April 2020: Blog; Courtesy ABPI
There are significant global efforts underway to diagnose, treat and prevent infections from the virus. Pharmaceutical companies are working globally to combat COVID-19.
Pharmaceutical companies have deep scientific knowledge gained from decades of experience with similar viruses. Companies are researching vaccine candidates and undertaking inventories of research portfolio libraries to identify additional potential treatments for R&D.
Some have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV. Other are exploring ways to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified
This page brings together examples of what pharmaceutical companies around the world are doing to tackle COVID-19. It’s updated regularly and sourced from EFPIA and their round-up of what companies are doing and the IFPMA and their hub of what companies are doing globally.
At the end of March, around 20 companies have potential medicines in various stages of development, with at least four existing medicines now in late phase clinical trials.
Meanwhile there are around fifty projects exploring a variety of vaccine technologies, many of them industry/academia collaborations, and the most advanced entering early phase clinical trials.
AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
Boehringer Ingelheim immediately identified the areas of expertise, where they can best contribute to developing therapies for COVID-19 in close collaboration with academic researchers, international institutions and others in the pharma industry.
BI has joined a fast track call for project submissions to develop therapies and diagnostic tools initiated by the Innovative Medicines Initiative (IMI) of the European Union to accelerate the development of potential therapies for COVID-19.
They are also working to develop neutralizing antibodies and investigating existing pipeline and in-market compounds as well as compounds from former research activities.
EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.
Johnson & Johnson. In partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), J&J are also working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.
Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.
Regeneron Pharmaceuticals and Sanofi SA started a clinical program in patients hospitalized with severe COVID-19.
Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease.
In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients.
AstraZeneca‘s Research and development teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19.
More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.
AstraZeneca will initiate a randomised, global clinical trial to assess the potential a treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients.
Eli Lilly and AbCellera have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will use AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19.
GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic.
Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.
MSD is working with the Bill and Melinda Gates Foundation and industry peers during this challenging period to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19. As part of this commitment of expertise and assets MSD will be actively participating in the Therapeutics, Vaccines Manufacturing, and Clinical and Regulatory workstreams.
Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative.
Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be used beyond their approved indications in response to the pandemic.
Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.
Roche has donated nearly $2 million-worth of one of its medicines to China to help the country manage the COVID-19 outbreak. The medicine has been on the European market since 2010 for treatment of several kinds of arthritis.
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials.
However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available.
This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval.
Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success. Company efforts include:
CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
CSL Limited partnered with the University of Queensland’s COVID-19 vaccine development program. They will provide technical expertise as well as a donation of Seqirus’ proprietary adjuvant technology to their pre-clinical development program.
GSK and Sanofi have joined forced to combine innovative technologies to develop an adjuvanted COVID-19 vaccine, which is expected to enter clinical trials in the second half of 2020 and, if successful and subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021.
This would be a significantly faster timeline than for normal vaccine development and teams from both companies are starting work on this urgently.
Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS) and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC) to accelerate development of a potential novel coronavirus vaccine.
Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate to prevent COVID-19 infection. The collaboration aims to accelerate global development which is expected to enter clinical testing by the end of April 2020.
Crescent Pharma Limited (UK) is working to develop a vaccine from chloroquine phosphate, which is being used in 10 COVID-19 trials in China.
GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary adjuvants – compounds that enhance the effectiveness of vaccines.
Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.
Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate.
Work is underway to use previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread.
However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world, especially in the United States and Europe, and governments are trying to ramp up their testing capacities.
Pharmaceutical companies are helping in this fight.
AstraZeneca & GSK
As part of the UK Government’s announcement of a new five pillar plan to boost testing for COVID-19, GSK, AstraZeneca and the University of Cambridge have formed a joint collaboration to take action to support this national effort.
A new testing laboratory will be set up by GSK, AstraZeneca and Cambridge at the University’s Anne McLaren laboratory. This facility will be used for high throughput screening for COVID-19 testing and to explore the use of alternative chemical reagents for test kits in order to help overcome current supply shortages.
Alongside this new testing facility, GSK and AstraZeneca are working together to provide process optimisation support to the UK national testing centres in Milton Keynes, Alderley Park and Glasgow for COVID-19, providing expertise in automation and robotics to help the national testing system to continue to expand capacity over the coming weeks.
Randox in Northern Ireland has a test that is compliant with WHO guidelines and identifies patients infected with COVID-19 and 8 other related/similar symptom viruses.
The test is currently available on a laboratory based system which tests up to 324 samples in 8 hours. Time to first result is ~ 4 hours. Randox are working with Bosch Healthcare to make available a point of care test which can give results in 3 hours
Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative (IMI) in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19 as well as inhibitors to help prevent future outbreaks.
Roche announced that the FDA issued an Emergency Use Authorization for its diagnostic kit, advancing coronavirus testing to meet urgent medical needs. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity.
In addition to the individual contributions companies are already making, a consortium of life sciences companies announced an important collaboration on March 25 to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19, alongside the Gates Foundation. Co-chaired by Vas Narasimhan, chief executive officer of Novartis, the consortium seeks out to accelerate solutions to this pandemic.
Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi.
Please visit www.apbi.org.uk