Expanding R&D pipeline and investments
In 2019, Takeda had more than 5,000 R&D employees worldwide, working together to advance new treatment options. We invested ¥492.4 billion in R&D and established 38 new R&D collaborations with biotech and academia, adding to the more than 200 active partnerships already in place.
Takeda’s R&D organization has produced exciting new molecular entities (NMEs) that represent potential best-in-class and/or first-in-class medicines in areas of high unmet need. We’ve also extended our leadership by growing Takeda’s focus and dedication to rare diseases in our efforts to build trust and reputation in the community as true partners and leaders in rare diseases.
Innovative Biopharma
Innovative Biopharma is the largest component of Takeda’s R&D investment and has produced approximately 40 NMEs that are now in our pipeline across our core therapeutic areas of Oncology, Rare Genetic and Hematology, Neuroscience and Gastroenterology. We pursue diseases in therapeutic areas with existing expertise and knowledge and collaborations. These are often diseases in targeted and rare patient populations.
Takeda has established a dynamic pipeline that includes 12 NMEs in Wave 1 that are intended to fuel our growth trajectory while our next-generation platforms mature in Wave 2. All 12 NMEs in Wave 1 have transformative potential for patients, representing the high innovation bar our R&D organization has established, positioning us to deliver several important medicines in the near future. For example:
Organized in March 2020 in response to the COVID-19 pandemic, Takeda helped co-found the COVID R&D Alliance. The Alliance brings together more than 20 of the world’s most experienced leaders in therapeutic drug research and development and the resources of their organizations to identify, study, and accelerate the most promising candidates across a broad spectrum of therapies and vaccines for COVID-19 and its related symptoms.
Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early-stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well-understood therapies and late-stage investigational medicines for hospitalized patients who need treatment options. Activities are testing re-purposed molecules, early-stage candidates and therapeutic drug combinations. Takeda has two approved products that are being studied in adaptive platform trials. The adaptive platform trial is designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs.
By collaborating, the COVID R&D Alliance hopes to advance candidates faster than a single company, government or nongovernment organization could alone — and in turn, serve the urgent global need.
Employees across Takeda R&D are advancing these and other near-term catalysts with a sense of urgency while building our next-generation platforms to sustain our long-term growth. Together, we aim fulfill our purpose to deliver Better health for people, brighter future for the world.
Plasma-derived therapies (PDT)
Even with the major advances of the last 75+ years, we believe there is an incredible untapped opportunity to innovate in PDT for the benefit of patients worldwide. In 2019, Takeda developed an end-to-end PDT strategy and created a dedicated team and budget to look at how we could reimagine plasma from collection through production to delivery. We’re not only extending the therapeutic potential of our existing therapies, but also innovating how we use PDTs to improve the health of the patients we aim to serve.
We’re fostering a culture of innovation in PDT R&D through two engines:
Along with the above, the PDT R&D strategy targets three additional areas of focus:
The PDT R&D team will capitalize on big data to drive precision medicine that improves patient outcomes. Whereas current treatment strategies apply a one-size-fits-all approach — meaning some patients benefit from treatments while others see a partial benefit or no benefit at all — Takeda is building specific datasets using cloud technologies from patients treated with plasma proteins that will enable us to better predict clinical outcomes, at faster speeds, for specific patients and to tailor treatments accordingly.
In response to the COVID-19 pandemic, we moved swiftly to begin development of potential treatments to the virus, including a novel plasma-derived therapy and the repurposing of two approved products and two assets in development. In April 2020, we co-founded the CoVIg-19 Plasma Alliance, which started with six leading plasma companies and now comprises a total of 13 companies, with several contributors and supporters from outside the plasma industry. This is an unprecedented partnership for an unprecedented global health care challenge. Rather than pursue individual interests, the Alliance members are putting public health and patients first through collaboration. Our goals are to accelerate the development of a potential medicine and then increase its supply and availability.
The scope of the Alliance’s activities includes collecting antibody-rich plasma from COVID-19 survivors; developing CoVIg-19 for clinical trials; distribution of CoVIg-19, if proven safe; and regulatory submissions. One of the Alliance’s core principles, should the medicine be successful, is equitable access and wide distribution — the medicine manufactured under the Alliance will be provided on a not-for-profit basis. The CoVIg-19 Alliance demonstrates the power of collaboration during challenging times and serves as a model for how we can address future pandemics and potentially save more lives more quickly.
In the age of recombinant proteins, gene therapies and other novel modalities, we believe there are persistent needs that can only be effectively addressed with PDT. We will continue to use our integrated capabilities to identify and deliver within those niche areas.
Takeda participates in the WIPO Research Consortium, a joint enterprise hosted by WIPO for promoting research and development for treatments and vaccines for neglected tropical diseases, malaria and tuberculosis. As part of the consortium, we’re taking steps to strengthen our health care platforms in developing countries predicted to be more badly affected by global climate change.
Global vaccine development
We’re developing new vaccines to address some of the world’s most pressing public health needs. Our Vaccine Business Unit (VBU) has developed a pipeline that focuses on diseases that impact regions around the world, including low- and middle-income countries (LMICs) that might be disproportionally affected. The VBU’s aim is to make vaccines available in countries with the highest unmet need, fully develop and register them and build capacity within our facilities to produce the millions of doses that are required to improve global health. Currently, vaccine efforts are focused on: