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European pharmaceutical industry response to COVID-19


EFPIA member companies are working around the clock to find vaccines, diagnostics and treatments and ensure patients get access to the medicines they need.

Worldwide, there are more than 100 vaccine candidates in development and over 600 clinical trials underway to  find a treatment to use in the fight against COVID-19.


As of June 22, 2020

AstraZeneca K.K.
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Treatment developments
CALAVI Study
We initiated a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients

DARE 19 Study
We also started the clinical trial in partnership with Saint Luke’s Mid America Heart Institute to evaluate whether a CVRM medicine Forxiga (Dapagliflozin) might reduce the risk of disease progression and new or worsened organ dysfunction in patients hospitalised with COVID-19 who also have cardiovascular, metabolic or kidney risk factors and are at risk of developing serious complications.

Vaccines developments
We concluded a landmark agreement with Oxford University to bring to patients the potential vaccine, now known as AZD1222. Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine.

We are collaborating with a number of countries and multilateral organizations to make the vaccine widely accessible around the world. We received support of from the US Biomedical Advanced Research and Development Authority (BARDA) for the development and production of the vaccine. We reached a $750million agreement with Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance to support the manufacturing, procurement and distribution of 300 million doses of the vaccine. We also reached a licensing agreement with Serum Institute of India (SII) to supply one billion doses for low and middle-income countries.

Relevent links
COVID-19 Information Hub

Bayer Yakuhin, Ltd.
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Treatment developments
Bayer is cooperating with governments and health authorities worldwide, including World Health Organization, to provide them with available stock of Bayer products that have indicated early signs of potential efficacy in treating patients with COVID-19, including chloroquine and to support clinical trials on further testing. Bayer has also joined forces with other manufacturers in the COVID-19 Therapeutics Accelerator Initiative, initiated by the Bill & Melinda Gates Foundation, thereby opening up our vast compound library to find and develop effective novel compounds against COVID-19. Bayer also responded to the European Innovative Medicines Initiative’s call for the development of therapeutics and diagnostics combatting coronavirus infections with an in-kind contribution covering the screening of a molecular target against the Bayer substance library.

Relevent links
Our Commitment during the Coronavirus Pandemic

CHUGAI PHARMACEUTICAL CO., LTD.
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Treatment developments
  • Clinical trial of ACTEMRA® (tocilizumab) for the treatment of novel coronavirus (COVID-19) pneumonia
    Chugai filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency on April 8th, 2020 for a Phase III clinical trial in Japan with ACTEMRA®, and enrollment started in Chugai’s Phase III clinical trial targeting hospitalized patients with severe COVID-19 pneumonia in May.

  • Joint Research on a Therapeutic Antibody to Fight COVID-19
    Chugai Pharmabody Research Pte. Ltd. (CPR), a Chugai Group research center in Singapore, has begun joint research on a therapeutic antibody to fight COVID-19, with the Agency for Science, Technology and Research (A*STAR) in Singapore.


Relevent links
Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

Chugai and A*STAR Begin Joint Research on a Therapeutic Antibody to Fight COVID-19

CSL Behring K.K.
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Treatment developments
  • CSL Behring is part of the CoVIg-19 Plasma Alliance, an unprecedented industry partnership to develop CoVIg-19, a potential plasma-derived therapy for treating COVID-19. The CoVIg-19 Plasma Alliance will work toward developing the unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19, and to support national governments in their efforts to fight the current pandemic. The collaboration will leverage leading-edge expertise and work that the companies already have underway. The Alliance is working with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is anticipated to start in the summer.

  • CSL Behring Australia is developing an anti-SARS-CoV-2 plasma product for the Australian market with the potential to treat people with serious complications of COVID-19, particularly those whose illness is progressing towards the need for ventilation. The investigational product, to be known as COVID-19 Immunoglobulin, is under development at the company’s advanced manufacturing facility located in Broadmeadows, Victoria.

  • Partnering with SAB Biotherapeutics, a clinical-stage biopharmaceutical company, to advance and deliver a novel immunotherapy targeting COVID-19. The potential therapy would be produced without the need for blood plasma donations from recovered COVID-19 patients. Clinical trials could begin this summer in North America.

  • CEngaging with investigators regarding the company’s monoclonal antibodies, to identify treatment candidates from the portfolio that have the potential to treat Diffuse Alveolar Damage – one of the devastating respiratory consequences of COVID-19. These are considered much more experimental approaches, but still potentially very important therapies for people who have suffered the potentially devastating impact of COVID-19

Vaccines developments
  • CSL/ Seqirus provides scientific and technical expertise together with its established MF59® adjuvant technology to the University of Queensland in Australia to fast-track R&D of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology.

  • Donation of Seqirus’ well-established adjuvant technology – MF59® – to multiple entities searching for a COVID-19 vaccine. MF59® is used in the company’s adjuvanted seasonal flu vaccine for the over-65 age group -- one of the most vulnerable populations to COVID-19. Adjuvants can help improve immune response and reduce the amount of antigen needed for each vaccine, enabling more doses to be manufactured more rapidly.

Relevent links
The CSL Group collaborates with Global Plasma Leaders to accelerate development of potential COVID-19 Hyperimmune therapy

SAB Biotherapeutics Announces Research Collaboration With CSL Behring

CSL Media Statement on Coronavirus

GlaxoSmithKline K.K.
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Treatment developments
GSK is exploring therapeutic options. Since April, we entered into a collaboration with Vir Biotechnology to identify and accelerate new anti-viral antibodies that could be used as therapeutic or preventative options for COVID-19 or future coronavirus outbreaks.

Additionally, we are screening GSK marketed and pipeline assets for potential anti-viral activity or potential use in prevention or treatment of symptoms related to COVID-19. This includes medicines with potential direct anti-viral activity and those with possible utility in prevention or treatment of secondary complications of COVID-19.

GSK is a member of the 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.

Vaccines developments
GSK's primary aim is to develop multiple adjuvanted COVID-19 vaccines, using our innovative adjuvant technology, and we are collaborating with seven companies and institutions across the world, including in North America, Australia and China. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to the protection of more people, sooner.

Overall GSK does not expect to profit from our portfolio of collaborations for COVID-19 vaccines during this pandemic. As any short-term profit generated will be invested in support of coronavirus related research and long-term pandemic preparedness, either through GSK’s internal investments, or with external partners. Making our adjuvant available to the world’s poorest countries will also be a key part of our efforts, including donations of this adjuvant, by working with governments and the global institutions that prioritise access.

Relevent links
GSK actions to support the global response to COVID-19

GSK and Vir Biotechnology enter collaboration to find coronavirus solutions

Ipsen Pharma Japan Representative Office
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Vaccines developments
Ipsen Global donated €2 million to the Institut Pasteur to support the 21 research projects currently ongoing to combat COVID-19.

Relevent links
Ipsen donates €2 million to the Institut Pasteur to support research on COVID-19

JANSSEN PHARMACEUTICAL K.K.
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Vaccines developments
The Company announced on March 30, 2020 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 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.
The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.
Through a landmark new partnership, BARDA, which is part of the Office of the ASPR at HHS, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

Relevent links
Our COVID-19 Response Efforts

Lundbeck Japan K.K.
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Treatment developments
Lundbeck Foundation, which owns 70% of Lundbeck, has earmarked DKK 30 million (USD 4.3 million) for research projects targeting the current coronavirus pandemic.

Merck Biopharma Co., Ltd.
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Treatment developments
Merck: As part of the global effort to investigate potential therapeutics for COVID-19 and Merck’s support of independent research, Merck recently donated a supply of interferon beta-1a to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. The trial is sponsored by INSERM and its launch has been announced by the French Health authorities on March 11. Merck is donating 290,000 units of its interferon beta-1a to the WHO for use in their global SOLIDARITY trial which investigates several potential therapeutics for the treatment of COVID-19.
On March 26, a consortium of healthcare and life sciences companies together with the Bill & Melinda Gates Foundation announced an important collaboration to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for Covid-19. We are proud to be part of this group. All partners contribute a range of assets, resources, and expertise needed to identify effective and scalable solutions to the pandemic, which is affecting billions worldwide.

Relevent links
Merck statement on Rebif (interferon beta-1a) donation to INSERM

Merck statement on Rebif® (interferon beta-1a) donation to the World Health Organization for the SOLIDARITY trial

Mylan EPD G.K.
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Treatment developments
Mylan is globally collaborating with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19. Under the terms of the license agreement, Mylan has rights to manufacture and distribute remdesivir in 127 low- and middle-income countries. The agreement is non-exclusive, allowing for multiple licensees to ensure extensive access to this treatment, once approved as safe and effective for COVID-19 patients.
Mylan re-started production of generic hydroxychloroquine sulfate tablets, 200mg, at its manufacturing site in the U.S. to meet increasing demand in the context of COVID-19. The company is donating 10 million tablets of hydroxychloroquine sulfate, 200mg, to the U.S. Department of Health and Human Services (HHS).
Mylan has voluntarily waived its exclusive rights in the U.S. to distribute its generic version of Kaletra® (lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg tablets. By doing so, Mylan will enable other generic applicants to be eligible for FDA approval of their medicines for patients in the U.S., expanding access in the event that additional clinical studies or other evaluations conclude that the product may be effective in treating COVID-19.

Nippon Boehringer Ingelheim Co., Ltd.
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Treatment developments
Boehringer Ingelheim 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. It is working to develop neutralizing antibodies against the SARS-CoV-2 spike protein. It is also joining 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.
In addition, it is investigating existing pipeline and in-market compounds as well as compounds from former HIV and HCV research activities. Furthermore, Boehringer Ingelheim is conducting a computational screening of its entire molecule library of more than one million compounds with the aim of identifying novel small molecules with activity against the virus. It is also screening its entire molecule library for compounds that could target the virus.

Relevent links
COVID-19

2019 performance: stronger foundation to absorb global effects of COVID-19 pandemic

Novartis Pharma K.K.
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Treatment developments
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 utilized beyond their approved indications in response to the pandemic. Novartis plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19. Novartis announced it would conduct a 450-person study in the U.S. to determine if its malaria drug hydroxychloroquine can effectively treat Covid-19.

Relevent links
Novartis announces broad range of initiatives to respond to COVID-19 Pandemic; Creates USD 20 million global fund to support impacted communities

Novartis steps up to study hydroxychloroquine in Covid-19

Sanofi K.K.
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Treatment developments
Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara(Sarilumab), originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.

Vaccines developments
Sanofi Pasteur, the vaccines global business unit of Sanofi, will leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi is collaborating with BARDA, expanding the company’s long-standing partnership with the Authority. Sanofi will use its recombinant DNA platform to produce a 2019 novel coronavirus vaccine candidate. The recombinant technology produces an exact genetic match to proteins found on the surface of the virus. The DNA sequence encoding this antigen will be combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product, and used to rapidly produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus. The company is also collaborating with and with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, where Sanofi is combining its deep vaccine expertise and support with Translate Bio's messenger RNA platform to discover, design, and manufacture a number of SARS-CoV-2 vaccine candidates.

Relevent links
Regeneron, Sanofi to Test Arthritis Drug as Coronavirus Treatment

Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19

UCB Japan Co., Ltd.
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Vaccines developments
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. They are also working with government agencies and the healthcare community to determine if any of their therapies could be used effectively against COVID-19.

Relevent links
COVID-19: Playing our part in the global response

Sanofi & GlaxoSmithKline
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Vaccines developments
Sanofi and GSK have signed a letter of intent to enter into a collaboration to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US. GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.
The companies plan to initiate phase I 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.

Relevent links
Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19