptor) when not bound to a G-protein is correlated with the length of time over which the agonist is effective, independently of its pharmacokinetic properties. The invention also provides PTH- and PTHrP-derived polypeptides.

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