European pharmaceutical industry response to COVID-19
As the impact of COVID-19 continues to be felt across the world, the biopharmaceutical industry in Europe remains committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.
for Japanese
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 26 October 2021
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 26 October 2021
AstraZeneca K.K.
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Treatment developments
To complement our vaccine programme, AstraZeneca is developing a long-acting antibody combination, which is currently being evaluated for both the prevention and treatment of COVID-19. AZD7442 is a combination of two long-acting monoclonal antibodies（mAbs). A request for an Emergency Use Authorization (EUA) for the LAAB has been submitted to the US FDA based on results from the Phase III trial presented in Q3 2021. It may offer protection to a range of different groups where there is currently an unmet need, including those who cannot mount an adequate response to vaccines, those who may not be possible to vaccinate, those at increased risk of SARS-CoV-2 infection based on their work or living situation, and those already infected with the virus.
Vaccines developments
AstraZeneca’s COVID-19 Vaccine is an effective vaccine against COVID-19. To date, more than 1.5 billion doses of the vaccine has been supplied to over 170 countries; approximately two thirds have gone to low-and lower-middle-income countries. AstraZeneca is committed to delivering its vaccine at no profit during the pandemic. The vaccine has been granted a conditional marketing authorisation or emergency use in more than 91 countries across six continents. AstraZeneca signed an agreement with the Japanese government for supply of 120 million doses of the vaccine. The vaccine has been included in the national vaccination program for people above 40 years old in Japan after its approval in May 2021.
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COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials
AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US
To complement our vaccine programme, AstraZeneca is developing a long-acting antibody combination, which is currently being evaluated for both the prevention and treatment of COVID-19. AZD7442 is a combination of two long-acting monoclonal antibodies（mAbs). A request for an Emergency Use Authorization (EUA) for the LAAB has been submitted to the US FDA based on results from the Phase III trial presented in Q3 2021. It may offer protection to a range of different groups where there is currently an unmet need, including those who cannot mount an adequate response to vaccines, those who may not be possible to vaccinate, those at increased risk of SARS-CoV-2 infection based on their work or living situation, and those already infected with the virus.
Vaccines developments
AstraZeneca’s COVID-19 Vaccine is an effective vaccine against COVID-19. To date, more than 1.5 billion doses of the vaccine has been supplied to over 170 countries; approximately two thirds have gone to low-and lower-middle-income countries. AstraZeneca is committed to delivering its vaccine at no profit during the pandemic. The vaccine has been granted a conditional marketing authorisation or emergency use in more than 91 countries across six continents. AstraZeneca signed an agreement with the Japanese government for supply of 120 million doses of the vaccine. The vaccine has been included in the national vaccination program for people above 40 years old in Japan after its approval in May 2021.
Relevent links
COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials
AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US
Bayer Yakuhin, Ltd.
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Treatment developments
Bayer earlier cooperated with governments, health authorities and research institutes worldwide, including World Health Organization, to provide them with available stock of Bayer products that indicated early signs of potential efficacy in treating patients with COVID-19 and to support clinical trials on further testing. Bayer also joined forces with other manufacturers in the COVID-19 Therapeutics Accelerator Initiative, initiated by the Bill & Melinda Gates Foundation, and responded to the European Innovative Medicines Initiative’s call for the development of therapeutics and diagnostics combatting coronavirus infections. Further, Bayer supports a Harvard Data Science Initiative (HDSI) research effort to study the public response to scientists and scientific findings in the wake of COVID-19. These findings can guide future activities that strengthen the role of science and facts in decision making.
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Update on COVID-19
Bayer earlier cooperated with governments, health authorities and research institutes worldwide, including World Health Organization, to provide them with available stock of Bayer products that indicated early signs of potential efficacy in treating patients with COVID-19 and to support clinical trials on further testing. Bayer also joined forces with other manufacturers in the COVID-19 Therapeutics Accelerator Initiative, initiated by the Bill & Melinda Gates Foundation, and responded to the European Innovative Medicines Initiative’s call for the development of therapeutics and diagnostics combatting coronavirus infections. Further, Bayer supports a Harvard Data Science Initiative (HDSI) research effort to study the public response to scientists and scientific findings in the wake of COVID-19. These findings can guide future activities that strengthen the role of science and facts in decision making.
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Update on COVID-19
CHUGAI PHARMACEUTICAL CO., LTD.
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Treatment developments
Relevent links
The Antibody Cocktail, RONAPREVE for Intravenous Infusion Set Receives the World’s First Regulatory Approval from MHLW for COVID-19
Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia
Chugai in-licenses New Oral Drug Candidate for COVID-19 from Roche
- Approval of the antibody cocktail Ronapreve for COVID-19
Chugai obtained regulatory approval from the Ministry of Health, Labour and Welfare in July 2021 for the antibody cocktail Ronapreve (generic name: casirivimab / imdevimab) for the indication of SARS-CoV-2 infection. The Special Approval for Emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval. - Clinical trial of ACTEMRA (tocilizumab) for the treatment of novel coronavirus (COVID-19) pneumonia
Results of a phase III clinical conducted in Japan for Actemra with hospitalized patients with severe COVID-19 pneumonia were annouced in February 2021. - In-license of Investigational Oral Agent for COVID-19
Chugai obtained development and exclusive marketing rights in Japan from Roche for AT-527, an investigational oral agent for COVID-19 in February 2021
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The Antibody Cocktail, RONAPREVE for Intravenous Infusion Set Receives the World’s First Regulatory Approval from MHLW for COVID-19
Results of Phase III Clinical Study in Japan for Actemra in COVID-19 Associated Pneumonia
Chugai in-licenses New Oral Drug Candidate for COVID-19 from Roche
CSL Behring K.K.
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Treatment developments
Vaccines developments
Relevent links
Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy
CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration
CSL Behring and SAB Biotherapeutics Join Forces to Deliver New Potential COVID-19 Therapeutic
CSL Media Statement on Coronavirus
THE FIGHT IS IN US
CSL’s Global Role in Battling COVID-19
- 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.
- The CoVIg-19 Plasma Alliance, which includes CSL Behring, has joined the “The Fight Is In Us” campaign - a coalition of world-leading medical and research institutions, blood centers, life science companies, technology companies, philanthropic organizations, and COVID-19 survivor groups has come together to support the rapid development of potential new therapies for patients with COVID-19. The coalition is seeking to mobilize tens of thousands of people in the United States who have recovered from COVID-19 to donate their blood plasma, which contains vital antibodies that have fought off the disease and could now help others do the same.
- 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.
- Engaging 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.
- CSL is partnering with the Coalition for Epidemic Preparedness Innovations (CEPI) and The University of Queensland (UQ) to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate. CEPI and CSL will fund the development and manufacture of UQ’s “molecular clamp” enabled vaccine. Funding will provide support for the pending phase 1 safety study being led by UQ followed by subsequent late stage clinical trials, and industrial-scale manufacturing, should the product be approved. The initial phase of large-scale production is planned to take place at CSL’s biotech manufacturing facilities in Melbourne, Australia. CSL anticipates that the production technology can be scaled to produce up to 100 million doses towards the end of 2021. The Phase 1 clinical trial commenced in July to assess safety. Should this be successful, CSL will manage phase 2 and 3 clinical trials.
- 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
Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy
CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration
CSL Behring and SAB Biotherapeutics Join Forces to Deliver New Potential COVID-19 Therapeutic
CSL Media Statement on Coronavirus
THE FIGHT IS IN US
CSL’s Global Role in Battling COVID-19
GlaxoSmithKline K.K.
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Treatment developments
GSK is continuing to work hard to find ways to help tackle the pandemic, including exploring potential therapeutic or treatment options for COVID-19 patients.
GSK is collaborating with Vir Biotechnology to investigate monoclonal antibodies to discover if they could be used as therapeutic or preventive options for COVID-19.
On 21 May, the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive scientific opinion following the referral of our monoclonal antibody candidate to the CHMP. The EMA’s recommendations can now be used to support national regulator advice on the possible use of this monoclonal antibody before a marketing authorisation is issued.
On 26 May, we received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for the same monoclonal antibody for the treatment of mild-to-moderate COVID-19 in high risk adults and paediatric patients.
A second antibody from our collaboration with Vir is also being investigated as a potential COVID-19 treatment. A phase 1/2 study in patients with mild to moderate COVID-19 is underway at multiple sites across the UK, as part of the NHS-supported AGILE platform study of potential COVID-19 therapeutics.
Also, GSK has looked at our marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic.
Following this work, GSK started a phase 2 study in May 2020 to assess whether one of our potential new medicines, otilimab – also a monoclonal antibody – can help treat adult patients who are hospitalised with COVID-19 related pulmonary disease. Results from this study were published in February 2021 and showed a potential clinical benefit from otilimab in patients aged 70-79.
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 is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. The use of an adjuvant is of importance in a pandemic situation where there is significant demand for a vaccine, since it may allow more doses to be produced from less ingredients and therefore enable manufacturing at scale. We believe more than one vaccine will be needed and we’re hoping that there will be several successful vaccines developed with our adjuvant technology.
GSK have joined forces with Sanofi, combining a vaccine candidate with our adjuvant technology to develop an adjuvanted COVID-19 vaccine candidate. An update was issued in December 2020 on the phase 1/2 clinical trial. The companies initiated a new phase 2 clinical trial in February 2021. Results from that study were published in May 2021. A phase 3 clinical trial has been initiated.
GSK is collaborating with Medicago to develop a COVID-19 vaccine by combining a plant-derived vaccine candidate with our adjuvant technology. A vaccine candidate entered phase 3 clinical trials in March 2021 following positive interim phase 2 clinical trial data that was published in May. This phase 3 trial is ongoing.
We are also working in collaboration with SK Bioscience on an adjuvanted COVID-19 vaccine. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. In August 2021 we began phase 3 testing following review of positive interim phase 1/2 data.
GSK has scaled up manufacturing of our pandemic adjuvant across our global network to support the adjuvanted COVID-19 vaccines in development through our collaborations. Also, in August 2020, GlaxoSmithKline Biologicals, a GSK group company specializes in vaccines, and KM Biologics Co., Ltd. announced that both companies agreed that they are going to explore to expand their strategic partnership and initiated discussion on the manufacturing of GSK’s adjuvant to support the supply - in Japan - of multiple adjuvanted COVID-19 vaccine candidates currently in development.
Our approach to pricing recognises the unprecedented scale of COVID-19 and the huge impact it is having on the world’s population and health systems; while striking a balance between supporting the sustainability of our business model. As part of this approach, we have made three commitments:We will supply our adjuvant to governments and institutions at a responsible price, either as standalone adjuvants or as part of an adjuvanted vaccine.
To make our adjuvant available to all countries, including the world’s poorest nations, we will offer donations - either as standalone adjuvants or as part of an adjuvanted vaccine - to global institutions who can determine the need and help with delivery on the ground.
We do not expect to profit from our vaccine collaborations during the pandemic. We will re-invest profits made on sales of our adjuvant during the COVID-19 pandemic phase to support coronavirus related research and long-term global pandemic preparedness.
Relevent links
Our response to COVID-19
GSK is continuing to work hard to find ways to help tackle the pandemic, including exploring potential therapeutic or treatment options for COVID-19 patients.
GSK is collaborating with Vir Biotechnology to investigate monoclonal antibodies to discover if they could be used as therapeutic or preventive options for COVID-19.
On 21 May, the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive scientific opinion following the referral of our monoclonal antibody candidate to the CHMP. The EMA’s recommendations can now be used to support national regulator advice on the possible use of this monoclonal antibody before a marketing authorisation is issued.
On 26 May, we received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for the same monoclonal antibody for the treatment of mild-to-moderate COVID-19 in high risk adults and paediatric patients.
A second antibody from our collaboration with Vir is also being investigated as a potential COVID-19 treatment. A phase 1/2 study in patients with mild to moderate COVID-19 is underway at multiple sites across the UK, as part of the NHS-supported AGILE platform study of potential COVID-19 therapeutics.
Also, GSK has looked at our marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic.
Following this work, GSK started a phase 2 study in May 2020 to assess whether one of our potential new medicines, otilimab – also a monoclonal antibody – can help treat adult patients who are hospitalised with COVID-19 related pulmonary disease. Results from this study were published in February 2021 and showed a potential clinical benefit from otilimab in patients aged 70-79.
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 is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. The use of an adjuvant is of importance in a pandemic situation where there is significant demand for a vaccine, since it may allow more doses to be produced from less ingredients and therefore enable manufacturing at scale. We believe more than one vaccine will be needed and we’re hoping that there will be several successful vaccines developed with our adjuvant technology.
GSK have joined forces with Sanofi, combining a vaccine candidate with our adjuvant technology to develop an adjuvanted COVID-19 vaccine candidate. An update was issued in December 2020 on the phase 1/2 clinical trial. The companies initiated a new phase 2 clinical trial in February 2021. Results from that study were published in May 2021. A phase 3 clinical trial has been initiated.
GSK is collaborating with Medicago to develop a COVID-19 vaccine by combining a plant-derived vaccine candidate with our adjuvant technology. A vaccine candidate entered phase 3 clinical trials in March 2021 following positive interim phase 2 clinical trial data that was published in May. This phase 3 trial is ongoing.
We are also working in collaboration with SK Bioscience on an adjuvanted COVID-19 vaccine. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. In August 2021 we began phase 3 testing following review of positive interim phase 1/2 data.
GSK has scaled up manufacturing of our pandemic adjuvant across our global network to support the adjuvanted COVID-19 vaccines in development through our collaborations. Also, in August 2020, GlaxoSmithKline Biologicals, a GSK group company specializes in vaccines, and KM Biologics Co., Ltd. announced that both companies agreed that they are going to explore to expand their strategic partnership and initiated discussion on the manufacturing of GSK’s adjuvant to support the supply - in Japan - of multiple adjuvanted COVID-19 vaccine candidates currently in development.
Our approach to pricing recognises the unprecedented scale of COVID-19 and the huge impact it is having on the world’s population and health systems; while striking a balance between supporting the sustainability of our business model. As part of this approach, we have made three commitments:
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Our response to COVID-19
Guerbet Japan KK
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Supportive activities
Guerbet provides unrestricted educational grants to the International Federation of fertility societies (IFFFS) as silver sponsor. The federation is conducting clinical trials on COVID-19 and reproductive medicine, and in 2020 they issued a joint statement on COVID-19 vaccination for pregnant women and women wishing to become pregnant.
Relevent links
COVID-19 Update (iffsreproduction.org)
Guerbet provides unrestricted educational grants to the International Federation of fertility societies (IFFFS) as silver sponsor. The federation is conducting clinical trials on COVID-19 and reproductive medicine, and in 2020 they issued a joint statement on COVID-19 vaccination for pregnant women and women wishing to become pregnant.
Relevent links
COVID-19 Update (iffsreproduction.org)
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.
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Ipsen donates €2 million to the Institut Pasteur to support research on COVID-19
Ipsen Global donated €2 million to the Institut Pasteur to support the 21 research projects currently ongoing to combat COVID-19.
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Ipsen donates €2 million to the Institut Pasteur to support research on COVID-19
JANSSEN PHARMACEUTICAL K.K.
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Treatment developments
In addition to their vaccine development efforts, globally Johnson & Johnson and the United States’ Biomedical Advanced Research and Development Authority (BARDA) have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
Vaccines developments
Globally, the Janssen Pharmaceutical Companies of Johnson & Johnson has shared that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine has elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study.
Based on the strength of this data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers has commenced in the United States and Belgium in July and a Phase 1 trial in Japan in September.
Planning is also underway for a Phase 2a study in the Netherlands, Spain and Germany.
As Johnson & Johnson progresses the clinical development of SARS-CoV-2, the Company is continuing to increase its global manufacturing capacity, and is in active discussions with global strategic partners to support worldwide access.
Relevent links
Our COVID-19 Response Efforts
In addition to their vaccine development efforts, globally Johnson & Johnson and the United States’ Biomedical Advanced Research and Development Authority (BARDA) have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
Vaccines developments
Globally, the Janssen Pharmaceutical Companies of Johnson & Johnson has shared that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine has elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study.
Based on the strength of this data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers has commenced in the United States and Belgium in July and a Phase 1 trial in Japan in September.
Planning is also underway for a Phase 2a study in the Netherlands, Spain and Germany.
As Johnson & Johnson progresses the clinical development of SARS-CoV-2, the Company is continuing to increase its global manufacturing capacity, and is in active discussions with global strategic partners to support worldwide access.
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.
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.
From November 2020, video is available to present EFPIA and Merck Global efforts to challenging against COVID-19.
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
Global fight against Covid-19(link to video)
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.
From November 2020, video is available to present EFPIA and Merck Global efforts to challenging against COVID-19.
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
Global fight against Covid-19(link to video)
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.
Boehringer Ingelheim participates to CARE consortium which has launched as the largest initiative in Europe to accelerate developement COVID-19 and future Coronavirus threats.
As a member of the CARE consortium, Boehringer Ingelheim will be leading the work stream of the consortium focusing on the development of virus neutralizing antibodies. Furthermore the company will provide antiviral molecules from its legacy HIV and HCV portfolio and small molecule candidates from a complete screen of its molecule library.
In July 2021, the company announced, that it will focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, called acute respiratory distress syndrome (ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the TRISTARDS Phase 2/3 study, following completion of the Phase 2b part of the study including 62 patients.
Relevent links
COVID-19
2019 performance: stronger foundation to absorb global effects of COVID-19 pandemic
Europe’s Largest Initiative Launches to Accelerate Therapy Development for COVID-19 and Future Coronavirus Threats
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.
Boehringer Ingelheim participates to CARE consortium which has launched as the largest initiative in Europe to accelerate developement COVID-19 and future Coronavirus threats.
As a member of the CARE consortium, Boehringer Ingelheim will be leading the work stream of the consortium focusing on the development of virus neutralizing antibodies. Furthermore the company will provide antiviral molecules from its legacy HIV and HCV portfolio and small molecule candidates from a complete screen of its molecule library.
In July 2021, the company announced, that it will focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, called acute respiratory distress syndrome (ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the TRISTARDS Phase 2/3 study, following completion of the Phase 2b part of the study including 62 patients.
Relevent links
COVID-19
2019 performance: stronger foundation to absorb global effects of COVID-19 pandemic
Europe’s Largest Initiative Launches to Accelerate Therapy Development for COVID-19 and Future Coronavirus Threats
Novartis Pharma K.K.
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Treatment developments
Novartis has entered 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.
Vaccines developments
Novartis announced on January 29, 2021 that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021 at its state-of-the art aseptic manufacturing plant in Stein. Initial shipment of finished product is expected in the third quarter.
The Novartis manufacturing team is in advanced discussions with a number of additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for Covid vaccines and therapeutics. The specifics will be disclosed once those discussions are concluded.
“Novartis has been mobilizing on multiple fronts to support the global pandemic response,” said Steffen Lang, Head of Novartis Technical Operations. “As a company reimagining medicine with advanced therapy platforms, we are committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world. We expect this to be the first of a number of such agreements.”
The Pfizer-BioNTech COVID-19 Vaccine has been authorized for use by the health regulatory authorities of about 50 countries, including Switzerland and the European Union member states where it has been granted Conditional Marketing Authorization and it has received authorizations for emergency use in e.g. the United Kingdom, the United States, and Canada, as well as in Hong Kong.
Relevent links
COVID-19 Information Center
Novartis has entered 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.
Vaccines developments
Novartis announced on January 29, 2021 that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021 at its state-of-the art aseptic manufacturing plant in Stein. Initial shipment of finished product is expected in the third quarter.
The Novartis manufacturing team is in advanced discussions with a number of additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for Covid vaccines and therapeutics. The specifics will be disclosed once those discussions are concluded.
“Novartis has been mobilizing on multiple fronts to support the global pandemic response,” said Steffen Lang, Head of Novartis Technical Operations. “As a company reimagining medicine with advanced therapy platforms, we are committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world. We expect this to be the first of a number of such agreements.”
The Pfizer-BioNTech COVID-19 Vaccine has been authorized for use by the health regulatory authorities of about 50 countries, including Switzerland and the European Union member states where it has been granted Conditional Marketing Authorization and it has received authorizations for emergency use in e.g. the United Kingdom, the United States, and Canada, as well as in Hong Kong.
Relevent links
COVID-19 Information Center
Novo Nordisk Pharma Ltd.
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Supportive activities
During the COVID-19 pandemic, our commitment to patients, our employees and the communities where we operate remains unchanged. We continue to supply our medicines to people living with diabetes and other serious chronic diseases, safeguard the health of our employees, and take actions to support doctors and nurses as they work to defeat COVID-19.
We are using our expertise, resources and global reach to contribute to research efforts and support with much needed medical supplies. We are working in close contact with authorities and international bodies responding to the COVID-19 pandemic.
Below are some of the actions currently taking place regarding COVID-19. (January to September 2021):
During the COVID-19 pandemic, our commitment to patients, our employees and the communities where we operate remains unchanged. We continue to supply our medicines to people living with diabetes and other serious chronic diseases, safeguard the health of our employees, and take actions to support doctors and nurses as they work to defeat COVID-19.
We are using our expertise, resources and global reach to contribute to research efforts and support with much needed medical supplies. We are working in close contact with authorities and international bodies responding to the COVID-19 pandemic.
Below are some of the actions currently taking place regarding COVID-19. (January to September 2021):
- USA
With the increasing impact of COVID-19 in the United States, we have extended our Patient Assistance Program until June 30, 2021, for those who have lost health insurance coverage because of a change in job status due to the pandemic. - India
The Novo Nordisk Foundation granted DKK 10 million (approximately USD 1.6 million) towards the establishment of four new emergency hospitals and a number of mobile hospital units. These have a total of 364 beds and the capacity to treat close on 1,300 COVID-19 patients per week, and include oxygen concentrators and ventilators among other equipment. - Brazil
We have provided a donation of BRL 1,285,000 (approximately USD 285k) to local hospitals to help with the shortage of critical medical supplies. The donations will cover supplies including medication, equipment, materials and food.
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COVID-19 actions & contributions
Sanofi K.K.
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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.
The vaccine candidate, developed in partnership by Sanofi Pasteur and GSK, uses the same recombinant protein-based technology as one of Sanofi Pasteur’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology. Sanofi Pasteur and GSK initiated global Phase 3 clinical efficacy study in May 2021. Also, Sanofi announced that the global Phase III clinical efficacy study of COVID-19 vaccine candidate has started in Japan as well. Product availability is now expected globally in Q4 2021 pending positive Phase 3 outcomes and regulatory reviews.
The development of this adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Sanofi Pasteur is also collaborating with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, where Sanofi Pasteur is combining its deep vaccine expertise and support with Translate Bio's mRNA platform to discover, design, and manufacture an mRNA vaccine. Both companies announced on March 12 that they have initiated Phase 1/2 clinical trial and expected interim results in Q3 2021.
Relevent links
Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate
Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate
Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate
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.
The vaccine candidate, developed in partnership by Sanofi Pasteur and GSK, uses the same recombinant protein-based technology as one of Sanofi Pasteur’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology. Sanofi Pasteur and GSK initiated global Phase 3 clinical efficacy study in May 2021. Also, Sanofi announced that the global Phase III clinical efficacy study of COVID-19 vaccine candidate has started in Japan as well. Product availability is now expected globally in Q4 2021 pending positive Phase 3 outcomes and regulatory reviews.
The development of this adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Sanofi Pasteur is also collaborating with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, where Sanofi Pasteur is combining its deep vaccine expertise and support with Translate Bio's mRNA platform to discover, design, and manufacture an mRNA vaccine. Both companies announced on March 12 that they have initiated Phase 1/2 clinical trial and expected interim results in Q3 2021.
Relevent links
Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate
Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate
Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate
UCB Japan Co., Ltd.
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Treatment developments
UCB is now enrolling patients in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomized, double-blind, placebo-controlled, adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients.
Uncontrolled vascular and immune inflammatory responses have proven to be hallmark symptoms in patients facing severe COVID-19 infections. These patients may face increased risk of acute respiratory distress syndrome (ARDS), stroke and death. UCB will enter into COMMUNITY zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to ARDS. Zilucoplan has not yet been approved by the FDA, EMA, or other health authorities for the treatment of COVID-19 or its symptoms.
The first UCB Community Health Fund funded in total 44 support projects and 6 research projects for an amount of 2.440.000 EUR. The grants for research projects are made available to hospitals and universities, studying the impact of COVID-19 on the health and wellbeing of young people in Belgium (4 projects) and the UK (2 projects).
The second Call for Projects was from May 15 to July 15 which aims to understand and reduce the medium- and long-term impact of the COVID-19 pandemic on the mental health of vulnerable young people (15-24 years old).The total budget available for this Call for Projects is in the range of € 2 million.
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
UCB Community Health Fund commits to 50 COVID-19 support and research projects
About the Fund
UCB is now enrolling patients in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomized, double-blind, placebo-controlled, adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients.
Uncontrolled vascular and immune inflammatory responses have proven to be hallmark symptoms in patients facing severe COVID-19 infections. These patients may face increased risk of acute respiratory distress syndrome (ARDS), stroke and death. UCB will enter into COMMUNITY zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to ARDS. Zilucoplan has not yet been approved by the FDA, EMA, or other health authorities for the treatment of COVID-19 or its symptoms.
The first UCB Community Health Fund funded in total 44 support projects and 6 research projects for an amount of 2.440.000 EUR. The grants for research projects are made available to hospitals and universities, studying the impact of COVID-19 on the health and wellbeing of young people in Belgium (4 projects) and the UK (2 projects).
The second Call for Projects was from May 15 to July 15 which aims to understand and reduce the medium- and long-term impact of the COVID-19 pandemic on the mental health of vulnerable young people (15-24 years old).The total budget available for this Call for Projects is in the range of € 2 million.
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
UCB Community Health Fund commits to 50 COVID-19 support and research projects
About the Fund
Sanofi & GlaxoSmithKline
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Vaccines developments
The vaccine candidate, developed in partnership by Sanofi Pasteur, the vaccines global business unit of Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi Pasteur’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology. Sanofi Pasteur and GSK initiated global Phase 3 clinical efficacy study in May 2021 which includes Japan as one of the countries. In parallel, an extension of the phase 2 study has been started end of July 2021, to evaluate different formulations of the candidate vaccine as a primary series and as a booster dose against COVID-19 in adults 18 years of age and older. Product availability is expected globally in Q4 2021 pending positive Phase 3 outcomes and regulatory reviews.
Relevent links
Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate
The vaccine candidate, developed in partnership by Sanofi Pasteur, the vaccines global business unit of Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi Pasteur’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology. Sanofi Pasteur and GSK initiated global Phase 3 clinical efficacy study in May 2021 which includes Japan as one of the countries. In parallel, an extension of the phase 2 study has been started end of July 2021, to evaluate different formulations of the candidate vaccine as a primary series and as a booster dose against COVID-19 in adults 18 years of age and older. Product availability is expected globally in Q4 2021 pending positive Phase 3 outcomes and regulatory reviews.
Relevent links
Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate