By Julie Kim
Throughout the past year, the coronavirus pandemic has presented extraordinary challenges for all of us, and many people across the globe continue to work tirelessly to stem the human, social and economic toll of the virus.
At Takeda, I am humbled that we have left no stone unturned in the many different avenues we are pursuing to bring our leadership, expertise and resources to the fight against COVID-19. A key part of this commitment has been the CoVIg-19 Plasma Alliance which we co-founded with CSL Behring in April 2020. We chose to set individual company interests aside and welcomed other leading global and regional manufacturers of plasma-derived therapies to work together at each company’s own risk and cost. Our goal was to develop an investigational non-branded plasma-derived hyperimmune globulin (H-Ig) medicine, referred to as CoVIg-19, as a potential treatment option for adults hospitalized with COVID-19 at risk for serious complications. We knew we could accelerate our work and potentially increase the scale of our effort through industry collaboration, in a way that would best serve patient and public health.
Unfortunately, we recently shared that the results of the Alliance’s multi-national Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its primary endpoints. While we are disappointed by the results, we are proud to have undertaken this work and extremely thankful for the support of colleagues, plasma donors, clinical trial participants, external partners, including the NIH/NIAID and global regulatory authorities, who made this program possible.
We know that strong scientific progress is sometimes as much about learning what does not work as it is about learning what does. In spite of the disappointing outcome of the study, our journey has offered us important learning.
First, our findings will contribute to advancing the scientific understanding of the role of antibody-based treatments to address the challenging and complex virus, notably how and when antibody-based treatments could be most effective. We’ve also added insights into clinical trial approaches to best explore the safety and efficacy of these varied therapies. Building this knowledge should benefit the entire health care community from our peers, to scientists, to health care workers and patients.
Second, through this experience, we have developed stronger relationships with those in the plasma industry and across the global health community. Collaboration has strengthened scientific and collegial relationships across our industry and has provided a blueprint and operational mechanisms for future alliances to address urgent needs.
And third, thanks to the heightened awareness of plasma during the pandemic and the positive engagement we’ve had with leading global health authorities, we see a unique opportunity to open the door to necessary change in the plasma industry to increase plasma supply and enhance sustainable access to plasma-derived therapies.
Plasma remains an important and often life-saving resource for thousands of people around the world with rare and complex diseases with few other treatment options. With plasma donations lower than usual through the pandemic and demand for plasma-derived therapies growing worldwide – the need for human plasma is more urgent than ever. We encourage healthy individuals to consider donating plasma to help those who often have few other treatment options regardless of the pandemic.
In addition to the CoVIg-19 Plasma Alliance, our teams across Takeda have come together in a variety of ways to look at opportunities with academia, industry and governments to battle COVID-19.
Our R&D efforts include researching novel approaches to treating future pandemics, investigating ways to repurpose marketed products and programs in development as potential treatments, data sharing initiatives and participating in industry-wide collaborations, such as:
We are also supporting global access to three different COVID-19 vaccines. For example, in Japan, we are partnering with Novavax to develop, manufacture and commercialize approximately 250 million doses of its COVID-19 vaccine. We also plan to import and distribute 50 million doses of Moderna’s mRNA COVID-19 vaccine working with Moderna and Japan’s Ministry of Health Labour and Welfare (MHLW). Most recently in Europe, Takeda and IDT Biologika GmbH agreed to utilize capacity for three months to manufacture the COVID-19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
All of Takeda’s COVID-19 efforts, including the CoVIg-19 Plasma Alliance, are characterized by a willingness to collaborate and bring together expertise, data and resources. This is how we can - and will - make an even greater impact for patients and society, particularly at a time of urgent unmet need. I’m excited about future opportunities for collaborations of all kinds that will advance science and deepen our understanding of the world’s most complex diseases. I look forward to continuing our vital work in plasma, and I am optimistic that we will apply many lessons learned through our experience to bring better health for people and a brighter future for the world.