DOCSLIB.ORG

Roche Q1 2021 Sales

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Roche Q1 2021 Sales Roche Q1 2021 Sales Basel, 21 April 2021 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. Group Severin Schwan Chief Executive Officer Q1 2021 performance Outlook 5 Responding quickly and broadly to the pandemic SARS-CoV-2 Rapid Antigen Nasal Test Casirivimab + imdevimab (nAb cocktail) • Reliably identifies highly infectious individuals in 15 minutes • Emergency use ongoing in US/EU for mild/moderate COVID-19 (Sensitivity: 89.6% at Ct≤30; Specificity 99.1%) at high risk for progression to severe disease and/or hospitalization • Performance independently and externally validated by • Positive Ph III results in confirmatory outpatient treatment University of Heidelberg and Charité Berlin – Significant reduction in risk of hospitalization or death for both tested doses (2.4g & 1.2g) vs. placebo • In a meta-analysis1 across 74 studies2 the Roche SARS-CoV-2 Rapid Antigen Test achieved the highest overall sensitivity3 • Positive Ph III results in prevention setting – Significant reduction in risk of symptomatic infection among those in close contact with infected patient 1 Source: https://www.medrxiv.org/content/10.1101/2021.02.26.21252546v1; 2 30,000 samples; 3 across all patient subgroups 6 Q1 2021: Strong Diagnostics Division driving Group sales growth 2021 2020 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 10.6 12.3 -14 -9 Diagnostics Division 4.3 2.9 50 55 Roche Group 14.9 15.1 -1 3 CER=Constant Exchange Rates 7 Q1 2021: Successfully managing the transition in a difficult environment Group sales 6% 8% 7% growth (CER) 4% 3% Group 100% sales 10% 80% 35% 41% 60% 16% 40% 20% 28% 20% 29% 21% 0% Q1 17 Q1 18 Q1 19 Q1 20 Q1 21 Diagnostics Division Other pharma AHR New products1 CER=constant exchange rates; AHR=Avastin, Herceptin & MabThera/Rituxan; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, 8 Phesgo, Enspryng, Evrysdi, casirivimab+imdevimab Q1 2021: Sales growth despite severe biosimilar impact New products accounting for 50% of Pharma sales Pharma sales mix +3% at CER Q1 2020 CHFm +880 33% 37% +1,538 -376 30% -641 Q1 2021 -1,614 22% 15,143 14,930 50% 28% Q1 2020 Pharma Pharma Pharma Diagnostics Fx Q1 2021 New products launched since 2012 new other Bx exposed Division Other products Herceptin + Rituxan + Avastin products 1 products products 2 Q1 values in reported CHFm, variances in CERm; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi, 9 casirivimab+imdevimab; 2 Avastin, Herceptin, MabThera/Rituxan Q1 2021: Pandemic continues to impact business dynamics % CER 1st wave 2nd wave 3rd wave +60% +50% Pharmaceuticals +50% +55% • Continued severe impact from biosimilars and +40% COVID-19, lack of new patients starts in particular +32% +28% in cancer care +30% +25% +20% +18% +20% +24% Diagnostics +10% +7% +2% +5% • Routine business showing strong growth +0% -6% -7% -9% -4% • COVID-19 testing gaining further momentum -10% Q1'20 vs. Q2'20 vs. Q3'20 vs. Q4'20 vs. Q1'21 vs. Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Diagnostics Pharma Pharma New Products Growth rates at CER (Constant Exchange Rates) 10 Q1 2021 performance Outlook 11 Continuing to invest in innovation Diversifying the late stage pipeline & launching new systems Achievements in Q1 2021: Pharma Achievements in Q1 2021: Diagnostics New to Phase II Serum work area systems launches Brain shuttle gantenerumab in Alzheimer’s disease cobas® pure GABA Aa5 PAM in autism spectrum disorder Optimizing efficiency for small size laboratories HBV siRNA in chronic Hepatitis B tiragolumab + Tecentriq in 1L PD-L1+ mSCCHN New to Phase III ® fenebrutinib in RMS (2x Ph III) cobas pro (high throughput) Increasing scalability and flexibility rhPTX-2 in IPF Kadcyla + Tecentriq in 2L+ HER-2+ PD-L1+ mBC faricimab in branch & central RVO (2x Ph III) Neuroscience Infectious Diseases Immunology Oncology/Hematology Ophthalmology 12 2021 outlook confirmed Further growing top and bottom line Group sales growth1 • Low- to mid-single digit Core EPS growth1 • Broadly in line with sales growth Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER); based on the current assessment of the COVID-19 impact 13 Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals Q1 2021: Pharmaceuticals Division sales Sales still impacted by COVID-19 and biosimilars 2021 2020 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 10,600 12,262 -14 -9 United States 5,292 6,616 -20 -14 Europe 2,175 2,264 -4 -6 Japan 852 948 -10 -7 International 2,281 2,434 -6 0 CER=Constant Exchange Rates 15 Q1 2021: Continued portfolio rejuvenation Ocrevus 16% Hemlibra 33% Tecentriq 26% Casirivimab + Imdevimab n/a Actemra / RoActemra 22% Evrysdi n/a Kadcyla 17% Alecensa 14% Phesgo n/a Perjeta 2% Enspryng n/a Polivy 18% Gazyva -2% Esbriet -8% Lucentis -7% Xofluza -100% US Xolair -6% Tarceva -56% Europe TNKase / Activase -17% Tamiflu -83% Japan Herceptin -35% Avastin -40% International MabThera -46% CHFm -800 -400 0 400 Absolute values and growth rates at Constant Exchange Rates (CER) 16 Pharma growth dynamic excl. AHR* slowed down by COVID-19 Quarterly sales development Pharmaceuticals Division (excl. AHR) CHFm 9,000 8,000 Pharma other 7,000 Infectious diseases 6,000 Ophthalmology 5,000 Immunology 4,000 Hemophilia A Neuroscience 3,000 Oncology 2,000 1,000 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 2020 2020 2020 2020 2021 2017 2018 2019 2020 2021 * AHR=Avastin, Herceptin, MabThera/Rituxan; all absolute values at Constant Exchange Rates (avg. FY 2020); “Pharma other” comprises the tail end products 17 Milestone achieved: 50% of Pharma sales are new products* Rolling filings for casirivimab/imdevimab and PDS started CHFm % of Pharma Sales 6,000 5,500 50% 5,000 37% 4,500 4,000 3,500 27% 3,000 2,500 19% 2,000 1,500 1,000 500 0 Q1 18 Q1 19 Q1 20 Q1 21 Erivedge Perjeta Kadcyla Gazyva Esbriet Cotellic Alecensa Tecentriq Ocrevus Hemlibra Xofluza Polivy Rozlytrek Phesgo Enspryng Evrysdi Casirivimab/Imdevimab * Venclexta sales are booked by partner AbbVie and therefore not included and Gavreto sales are initially booked by partner Blueprint and therefore not included; NME=new molecular entity 18 Q1 2021: Oncology -19% due to biosimilars & COVID-19 YoY CER growth HER2 franchise Phesgo • Kadcyla (+17%) with growth in all regions due to adjuvant BC HER2 franchise Herceptin Perjeta (+2%) -11% • Perjeta (+2%) with growth driven by International Kadcyla (+17%) • Successful Phesgo launch in US and EU on-going Avastin Avastin -40% Avastin franchise Tecentriq Tecentriq +26% • Biosimilar erosion in all regions Polivy (+18%) Hematology Hematology franchise* Rituxan -37% franchise • Venclexta: Strong growth in 1L AML Gazyva (-2%) Alecensa +14% • Gazyva (-2%): Stable sales in 1L CLL and 1L FL due to COVID-19 Cotellic • Polivy (+18%): Growth in R/R DLBCL; Ph III (POLARIX) results in 1L Cotellic + Zelboraf -30% DLBCL expected in H2 2021 Tarceva -56% Tecentriq • Growth driven by 1L SCLC, 1L TNBC and 1L HCC Rozlytrek +187% Alecensa CHFbn 0 1 2 3 • Growth driven by International CER=Constant Exchange Rates; Q1 2021 Oncology sales: CHF 5.1bn; CER growth -19% ; * Venclexta sales booked by AbbVie and therefore not included (FY-2020 sales of USD 1,337m); Polivy in collaboration with Seagen; BC=breast cancer; AML=acute myeloid leukemia; CLL=chronic lymphocytic leukemia; FL=follicular lymphoma; R/R DLBCL=relapsed/refractory diffuse large B cell lymphoma; SCLC=small cell lung cancer; TNBC=triple negative breast cancer; HCC=hepatocellular carcinoma 19 Tecentriq overview: Growth driven by first-in-class indications Landmark results in adjuvant NSCLC announced Tecentriq Q1 update CHFm YoY
Load more

Recommended publications
  • The Angiopoietin-2 and TIE Pathway As a Therapeutic Target for Enhancing Antiangiogenic Therapy and Immunotherapy in Patients with Advanced Cancer
    International Journal of Molecular Sciences Review The Angiopoietin-2 and TIE Pathway as a Therapeutic Target for Enhancing Antiangiogenic Therapy and Immunotherapy in Patients with Advanced Cancer Alessandra Leong and Minah Kim * Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, NY 10032, USA; afl[email protected] * Correspondence: [email protected] Received: 26 September 2020; Accepted: 13 November 2020; Published: 18 November 2020 Abstract: Despite significant advances made in cancer treatment, the development of therapeutic resistance to anticancer drugs represents a major clinical problem that limits treatment efficacy for cancer patients. Herein, we focus on the response and resistance to current antiangiogenic drugs and immunotherapies and describe potential strategies for improved treatment outcomes. Antiangiogenic treatments that mainly target vascular endothelial growth factor (VEGF) signaling have shown efficacy in many types of cancer. However, drug resistance, characterized by disease recurrence, has limited therapeutic success and thus increased our urgency to better understand the mechanism of resistance to inhibitors of VEGF signaling. Moreover, cancer immunotherapies including immune checkpoint inhibitors (ICIs), which stimulate antitumor immunity, have also demonstrated a remarkable clinical benefit in the treatment of many aggressive malignancies. Nevertheless, the emergence of resistance to immunotherapies associated with an immunosuppressive tumor microenvironment has restricted therapeutic response, necessitating the development of better therapeutic strategies to increase treatment efficacy in patients. Angiopoietin-2 (ANG2), which binds to the receptor tyrosine kinase TIE2 in endothelial cells, is a cooperative driver of angiogenesis and vascular destabilization along with VEGF. It has been suggested in multiple preclinical studies that ANG2-mediated vascular changes contribute to the development and persistence of resistance to anti-VEGF therapy.
    [Show full text]
  • HY 2021 Results
    Roche HY 2021 results Basel, 22 July 2021 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]
  • Presentation
    ➢ ➢ ➢ ➢ ➢ ➢ • • • • • • • ✓ • • ✓ • • ✓ • • • o o o o o + = o o o o o O + P N O O Zhang et al, Effect of Salt on Phosphorylcholine-based Zwitterionic Polymer Brushes, Langmuir 2016, 32, 5048−5057 O Ishihara et al, Why do phospholipid polymers reduce protein adsorption? J. Biomed. Mater. Res. 1998, 39, 323−330. Schlenoff, Zwitteration: coating surfaces with zwitterionic functionality to reduce nonspecific adsorption. Langmuir 2014, 30, 9625−9636. Phosphorylcholine Yang et al, Salt-responsive zwitterionic polymer brushes with tunable friction and antifouling properties Langmuir 2015, 31, 9125−9133. 1.0 Conjugate Antibody Biopolymer PDI = 1.043 PDI = 1.002 PDI = 1.052 5.0 + = SCALE RELATIVE 0.0 7.0 8.0 9.0 10.0 150kD 800KD 950KD VOLUME (mL) Ranibizumab profile was adapted from Gaudreault et al, Invest Ophthalmol Vis Sci. 2005 46(2):726-33 KSI-301 profile was adjusted from 725µg/eye dose to 500µg/eye dose to match that of ranibizumab Yeung et al 2010 cancer research Interim data. Includes patients that reached the first retreatment opportunity (Week 12 visit) by the data cutoff date of 10 Oct 2019. Each bar represents an individual patient. All depicted patients continue to be followed (no discontinuations) Extended Durability in Exudative Retinal Diseases Using the Novel Intravitreal Anti-VEGF Antibody Biopolymer Conjugate KSI-301 First-time Results from a Phase 1b Study in Patients with wAMD, DME and RVO Charles C. Wykoff, MD, PhD Retina Consultants of Houston Houston, TX AAO Annual Meeting – Retina Subspecialty Day October 11, 2019 Disclosures ▪ Financial: Adverum (C, R); Aerpio (C, R); Alimera Sciences (C); Allegro (C); Allergan (C, R); Apellis (C, R); Bayer (C); Clearside Biomedical (C, R); Chengdu Kanghong (R); DORC (C); EyePoint (C); Fosun (C); Genentech/Roche (C, R); Iveric Bio (formerly Ophthotech) (C, R); Kodiak Sciences (C, R); Neurotech (R), Novartis (C, R); ONL Therapeutics (C); Opthea (R); PolyPhotonix (C); Recens Medical (C, R); Regeneron (C, R, S); Regenxbio (C, R); Samsung (R), Santen (C, R), Takeda (C).
    [Show full text]
  • Review of Neovascular Age-Related Macular Degeneration Treatment Options Nancy M
    REPORT Review of Neovascular Age-Related Macular Degeneration Treatment Options Nancy M. Holekamp, MD Disease Overview ABSTRACT Age-related macular degeneration (AMD) causes irreversible destruc- tion of the macula, which leads to loss of the sharp, fine-detail, Due to an aging population, visual impairment from neovascular “straight ahead” vision that is required for activities such as reading, age-related macular degeneration (nAMD) is increasing in the United driving, recognizing faces, and seeing in color. It is a leading cause of States. Despite unprecedented improvements in vision preservation that patients can achieve with anti-vascular endothelial growth factor (VEGF) irreversible visual impairment in the world.1,2 Over the past 15 years, agents, innovations are needed to reduce the burden of intravitreal anti-vascular endothelial growth factor (VEGF) agents have profoundly injections and improve outcomes in patients who do not respond transformed the management of neovascular AMD (nAMD) and are adequately to currently available agents. The best present option for credited with unprecedented improvements in vision preserva- vision preservation is a “zero-tolerance for fluid” schedule of monitoring tion and quality of life for millions of patients in the United States. and intravitreal injections that patients may need to follow for many years. This treatment burden has resulted in patients not achieving optimal After 2 years of treatment with an anti-VEGF agent, more than 95% benefit or even falling through the cracks. This article reviews state-of- of patients can expect to remain within 3 lines of their baseline the-art management approaches including as-needed and treat-and- visual acuity, and up to 40% can expect an improvement of 3 lines extend dosing regimens designed to reduce treatment burden.
    [Show full text]
  • Advances and Developments in Medical Retina
    FEATURE Advances and developments in medical retina BY ROD MCNEIL The author provides an update on late breaking clinical trial results in neovascular age-related macular degeneration (nAMD) and presentations on diabetes management from the American Academy of Ophthalmology Retina Subspecialty Day, held during the Academy’s annual meeting in Chicago, October 2018. Late breaking developments and predictive of continuing on that same four- or two-week adjustment increments, clinical trial results in nAMD quarterly treatment interval until week minimum treatment interval of eight weeks Brolucizumab in nAMD: HAWK and 96. Of the patients on brolucizumab 6mg and a maximum extension of 16 weeks) for HARRIER 96-week results who successfully completed year one on treatment naive nAMD patients through In the HAWK and HARRIER phase 3 nAMD a q12w dosing interval (i.e., 56% in HAWK 96 weeks. Mean BCVA gains from baseline (~55 letters) were 8.4 to 9.0 letters at week studies, the primary endpoint of non- and 51% in HARRIER), 82% in HAWK and 52 and 6.1 to 7.6 letters at week 96 for inferiority of brolucizumab 6mg (Novartis) 75% in HARRIER were maintained on a the four-week and two-week adjustment to aflibercept (Eylea®, Regeneron, Bayer) in q12w dosing interval in year two (overall, groups, respectively [4-6]. There was a mean change in best corrected visual acuity ~46% in HAWK and 38% in HARRIER). The mean of 10.4 injections given overall, (BCVA) from baseline was met at week 48 overall safety profile of brolucizumab was with a mean of 3.6 to 3.7 injections in the [1].
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • NETTER, Jr., Robert, C. Et Al.; Dann, Dorf- (21) International Application
    ll ( (51) International Patent Classification: (74) Agent: NETTER, Jr., Robert, C. et al.; Dann, Dorf- C07K 16/28 (2006.01) man, Herrell and Skillman, 1601 Market Street, Suite 2400, Philadelphia, PA 19103-2307 (US). (21) International Application Number: PCT/US2020/030354 (81) Designated States (unless otherwise indicated, for every kind of national protection av ailable) . AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 29 April 2020 (29.04.2020) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, (26) Publication Language: English KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (30) Priority Data: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/840,465 30 April 2019 (30.04.2019) US OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, (71) Applicants: INSTITUTE FOR CANCER RESEARCH TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW. D/B/A THE RESEARCH INSTITUTE OF FOX CHASE CANCER CENTER [US/US]; 333 Cottman Av¬ (84) Designated States (unless otherwise indicated, for every enue, Philadelphia, PA 191 11-2497 (US). UNIVERSTIY kind of regional protection available) . ARIPO (BW, GH, OF KANSAS [US/US]; 245 Strong Hall, 1450 Jayhawk GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, Boulevard, Lawrence, KS 66045 (US).
    [Show full text]
  • © 2021 Reachmd Page 1 of 8
    Transcriipt Detaiills This is a transcript of a continuing medical education (CME) activity accessible on the ReachMD network. Additional media formats for the activity and full activity details (including sponsor and supporter, disclosures, and instructions for claiming credit) are available by visiting: https://reachmd.com/programs/cme/advances-angiostatic-treatment-retinal-disease-demystifying-novel-therapeutic- targets/12490/ Released: 04/30/2021 Valid until: 04/30/2022 Time needed to complete: 30 minutes ReachMD www.reachmd.com [email protected] (866) 423-7849 Advances in Angiostatic Treatment for Retinal Disease: Demystifying Novel Therapeutic Targets Announcer: Welcome to CME on ReachMD. This activity entitled Advances in Angiostatic Treatment for Retinal Disease – Demystifying Novel Therapeutic Targets is provided by MedEdicus LLC and is supported by an independent education grant from Genentech Incorporated. Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements, as well as the learning objectives. Dr. Eichenbaum: Welcome to Advances in Angiostatic Treatment for Retinal Disease – Demystifying Novel Therapeutic Targets . I’m David Eichenbaum, Collaborative Associate Professor of Ophthalmology at the Morsani College of Medicine at the University of South Florida and I’m Director of Research of Retina Vitreous Associates of Florida and Tampa Bay, Florida. I’m joined by my esteemed colleague and good friend, Charlie Wykoff, Director of Research at Retina Consultants of Texas
    [Show full text]
  • (INN) for Biological and Biotechnological Substances
    WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) FORMER DOCUMENT NUMBER: INN Working Document 05.179 © World Health Organization 2019 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
    [Show full text]
  • Improving Treatment Burden and Outcomes for Patients with Neovascular Age-Related Macular Degeneration Now and Into the Future
    199 AAO 2019_Novartis AMD Monograph_12pgs rev 2.qxp 1/31/20 1:20 PM Page 1 CME Monograph VISIT HTTPS://TINYURL.COM/NAMDCME FOR ONLINE TESTING AND INSTANT CME CERTIFICATE. IMPROVING TREATMENT BURDEN AND OUTCOMES FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION NOW AND INTO THE FUTURE FACULTY NANCY M. HOLEKAMP, MD (CHAIR) PRAVIN U. DUGEL, MD BARUCH D. KUPPERMANN, MD, PHD CARL D. REGILLO, MD This continuing medical education activity is jointly provided by Original Release: March 1, 2020 New York Eye and Ear Infirmary of Mount Sinai and MedEdicus LLC. Expiration: March 31, 2021 This continuing medical education activity is supported through an unrestricted educational grant from Novartis Pharmaceuticals Corporation. Distributed with 199 AAO 2019_Novartis AMD Monograph_12pgs rev 2.qxp 1/31/20 1:20 PM Page 2 LEARNING METHOD AND MEDIUM NeoVista Inc; Neurotech Pharmaceuticals; Novartis Pharmaceuticals Corporation; This educational activity consists of a supplement and ten (10) study questions. Oculis; Omeros Corporation; Opthea; Optovue, Incorporated; Ora, Inc; Oxurion NV; The participant should, in order, read the learning objectives contained at the PanOptica; Pieris; QLT Inc; Regeneron Pharmaceuticals, Inc; Regenxbio Inc; beginning of this supplement, read the supplement, answer all questions in the ReNeuron Group PLC; Retinagenix; Santen Inc; SciFluor Life Sciences, Inc; Shire; post test, and complete the Activity Evaluation/Credit Request form. To receive Spark Therapeutics, Inc; Stealth BioTherapeutics Inc; Topcon Medical Systems, Inc; credit for this activity, please follow the instructions provided on the post test and TrueVision; and Zeiss; Ownership Interest (Stock options, or other holdings, Activity Evaluation/Credit Request form. This educational activity should take a excluding diversified mutual funds): Aerpio Therapeutics; Allegro Ophthalmics, LLC; maximum of 1.5 hours to complete.
    [Show full text]
  • A61K9/51 (2006.01) — with International Search Report (Art
    ) ( 2 (51) International Patent Classification: Published: A61K9/51 (2006.01) — with international search report (Art. 21(3)) (21) International Application Number: — before the expiration of the time limit for amending the PCT/US20 19/033 875 claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) (22) International Filing Date: 24 May 2019 (24.05.2019) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/676,169 24 May 2018 (24.05.2018) US (71) Applicant: ELEKTROFI, INC. [US/US]; 75 Kneeland Street, 14th Floor, Boston, MA 021 11 (US). (72) Inventors: COFFMAN, Chase; 86 Worcester Street, Unit 3, Boston, MA 021 18 (US). CHARLES, Lyndon; 600 Main St Apt 3, Medford, MA 02155 (US). BROWN, Paul; 156 W 6th St, Unit 2, Boston, MA 02127 (US). DADON, Daniel, Benjamin; 2 Garden Court, Apt. 1, Cambridge, MA 02138 (US). LIU, Lisa; 111 Bartlett Street, Apt 2, Somerville, MA 02145 (US). SHADBAR, Sadiqua; 1307 Commonwealth Avenue, Apt 9, Allston, MA 02135 (US). SUDRIK, Chaitanya; 7 1 Elm Street, Apartment #2, Cam¬ bridge, MA 02139 (US). (74) Agent: BELLIVEAU, Michael J. et al.; Clark & Elbing LLP, 101 Federal Street, 15th Floor, Boston, MA 021 10 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 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.
    [Show full text]
  • Evolution of Escherichia Coli Expression System in Producing Antibody Recombinant Fragments
    International Journal of Molecular Sciences Review Evolution of Escherichia coli Expression System in Producing Antibody Recombinant Fragments Annamaria Sandomenico *, Jwala P. Sivaccumar and Menotti Ruvo * Istituto di Biostrutture e Bioimmagini, CNR, via Mezzocannone, 16, 80134 Napoli, Italy; [email protected] * Correspondence: [email protected] (A.S.); [email protected] (M.R.) Received: 26 July 2020; Accepted: 25 August 2020; Published: 31 August 2020 Abstract: Antibodies and antibody-derived molecules are continuously developed as both therapeutic agents and key reagents for advanced diagnostic investigations. Their application in these fields has indeed greatly expanded the demand of these molecules and the need for their production in high yield and purity. While full-length antibodies require mammalian expression systems due to the occurrence of functionally and structurally important glycosylations, most antibody fragments and antibody-like molecules are non-glycosylated and can be more conveniently prepared in E. coli-based expression platforms. We propose here an updated survey of the most effective and appropriate methods of preparation of antibody fragments that exploit E. coli as an expression background and review the pros and cons of the different platforms available today. Around 250 references accompany and complete the review together with some lists of the most important new antibody-like molecules that are on the market or are being developed as new biotherapeutics or diagnostic agents. Keywords: antibody fragment; Fab; scFv; E. coli 1. Introduction Antibody fragments are widely utilized in therapeutic and diagnostic applications as well as in basic life science research [1]. Unlike conventional immunoglobulins, these smaller biomolecules take several pharmacokinetics advantages over whole antibodies including better penetration into tissues, faster clearance for imaging purposes and generally lower immunogenicity.
    [Show full text]