PhRMA Member Company Efforts to Beat COVID-19

Eisai is collaborating with a variety of companies, health authorities and nonprofit organizations on clinical research projects designed to treat COVID-19.They have donated compounds developed in-house, as well as pharmaceutical ingredients they believe will be helpful in the creation of potential treatments.

These research projects include the following collaborations:

• Eisai supplied its investigational Toll-Like Receptor 4 (TLR4) inhibitor eritoran (E5564), created internally and previously developed as a potential treatment for sepsis, to the international network REMAP-CAP-COVID (Randomized, Embedded, Multi-factorial, Adaptive Platform-Community Acquired Pneumonia COVID), which aims for novel coronavirus medicine development. Eisai and the Global Coalition for Adaptive Research (GCAR), in collaboration with the University of Pittsburgh Medical Center, began an international clinical trial in novel coronavirus patients who are hospitalized and are in a progressing disease state in June 2020. By suppressing the most upstream TLR4 activity, which controls production of multiple cytokines, the trial hopes the cytokine storm in patients can be suppressed and pneumonia can thus be prevented from becoming severe.
• Eisai provided a unique collection of about 2,600 natural product compounds to the Scripps Institute to be added to a compound library for the development of treatments. This effort is part of their involvement in the consortium of life science companies called “COVID-19 Therapeutics Accelerator,” which was initiated by the Bill & Melinda Gates Foundation and formed with collaboration from Wellcome and MasterCard. Eisai will also be providing its vaccine adjuvant (E6020) for boosting antibody production.
• Eisai supplied active pharmaceutical ingredients to the Japanese National Institute of Infectious Diseases, in response to their request for active compounds for screening of remedies for the novel coronavirus.
• Gimsilumab, the anti-GM-CSF antibody which Eisai licensed to Roivant, is being tested in a placebo-controlled, double-blind study conducted in the U.S. by Roivant on acute respiratory distress syndrome (ARDS) caused by the novel coronavirus.

Building on the groundbreaking science and scalable production platforms that were used to construct Ebola, Zika and HIV investigational vaccine candidates, Johnson & Johnson is committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use as soon as early 2021, provided the investigational vaccine is safe and effective. Johnson & Johnson has selected a COVID-19 vaccine candidate from constructs they have been working on since January 2020 and is working closely with global partners to identify devices and potential treatments that could contribute to providing immediate relief to the current pandemic.

On August 5, 2020 Johnson & Johnson announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the FDA.

The company’s preclinical data, which were published in the journal Science, validated the preclinical vaccine challenge model and showed that prototype DNA vaccines were able to elicit an immunity.

On July 30, 2020 Johnson & Johnson announced the findings of the preclinical study conducted in collaboration with Beth Israel Deaconess Medical Center. The data, published in Nature, show the investigational vaccine elicited an immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection in all the non-human primates (NHPs) involved in the study.

Based on this total package of pre-clinical results, the company initiated Phase 1/2a studies, which it kicked off in late-July.

Johnson & Johnson is in discussions with the National Institutes of Health with the objective to start the Phase 3 clinical trial ahead of its original schedule, potentially in late September, to evaluate the effectiveness of the investigational vaccine.

Through its Innovation Centers and Business Development teams across the Johnson & Johnson global innovation network, Johnson & Johnson has been reviewing novel science and technologies to help address the pandemic. Having screened over 100 ideas related to potential vaccines, antiviral therapeutics and diagnostics/consumer aids since the outbreak began, several are under detailed evaluation. More than 60 resident companies in their global incubator network Johnson & Johnson Innovation – JLABS are currently exploring novel approaches to help address the COVID-19 pandemic.

The COVID-19 pandemic is disproportionately impacting communities of color. While no single organization can solve the full range of challenges exacerbated by the global public health crisis of the coronavirus pandemic, Johnson & Johnson is working to advance racial and ethnic health equality through a series of targeted COVID-19 programs and collaborations.

Johnson & Johnson is exploring ways to contribute to the body of research generating deeper and more granular insights into how COVID-19 is impacting diverse communities. This research, which will be conducted at a national and county level, will be used to develop shareable insights and resources, submitted for publication, shared with policymakers and disseminated as a public good. Johnson & Johnson hopes to collect some of this information through our partnerships on clinical trials.

They are also working directly with many branches of government, as well as partnering with advocates, NGOs and leaders like the Congressional Black Caucus, to lend its voice, expertise and perspective to improving health outcomes in Black communities. Johnson & Johnson testified before the U.S. House of Representatives Energy and Commerce Committee on its vaccine research and manufacturing efforts. Additionally, Johnson & Johnson was one of a few companies to sign on to a coalition letter to Congressional leaders in the U.S. calling for increased and improved data collection and dissemination for COVID-19 patients. They have taken the position that without timely and systematic collection of this health data, we will not be able to fully understand – and address – the pandemic and its disproportionate impact on communities of color.

In company-sponsored COVID-19 clinical trials, Johnson & Johnson is leveraging a special engagement strategy that includes a digital and community outreach plan to provide resources to help identify opportunities to participate in clinical research, identifying and implementing ways to reduce operational barriers and patient burden, applying lessons from other trial recruitment efforts and educating Black and Brown communities across the U.S. about clinical trials and the importance of participation.

AbbVie is collaborating with select health authorities and institutions globally on clinical research related to COVID-19. AbbVie is supporting clinical studies and basic research, working closely with European health authorities and the FDA, CDC, NIH and BARDA to coordinate on these efforts. This includes determining antiviral activity, as well as efficacy and safety of KALETRA®/Aluvia (lopinavir/ritonavir), AbbVie’s antiretroviral therapy for the treatment of HIV, against COVID-19.

AbbVie, Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19. The focus of the collaboration is on advancing the fully human, neutralizing antibody 47D11 discovered by UU, EMC and HBM, which targets the conserved domain of the spike protein of SARS-CoV-2.

They continue to closely manage manufacturing and supply chain resources around the world to help ensure patients continue to receive an uninterrupted supply of their medicines.

For additional information, please visit: https://www.eisai.com/sustainability/support/antivirus.html