DOCSLIB.ORG

Roche/Genentech Managed RG7986 ADC R/R NHL CHU Chugai Managed IONIS IONIS Managed 74 Status As of January 28, 2016 PRO Proximagen Managed

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Roche/Genentech Managed RG7986 ADC R/R NHL CHU Chugai Managed IONIS IONIS Managed 74 Status As of January 28, 2016 PRO Proximagen Managed Roche 2015 results London, 28 January 2016 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected. 3 Group Severin Schwan Chief Executive Officer 4 2015 performance Outlook 5 2015: Targets fully achieved Targets for 2015 FY 2015 Group sales growth1 Mid-single digit +5% Core EPS growth1 Ahead of sales growth2 +7% Further increase dividend in Swiss francs3 Dividend outlook CHF 8.10 (Payout ratio increased to 60% from 56%) 1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014; 3 2015 dividend as proposed by the Board of Directors 6 2015: Highlights Growth Sales • Group sales +5%1 driven by HER2 franchise (+19%), Avastin (+9%), Esbriet (n.m.), Actemra (+23%) and Professional Diagnostics (+8%) Profit • +7% Core EPS growth1,2 driven by strong underlying business Innovation Oncology • Cancer immunotherapy: Phase II lung (POPLAR, BIRCH), rolling filing initiated; Phase II bladder (IMvigor 210), filed in US; 9 NMEs in clinical development • Alecensa (alectinib): Approved in US, filed in EU • Cotellic (cobimetinib): Approved in US and EU Hematology • Venetoclax: Filing acceptance in R/R CLL including 17p del in US • Gazyva: Phase III (GADOLIN) in R/R iNHL, filed in US and EU • Emicizumab (ACE 910): Updated phase Ib, start of Phase III in inhibitors Neuroscience • Ocrelizumab: Phase III in RMS (OPERA I/II) and PPMS (ORATORIO) 1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014 7 2015: Strong sales growth in both divisions 2015 2014 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 37.3 36.7 2 5 Diagnostics Division 10.8 10.8 0 6 Roche Group 48.1 47.5 1 5 CER=Constant Exchange Rates 8 2015: Sales growth for fifth consecutive year 10% 8% 8% 7% 7% 6% 6% 6% 6% 6% 5% 5% 6% 4% 5% 4% 4% 4% 4% 4% 2% 2% 0% 0% 1% 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 15 All growth rates at Constant Exchange Rates (CER) 9 2015: Strong sales growth in all regions CHFbn 21 +5% +1% 18 15 +3% +7% 12 +2% Diagnostics +13% 9 +6% Pharma 6 +5% 0% +5% +4% 3 +6% 0 Japan International Europe US All growth rates are YoY at Constant Exchange Rates (CER) 10 Roche: Significantly advancing patient care Recognition for innovation 2013-present Breakthrough Therapy Year Molecule Venetoclax (AML) 11 Designations 2016 Venetoclax + Rituxan (R/R CLL) Actemra (Systemic sclerosis) Rank Company # Atezolizumab (NSCLC) 2015 1 Roche 11 Venetoclax (R/R CLL 17p del) 2 BMS 8 Emicizumab/ACE 910 (Hemophilia A) 3 Novartis 6 Esbriet (IPF) 2014 Lucentis (DR) 3 Merck 6 Atezolizumab (Bladder) 3 Pfizer 6 Alectinib (2L ALK+ NSCLC) 2013 4 GSK 5 Gazyva (1L CLL) Source: http://www.focr.org/breakthrough-therapies as at 21 January 2016; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non- 11 Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 2015: Strong underlying Group Core operating profit & margin % of sales 37.7% 38.3% 37.2% 36.4% (+0.7%*) 35.6% +5% at CER (+7%*) CHFbn 17.5 17.9 17.2 17.6 15.1 2011 2012 2013 2014 2015 CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 12 2015: Strong underlying Core EPS growth +4% at CER (+7%*) 13.49 14.27 14.29 13.49 CHF 12.30 2011 2012 2013 2014 2015 All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014 13 2015: Dividend and payout ratio further increased CHF Dividend payout ratio (%) 60.0 10 55.3 56.0 9 2015 payout ratio: 60.0% 54.5 54.7 8.10 8 51.6 48.6 7 44.8 6 38.8 34.5 5 31.9 4 3 2 1 0 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Payout ratio calculated as dividend per share divided by Core earnings per share (diluted); 2015 dividend as proposed by the Board of Directors; 14 Note:1 compound For 1995, a annualspecial dividend growth was rate paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996 2015: Core EPS growth bridge +2.9% +6.6% one-time +5.3% filgrastim* +3.7% Core EPS Core EPS Sales Full Year 2015 Full Year 2015 figures as reported excl. filgrastim* All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014 15 2015 performance Outlook 16 2016 onwards: Significant launch activities Venetoclax R/R CLL including 17p del Cotellic + Zelboraf Emicizumab (ACE910) BRAFmut melanoma Hemophilia A Alecensa Lebrikizumab NMEs 2L ALK+ lung cancer Severe Asthma Atezolizumab Ocrelizumab Lampalizumab 2L+ lung and bladder cancer RMS/ PPMS Geographic atrophy 2016 2017 2018 Gazyva Perjeta + Herceptin Atezolizumab + abraxane Refractory iNHL (GADOLIN) eBC HER2+ (APHINITY) TNBC Gazyva Atezolizumab+Avastin+chemo ine ine 1L aNHL (GOYA) 1L NSCLC l Actemra Atezolizumab + Avastin extensions Giant cell arteritis 1L RCC Gazyva 1L iNHL (GALLIUM) Alecensa 1L ALK+ NSCLC Oncology/ FDA Breakthrough Neuroscience Ophthalmology Immunology hematology Therapy Designation Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 17 2016 outlook Group sales growth1 Low to mid-single digit Core EPS growth1 Ahead of sales growth Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 18 Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals 19 2015 results Innovation Outlook 20 2015: Pharma sales Strong growth driven by all regions 2015 2014 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 37,331 36,696 2 5 United States 17,616 15,822 11 6 Europe 8,734 9,422 -7 4 Japan 3,224 3,301 -2 6 International 7,757 8,151 -5 5 CER=Constant Exchange Rates 21 2015: Pharma Division Core operating profit growth +8%* 2015 2015 vs. 2014 CHFm % sales CER growth Sales 37,331 100.0 5% Excl. filgrastim* Royalties & other op. inc. 2,119 5.7 -11% +10% Cost of sales -7,900 -21.2 7% Capacity increase in manufacturing M & D -6,066 -16.2 4% R & D -8,134 -21.8 4% G & A -1,295 -3.5 -17% Excl. filgrastim* Core operating profit 16,055 43.0 5% +8% 0% in CHF CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 22 2015: Strong performance from oncology and immunology franchises Herceptin +10% Avastin +9% Perjeta +61% Esbriet n.m. MabThera/Rituxan +5% Actemra/RoActemra +23% Kadcyla +51% Xolair +25% Xeloda -31% Lucentis -15% US Tamiflu -28% Europe Japan Valcyte/Cymevene -45% International Pegasys -44% CHFm -600 -400 -200 0 200 400 600 Absolute amounts and growth rates at Constant Exchange Rates (CER) 23 2015: Oncology with +8% growth YoY CER growth Perjeta HER2 Herceptin +19% • Strong uptake of Perjeta and Kadcyla • Growth of Herceptin due to longer treatment Kadcyla • Growth driven mainly by cervical and ovarian Avastin +9% • International: Strong growth in all regions MabThera/ Rituxan +4% • US: Growth in iNHL maintenance (Oncology) • In-class competition Tarceva -7% • EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC Xeloda -31% • Loss of exclusivity • Competitive pressure in US and EU Zelboraf -21% • Cotellic + Zelboraf approved in Q4 CHFbn 0 2 4 6 8 10 CER=Constant Exchange Rates; 2015 Oncology sales: CHF 23.7bn; CER growth +8% 24 HER2 franchise: Continued strong growth CHFm YoY CER growth HER2 franchise Q4 2015 2,500 +18% • Herceptin (+10%): Longer treatment +19% duration in combo with Perjeta 2,000 • Perjeta (+50%): Strong demand in 1L mBC +20% +10% • Kadcyla (+36%): Growth driven by EU 1,500 1,000 Outlook 2016 • Perjeta: Further increasing penetration and 500 neoadjuvant uptake • Kadcyla: Increasing penetration and new 0 countries Q4 12 Q4 13 Q4 14 Q4 15 • Ph III APHINITY data (adj. HER2+) expected Herceptin Perjeta Kadcyla CER=Constant Exchange Rates 25 Strong subcutaneous conversion rates for Herceptin and MabThera Check SC share of Herceptin sales in SC share of MabThera NHL launched countries* sales in launched countries* NHL sales 40% 35% 30% 30% 25% 20% 20% 15% 10% 10% Sales market share (%) market Sales
Load more

Recommended publications
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Version Introducing VHIO Foreword
    2017SCIENTIFIC REPORT Vall d'Hebron Institute of Oncology (VHIO) CELLEX CENTER C/Natzaret, 115 – 117 08035 Barcelona, Spain Tel. +34 93 254 34 50 www.vhio.net Direction: Amanda Wren Design: Parra estudio Photography: Katherin Wermke Vall d'Hebron Institute of Oncology (VHIO) | 2018 VHIO Scientific Report 2017 Index Scientific Report INTRODUCING VHIO CORE TECHNOLOGIES 02 Foreword 92 Cancer Genomics Group 08 2017: marking the next chapter of 94 Molecular Oncology Group VHIO's translational story 96 Proteomics Group 18 Scientific Productivity: research articles VHIO'S TRANSVERSAL CLINICAL 19 Selection of some of the most relevant TRIALS CORE SERVICES & UNITS articles by VHIO researchers published in 2017 100 Clinical Trials Office 25 A Golden Decade: reflecting on the 102 Research Unit for Molecular Therapy past 10 years of VHIO's translational of Cancer (UITM) – ”la Caixa” success story 104 Clinical Research Oncology Nurses 106 Clinical Research Oncology Pharmacy PRECLINICAL RESEARCH Unit 49 From the Director 50 Experimental Therapeutics Group RECENTLY INCORPORATED GROUPS 52 Growth Factors Group 110 Cellular Plasticity & Cancer Group 54 Mouse Models of Cancer Therapies 112 Experimental Hematology Group Group 114 Tumor Immunology 56 Tumor Biomarkers Group & Immunotherapy Group 116 Applied Genetics of Metastatic Cancer TRANSLATIONAL RESEARCH Group 61 From the Director 118 Chromatin Dynamics in Cancer Group 62 Gene Expression & Cancer Group 120 Prostate Cancer Translational Research Group 64 Stem Cells & Cancer Group 122 Radiomics Group CLINICAL
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • 2017 Immuno-Oncology Medicines in Development
    2017 Immuno-Oncology Medicines in Development Adoptive Cell Therapies Drug Name Organization Indication Development Phase ACTR087 + rituximab Unum Therapeutics B-cell lymphoma Phase I (antibody-coupled T-cell receptor Cambridge, MA www.unumrx.com immunotherapy + rituximab) AFP TCR Adaptimmune liver Phase I (T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com anti-BCMA CAR-T cell therapy Juno Therapeutics multiple myeloma Phase I Seattle, WA www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 "armored" CAR-T Juno Therapeutics recurrent/relapsed chronic Phase I cell therapy Seattle, WA lymphocytic leukemia (CLL) www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 CAR-T cell therapy Intrexon B-cell malignancies Phase I Germantown, MD www.dna.com ZIOPHARM Oncology www.ziopharm.com Boston, MA anti-CD19 CAR-T cell therapy Kite Pharma hematological malignancies Phase I (second generation) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD Medicines in Development: Immuno-Oncology 1 Adoptive Cell Therapies Drug Name Organization Indication Development Phase anti-CEA CAR-T therapy Sorrento Therapeutics liver metastases Phase I San Diego, CA www.sorrentotherapeutics.com TNK Therapeutics San Diego, CA anti-PSMA CAR-T cell therapy TNK Therapeutics cancer Phase I San Diego, CA www.sorrentotherapeutics.com Sorrento Therapeutics San Diego, CA ATA520 Atara Biotherapeutics multiple myeloma, Phase I (WT1-specific T lymphocyte South San Francisco, CA plasma cell leukemia www.atarabio.com
    [Show full text]
  • Current Strategies to Target Tumor-Associated-Macrophages to Improve Anti-Tumor Immune Responses
    cells Review Current Strategies to Target Tumor-Associated-Macrophages to Improve Anti-Tumor Immune Responses Clément Anfray 1, Aldo Ummarino 2 , Fernando Torres Andón 1,3 and Paola Allavena 1,* 1 IRCCS Istituto Clinico Humanitas, Via A. Manzoni 56, 20089 Rozzano, Milan, Italy; [email protected] (C.A.); [email protected] (F.T.A.) 2 Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy; [email protected] 3 Center for Research in Molecular Medicine & Chronic Diseases (CIMUS), Universidade, de Santiago de Compostela, Campus Vida, 15706 Santiago de Compostela, Spain * Correspondence: [email protected] Received: 4 December 2019; Accepted: 20 December 2019; Published: 23 December 2019 Abstract: Established evidence demonstrates that tumor-infiltrating myeloid cells promote rather than stop-cancer progression. Tumor-associated macrophages (TAMs) are abundantly present at tumor sites, and here they support cancer proliferation and distant spreading, as well as contribute to an immune-suppressive milieu. Their pro-tumor activities hamper the response of cancer patients to conventional therapies, such as chemotherapy or radiotherapy, and also to immunotherapies based on checkpoint inhibition. Active research frontlines of the last years have investigated novel therapeutic strategies aimed at depleting TAMs and/or at reprogramming their tumor-promoting effects, with the goal of re-establishing a favorable immunological anti-tumor response within the tumor tissue. In recent years, numerous clinical trials have included pharmacological strategies to target TAMs alone or in combination with other therapies. This review summarizes the past and current knowledge available on experimental tumor models and human clinical studies targeting TAMs for cancer treatment.
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.
    [Show full text]
  • Irp180426-A.Pdf
    Roche Q1 2018 results Basel, 26 April 2018 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected.
    [Show full text]
  • WO 2016/176089 Al 3 November 2016 (03.11.2016) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/176089 Al 3 November 2016 (03.11.2016) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A01N 43/00 (2006.01) A61K 31/33 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/US2016/028383 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 20 April 2016 (20.04.2016) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/154,426 29 April 2015 (29.04.2015) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: KARDIATONOS, INC. [US/US]; 4909 DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Lapeer Road, Metamora, Michigan 48455 (US).
    [Show full text]
  • University of Groningen PET Imaging and in Silico Analyses to Support
    University of Groningen PET imaging and in silico analyses to support personalized treatment in oncology Moek, Kirsten DOI: 10.33612/diss.112978295 IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2020 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Moek, K. (2020). PET imaging and in silico analyses to support personalized treatment in oncology. Rijksuniversiteit Groningen. https://doi.org/10.33612/diss.112978295 Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license. More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne- amendment. Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 30-09-2021 06 The antibody-drug conjugate target landscape across a broad range of tumor types Kirsten L.
    [Show full text]
  • INN-Nimet 1 1.4.2019 a Abacavir Abacavirum Abakaviiri Abagovomab Abagovomabum Abagovomabi Abaloparatide Abaloparatidum Abalopara
    INN-nimet Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency 1.4.
    [Show full text]