Switzerland's Biotech

Total Page:16

File Type:pdf, Size:1020Kb

Switzerland's Biotech Switzerland’s biotech hub - a powerful source of innovation AFSSI Connexions, Convention 2019, July 2nd, Lyon Michael Altorfer CEO, Swiss Biotech Association The Swiss biotech industry is a key asset Switzerland is one of the best Local companies hold and most innovative locations leading positions throughout many for biotechnology in Europe and sectors and thus attract capital and the world researchers from all over the world The basis for this success is a In addition to being an attractive close-knit network between place to live for international research and development, driven specialists, Switzerland also offers a by renowned universities, highly modern infrastructure, a specialized SMEs and strong beneficial funding environment multinational corporations and access to a highly-qualified workforce 2 swissbiotech.org A tight cross-functional network Veterinary R&D CMO Bio-IT Analytical Therapeutics Engineering SBA member company activities Cell culture Food & industrial Medtech Biotech consulting Diagnostics Agriculture Chemicals reagents Labware Bio-equipment Non-biotech consulting 3 swissbiotech.org Swiss Biotech: Structural changes offer new investment and partnering opportunities CRO share research risk Biotech companies stay independent: CMOs take over production sites • build their commercial Clinical trials are outsourced organizations and even financed by partners • partner with distributors team up with partners Service providers start that have access to SBA member sharing risks and benefit patients company activities • combine drug and Business models not relying medical device or on product development service provider Investors go it alone, build Some Biotech companies are virtual project teams rather fully financed, eliminating the than companies need for small incremental financing rounds 4 swissbiotech.org Capital investment in Swiss biotech companies 5 Swiss Biotech Day 2019 From 2007 - 2018 Venture Kick invested CHF 3.16 million in 48 Swiss biotech startups. This amount was amplified 159 fold by grants and VC investments. 6 Swiss Biotech Day 2019 High impact patents reflect innovation power 2.0 Switzerland France Denmark Netherlands 1.8 UK Germany 1.6 Canada Australia 1.4 USA 1.2 Japan 1.0 Market coverageMarket 0.8 0.6 China Bubble size represents the number of active patents per country of inventor origin, 0.4 South Korea reporting year 2016 Russia 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4 2.6 Technology relevance Source: IPI, Swiss Biotech Report 2017 7 swissbiotech.org Major investments in biopharmaceutical production sites Novartis, 2020 Ciba-Geigy, Roche, 2007 EUR 100 million 1996 CHF 400 million MSD (former Werthenstein) 2015, 2008, 2000 MSD (former Werthenstein) 2015, 2008, 2000 Biogen, 2019 CHF 1.5 billion UCB Pharma, 2007 CHF 400 million CSL Behring, 2020 Ferring, 2001 CHF 1 billion CHF 30 million Lonza, 2020 CHF 290 million Serono, 1999 EUR 300 million Cerbios, 2013 SBA, Swiss Biotech Report 2018 Significant and growing export factor 9 swissbiotech.org Swiss Biotech industry in numbers Global talent competitiveness 18 16 8 9 24 17 12 40 7 11 10 31 35 5 1 3 13 25 4 6 2 75 70 65 Score 60 55 50 X Ranking Source: Instead, GTCI Report 2017 11 swissbiotech.org A world-leading Biotech hub • Attractive and reliable framework conditions • Stable political environment • Strong intellectual property protection • Renowned universities • Highly-qualified workforce • Excellent R&D infrastructure • Beneficial funding environment • Superb quality of life 1 Nation - 1 Biotech Cluster 13 swissbiotech.org Swiss Biotech Association The central resource for the Swiss biotech industry Members of the Swiss Biotech Association (255) 3M • Abologix • AC Bioscience • AC Immune • Activen • ADC Therapeutics • Addex Therapeutics • Adolf Kühner • Agidens • Alphastrat • AlveoliX • Amal Therapeutics • Anaveon • Anergis • Anjarium Biosciences • Asceneuron • Assystem Care • Aurealis Pharma • Axon Lab • B3C Group • Baccinex • Bachem • Baliopharm • Basilea Pharmaceutica • BC Platforms • Becton Dickinson • Bench • Bideco • Bio Innovations • BioConcept • Bioengineering • Biogen • BioLingus • Biomapas • Biopôle • Bio-Rad • Biosynth • Bio- Technopark Schlieren-Zürich • BioVersys • blsc • Bucher Biotec • Büchi • BÜHLMANN • Cabinet Privé de Conseils • Calypso Biotech • Canlion • Carbogen Amcis • CarthaGenetics • C-CIT Sensors • CDR-Life • CEBIS International • Celerion • Cell Medica • Cellestia Biotech • Cerbios-Pharma • certus molecular diagnostics • Chemgineering Technology • Cilatus Biopharma Consulting • CimArk • CIS Pharma • Clinipace • Consultants in Science • Coulter & Partners • CRB • Creoptix • CSL Behring • CTC Clinical Trial Consulting • Culture Collection of Switzerland • Curatis • Debiopharm International • DXC RT • EffRx Pharmaceuticals • Elanix Biotechnologies • Elthera • Eurofins Medical Device Testing • EVA • Evitria • ExcellGene • ExpertInova • Finox Biotech • Future Health Pharma • Gain Therapeutics • GBiotech • GE Healthcare • Geistlich Pharma • Gene Signal • Genedata • GeNeuro • Genkyotex • Glenmark Pharmaceuticals • GMT Fine Chemicals • Healthcare Impact Foundation • Hemex • Heptares Therapeutics • HGF • Homburger • Humabs BioMed • IBR • ICON Clinical Research • Idorsia Pharmaceuticals • IE Life Science Engineering • Incyte Biosciences International • Inflamalps • Infors • InnoMedica • Inofea • Inositec • InSphero • Integra Biosciences • InterAx Biotech • Janssen-Cilag • Jenal & Partners Biosafety Consulting • Jung & Partners • KPMG • Labatec Pharma • Laves- Arzneimittel • LeadXpro • LimmaTech Biologics • Lipidon • Lonza • Loroch • LubioScience • Lunaphore Technologies • LYO-X • Malcisbo • Marsa Corporate Finance • Maxia Strategies • MD Biosciences • Med Discovery • Mediatum • Memo Therapeutics • Merck & Cie • MetrioPharm • Micro-Sphere • Microsynth • Molecular Partners • Morgan Sindall • Mymetics • NBE-Therapeutics • NDA • Neurimmune • Novartis Pharma • NovImmune • Numab • ObsEva • Oculis • OLS • Omya • Onelife • P & G MedChem • Pall • PAREXEL • Phargentis • Philip Morris International • Philochem • Phoenixus Pharmaceuticals • PIQUR • PolyGene • Polyneuron • Polyphor • Preclin Biosystems • PreComb Therapeutics • Promega • ProteoMediX • PSI CRO • Quotient Suisse • Recordati • Redbiotec • RegenLab • regulanet • ReseaChem • Roche Glycart • SAKK • Santhera • Sartorius • Schmidt Versicherungs Treuhand • Seagen International • Securecell • Selexis • Servier • SFL Pharma • SGS M-Scan • Shimadzu • SimplicityBio • Socorex • SOPHiA GENETICS • SpacePharma • Dr. Rudolf K.Sprüngli • Strekin • SunRegen Healthcare • Swiss Institute for Regenerative Medicine • Swissfillon • Switzerland Global Enterprise • SynDermix • Syngenta • Synlab • Synple Chem • T3 Pharma • Talentmark • Target BioScience • tepthera • the RSA Group • Therachon • Thermo Fisher Life Technologies • Thermo Fisher Scientific Prionics • Tigermed • Tillotts Pharma • tiventa • TJM Conseils • Tolerys • TOLREMO therapeutics • Toolpoint for Lab Science • Topadur • Triplan Ingenieur • UCB • Unitectra • ValuationLab • Vaxxilon • Venture Valuation • Versameb • Versantis • Virometix • Voisin Consulting Life Sciences • MSD Werthenstein BioPharma • Wyss Zurich 15 swissbiotech.org Our mission Developing favorable and competitive framework conditions Attracting talent, know-how and financial resources to drive innovation and growth 16 swissbiotech.org Swiss Biotech Association Improving framework conditions Clinical Technology transfer developments Seed / venture Academia – Industry Industry – Hospital Taxation capital collaborations collaborations 17 swissbiotech.org Swiss Biotech Association Business solutions Co-promotions SBA Academy Discounted business Promotion support Discounted access Seminars offerings (e.g. Biotech directory, Speaker Workshops pension fund) jobs, clinical pipeline opportunities 18 swissbiotech.org Our mission Developing favorable and competitive framework conditions Attracting talent, know-how and financial resources to drive Promoting the innovation and growth accomplishments of the Swiss biotech industry Fostering networking through strategic, national and international partnerships 19 swissbiotech.org The Swiss Biotech Directory Finding the right partner – Switzerland's most comprehensive database www.swissbiotech.org/companies/ 20 swissbiotech.org Celebrating and honoring major achievements The Swiss Biotech Association has launched Swiss Biotech Success Stories to celebrate those who have made significant contributions to the industry Dedicated to scientists, pioneers, entrepreneurs, innovators and supporters who led the way, opened the horizon and prepared the ground for lasting achievements Swiss Biotech Success Stories accentuate past industry highlights and act as motivator for future achievements Award winner 2019 Launched the Swiss Biotech Success Stories Award The first awards went to: • Biogen • Okairos • Roche Glycart • Selexis • Vifor Fresenius Renal Medical Care Pharma General Assembly, 23 swissbiotech.org May 7, 2019 National biotech convention: Swiss Biotech Day in Basel > 850 participants (plus 30%) 1st year of success story award 38% participants from abroad (plus 5%) 47 new members of the 42 exhibitors (plus 55%) Swiss Biotech Association (plus 25%) 906 organizations in 2019 Swiss Biotech Swiss Biotech Directory (plus 35%) > 30 co-promotion partner Report (plus 200%) 34 swissbiotech.org .
Recommended publications
  • Darpinstm the Next Generation of Protein Drugs MP0112 – the Best
    Developing DARPin® therapies to improve health and advance modern medicine Corporate Presentation June 2015 Disclaimer NEITHER THIS DOCUMENT NOR ANY PART OR COPY OF IT NOR THE INFORMATION CONTAINED IN IT AND ANY RELATED MATERIALS MAY BE TAKEN OR TRANSMITTED INTO THE UNITED STATES OR DISTRIBUTED OR REDISTRIBUTED, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES. This presentation is not an offer to sell or a solicitation of offers to purchase or subscribe for shares of Molecular Partners AG, nor shall it or any part of it nor the fact of its distribution form the basis of, or be relied on in connection with, any contract or investment decision. This presentation is not an offering circular within the meaning of Article 652a of the Swiss Code of Obligations, nor is it a listing prospectus as defined in the listing rules of the SIX Swiss Exchange AG or a prospectus under any other applicable laws. Copies of this presentation may not be sent to countries, or distributed in or sent from countries, in which this is barred or prohibited by law. This document is not a prospectus or a prospectus equivalent document and investors should not subscribe for or purchase any securities referred to in this document. This document does not constitute a recommendation regarding the shares. This presentation contains specific forward-looking statements, beliefs or opinions, including statements with respect to the product pipelines, potential benefits of product candidates and objectives, estimated market sizes and opportunities as well as the milestone potential under existing collaboration agreements, which are based on current beliefs, expectations and projections about future events, e.g.
    [Show full text]
  • Investor Presentation
    Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.
    [Show full text]
  • 5 EVENTS in ONE: Head Real World Evidence and Big Data Solutions Novartis, Switzerland
    FIFTH ANNUAL - LIFE SCIENCE R&D DATA INTELLIGENCE LEADERS FORUM Basel, Switzerland January 23-24th, 2018 Optional Workshop 22nd, January Hear keynote presentations from the experts: Etzard Stolte Global Head Knowledge Management Roche, Switzerland Abhimanyu Verma 5 EVENTS IN ONE: Head Real World Evidence and Big Data Solutions Novartis, Switzerland Day 1: Torsten Niederdraenk Head of Technology Center Strategic Developments in R&D Big Siemens Healthcare, Germany Data Catherine Brownstein Scientific Director Day 2 (am): Stream 1 Manton Center for Orphan Disease Research Boston Children’s Hospital, USA Discovery & Omics Data Excellence Navin Ramachandran Radiology Consultant Day 2 (am): Stream 2 University College London Hospitals NHS Foundation Trust, Healthcare specialist in distributed ledgers and IoT Clinical & Patient Level Data IOTA Foundation, UK Excellence Marie-Claire Peakman Executive Director, Head Hit Discovery & Lead Profiling, Medicine Design Day 2 (pm): Stream A Pfizer, USA R&D IT & Bioinformatics Alex Zhavoronkov Co-founder, Insilico Medicine, CSO Day 2 (pm): Stream B The Biogerontology Research Foundation, UK Ivana Schnur Digital Health Collaborations Co-founder, CMO Sense.ly, USA Pre-Event Workshop: Jan 22nd Paul Wicks Artificial Intelligence for Drug Vice President of Innovation PatientsLikeMe, UK Discovery: Workshop for Senior Jazz Panchoo Global Strategy Head, VP, Digital Platforms Executives Ascensia Diabetes Care, Switzerland This Event is Certified for Continuing Professional Development with more than 30 presentations
    [Show full text]
  • Swiss Biotech Report – "Agility, Leadership and Innovation in the Time of COVID-19” – Is Indeed Appropriate
    SwissSwiss BiotechBiotech ReportReport 2021 2019Agility, leadership and innovation in the time of COVID-19 Schweizerische Eidgenossenschaft Confédération suisse Confederazione Svizzera Confederaziun svizra Swiss Confederation Innosuisse – Swiss Innovation Agency “The biopharma industry’s response to COVID-19 has truly been a global one – with Swiss companies and academic institutions at the forefront. Swiss-based biopharma players are contributing across the spectrum of patient needs.” George Scangos | Vir Biotechnology, Inc. “2020 was the best year ever for Swiss biotech in relation to financing activities, with a total of approximately CHF 3.4B raised” Jürg Zürcher | GSA Biotechnology Leader, EY “Compared to 2019, trading volumes rose sharply by 177% and the total free float market capitalization of all SIX-listed biotech companies was up 30% on 2020.” Fabian Gerber | SIX Agility, leadership and innovation in the time of COVID-19 “Technologies developed by scientists in Switzerland have been crucial in the fight against COVID-19, including cloning the virus, cryo electron microscopy to visualize the spike proteins, and the use of radioactive molecules that bind to receptor proteins to investigate how the virus enters the host.” Florian Fisch | Swiss National Science Foundation “On May 1 2020, Moderna and Lonza announced a strategic collaboration to enable manufacturing of up to 1 billion doses of the vaccine per year. Lonza acquired equipment and built the production lines in just 8 months.” Jan Lucht | scienceindustries “Industrial
    [Show full text]
  • European Human Genetics Conference 2017 Programme
    There’s nothing more 1967 - 2017 | 50th Anniversary Meeting personal than genomics Discover genomic solutions across the research continuum Visit us at stand 140 and discover how our portfolio of next-generation sequencing (NGS), microarray and informatic solutions can help empower your next breakthrough. EUROPEAN HUMAN Come learn how you can become a part of the scientic innovation happening in: GENETICS CONFERENCE 2017 • Complex Diseases • Rare or Undiagnosed Genetic Diseases Bella Center | Copenhagen, Denmark | May 27 - 30 • Reproductive Health • Cancer Genetics • Microbiology Experience the NovaSeq™ Series Discover a leap forward in technology by attending one of our stand presentations, or take a virtual reality tour. Attend the Illumina Satellite Workshop Sunday, 28 May | 19.15 – 20.45 | Room Ballerup Anniversary Meeting | Programme | European Human Genetics Conference 2017 | Copenhagen - Denmark 2017 | Copenhagen Human Genetics Conference | European Anniversary Meeting | Programme th 1967 - 2017 | 50 www.illumina.com Programme For Research Use Only. Not for use in diagnostic procedures. © 2017 Illumina, Inc. All rights reserved. European Society www.eshg.org @eshgsociety of Human Genetics facebook.com/eshg.org #eshg2017 GENERAL FLOORPLAN METRO Ground Floor Ballerup LECTURE HALLS B - CORPORATE SATELLITES Berlin Barcelona Brussels Birmingham Belgrade WC WC WC WC Bags Registration CENTERHALL Exhibition Service WC Athens Lead Retrieval Poster Printing LECTURE HALLS A Cambridge Gastro Café Exhibition Aarhus Centre Coffee & Lunch Preview Copenhagen Cash Bar MAIN LOBBY Live Stream Posters Amsterdam E-Posters WC AC Hotel FOYER Bella Sky LECTURE HALLS C Cannes Main Entrance Cologne First Floor 5 Athens CENTERHALL 16 17 WC 18 25 A Aarhus 18 19 20 LECTURE HALLS A Amsterdam MAIN LOBBY FOYER Ancona conf.
    [Show full text]
  • BOOKLET Santiago
    !1 14th International Symposium on Variants in the Genome: detection, sequencing & interpretation 5 - 7 June 2017 NH Collection Santiago Santiago de Compostela, Spain Scientific Programme Committee Prof. Johan T. den Dunnen (Leiden, Nederland) CHAIR Prof. Sir John Burn (Newcastle, UK) Prof. Angel Carracedo (Santiago de Compostela, Spain) Dr Reece Hart (San Francisco, CA, USA) Dr Andreas Laner (Munich, Germany) Dr Maria-Jesus Sobrido (Santiago de Compostela, Spain) Organising Committee Maria Torres (CEGEN-PRB2, Universidade de Santiago de Compostela) Rania Horaitis; Event Manager (Meeting Makers www.meeting-makers.com) Previous Meetings 2003 Palm Cove, Australia 1991 Oxford, UK 2005 Santorini, Greece 1993 Lago D’Orta, Italy 2007 Xiamen, China 1995 Visby, Sweden 2009 Paphos, Cyprus 1997 Brno, Czech Republic 2011 Santorini, Greece 1999 Vicoforte, Italy 2013 Lake Louise, Canada 2001 Bled, Slovenia 2015 Leiden, Netherlands !2 !3 !4 !5 !6 !7 !8 !9 !10 !11 !12 !13 Oral Presentation Abstracts Exomiser to include an assessment of SESSION 1 regulatory regions, in an application called the Genomiser. Simulations show an ability to rank the seeded causative variant in first place Phenotype Driven Genomic over an entire genome in over 60% of cases. Diagnostics In this talk, I will review how computational phenotype analysis with the HPO works and Peter N Robinson how we have used it for the Exomiser and Genomiser. Professor of Computational Biology, The Jackson Laboratory for Genomic Medicine, 10 Discovery Drive, Farmington, CT 06032, USA CNV detection from targeted [email protected] next-generation panel sequencing www.jax.org Robinson lab: https://robinsongroup.github.io/ data in routine diagnostics Anna Benet-Pagès, Anke M.
    [Show full text]
  • Sophia GENETICS SA (Exact Name of Registrant As Specified in Its Charter)
    As filed with the Securities and Exchange Commission on July 23, 2021 Registration No. 333-__________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SOPHiA GENETICS SA (Exact name of registrant as specified in its charter) Switzerland Not Applicable (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Rue du Centre 172, CH-1025 Saint-Sulpice, Switzerland (Address of Principal Executive Offices) SOPHiA GENETICS Incentive Stock Option Plan SOPHiA GENETICS 2019 Incentive Stock Option Plan (Full title of the plans) SOPHiA GENETICS, Inc. 185 Dartmouth Street, Suite 502 Boston, MA 02116 (Name and Address of Agent For Service) (617) 982-1210 (Telephone number, Including Area Code, of Agent For Service) Copies of all communications, including all communications sent to the agent for service, should be sent to: Kyoko Takahashi Lin Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 (212) 450-4000 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer o Accelerated filer o Non-accelerated filer o Smaller reporting company o (Do not check if a smaller reporting company) Emerging Growth Company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
    [Show full text]
  • Molecular Partners Reports Key Financials for H1 19 and Corporate Highlights: EMA Has Validated the Marketing Authorization Appl
    Molecular Partners reports key financials for H1 19 and corporate highlights: EMA has validated the marketing authorization application for abicipar; Focus of MP0250 on multiple myeloma with expected initiation of ph2 IMiD trial in Q4 19; MP0310 ph1 start on track for H2 19 August 27, 2019 Research & Development: MP0250 (VEGF x HGF) in MM: PI Trial (in combination with Velcade®) – Encouraging responses observed in first patient cohorts triggered decision for further investment; IMiD Trial (in combination with Pomalyst®) – Start of phase 2 trial expected in Q4 19, having received FDA approval MP0250 in EGFR-mutated Non-Small Cell Lung Cancer (EGFR-mut NSCLC) in combination with Tagrisso®: Following lift of partial clinical hold by FDA, strategic decision to discontinue phase 2 trial and focus resources on MM trials MP0274 (Her2): Phase 1 dose escalation trial in Her2-positive cancer patients progessing; first patients dosed at level of 4mg/kg MP0310 (FAP x 4-1BB): Novel Therapeutic Design for tumor-localized immune-modulator on track to dose the first patient in the phase 1 trial in H2 19 (co-development with Amgen) Research portfolio is focused on DARPin® candidates with innovative therapeutic designs, including tumor-localized FAP x CD40, peptide-MHC DARPin® binders and DARPin® T cell-engager candidates, and continues to progress according to plan Abicipar (VEGF): EMA has validated marketing authorization application for abicipar; EMA decision may be received in H2 20; US launch, following FDA filing and review, expected mid-2020; abicipar
    [Show full text]
  • ESMO 2019 Exhibitors' List
    ESMO 2019 - Exhibitors' list (as of 21 of August 2019) Booth Number Company name 441 3D TECH OMEGA ZETA 469 3DforScience - Visuals for Bio & Health 235 10x Genomics 315 AbbVie 227 Abcam 213 Accord Healthcare 471 Adaptive Biotechnologies 208 Advanced Accelerator Applications, a Novartis company 465 Agendia 456 Alkermes, Inc 473 Almac Group 403 Amgen Inc. 415 Amoy Diagnostics Co., Ltd. 211 Aptitude Health 248 ArcherDX 309 Astellas 305 AstraZeneca 467 Avaden BioSciences, Inc. 463 Axiom Healthcare Strategies 446 Baxter 306 Bayer 419 BEACON Medicare Limited 443 BEIGENE, LTD. 233 Biocartis 245 Biotype GmbH 302 Bristol-Myers Squibb 401 Boehringer Ingelheim 238 Calithera Biosciences 476 Cancer Drug Interactions 407 Caris Life Sciences 225 CATALYSIS S.L. 318 CeGaT 215 Celgene 409 Celltrion Healthcare Co., Ltd. 454 Chemo Mouthpiece 450 Clinical Research Malaysia 217 Clovis Oncology 421 COMECER 411 Covance, Inc. 462 Cytel 205 Daiichi Sankyo, Inc. 413 DAVA Oncology 452 ECS Progastrin 207 Eisai Ltd. 229 Elevar 239 EntroGen 247 Erytech Pharma SA 440 Europital 402 EUSA Pharma 214 Exelixis, Inc. 303 F. Hoffmann-La Roche AG 458 Ferring Pharmaceuticals 244 FibroGen, Inc. 455 FRENCH HEALTHCARE 422 Fresenius Kabi 448 geneXplain GmbH 221 Genmab 404 GENOMIC HEALTH 206 GSK 249 Guardant Health 246 HalioDx 474 Halozyme Therapeutics 417 Helsinn Healthcare 445 HTG Molecular Diagnostics 251 IBM Watson Health 319 Illumina 477 ImaginAb, Inc. 216 Incyte Biosciences International Sàrl 242 Institut Curie 310 IPSEN 472 IQVIA Biotech 210 ITM Isotopen Technologien Muenchen AG 220 Janssen-Cilag International NV P432 Jiahui International Hospital 406 Kaiku Health 420 Kite, a Gilead Company 236 KoNECT (Korea National Enterprise for Clinical Trials) 475 Leica Biosystems 307 Lilly 237 Linical 204 Loxo Oncology, Inc.
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2021 Commission File Number: 001-40488 Molecular Partners AG (Translation of registrant's name into English) Wagistrasse 14 8952 Zurich-Schlieren Switzerland (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ] Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): EXHIBIT INDEX Exhibit No. Description 99.1 Press Release dated August 26, 2021 99.2 Half-Year Report SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Molecular Partners AG (Registrant) Date: August 26, 2021 /s/ PATRICK AMSTUTZ Patrick Amstutz Chief Executive Officer EXHIBIT 99.1 Molecular Partners Reports Corporate Highlights and Key Financials for H1 2021 -- Significant progress in COVID-19 trials, including positive results from healthy subjects and COVID-19 patients, supporting the launch of ongoing late-stage trials EMPATHY and ACTIV-3 Research & Development: Initiated two global Phase 2 and
    [Show full text]
  • Cynosure Aces Single-Audit Program Twice
    POLICY & REGULATION COMMERCIAL R&D An update on NEST real-world Mark Hitchman of Canon Medical Two firms nab US breakthrough evidence efforts, p. 6 Systems discusses market growth status, p. 22 strategies, p. 15 Medtech Issue 80 Pharma Intelligence Informa February 5, 2018 medtech.pharmaintelligence.informa.comInsight 'WE SURVIVED MDSAP': The final visit from the US agency that year was the last straw, she said. "That FDA inspection really made me Cynosure Aces Single-Audit Program want to get Cynosure involved in MDSAP because I cancelled a vacation to Indonesia Twice; Tells How Your Firm Can, Too to stay behind for that inspection," Hoy said. "That's when I learned that travel insurance SHAWN M. SCHMITT [email protected] doesn't consider an FDA inspection to be an emergency that's reimbursable." MDSAP , created by the International Medical Device Regulators Forum (IMDRF), allows firms to undergo only one audit by an accredited third party to satisfy quality regulations for five countries: the US, Can- ada, Brazil, Japan and Australia. The program runs on a three-year cycle, albeit with differing scopes for each audit. Firms are certified to MDSAP in the first year; in the second and third years, they submit to surveillance audits, which are typically quicker than a certification audit. The cycle then repeats, with recertification to MDSAP Shutterstock: alphaspirit Shutterstock: occurring in the fourth year, and so on. MDSAP ran as a pilot program for three or longtime quality and regulatory "It was particularly difficult that year to full years from January 2014 through expert Connie Hoy, the decision to be in the quality department at Cynosure December 2016, but is now a bona-fide F ditch the prying eyes of multiple because all we did was get audited.
    [Show full text]
  • Molecular Partners Reports Key Financials for FY 2019 and Corporate Highlights from Q4 2019
    Molecular Partners reports key financials for FY 2019 and corporate highlights from Q4 2019 January 6, 2020 Research & Development: Abicipar in Neovascular Wet Age-Related Macular Degeneration: Two-year results from CEDAR and SEQUOIA presented at AAO in October 2019 demonstrate that vision gains observed after one year with both, every 8-week and every 12-week dosing were maintained in second year FDA and EMA filings accepted and under review MP0250 (VEGF x HGF) in Multiple Myeloma: Updated data presented at ASH in December show long-lasting and deepening responses in patients with relapsed/refractory disease U.S. FDA Orphan Drug Designation received in December 2019 Previously planned clinical trial investigating MP0250 in combination with an IMiD will not be initiated, in alignment with company’s corporate strategy to pursue combination data in collaboration with a partner MP0310 / AMG 506 (FAP x 4-1BB): Dose escalation ongoing; current clinical timelines on track with additional clinical updates expected in H2 2020 MP0317 (FAP x CD40): Tumor-localized immune agonist nominated as second DARPin® protein in company’s immuno-oncology pipeline Research: Progress continues on novel therapeutic designs including tumor-localized immune-cell agonists, peptide-MHC complex DARPin® binders, and next-generation immune cell engagers Financial Highlights: Strong financial position with CHF 95.1 million in cash (incl. short-term deposits) as of December 31, 2019 Net cash used in operating activities of CHF 1.2 million in 2019 – Upfront free from Amgen (USD 50 million) reflected the majority of our investments into the pipeline Operating loss of CHF 37.2 million and net loss of CHF 36.8 million in 2019 Company funded into H2 2021, one year beyond expected FDA decision regarding Abicipar Talent base of 135 full-time employees at year-end 2019 (+15% year-on-year), reflective of growth of the company and its pipeline Zurich-Schlieren, Switzerland, February 6, 2020.
    [Show full text]