As a global, values-based, R&D-driven biopharmaceutical company, we are committed to bringing Better Health and a Brighter Future to people worldwide. Our Wave 1 pipeline is reflective of our vision to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet.
Recently, we held a call to provide updates on select innovative New Molecular Entities (NMEs) in our Wave 1 portfolio, as FY2021 is expected to be an inflection year for our pipeline.
Through FY2021, we anticipate up to six new molecular entity regulatory submissions, with the potential for four approvals. In addition, we expect another seven programs in pivotal studies across 10 indications by year-end FY2021.
Takeda is also collaborating to provide fast and sustained access to COVID-19 vaccines 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). 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.
Updates on NMEs in the pipeline include:
Maribavir (TAK-620) is a potential game changer in the treatment of post-transplant cytomegalovirus (CMV) infection. Today, no therapies are currently approved for post-transplant treatment of CMV, which impacts about one-quarter1,2 of all transplant recipients and can lead to graft loss, morbidity and mortality. Maribavir has the potential to treat a broad spectrum of patients through its improved safety profile and novel mechanism-of-action. Maribavir is one of the Wave 1 NMEs that is on track to be submitted for regulatory review this fiscal year.
In our neuroscience portfolio, we recently secured global rights to develop and commercialize soticlestat (TAK-935), a potential first-in-class therapy with a novel mechanism of action for the treatment of developmental and epileptic encephalopathies. We intend to initiate Phase 3 studies of soticlestat in children and young adults with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in FY2021. If successful, it has the potential to bring new treatment options that provide greater seizure control, tolerability and function to DS and LGS patients around the world.
The team also provided an update on our orexin franchise, including the oral orexin agonist TAK-994. We plan to move TAK-994 into registrational trials in narcolepsy type 1 (NT1) first with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) to follow as potential additional indications and orexin assets to be developed in parallel. NT1 is a rare, underdiagnosed and undertreated condition caused by an orexin deficiency which disrupts the sleep awake cycles. Current NT1 treatments do not address underlying orexin deficiency. If approved, TAK-994 will be the first therapy to treat orexin deficiency.
The bottom line: Our pipeline is poised to deliver now and in the future. In fact, the new molecular entities in the pipeline can have the potential to deliver aggregate potential peak sales of more than $10 billion.3 And, the momentum is only building as we plan to increase our R&D investment to JPY500-550 billion (~$4.5-5 billion) in FY2021 to accelerate progress in our pipeline.
If the global COVID-19 pandemic taught us one thing, it’s that speed in R&D can be achieved through effective collaboration and partnerships. This is something we’ve long believed and done at Takeda as we innovate through a combination of our world-class internal laboratories and our unique network of research partnerships. Our robust partnership model allows us to access innovation wherever it originates – whether in our lab or one of our partners' – and today, we have more than 200 R&D partnerships.
Equally important is our expertise translating scientific discoveries into meaningful medicines for patients. We have the global capabilities to deliver these life-transforming treatments to patients, bringing our pipeline to life.
To access a replay of our Wave 1 Pipeline Market Call, including presentation slides, visit www.takeda.com/investors/ir-events.
Some of the statements contained in this communication may constitute forward-looking statements within the meaning of the U.S. federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. More detailed information about factors that may affect our performance may be found in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this communication or any other forward-looking statements it may make, except as required by law or stock exchange rule.
2 Niederwieser, D., Baldomero, H., Atsuta Y et al.One and Half Million Hematopoietic Stem Cell Transplants (HSCT). Dissemination, Trends and Potential to Improve Activity By Telemedicine from the Worldwide Network for Blood and Marrow Transplantation (WBMT).Blood (2019) 134 (Supplement_1): 2035
3 Non-PTS Adjusted figure. Includes incremental revenue not adjusted for Non-PTS Adjusted figure. Includes incremental revenue not adjusted for Probability of Technical Success (PTS) and is not a “forecast” or “target” figure. PTS applies to the probability that a given clinical trial/study will be successful based on a pre-defined endpoints, feasibility and other factors and regulatory bodies will grant approval. Actual future net sales achieved by our commercialized products and pipelines will be different, perhaps materially so, as there is a range of possible outcomes from clinical development, driven by a number of variables, including safety, efficacy and product labelling. If a product is approved, the effect of commercial factors including the patient population, the competitive environment, pricing and reimbursement is also uncertain.