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Biocompatibles Presentation 20091203
Biocompatibles International plc Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke • Financial Review and 2009 Goals Five Key Points for New Investors • Business Overview – Oncology Products : Proprietary Medical Devices: • Drug-Eluting Beads • Radiation Seeds – Licensing : Ambitious R&D/Partnering programmes: • AstraZeneca • Medtronic • Sales of £25m, growing at 30%+ per annum • Dividend of 5p/share paid in May 2009 • Contribution to R&D of £12m. Net R&D of £14m* • Net funds of £30m…market cap. of £95m** * Illustrative doubling of half-year figures ** Market cap. based on share price of 241.5p on 20 November, 2009 Two Divisions in Three Locations GROUP Oncology Products Licensing US and UK Mainly Germany Sales: £18m Sales: £7m Not Partnered Bead Brachytherapy AstraZeneca Products Products Medtronic Stroke Merz RNAi Group Sales £m 15 Mid Guidance 10 CellMed Licensing BrachySciences Beads 5 0 H1 2005 H2 2005 H1 2006 H2 2006 H1 2007 H2 2007 H1 2008 H2 2008 H1 2009 H2 2009 Sales Growth and Data are driving Value • 2009-11: • Dividend • Financial Guidance and Goals • Drug-Eluting Beads: • Continuing the growth • China and Japan • Accumulating clinical data • Acquisitions / Business Development • Towards break-even and profit • 2011-12 inflection points – AstraZeneca potential option exercise – Drug-Eluting Beads breakthrough: • SPACE • PARAGON Studies Agenda • Overview • Key Programmes: -
Medical Research Council
Elan Pharmaceuticals University of Kansas Parke-Davis Basilea Pharmaceutica Office of Rare Diseases (ORD) Swedish Orphan Biovitrum Astellas Pharma US, Inc. Food and Drug Administration (FDA) Biogen Idec AVEO Pharmaceuticals, Inc. Bioclin Research Laboratories Rare Diseases Clinical Research Network Birmingham Clinical Trials Unit Astellas Pharma Inc Baylor College of Medicine Astellas Pharma Europe BV Abbott Biotherapeutics Corp. OSI Pharmaceuticals Anglo-European College of Chiropractic The Beverage Institute. National Development and Research Institutes, Inc. Boston University University of Rochester Medstar Research Institute Omnicare Clinical Research ABX-CRO Bio-Kinetic Europe Ltd MRC Human Nutrition Research, Cambridge, UK. Shionogi Astellas Pharma Global Development, Inc. Ethicon, Inc. Symphogen A/S Averion-Hesperion Quintiles Laboratories Temple University Emory University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) European Chiropractors Union Children's Hospital Boston Colchester Hospital University NHS Foundation Trust Covance GE Healthcare EMSI National Institute for Chiropractic Research Muscular Dystrophy Association Phoenix Children's Hospital OMRIX Biopharmaceuticals University of California, Los Angeles Cancer and Leukemia Group B University Health Network, Toronto University of Iowa Sarcoma Alliance for Research through Collaboration Westat Medivation, Inc. International Breast Cancer Study Group National Institute of Neurological Disorders and Stroke (NINDS) ClinPhone, Inc. Southwest Oncology Group Multi-Imagem and CDPI, Rio de Janeiro, Brasil Dutch Cancer Society Gary Cutter, PhD Murdoch Childrens Research Institute Chiltern International Inc. Janssen Research & Development, LLC Birmingham Children's Hospital NHS Foundation Trust Southwestern Oncology Group (SWOG) CIHR Canadian HIV Trials Network Royal Liverpool University Hospital Vertex Pharmaceuticals Incorporated UCB, Inc. Royal Hospital for Sick Children Trimeris Cystic Fibrosis Foundation Eisai Limited Eisai Inc. -
ECIO 2021 Disclosures
Pres. No. Presenter Disclosure Company G. Argilés Honoraria or consultation 101.2 Roche, Amgen, Merck Serono, BMS, Bayer, Sevier (New York, US) fees G. Argilés 101.2 Grants/research supports Bayer (New York, US) R. Duran Honoraria or consultation 101.3 BTG/Boston Scientific, Guerbet (Lausanne, CH) fees R. Duran Society of Interventional Oncology/Immuno-oncology 101.3 Grants/research supports (Lausanne, CH) Research Grant, BTG/Boston Scientific, Guerbet F. Veloso Gomes Honoraria or consultation 102.1 Bayer, Roche (Lisbon, PT) fees F. Veloso Gomes 102.1 Grants/research supports Terumo (Lisbon, PT) N. Costa Speaker agreement for Merit Medical, Terumo, Bayer 102.3 Other support (Lisbon, PT) and Philips M. R. Meijerink Honoraria or consultation 301.1 Medtronic, Angiodynamics (Amsterdam, NL) fees M. R. Meijerink Medtronic, Angiodynamics, Johnson-Johnson, Bristol- 301.1 Grants/research supports (Amsterdam, NL) Myers-Squibb J. Palussière 401.3 Grants/research supports Boston Scientific (Bordeaux, FR) C. Pettinato Honoraria or consultation 401.4 Sirtex (Milan, IT) fees P. Schirmacher Honoraria or consultation 402.1 Roche, BMS, Incyte, MSD (Heidelberg, DE) fees Participation in a company P. Schirmacher 402.1 sponsored speaker’s Janssen, Incyte (Heidelberg, DE) bureau P. Schirmacher 402.1 Grants/research supports BMS, Incyte (Heidelberg, DE) J. Debus 402.4 Grants/research supports Merck Serono, Siemens, Accuray (Heidelberg, DE) Roche, Bayer, Sanofi, BMS, Lilly, Novartis, EISAI, A. Vogel Honoraria or consultation 402.5 AstraZeneca, Merck, Incyte, Ipsen, PierreFabre, MSD, (Hannover, DE) fees Janssen T. De Baère Honoraria or consultation 402.6 Sirtex / Boston Scientific / Terumo (Villejuif, FR) fees T. De Baère 402.6 Grants/research supports Terumo (Villejuif, FR) J. -
Oncology Drugs in the Pipeline
60 HemOnc today | MAY 25, 2013 | Healio.com/HemOnc Oncology Drugs in the Pipeline HemOnc Today presents the most recent information about oncology drugs in the pipeline. Drugs listed here are in phase 2 or phase 3 development for a variety of indications. Clinicians can use this chart as a quick reference to learn about the status of those drugs that may be clinically signifi cant to their practice. GGenericeneric nnameame ((BrandBrand nname,ame, MManufacturer)anufacturer) IIndication(s)ndication(s) DDevelopmentevelopment sstatustatus 131I-chTNT-1/B mAb (Cotara, Peregrine Pharmaceuticals) glioblastoma phase 2 18F-fl uorothymidine (Merck) breast cancer diagnosis phase 2 A6 (Angstrom Pharmaceuticals) ovarian cancer phase 2 abagovomab (Menarini) ovarian cancer phase 3 abexinostat (Pharmacyclics) follicular lymphoma, mantle cell lymphoma phase 2 ABI-008 (Celgene) prostate cancer phase 2 ABIO-0501 (Abiogen Pharma) chronic myeloid leukemia phase 2 abiraterone (Zytiga, Janssen Biotech) breast cancer/prostate cancer phase 2/phase 3 ABT-888 (Abbott Laboratories) breast cancer, colorectal cancer, fallopian tube cancer, lymphoma, mela- phase 2 noma, non–small cell lung cancer, ovarian cancer ACE-041 (Acceleron Pharma) head and neck cancers phase 2 acolbifene (EndoCeutics) breast cancer phase 2 ACY-1215 (Acetylon Pharmaceuticals) myeloma phase 2 ado-trastuzumab emtansine (Kadcyla, Genentech) fi rst-line and third-line HER-2–positive breast cancer phase 3 ADXS-HPV(Advaxis) cervical cancer phase 2 AE37 peptide vaccine (Antigen Express) breast cancer phase 2 AEE788 (Novartis Pharmaceuticals) glioblastoma phase 2 AEG35156 (Aegera Therapeutics) acute myelogenous leukemia, chronic lymphocytic leukemia, B-cell phase 2 lymphoma AEZS-108 (Aeterna Zentaris) bladder cancer, endometrial cancer, ovarian cancer, prostate cancer phase 2 afatinib (Boehringer Ingelheim) glioblastoma/breast cancer, non–small cell lung cancer, head and neck phase 2/phase 3 READ PERSPECTIVE cancers on this drug from Tobenna Nwizu, MD, on page 76. -
Representing the Drug Or Medical Device Manufacturer in an Investigation
This material is chapter 10 of Deskbook on Internal Investigations, Corporate Compliance, and White Collar Issues (2nd ed.), by Arnold & Porter Kaye Scholer LLP (©2016 & Supp. 2019 by Practising Law Institute), www.pli.edu. Reprinted with permission for www.arnoldporter.com. Not for resale or redistribution. Chapter 10 Representing the Drug or Medical Device Manufacturer in an Investigation § 10:1 Introduction § 10:2 The Statutory and Regulatory Scheme § 10:2.1 The FDCA § 10:2.2 The Anti-Kickback Statute § 10:2.3 The False Claims Act § 10:2.4 The Foreign Corrupt Practices Act § 10:2.5 Other Regulatory Tools [A] Corporate Integrity Agreements [B] Exclusion from Federal Healthcare Programs [C] Fines § 10:3 Recent Developments in Enforcement Actions § 10:3.1 Enforcement Actions Against Pharmaceutical Manufacturers § 10:3.2 Enforcement Actions Against Medical Device Manufacturers § 10:3.3 Individual Accountability § 10:3.4 Sorrell, Caronia, and First Amendment Challenges § 10:4 FDA Warning and Untitled Letters to Pharmaceutical Companies Regarding Promotional Materials § 10:5 Compliance Strategies § 10:6 Conclusion (White Collar, Rel. #6, 11/19) 10–1 ©2016 & Supp. 2019 by Practising Law Institute. § 10:1 White Collar Issues Deskbook § 10:1 Introduction The variety of criminal statutes and theories used to prosecute drug and device manufacturers is so diverse as to defy easy summary. At one end of the spectrum are those dealing with general offenses, such as the Civil War–era statute criminalizing the submission of false claims to a department or agency of the United States,1 or the mail2 and wire fraud3 statutes—each of which could be used by the government against pharmaceutical companies and medical device manufacturers and their executives. -
Venous Thromboembolism in Over 16S: Reducing the Risk of Hospital-Acquired Deep Vein Thrombosis Or Pulmonary Embolism (Update) Stakeholders
Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism (Update) Stakeholders Academy for Healthcare Science Active Lifestyles, Salford Community Leisure Alere Ltd AntiCoagulation Europe ArjoHuntleigh Ashford and St Peter's Hospitals NHS Trust Association for Perioperative Practice Association of Anaesthetists of Great Britain and Ireland Association of Directors of Public Health Association of Independent Healthcare Organisations Astrazeneca UK Ltd Atrial Fibrillation Association Australian Commission on Safety and Quality in Health Care Barnet Enfield and Haringey Mental Health Trust Barnsley Hospital NHS Foundation Trust Barts Health NHS Trust Basildon and Thurrock University Hospitals NHS Foundation Trust Bayer plc Belfast Health and Social Care Trust Besins Healthcare Betsi Cadwaladr University Health Board BHR Pharmaceuticals Ltd Biocompatibles Birmingham Women’s NHS Foundation Trust Black and Ethnic Minority Diabetes Association Boehringer Ingelheim Ltd Bolton Council Boston Scientific Bristol-Myers Squibb Pharmaceuticals Ltd British Association of Critical Care Nurses British Association of Day Surgery British Association of Prosthetists & Orthotists British Dietetic Association British Geriatrics Society British Heart Foundation British Lymphology Society British Medical Association British Medical Journal British National Formulary British Nuclear Cardiology Society British Orthopaedic Association British Pregnancy Advisory Service British Psychological Society British -
Royal Free London NHS Foundation Trust Open Studies
Royal Free London NHS Foundation Trust Open Studies R&D No Short Title Sponsor Organisation Principal Investigator EuroSIDA HIV/AIDS 10 year Eurpean cohort - European Virology co-ordinating 5162 Centre for Health and Infectious Disease Research Professor Clive Loveday centre (2000-2004) 5658 Fabry outcome survey [FOS] Shire Human Genetic Therapies UK Ltd Dr Derralynn Hughes 6339 Clinical pancreatic islet transplantation in patients with insulin dependent diabetes. The Royal Free Hospital Dr Martin Press Elucidating the pathogenesis of systemic sclerosis by studying skin, blood and 6398 Royal Free London NHS Foundation Trust Prof Carol M Black tissue samples from s Non-invasive prenatal diagnosis of haemophilia using free fetal DNA in maternal 6441 Royal Free London NHS Foundation Trust Miss Rezan A Abdul-Kadir plasma. British Regional Heart Study (BRHS). Strategies for the prevention of cardiovascular 6755 University College London Professor P Whincup disease in olde Database of patients with movement disorders and prospective collection and 6540 UCL Dr Anette Schrag storage of DNA samples. 6884 The Investigation of the cause and the mechanism of Immunodeficiency diseases. Royal Free London NHS Foundation Trust Prof Bodo Grimbacher Bilibaby- The Relationship Between Neonatal Scleral Tone and Serum Bilirubin 6899 UCL Dr Alastair. Sutcliffe Levels. 7190M Identification and molecular analyses of families with susceptibility to breast cancer. ICR Dr James Mackay The Gaucher Registry: an ongoing, observational database that tracks the natural