What are pharmaceutical companies doing to tackle COVID-19?

By the middle of May there were more than 1,000 clinical trials ongoing with over 150 treatments being tested.

Pharmaceutical companies are prioritising research and development of COVID-19 related diagnostics, treatments, health technologies and vaccines, as well as looking at the potential of existing treatments.

AbbVie 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.

Alexion, a global biopharmaceutical company focused on serving patients and families with rare and devastating disorders, has initiated a Phase III clinical trial of one of its medicines in hospitalised adult patients with severe COVID-19 pneumonia or acute respiratory distress syndrome (ARDS). NHS centres are also conducting their own clinical trial with this Alexion medicine.

Alexion and Lilly are working with the NIHR Cambridge Biomedical Research Centre and the Cambridge Clinical Trials Unit as they test whether two drugs that are already in use to treat other immune-related conditions can prevent the development of severe COVID-19 infection. The partnership will ensure that, if either is successful, production is ready to be scaled up to ensure that there is a suitable supply available to treat those who need it.

Amgen and Adaptive Biotechnologies (Seattle, USA) are partnering to combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.

Boehringer Ingelheim has a growing team of more than 100 scientists from all areas of research and development (R&D) who have contributed to projects aimed at finding potential treatment solutions for COVID-19.

Most of the projects are part of larger collaborative efforts with academia, biotech and other pharma companies. Among them is a call by the Innovative Medicines Initiative of the EU (IMI), to which Boehringer Ingelheim is planning to commit in excess of 11,000 work hours in R&D.

The company also joined the Bill & Melinda Gates Foundation COVID-19 Therapeutic Accelerator. In addition, Boehringer Ingelheim supports scientists worldwide with its open innovation portal opnMe.com, which offers 6 anti-viral compounds out of 43 high quality pharmacological tool compounds at no cost for pre-clinical testing of research hypotheses.

As this work evolves, the company will commit further experts from multiple disciplines, as well as increased lab capacity.

Eisai has joined the COVID-19 Therapeutics Accelerator initiative, initiated by the Gates Foundation, Wellcome and Mastercard, to speed up the development of therapeutics, but also vaccines and diagnostics for COVID-19.

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.

Eli Lilly has also entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study one of their medicines as a potential treatment for hospitalized patients diagnosed with COVID-19. The medicine is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis.

Eli Lilly is also working with BenevolentAI to use their artificial intelligence capability to understand how one of Lilly's medicines may help treat coronavirus.

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.

Novartis is rapidly evaluating existing products to see if any could be utilized beyond their approved indications in response to the pandemic. It has announced a 440 person study in the US to determine if its malaria drug can effectively treat COVID-19.

Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The company aims to rapidly enroll 450 patients at multiple medical centers across France, Germany, Italy, Spain, UK and the US.

Novartis is co-chairing the COVID-19 Therapeutics Accelerator initiative, initiated by the Gates Foundation, Wellcome and Mastercard, to speed of the development of therapeutics, but also vaccines and diagnostics for COVID-19.

Regeneron Pharmaceuticals and Sanofi SA started a clinical program in patients hospitalized with severe COVID-19.

UCB is working with the US-based Seattle Structural Genomics Center for Infectious Disease to identify crystal structures of SARS-CoV-2 proteins. It is also partnering with UK-based Diamond Light Source and The University of Oxford to design inhibitors of SARS-CoV-2’s main protease for treatment of COVID-19 patients.

It is also working with government agencies and the healthcare community to determine if any of their therapies could be used effectively against COVID-19.

Astellas is providing compounds in response to a request from the Ministry of Health, Labour and Welfare and National Institute of Infectious Diseases in Japan to cooperate in the “Basic Screening Plan for Drugs for Coronavirus Disease”. They are also responding to requests from EFPIA and the Innovative Medicines Initiative (IMI) to cooperate in “Activities Aimed at Developing Drugs for the Novel Virus” and providing consultation on countermeasures.

AstraZeneca's Research and development teams have 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.

Bristol-Myers Squibb (BMS) has joined the COVID-19 Therapeutics Accelerator initiative, initiated by the Gates Foundation, Wellcome and Mastercard, to speed up the development of therapeutics, but also vaccines and diagnostics for COVID-19.

BMS identified 1,000 compounds in its discovery library that they are making available to collaborators for screening for potential treatments for COVID-19. BMS is actively evaluating certain medicines in its portfolio that could be included in near-term clinical trials with a focus on agents impacting the inflammatory immune response associated with COVID-19.

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.

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 As a company dedicated to saving and improving lives, MSD recognises it has a special responsibility to help. MSD remains focused on protecting the safety of its employees and their families, ensuring the supply and manufacture of medicines and vaccines for patients and populations, contributing scientific expertise to the development of antiviral approaches, and supporting healthcare providers and the communities in which they serve.

To support this focus, MSD is studying potential antiviral therapies that could be deployed more rapidly, in addition to evaluating compounds in their laboratories. They have also identified programmes in other laboratories that could prove beneficial and have announced that they are participating in a new research collaboration with the Institute for Systems Biology in the US to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines.

They are also in collaboration with the NIH-led Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV consortium). It aims to develop a collaborative framework for prioritising vaccine and drug candidates, streamlining clinical trials and regulatory processes, and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.

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.

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.

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.

Roche is working with the US FDA to initiate a Phase III clinical trial to evaluate the safety and efficacy of a medicine in hospitalised adult patients with severe COVID-19 pneumonia.

This is the first global study in this setting and is expected to begin enrolling in early April hoping to attract 330 patients globally, including the US.

At mid August, there were 167 confirmed vaccine projects in development globally. 29 of these were in clinical trials. In April it was reported that 72% of confirmed vaccine projects were being led by the pharmaceutical industry with the remaining 28% by academic, public sector and other NPOs.

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.

At the start of the pandemic, experts were hoping it would take as little as 12 to 18 months before a vaccine became available.

This was a best-case estimate that assumed 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.

As part of Daiichi Sankyo’s efforts to combat the spread of the virus that causes COVID-19, the Daiichi Sankyo group is actively engaged in various measures and initiatives such as, but not limited to, contributing to vaccination and drug research and development, ensuring a continuous supply of the Daiichi Sankyo group products, and providing disaster relief supports.

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.

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.

Seqirus is collaborating with the University of Queensland to support its CEPI-funded COVID-19 vaccine programme, which is based on molecular clamp technology.

The company is providing its vaccine development expertise and has donated its well-established adjuvant technology to the programme, as well as to multiple other entities around the world.

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.

J&J also 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.

MSD has announced three scientific initiatives including two agreements with Themis Bioscience and IAVI to develop potential vaccines against SARS COVID-19 and a collaboration with Ridgeback Bio advance the development of a novel antiviral treatment.

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.

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.

Read more from AstraZeneca and GSK.

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.

Roche has also announced it has developed a new antibody test which they aim to have available in early May. It is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2.

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.

As part of the health community, the life sciences sector in the UK wants to play as big a role as possible in tackling COVD-19 – both in the search for effective diagnostics and treatments and by supporting patients, the NHS and Government across the UK.

Our companies have the experience, knowledge and facilities to provide support across healthcare if they work together during this crisis.

Alexion Globally, the Alexion Charitable Foundation has donated funds to three nonprofit partner organisations, including the World Health Organization’s (WHO) Covid-19 Solidarity Response Fund. 

Additionally, and separate from the monetary charitable donations, Alexion Pharmaceuticals has donated lab equipment and instruments to enable hospital laboratories in their surrounding communities to perform diagnostics testing, sample preparation and research to help meet the challenge of diagnosing and treating patients with COVID-19. 

AstraZeneca is donating nine million face masks to support healthcare workers around the world as they respond to the COVID-19 (novel coronavirus) global pandemic.

Boehringer Ingelheim has made available EUR 5.8 million for financial and in-kind donations for local emergency aid across its markets. This includes, for example, protective masks, disinfectants, inhalers and medicines. The company is also working with local organisations that use financial and medicine donations to organize help for patients in their communities.

The company is also offering all of its 51,000 employees the opportunity to take up to 10 days of paid leave to join approved external organisations as a volunteer to bring COVID-19 relief. Employees who are unable to perform their work on-site or from home, are given the opportunity to volunteer for longer while paid their regular salaries, until they can resume their work.

Johnson & Johnson is making a number of donations, including £1 million for the London School of Hygiene & Tropical Medicine to study public sentiments regarding current and potential future measures to contain and treat COVID-19, £250,000 of hand cream products to be distributed to NHS healthcare workers and 30,000 bottles of essential toiletries to In Kind Direct – a charity which distributes consumer goods to not-for-profit organisations and social enterprises working in the UK and abroad.

They have also provided product, service, and crisis commercial terms to help enable the delivery of the Nightingale Hospital in London, and are helping medically trained company employees including doctors, nurses and pharmacists to volunteer in the NHS in support of the ongoing fight against COVID-19.

Takeda UK is supporting vulnerable communities as well as patient communities at this time. It has provided over £100,000 in donations to patient organisations and charities in need of emergency support such as Age UK who will use the money to deliver meals, medicines and groceries to those in need, Fare Share who provide meals for the elderly and homeless and the Childhood Trust, to help provide food and support to children in London who are living in poverty.

They are also supporting employees who want to volunteer with the NHS and have some HCP employees returning to work in the NHS and the police.  They are also donating iPads and iPhones so that people in hospital with COVID-19 can stay in touch with their families. 

MSD is looking at additional ways to help people and communities in the UK and around the world.

Recognising the need for additional health care professionals including doctors, nurses and medical laboratory technicians to assist the NHS, MSD has updated its company volunteering policy to allow employees who are trained in health professions such as medicine, nursing, laboratory technology, and other areas to volunteer for COVID-19 healthcare-related activities while maintaining their base pay.

Novo Nordisk worked with the NHS on new helpline which has now been launched to support people with diabetes during the COVID-19 outbreak. The initiative came from discussions and collaboration between NHS England, Diabetes UK and Novo Nordisk, including Novo Nordisk Diabetes Specialist Nurses.

In March, Novo Nordisk worked closely with NHS England and Diabetes UK to develop and set up the helpline to advise those who need help with insulin. The company is supporting the helpline with volunteering diabetes specialist nurses’ time and expertise, as well as leading the coordination of the industry support. So far, the helpline has 18 volunteers from Novo Nordisk, working alongside others. More volunteers are joining over the next few weeks.