Corporate Strategies Fact File: Coronavirus Pipeline and Corporate Updates

Total Page:16

File Type:pdf, Size:1020Kb

Corporate Strategies Fact File: Coronavirus Pipeline and Corporate Updates Corporate Strategies Fact File: Coronavirus Pipeline And Corporate Updates Executive Summary confirmed cases of COVID-19, the newly named The coronavirus outbreak is at a tipping point, disease caused by the coronavirus outbreak that after which its development into a global originated in Wuhan, China, at the end of 2019. pandemic may be unstoppable. Companies large According to the World Health Organization, there and small have mobilized in the fight against the have been more than 3,190 deaths from the virus disease bringing new and repurposed treatment and there are now cases recorded in 76 countries. options into development and preparing their business for the unsteady months ahead. While more than 80,000 of the coronavirus infections are in China, substantial outbreaks have occurred in South Korea, Italy and Iran (see exhibit 1a & 1b). As of March 4, 2020, there were more than 93,000 Exhibit 1a: The Five Worst Hit Countries Data correct as of 4 March 2020 Source: WHO Data 2 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Exhibit 1b: Virus Spread Outside Of China Data correct as of 4 March 2020 Source: WHO Data R&D Progress have been launched in China to determine Research efforts are now underway to investigate the safety and efficacy of two existing antiviral a range of novel and established drug platforms, therapies: AbbVie Inc.’s HIV combination Kaletra including repurposed medicines, prophylactic (lopinavir and ritonavir) and Gilead Sciences vaccines and therapeutic treatments against the Inc.’s nucleotide analogue remdesivir, which was virus, known as SARS-CoV-2 (see Exhibit 2). already under development for Ebola. The World Health Organization is leading the According to data from Pharmaprojects there charge by working with Chinese researchers to are 35 vaccines and therapies in development conduct rapid clinical trials of existing antiviral against COVID-19, though the majority of recent treatments to treat patients infected with SARS- R&D efforts have been directed towards vaccine CoV-2. It announced on 20 February that trials approaches. 3 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Exhibit 2: COVID-19 Development Pipeline In March 2020 Data correct as of 4 March 2020 Source: Pharmaprojects | Informa Pharma Intelligence 4 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) A vaccine from US biotech firm Moderna Inc. their programs for SARS-CoV-2. US biotech Inovio for COVID-19 has been readied for a Phase I Pharmaceuticals Inc. has said it is preparing its trial, moving from the lab to ready for testing vaccine INO-4700 for clinical studies as early as in humans in a remarkable 42 days. It uses this summer. The Nasdaq-listed firm recently messenger RNA (mRNA) technology. The partnered with Beijing Advaccine for tests on Cambridge, MA-based company shipped its patients with COVID-19 disease in China. mRNA-1273 vaccine to the National Institute of Allergy and Infectious Diseases (NIAID) on UK-based GlaxoSmithKline PLC is also partnering 24 February for use in a US Phase I study. It with Chinese firm Clover Corp. Ltd. to develop a targets a pre-fusion stabilized form of the Spike novel protein-based COVID-19 S-Trimer vaccine, protein, selected by the firm in collaboration with developed by Clover. GSK will provide the investigators at the NIAID’s Vaccine Research company with its pandemic adjuvant system to Center. (Also see “Moderna Marches First evaluate the candidate in preclinical studies, and Coronavirus Vaccine To US Test “ - Scrip, 25 Feb, Clover is readying its cGMP facilities in China for 2020.) scale-up and mass production. To date, Moderna has produced and released Johnson & Johnson and Sanofi Pasteur meanwhile more than 100 batches of the vaccine candidate are partnering with the US Department of Health from its Norwood manufacturing site for human and Human Services to develop vaccines against clinical trials. the outbreak. Sanofi Pasteur, the vaccines division of Paris-based Sanofi, has confirmed a new Messenger RNA is increasingly becoming a research effort being funded by the US agency leading technology in fighting virus outbreaks and BARDA, which will focus on bringing a new vaccine Moderna is developing six vaccines: a respiratory into in vitro testing within six months and into syncytial virus (RSV) vaccine for older adults, initial clinical trials within 12-18 months. an RSV vaccine for young children, a meta- pneumovirus vaccine, influenza H7N9 vaccine and Despite the rapidity of the response from vaccine the COVID-19 vaccine. companies, these 12-18 month timelines will not see the vaccines distributed on a mass scale, Meanwhile, on 4 March, Vir Biotechnology Inc. which could take at least another 12 months. and Alnylam Pharmaceuticals Inc. announced By this time, the coronavirus threat may have that they would move forward with one or more receded or, alternatively, grown. Experts say the RNAi (RNA interference) therapeutics targeting profile of the disease – less frequently deadly SARS-CoV-2. The companies are expanding on a than the SARS outbreak of 2002-03, but more 2017 alliance to utilize Alnylam’s recent advances easily transmitted – suggests it could become a in lung delivery of novel conjugates of siRNA – permanent background threat similar to seasonal the molecules that mediate RNAi – together with influenza. Vir’s infectious disease expertise. They expect to progress one or more siRNAs to treat SARS-CoV-2 Biopharma Market Worries and potentially other coronaviruses as well. Vir Major events worldwide, such as Facebook’s will lead all development and commercialization annual F8 Conference in San Jose, CA, and the of any selected candidates. World Indoor Championships in Nanjing, China, have been cancelled – with rumors that the Multiple other vaccine developers are accelerating Olympics games, due to begin on July 24 in Tokyo, 5 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) could also be postponed. In the biopharma Anxiety about the continuing spread of sector, two conferences scheduled to take place in coronavirus is also evidenced by companies Amsterdam in March – the Medicines for Europe cutting back on appearances at investor conference on biosimilars and the World Pharma conferences and advising employees to eliminate Pricing Congress – have been postponed until unnecessary travel. September. Global Reach Of Coronavirus For the moment, Vertex and Seattle Genetics The global outbreak and its disruption of travel represent the most cautious response, as many and business has had an immediate impact on the other companies carried on plans for the Cowen economic outlook: $1.7tn was wiped off US stock conference – including Merck & Co. Inc. and market values last week, with pharma majors Alnylam Pharmaceuticals Inc.. such as Pfizer Inc. and Merck & Co. Inc. as badly affected as any another blue chip company. 6 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Medtech Ups And Downs Investor fears are at an all-time high over the And market leader Medtronic PLC has also impact of coronavirus and companies are having reported that it will be impacted financially by the to act now on decision-making to protect overall reduction in elective surgeries in China related performances in 2020. The outbreak has been to the outbreak. The country accounts for 7% of likened to the SARS epidemic in 2002-03, but the company’s global business, generating about China’s economy is seven times larger now $2.14bn for Medtronic in 2019. China is also the that it was then, making up 16% of global GDP, location of Medtronic’s largest manufacturing and compared with 4% in 2003. research facilities outside of the US. In the medtech sector, supply chain disruption But it is not all doom and gloom for every and a decrease in elective surgeries are having medtech company. Manufacturers of syringes the biggest impact on the industry. Medtech and sets for blood collection could be one of multinationals with manufacturing plants the biggest financial winners in the outbreak, so clustered in China are expecting disruption to Becton Dickinson & Co. could see a financial boost supply chains due to travel bans and quarantine from the crisis. measures. Boston Scientific Corp. management announced that it expects the outbreak to lead The pandemic has also increased demand for to a $10-40m loss in first-quarter sales with lower respiratory masks and protective gear. The share procedures volumes and disrupted supply chains price for conglomerate 3M Co. has risen since in China. Travel limitations are also expected to the outbreak as a result of an increase in sales of hinder exports from China to the US and Europe the company’s face masks. 3M announced it had for finishing product assembly. increased production to meet demand. The virus has caused uncertainty for Smith & Medtech companies in the race to produce a Nephew PLC’s 2020 outlook. China accounts for diagnostic test for COVID-19 may also begin first 7% of the orthopedics company’s revenues and sales this month. French company Novacyt SA has been a key growth driver to its business. The announced it has signed its first major agreement company’s annual results showed that emerging with a distributor to supply a COVID-19 test to two markets, including China, helped boost revenues Asian territories outside mainland China. Initial in 2019 with sales in the region up 16.6% in the sales, which are subject to local emergency-use fourth quarter. During its 20 February sales and approval, are anticipated to be £2.1m during the earnings call, Smith & Nephew executives said first six months of the agreement. It is anticipated the company expects a considerable impact that the first sales under this agreement will take on business in February as a result of a lack of place in March 2020.
Recommended publications
  • Sample of Current Attendees
    SAMPLE OF CURRENT ATTENDEES TITLE COMPANY Sr Mgr Global Meetings Mgmt Amgen Prin Tradeshow Spec Boston Scientific Events Mgr PR Medical Events Sr Buyer Pharma Ops ITA Group Travel Services Supv Grifols Asia Pacific Pte Ltd Compliance Specialist GCO Spend Jouney Lead Global Mtgs Travel Events UCB Category Project Specialist Roche Events & Travel Mgr Teva Brasil Mgr Event Mgmt Bayer Congress Mgr MediCongress Services Global Events Mgmt Sr Assoc Amgen Assoc Dir Congresses & Events MSD Internal Event Mgr Gilead Sourcing Mgr BMS Dir Sourcing Meeting Alliance Custoerm Srvs Meetings Mgr Eli Lilly & Company Sr Congress Mgr Novartis Pharmaceuticals Sourcing Mgr BCD Meetings & Events Sr Buyer Meetings & Incentives Worldwide Sourcing Mgr American Express GBT Acct Mgr Venue Sourcing Ashfield Meetings & Events Mtg Planner AbbVie Sr Sourcing Mgr CWT Dir Sourcing Planning Partners International Meetings Mgr ACOG Meeting Mgr Pfizer Canada Global Event Lead Astellas Meeting & Events Sanofi Events Specialist Cook Medical Meetings & Events Mgr Pfizer Spain Pfizer Spain Sr Mgr Hotel Procurement Meetings & Incentives WorldWide Inc Event Planner SFU BCcampus Mgr Global Strategic Mtg Mgmt Teva Pharmaceuticals Global Mtgs & Events Virtual Mtgs Specialist AstraZeneca Global Congress Strategy Lead MSD Assoc Dir Congresses & Events Alnylam Pharmaceuticals Event Planner AbbVie Institutional & Scientific Events Coordr Almirall Congress Mgr AO Spine Sr Meeting Planner Medtronic Mgr Global Mtgs Mgmt Alnylam Pharmaceuticals Meeting Planner AbbVie Global Audit Meetings
    [Show full text]
  • View State-Of-The-Art Clinical Symposium Disclosures
    Planning Committee Members The following Planning Committee members have no relevant financial relationship(s) with ineligible companies to disclose. Mastering E/M Changes for 2021 • Antanya Chung-Gardiner, BSc • Melesia Tillman 2021 Access in Rheumatology Planning Committee • Marcus Snow, MD 2021 Fellow-in-Training Educational Session Planning Committee • Nadia Elias, MD • Tate Johnson, MD • Justin Levinson, MD, MBA • Jean Lin, MD, PhD • Megan Lockwood, MD • Tyler Reese, MD • Zahra Rehman, MD • Didem Saygin, MD • Rachel Wallwork, MD 2021 State-of-the-Art Clinical Symposium Planning Committee • Sobia Hassan, MD • Aman Kugasia, MD • Jeanie Lee, MD • Manjari Malkani, MD • Rebecca Manno, MD, MHS The following Planning Committee members have relevant financial relationship(s) with ineligible companies to disclose. 2021 Access in Rheumatology Planning Committee • Christopher Phillips, MD - Pfizer (Self): 5 2021 Fellow-in-Training Educational Session Planning Committee • Mary Mamut, DO - Bendcare (Self): 8 2021 State-of-the-Art Clinical Symposium Planning Committee • Rohit Aggarwal, MD, MS - AbbVie, Amgen, , Genzyme, , Novartis, Roche, Sandoz, UCB (Self): 1, 5, 2; AdMIRx, Inc. / Now Q-32 (Self): 5, 2; Alexion (Self): 5; Argenx (Self): 5; AstraZeneca (Self): 5; Boehringer Ingelheim (BI) (Self): 5; Bristol-Myers Squibb(BMS) (Self): 5, 2; Corbus (Self): 5; CSL Behring (Self): 1, 5; EMD Serono (Self): 5, 2; Genentech (Self): 2; Janssen (Self): 5; Kezar (Self): 5; Kyverna (Self): 5; Mallinckrodt (Self): 1, 2; Octapharma (Self): 1, 5; Orphazyme (Self): 1; Pfizer (Self): 5, 2; Scipher Medicine: 5 • Narender Annapureddy, MD, MS - Medpage (Self): 1, Expert Reviewers for the ACR Reading Room section of MedPage Today. • Lianne Gensler, MD - AbbVie (Self): 1, 5; Eli Lilly (Self): 5; Gilead: 5; GSK (Self): 5; Janssen (Self): 5; Novartis (Self): 5; Pfizer (Self): 5, 2; UCB: 5 Faculty The following Faculty members have no relevant financial relationship(s) with ineligible companies to disclose.
    [Show full text]
  • Pushing the Limits: Being Innovative in a Regulated Industry
    ISPE Boston Area Chapter Presents: Pushing the Limits: Being Innovative in a Regulated Industry Thursday, November 15, 2018 5:30 pm to 8:30 pm Alnylam 300 Third Street THANK YOU TO OUR PROGRAM SPONSOR Cambridge, MA 02142 EVENT INFORMATION: Join the ISPE Boston Area Chapter for an open forum on innovation. Push your own limits by participating in our pre-program activity with pharma colleagues while enjoying refreshments and a cash bar. Please have valid I. D. ready for a security checkpoint. Walk-ins are still welcome to register onsite. PROGRAM SUMMARY: Innovation comes in many forms ranging from scientific breakthroughs to new technologies and processes. This panel discussion will focus on innovation, and how it impacts the phases of the drug development lifecycle through regulatory compliance. The intent of this discussion is to allow for an interactive look into how innovation can be applied in a regulated field by providing an open forum for the moderator and audience to interact with industry leaders. If you want to better understand how to integrate innovation in your business, or the effects of innovation on your business, this panel will provide much-needed insight. By having people walking the walk of innovation from Development, Engineering, Manufacturing and Regulatory Affairs, we will be able to look to interdependencies, conflict, and synergies of innovative products. Topics will range from technical, personnel, and regulatory decisions needed to incorporate innovation into your business. WHO SHOULD ATTEND: Development, Engineering, Manufacturing, Quality Assurance and Regulatory Affairs personnel. Anybody that wants to better understand how to develop and execute teams when implementing innovative platforms or technologies.
    [Show full text]
  • Human Sequencing Resource with UK Biobank
    January 8, 2018 Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-Available 'Big Data' Human Sequencing Resource with UK Biobank By end of 2019, Regeneron plans to sequence the exomes of all 500,000 people within the UK Biobank resource, all with associated health records, creating an unprecedented resource linking human genetic variations to human biology and disease AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer will join Regeneron to co-fund one of the industry's most ambitious 'pre-competitive' research efforts Exome sequencing data and findings will be openly available to other researchers TARRYTOWN, N.Y., Jan. 8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), along with new collaborators AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc., today announced the formation of a major 'pre-competitive' consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource. The newly announced collaborators will each commit $10 million to enable a dramatic acceleration of sequencing timelines, and additional companies are considering joining the consortium. Regeneron will conduct the sequencing effort. The sequencing data will be paired with detailed, de-identified medical and health records within the UK Biobank resource, including enhanced measures such as brain, heart and body imaging, to create an unparalleled resource for linking human genetic variations to human biology and disease. It was originally planned that sequencing of all 500,000 samples in the UK Biobank would be completed by 2022, with the first 50,000 people sequenced during 2017 with funding from Regeneron and GlaxoSmithKline.
    [Show full text]
  • Cell and Gene Therapy Gathers Pace
    Next-generation therapeutics: cell and gene therapy gathers pace At one of its most exciting phases of growth, the cell and gene therapy market has gained momentum in dealmaking, product sales and big Brain light/Alamy Stock Photo Stock Brain light/Alamy pharma interest, all of which are analyzed in this feature. feature Paul Verdin and Lisa Urquhart Therapeutic approaches employing whole cells are not new—for is substantial ongoing work in oncology, the majority of programs example, techniques based on cultured autologous epidermal cells (65%) across the combined pipeline are in non-oncology indications. for burn treatment and chondrocytes for knee cartilage repair have The value picture reveals a similar overall distribution—indications been available for more than a decade. Gene therapy and other gene outside oncology account for 76% of the 2024 forecasted sales transcription and translation-targeted approaches such as RNA inter- value, and only three oncology indications are included in the top ference (RNAi) are a much more recent addition to the therapeutic 20 indications by 2024 forecast sales (Fig. 2). The top 20 list reveals a arsenal, and coupled with the high-profile arrival of chimeric antigen wide variety of indications, including SMA, amyloidosis, hemophilia receptor (CAR)-T cells are ushering in a new era for cell-based and A and B, sickle cell disease, Huntington’s disease and amyotrophic gene-based medicine. lateral sclerosis. Logically, nucleic acid approaches are on the whole These groundbreaking scientific advances have also brought with focused on those diseases with a clearer genetic basis, whereas cell them intense debate about payment models and affordability, add- therapies are being explored in oncology and those indications with ing fuel to the broader fire raging around drug pricing.
    [Show full text]
  • 2021 Rnai Roundtable
    Glaucienne Diagnosed with AHP (Brazil) Zilebesiran (ALN-AGT), in Development for the Treatment of Hypertension June 30, 2021 © 2021 Alnylam Pharmaceuticals, Inc. 1 Agenda Welcome • Christine Lindenboom – Senior Vice President, Investor Relations & Corporate Communications Introduction • Pushkal Garg, M.D. – Chief Medical Officer Hypertension Background • Elizabeth Ofili, M.D., MPH, FACC; Professor of Medicine (Cardiology), Morehouse School of Medicine Zilebesiran Background and Development Program • Stephen Huang, M.D. – Senior Director, Clinical Research Commercial Outlook • Eric Green – Senior Vice President, Development Programs Q&A Session 2 Reminders Event will run for approximately 60-75 minutes Q&A session at end of presentation • Questions may be submitted at any time via the ‘Ask a Question’ field on the webcast interface Replay, slides and transcript available at www.alnylam.com/capella 3 Alnylam Forward Looking and Disclosure Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including expectations regarding the potential of RNAi therapeutics to reimagine the treatment of hypertension, results from our Phase 1 study of zilebesiran (formerly known as ALN-AGT) supporting further development and the expected timing of additional Phase 1 data readouts, the design and conduct of our KARDIA-1 Phase 2 study of zilebesiran and the expected timing of the initiation of add-on studies, targeting 24 hour blood pressure control with the goal of minimizing CV risk and reducing the risk of organ failure, the potential features of zilebesiran and the potential commercial outlook, our aspiration to become a leading biotech company, and the planned achievement of our “Alnylam P5x25” strategy.
    [Show full text]
  • Rebateable Manufacturers
    Rebateable Labelers – July 2021 Manufacturers are responsible for updating their eligible drugs and pricing with CMS. Montana Healthcare Programs will not pay for an NDC not updated with CMS. Note: Some manufacturers on this list may have some NDCs that are covered and others that are not. Manufacturer ID Manufacturer Name 00002 ELI LILLY AND COMPANY 00003 E.R. SQUIBB & SONS, LLC. 00004 HOFFMANN-LA ROCHE 00006 MERCK & CO., INC. 00007 GLAXOSMITHKLINE 00008 WYETH PHARMACEUTICALS LLC, 00009 PHARMACIA AND UPJOHN COMPANY LLC 00013 PFIZER LABORATORIES DIV PFIZER INC 00015 MEAD JOHNSON AND COMPANY 00023 ALLERGAN INC 00024 SANOFI-AVENTIS, US LLC 00025 PFIZER LABORATORIES DIV PFIZER INC 00026 BAYER HEALTHCARE LLC 00032 ABBVIE INC. 00037 MEDA PHARMACEUTICALS, INC. 00039 SANOFI-AVENTIS, US LLC 00046 WYETH PHARMACEUTICALS INC. 00049 ROERIG 00051 ABBVIE INC 00052 ORGANON USA INC. 00053 CSL BEHRING L.L.C. 00054 HIKMA PHARMACEUTICAL USA, INC. 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00065 ALCON LABORATORIES, INC. 00068 AVENTIS PHARMACEUTICALS 00069 PFIZER LABORATORIES DIV PFIZER INC 00071 PARKE-DAVIS DIV OF PFIZER 00074 ABBVIE INC 00075 AVENTIS PHARMACEUTICALS, INC. 00078 NOVARTIS 00085 SCHERING CORPORATION 00087 BRISTOL-MYERS SQUIBB COMPANY 00088 AVENTIS PHARMACEUTICALS 00093 TEVA PHARMACEUTICALS USA, INC. 00095 BAUSCH HEALTH US, LLC Page 1 of 19 Manufacturer ID Manufacturer Name 00096 PERSON & COVEY, INC. 00113 L. PERRIGO COMPANY 00115 IMPAX GENERICS 00116 XTTRIUM LABORATORIES, INC. 00121 PHARMACEUTICAL ASSOCIATES, INC. 00131 UCB, INC. 00132 C B FLEET COMPANY INC 00143 HIKMA PHARMACEUTICAL USA, INC. 00145 STIEFEL LABORATORIES, INC, 00168 E FOUGERA AND CO. 00169 NOVO NORDISK, INC. 00172 TEVA PHARMACEUTICALS USA, INC 00173 GLAXOSMITHKLINE 00178 MISSION PHARMACAL COMPANY 00185 EON LABS, INC.
    [Show full text]
  • Current Sustaining Member Companies
    CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2018 Coherus Biosciences 2019 Ipsen Biopharmaceuticals, Inc. 2011 Remund Group, LLC 1985 Abbott Laboratories, Inc. 2017 Cook Medical, LLC 2018 IT Cadre 2018 Rigel Pharmaceuticals 2013 AbbVie Inc. 2020 D2 Pharma Consulting, LLC 1989 J & J Health Care Systems, Inc. 2000 Sanofi 2021 Adaptive Biotechnologies 2007 Daiichi Sankyo, Inc. 2014 Jazz Pharmaceuticals Inc. 2020 Seattle Genetics 2017 ACADIA Pharmaceuticals, Inc. 2020 Deciphera Pharmaceuticals, LLC 2007 Karl Storz Endoscopy America 2004 Siemens Medical Solutions 2020 AcelRx Pharmaceuticals, Inc. 2009 Deloitte 2020 Lipogems 2019 SK Life Science, Inc. 2020 Acorda Therapeutics 2020 Dexcom, Inc. 2010 LLC Federal Solutions 2002 Smith & Nephew, Inc. 2019 Aimmune 2020 Drip Drop Hydration 2014 Lovell Government Services LLC 2019 Sobi Inc. 2003 Alcon Laboratories, Inc. 2017 Eagle Pharmaceuticals, Inc. 2014 Mallinckrodt Pharmaceuticals 2013 Stryker Orthopaedics 2019 Alexion Pharmaceuticals, Inc. 2005 Eisai, Inc. 2020 MannKind Corporation 2018 Sun Pharmaceutical 2017 Alkermes, Inc. 2019 electroCore, Inc. 1999 Marketing Assessment, Inc. 1999 Sunovion Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2010 Endo Pharmaceuticals 2009 Masimo Corporation 2016 Taiho Oncology, Inc. 2019 Altarum Institute 2017 Exelixis 2019 Medical Strategies International, LLC 2015 Takeda Oncology 2020 Amarin Corporation 2016 Express Scripts Federal Pharmacy 2016 Melling Medical 2000 Takeda Pharmaceutical USA, Inc. 1994 AmerisourceBergen 2010 Federal Practitioner 1954 Merck & Co., Inc. 2020 Telemynd 1992 Amgen 2018 Foundation Medicine, Inc. 2002 MerzNorth America 2020 TerSera Therapeutics 2020 Amneal Pharmaceutical 2021 Frontier Technology Inc. (FTI) 2018 Mitsubishi Tanabe Pharma America 1990 Teva 2019 Aptive Resources LLC 2020 Fresenius Medical Care North America 2014 Nationwide Pharmaceutical LLC 2019 The Coalition for Government Procurement 2011 Arbor Pharmaceuticals, LLC 1989 Genentech Inc.
    [Show full text]
  • Alnylam Prepares to Land First Rnai Drug Approval
    NEWS & ANALYSIS Nature Reviews Drug Discovery | Published online 28 Feb 2018; doi:10.1038/nrd.2018.20 “We’ve had our near-death experiences,” concedes Maraganore. Alnylam prepares to land first Merck continued to outwardly express enthusiasm for RNAi for a few years longer, but never moved any RNAi therapies into its RNAi drug approval publicly disclosed pipeline, and eventually With Alnylam’s rare disease drug candidate patisiran nearing the regulatory sold its Sirna intellectual property (IP) to finish line, the RNA interference community is now turning its attention to once-arch-rival Alnylam in early 2014 for less next-generation delivery technology to solidify the future of the emerging modality. than a sixth of the Sirna purchase price. “I think that large companies, and large pharma in particular, really stink at Chris Morrison start-ups captured the imaginations and innovation around platforms, and we saw enthusiasm of venture capitalists and public that with RNAi,” Maraganore says. The Drug developers have been fishing in the investors, and industry’s largest companies near-death experiences that strengthened bumpy RNA interference (RNAi) waters for eventually bought into the hope and hype as Alnylam’s resolve are culturally incompatible years without a catch in sight. They probably well. Novartis committed hundreds of millions with large organizations, he argues. And so won’t have to wait much longer. In December of US dollars for access to Alnylam’s platform when early generation RNAi candidates 2017, RNAi pioneer Alnylam Pharmaceuticals in 2005, and Roche followed suit in 2007. In failed to deliver on their promise, it was finalized its regulatory submissions to the 2006, Merck & Co.
    [Show full text]
  • Current Sustaining Member Companies
    CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2018 Coherus Biosciences 2019 Ipsen Biopharmaceuticals, Inc. 2011 Remund Group, LLC 1985 Abbott Laboratories, Inc. 2017 Cook Medical, LLC 2018 IT Cadre 2018 Rigel Pharmaceuticals 2013 AbbVie Inc. 2020 D2 Pharma Consulting, LLC 1989 J & J Health Care Systems, Inc. 2000 Sanofi 2021 Adaptive Biotechnologies 2007 Daiichi Sankyo, Inc. 2014 Jazz Pharmaceuticals Inc. 2020 Seattle Genetics 2017 ACADIA Pharmaceuticals, Inc. 2020 Deciphera Pharmaceuticals, LLC 2007 Karl Storz Endoscopy America 2004 Siemens Medical Solutions 2020 AcelRx Pharmaceuticals, Inc. 2009 Deloitte 2021 Lantheus Holdings 2019 SK Life Science, Inc. 2020 Acorda Therapeutics 2020 Dexcom, Inc. 2020 Lipogems 2002 Smith & Nephew, Inc. 2019 Aimmune 2020 Drip Drop Hydration 2010 LLC Federal Solutions 2019 Sobi Inc. 2003 Alcon Laboratories, Inc. 2017 Eagle Pharmaceuticals, Inc. 2014 Lovell Government Services LLC 2013 Stryker Orthopaedics 2019 Alexion Pharmaceuticals, Inc. 2005 Eisai, Inc. 2014 Mallinckrodt Pharmaceuticals 2018 Sun Pharmaceutical 2017 Alkermes, Inc. 2019 electroCore, Inc. 2020 MannKind Corporation 1999 Sunovion Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2010 Endo Pharmaceuticals 1999 Marketing Assessment, Inc. 2016 Taiho Oncology, Inc. 2019 Altarum Institute 2017 Exelixis 2009 Masimo Corporation 2015 Takeda Oncology 2020 Amarin Corporation 2016 Express Scripts Federal Pharmacy 2019 Medical Strategies International, LLC 2000 Takeda Pharmaceutical USA, Inc. 1994 AmerisourceBergen 2010 Federal Practitioner 2016 Melling Medical 2020 Telemynd 1992 Amgen 2021 Ferring Pharmaceuticals Inc. 1954 Merck & Co., Inc. 2020 TerSera Therapeutics 2020 Amneal Pharmaceutical 2018 Foundation Medicine, Inc. 2002 MerzNorth America 1990 Teva 2019 Aptive Resources LLC 2021 Frontier Technology Inc.
    [Show full text]
  • CY 2020 CDER Drug and Biologic Calendar Year Approvals As of December 31, 2020
    CY 2020 CDER Drug and Biologic Calendar Year Approvals As of December 31, 2020 This report reflects the data shown as it is identified in the database. Selection Criteria: User Response: Start Date: 1/1/2020 End Date: 12/31/2020 Sort Order: Approval Date New Drug Application (NDA) Approvals: APPLICATION REVIEW 505(B)(2) PROPRIETARY NAME ESTABLISHED NAME APPLICANT APPROVAL DATE NUMBER CLASSIFICATION APPROVAL NDA 212608 AYVAKIT AVAPRITINIB BLUEPRINT MEDICINES CORP P,O 1/9/2020 CODY LABORATORIES INC A WHOLLY OWNED NDA 209575 NUMBRINO COCAINE HYDROCHLORIDE SUBSIDIARY OF LANNETT CO INC S Y 1/10/2020 NDA 211635 VALTOCO DIAZEPAM NEURELIS INC S,O Y 1/10/2020 NDA 208171 MONOFER FERRIC DERISOMALTOSE PHARMACOSMOS AS S 1/16/2020 NDA 211723 TAZVERIK TAZEMETOSTAT EPIZYME INC P,O 1/23/2020 NDA 213138 DIFICID FIDAXOMICIN CUBIST PHARMACEUTICALS LLC P,O 1/24/2020 EMPAGLIFLOZIN, LINAGLIPTIN, AND BOEHRINGER INGELHEIM PHARMACEUTICALS NDA 212614 TRIJARDY XR METFORMIN HYDROCHLORIDE INC S 1/27/2020 NDA 213224 BYNEFEZIA PEN OCTREOTIDE ACETATE SUN PHARMACEUTICAL INDUSTRIES LTD S Y 1/28/2020 NDA 211281 PIZENSY LACTITOL BRAINTREE LABORATORIES INC S Y 2/12/2020 ETHINYL ESTRADIOL AND NDA 204017 TWIRLA LEVONORGESTREL AGILE THERAPEUTICS INC S Y 2/14/2020 NDA 213491 PROCYSBI CYSTEAMINE BITARTRATE HORIZON PHARMA USA INC S,O Y 2/14/2020 NDA 210583 ANJESO MELOXICAM BAUDAX BIO INC S Y 2/20/2020 NDA 211616 NEXLETOL BEMPEDOIC ACID ESPERION THERAPEUTICS INC S 2/21/2020 NDA 209510 BARHEMSYS AMISULPRIDE ACACIA PHARMA LTD S Y 2/26/2020 NDA 211617 NEXLIZET BEMPEDOIC ACID AND EZETIMIBE
    [Show full text]
  • Table of Contents
    Table of contents Executive Summary Chapter 1 – Introduction Chapter 2 – Trends in drug delivery dealmaking 2.1. Introduction 2.2. Drug delivery partnering over the years 2.3. Bigpharma drug delivery dealmaking activity 2.4. Big biotech drug delivery dealmaking activity 2.5. Most active drug delivery dealmakers 2.6 Drug delivery partnering by deal type 2.7. Drug delivery partnering by disease type 2.8. Partnering by drug delivery technology type 2.9. Average deal terms for drug delivery partnering 2.9.1 Drug delivery headline values 2.9.2 Drug delivery upfront payments 2.9.3 Drug delivery milestone payments 2.9.4 Drug delivery royalty rates 2.10. The anatomy of drug delivery partnering 2.11. Drug delivery or specialty pharma? 2.11.1. Is specialty pharma the only way for drug delivery? 2.11.2. Best practice for optimizing drug delivery program development 2.11.3. The anatomy of a drug delivery deal 2.11.3.a. Case study 1: Alpharma – Durect 2.11.3.b. Case study 2: Bayer – MDRNA 2.11.3.c. Case study 3: Endo Pharmaceuticals – BioDelivery Sciences Chapter 3 – Leading drug delivery deals 3.1. Introduction 3.2. Top drug delivery deals by value Chapter 4 – Bigpharma drug delivery deals 4.1. Introduction 4.2. How to use bigpharma drug delivery partnering deals 4.3. Big pharma drug delivery partnering company profiles Abbott Actavis Inc (formerly Watson Pharmaceuticals) Actavis (merged with Watson Pharmaceuticals Oct 2012) Actelion Allergan Amgen Astellas AstraZeneca Baxter International Bayer Biogen Idec Boehringer Ingelheim Bristol-Myers Squibb Celgene CSL Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly Endo Pharmaceuticals Forest Laboratories Galderma Gilead Sciences GlaxoSmithKline Grifols Hospira Johnson & Johnson Kyowa Hakko Kirin Lundbeck Menarini Merck & Co Merck KGaA Mylan Novartis Novo Nordisk Otsuka Pfizer Purdue Roche Sanofi Shionogi Shire Takeda Teva UCB Valeant Warner Chilcott Chapter 5 – Bigbiotech drug delivery deals 5.1.
    [Show full text]