• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Solution Center
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Solution Center
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Pharma Supply Chains: From Fragile to Agile

    Advanced Manufacturing and a Roadmap to the Facility of the Future

    Solving Pharma’s Underlying Rebate Leakage Problem

    Pharmaceutical Labeling: Overcoming Regulatory & Operational Challenges

    Revolutionizing Pharma’s Supply Chain
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Univercells Expands into the U.S. With New Offices in Andover, MA

    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment

    Ionis, Roche Partner on RNA-targeted Programs for AD and HD

    Sanner Group Opens Second Manufacturing Facility in China

    Körber Integrates Werum PAS-X MES with Bausch+Ströbel Systems
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Univercells Expands into the U.S. With New Offices in Andover, MA

    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment

    Sanner Group Opens Second Manufacturing Facility in China

    Körber Integrates Werum PAS-X MES with Bausch+Ströbel Systems

    "3 Key Trends" with Srinivasan Shanmugam
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Pharmaceutical Continuous Manufacturing: USP Technical Guide

    Mikart Expands Production and Packaging Capabilities

    Flavor Masking for Rx and OTC Drugs

    Prefilled Syringe Production: Filling a Need with Modern Equipment

    Making the Complex, Simple: A Roadmap for Your OSD Journey
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment

    Ionis, Roche Partner on RNA-targeted Programs for AD and HD

    Modern Partnerships with CROs

    Merck KGaA, Quris-AI Expand Collaboration

    BioCity, AstraZeneca Partner on Treatment of Advanced HCC
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Pharmaceutical Labeling: Overcoming Regulatory & Operational Challenges

    Rentschler Biopharma’s ATMP UK Facility Receives MHRA Approval

    Aurisco's Manufacturing Site in China Clears FDA Inspection

    LighthouseAI Secures $2.25M Investment to Grow Supply Chain Products

    Valisure, DoD Conduct Pharmaceutical Quality Risk Assessment Study
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    AMERIPHARMA

    Syngene International Ltd.

    U.S. Pharmacopeia (USP)

    CMC Pharmaceuticals

    Lannett CDMO
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    AMERIPHARMA

    Syngene International Ltd.

    U.S. Pharmacopeia (USP)

    CMC Pharmaceuticals

    Lannett CDMO
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Microsites
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Top Companies Report

    Gilead Sciences

    ...

    Gilead Sciences
    07.15.19
    Headquarters: Foster City, CA
    twitter.com/gileadsciences
    www.gilead.com


    Headcount: 11,000
    Year Established: 1987
    Revenues:  $22,127  (-15%)
    Net Income:  $5,455  (+18%)
    R&D:  $5,018  (+34%)

    TOP SELLING DRUGS  
    Drug Indication 2018 Sales (+/-%)
    Genvoya HIV treatment $4,624 26%
    Truvada HIV treatment $2,997 -4%
    Epclusa Pre-exposure prophylaxis (PrEP) $1,966 -44%
    Odefsey Hepatitis C treatment $1,598 44%
    Descovy Liver cirrhosis $1,581 30%
    Harvoni HIV treatment $1,222 -72%
    Atripla HIV treatment $1,206 -33%
    Biktarvy Hepatitis C treatment $1,184 n/a
    Letairis HIV treatment $943 6%
    Ranexa HIV treatment $758 6%


    Climbing out of a two-year downturn, the light at the end of the tunnel revealed itself in the first quarter of 2019, with revenues up 4% to $5.3 billion and earnings up 28% to $2.0 billion. Still recovering financially from HCV franchise declines, Gilead has finally returned to growth thanks to its flagship HIV franchise and Yescarta, its first commercially available CAR-T cancer therapy.

    While chronic hepatitis C virus (HCV) product sales, which consist of Epclusa, Harvoni, Vosevi, and Sovaldi, were down nearly 60% to $3.7 billion in 2018, and down 26% in the first quarter of 2019 to $790 million, HIV product sales were up 12% to $14.6 billion for the year, primarily due to the launch of Biktarvy and the continued uptake of Descovy, Genvoya and Odefsey. In 1Q19, HIV product sales were up 13% to $3.6 billion, thanks to Biktarvy.

    Yescarta, a chimeric antigen receptor (CAR) T cell therapy launched in the U.S. in October 2017 to treat large B-cell lymphoma, generated $264 million in sales in 2018. Resulting from the 2017 acquisition of Kite Pharma, Yescarta was the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). Yescarta generated $96 million in sales in the first quarter compared to $40 million in 1Q18.

    Kite Pharma, a Gilead company, is significantly expanding its ability to manufacture a variety of CAR-T therapies, including Yescarta, for both clinical and commercial use with a new biologics facility in Urbana, MD. Kite specializes in cancer treatments and the facility will focus on chimeric antigen receptor T (CAR-T) therapies, which uses a patient’s white blood cells to destroy cancer cells. Producing these therapies requires complex processes and the new facility aims to better meet these specifications. It will become part of Kite’s commercial manufacturing network that includes sites in CA and the Netherlands. Yescarta is also being investigated in solid tumors. To date, CAR-T therapies have only proven successful in blood cancers.

    Executive moves
    As of March 1, 2019, Daniel O’Day took the helm as Gilead’s chairman and chief executive officer, succeeding John F. Milligan, Ph.D., who stepped down after a 28-year career with the company. Mr. O’Day previously served as CEO of Roche Pharmaceuticals, a position he held since 2012, and prior to that led Roche Diagnostics. His career spans three decades of leadership roles across North America, Asia Pacific and Europe.   

    In other recent executive moves, Gilead appointed Johanna Mercier as its new chief commercial officer, joining the senior leadership team on July 1, and succeeding Laura Hamill, who is departing from Gilead after less than a year in the role.

    Also, Robin Washington, executive vice president and chief financial officer, plans to retire from her role, effective March 1, 2020, and Alessandro Riva, MD, executive vice president, Oncology Therapeutics, has decided to leave the company to pursue another opportunity. The company has yet to name successors for these two roles.
    R&D
    Updates to Gilead’s HIV and liver diseases programs include approvals in China of Harvoni for the treatment of HCV genotype 1-6 infection, Vemlidy for the treatment of chronic HBV infection, and Descovy for the treatment of HIV-1 infection. Also, findings from two studies support the further development of GS-6207, a first-in-class, investigational capsid inhibitor, which may represent a novel approach to HIV treatment due to its long-acting characteristics and potent antiviral activity seen in vitro.

    However, recent results from a Phase III study evaluating the safety and efficacy of selonsertib, an investigational, once daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), for patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH), did not meet its primary endpoint of improvement in fibrosis without worsening of NASH.

    Gilead’s oncology and cell therapy programs recently achieved promising study results from a Phase I/II study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in relapsed or refractory acute lymphoblastic leukemia. With a median follow-up of 15 months following a single infusion of KTE-X19, 69% of patients achieved complete tumor remission, and the rate of undetectable minimal residual disease in patients who achieved complete tumor remission was 100%.

    Also, two-year efficacy and safety data of  Yescarta in patients with refractory large B-cell lymphoma, showed 39% of patients were in an ongoing response with a median follow up of 27 months.
    Additionally, results from an ongoing Phase III study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in moderate-to-severe active rheumatoid arthritis, achieved its primary endpoint of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 24. The proportion of patients achieving the primary endpoint was significantly higher for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with MTX alone.

    Lastly, a Phase II study of filgotinib in severe active ankylosing spondylitis (AS) achieved its primary endpoint of significantly greater improvements in AS Disease Activity Score at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo. More patients receiving filgotinib also achieved an ASAS20 response compared to those treated with placebo.

    Major investments
    In its most recent deal, Gilead will pay Nurix Therapeutics $45 million up front and as much as $2.3 billion in milestones under a global strategic collaboration to develop and commercialize a pipeline of innovative targeted protein degradation drugs for cancer and other challenging diseases. Dysregulated and/or mutated proteins play a central role in the development and progression of many human diseases. Nurix’s technology platform is focused on the manipulation of the ubiquitin system and its component E3 ligases, the key enzymes responsible for controlling protein levels in human cells.
    Under an alliance with Agenus, Inc. focused on the development and commercialization of novel immuno-oncology therapies, Agenus will receive $150 million upfront including $30 million equity investment, and the agreement also includes approximately $1.7 billion in potential milestones.

    A strategic collaboration with Scholar Rock Holding Corp. aims to discover and develop highly specific inhibitors of transforming growth factor beta activation for the treatment of fibrotic diseases. Scholar Rock will receive $80 million upfront in payments, including the purchase of Scholar Rock stock, and the company is eligible to receive up to an additional $1.4 billion in potential payments across three programs.

    Moreover, a global strategic collaboration with Tango Therapeutics aims to develop and commercialize a pipeline of innovative targeted immuno-oncology treatments. Tango will receive $50 million upfront and is eligible to receive approximately $1.7 billion in additional payments across all programs.

    Finally, Gilead is not giving up on nonalcoholic steatohepatitis (NASH) and has partnered with several companies to help advance its efforts. Gilead and Novo Nordisk are collaborating on a clinical trial combining compounds from their respective pipelines in NASH. The trial will combine Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor). The companies are also exploring the potential to collaborate on preclinical research to advance understanding of the disease. 

    Under a licensing and collaboration deal with Yuhan Corp. to develop novel NASH candidates, Gilead acquired global rights to small molecules against two targets for $15 million upfront and up to an additional $770 million in potential milestones.

    Lastly, Gilead and insitro partnered to discover and develop NASH therapies leveraging insitro’s Human (ISH) platform to create disease models for NASH and discover targets that have an influence on clinical progression and regression of the disease. The insitro Human (ISH) platform applies machine learning, human genetics and functional genomics to generate and optimize unique models to drive discovery and development. Gilead can advance up to five targets identified through this collaboration. 
    Related Searches
    • Manufacturing
    • china
    • ceo
    • hepatitis
    Suggested For You
    Mogene Mogene
    Softweb Solutions Softweb Solutions
    Top 25 Pharma and Biopharma Companies Top 25 Pharma and Biopharma Companies
    Novo Nordisk Novo Nordisk
    Johnson & Johnson Johnson & Johnson
    Roche Roche
    Gilead Inks 10-year $5B Deal with Galapagos Gilead Inks 10-year $5B Deal with Galapagos
    The Top Companies Report The Top Companies Report
    Gilead Appoints CEO of Kite Gilead Appoints CEO of Kite
    Boehringer, Yuhan Enter NASH Pact Boehringer, Yuhan Enter NASH Pact
    Vineti Opens New Regional HQ in Maryland Vineti Opens New Regional HQ in Maryland
    Gilead, Goldfinch Enter Kidney Collaboration Gilead, Goldfinch Enter Kidney Collaboration
    Are Biotech Companies Strong Investments? Are Biotech Companies Strong Investments?
    The Manufacturing Revolution In Medicine The Manufacturing Revolution In Medicine
    Financial Report: Gilead Financial Report: Gilead

    Related Buyers Guide Companies

    • Mogene

      ...
      Craig Morley, CEO 11.17.20

    • Softweb Solutions

      ...
      Micheal Jury, Marketing Manager 09.23.20

    • Top 25 Pharma and Biopharma Companies

      Top 25 Pharma and Biopharma Companies

      ...
      07.15.19


    • Novo Nordisk

      Novo Nordisk

      ...
      07.15.19

    • Johnson & Johnson

      Johnson & Johnson

      ...
      07.15.19

    Loading, Please Wait..
    Breaking News
    • Univercells Expands into the U.S. With New Offices in Andover, MA
    • Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment
    • Ionis, Roche Partner on RNA-targeted Programs for AD and HD
    • Sanner Group Opens Second Manufacturing Facility in China
    • Körber Integrates Werum PAS-X MES with Bausch+Ströbel Systems
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Pharma Supply Chains: From Fragile to Agile
    • Overcoming Stressors in Knowledge Transfer
    • Innovations in Pharma Packaging
    • HPAPI Manufacturing Trends
    • Sustainable Packaging in Pharma: No Longer a Pipe Dream
    • Revolutionizing Pharma’s Supply Chain
    • Pharmaceutical Labeling: Overcoming Regulatory & Operational Challenges
    • Solving Pharma’s Underlying Rebate Leakage Problem
    • Advanced Manufacturing and a Roadmap to the Facility of the Future
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    D2C Supplement Brand Launches Blood Sugar Support Supplement, Gluco-Control
    Natrol Launches First Non-Melatonin Sleep Supplement
    Metagenics Releases Consumer Survey on Menopausal Support Supplement
    Coatings World

    Latest Breaking News From Coatings World

    California Sports Surfaces Celebrates 70 Years
    ROSS Offers Cost-Effective, Expertly Reconditioned Equipment
    AkzoNobel Shares Sustainable Architectural Solutions at Conference
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman
    SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device
    ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Univercells Expands into the U.S. With New Offices in Andover, MA
    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment
    Ionis, Roche Partner on RNA-targeted Programs for AD and HD
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    YSL Beauty Taps Finn Wolfhard, Lil Yachty & More for Fragrance Campaign
    74% of Makeup Users Open to Affordable ‘Dupes,’ Mintel Says
    Stoelzle Glass Group Names New CEO
    Happi

    Latest Breaking News From Happi

    The Estée Lauder Companies Launches 2023 Breast Cancer Campaign
    BASF Personal Care Introduces New Cosmetic Ingredient
    Breakfast with Oral Care Benefits?
    Ink World

    Latest Breaking News From Ink World

    Siegwerk’s Climate Targets Validated by SBTi
    ROSS Offering Cost-Effective, Expertly Reconditioned Equipment
    Amcor plc Adds Lucrèce Foufopoulos-De Ridder to Board of Directors
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    SABIC and partners launch bio-based IML solution for food packaging
    tesa completes expansion of Michigan manufacturing facility
    Comexi and Asahi to host 'Effortless Platemaking' event
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Greentech Introduces Air Filter with Advanced Odor Elimination
    Ontex Divests Pakistan Operations to ASAIA Holding
    Goodnites Bedwetting Underwear Recognized by Good Housekeeping
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Lazurite Adds Benchmark Medical as a Distributor for its ArthroFree Wireless Camera System
    ChitogenX Granted New U.S., Canadian ORTHO-R Patent
    Centinel Spine prodisc System Surpasses 2,500-Implant Milestone
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Jabil Posts Fourth Quarter, Fiscal Year 2023 Results
    Ink-Borne ‘Chiplets’ Could Lead to Printable Displays, Electronics and More
    SCHOTT Strengthens Glass Substrate Portfolio

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login