Takeda Pharmaceutical Company Limited (“Takeda”) has released an update to its pipeline portfolio as part of its call for an opportunity to market for Wave 1 pipelines that has the potential to add materially to the company’s revenue growth over the next decade. The company also shared its PTS-adjusted view for fiscal year 2009/30 revenue CAGR (low single digit) and its target for fiscal year 2009/2030 (mid single digit) revenue CAGR of JPY5 trillion ($ 47 billion) by fiscal 2010.
Most of this revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique New Molecular Entities (NMEs) that represent potential top-notch / top-notch therapies, as well as the 14 existing global brands. Of the Wave 1 programs, five received Breakthrough Therapy awards and three were Fast Track recognized by the US Food and Drug Administration (FDA). In addition, one program was named after the SAKIGAKE naming system by the Japanese Ministry of Health, Labor and Social Welfare, and another program was the first groundbreaking award the China Food and Drug Administration bestowed on a multinational biopharmaceutical company.
Our vision is to discover and offer life changing treatments that are guided by our commitment to patients, our people and the planet. Our Wave 1 pipeline reflects the high bar that we have focused solely on finding treatments, preventions and remedies for target groups with high unmet medical needs and making them available to patients around the world. “
Christophe Weber, President and CEO of Takeda
During the call, Takeda gave an in-depth look at TAK-721, which may be the first FDA-cleared drug for the treatment of eosinophilic esophagitis (EoE), and TAK-003, a live attenuated tetravalent vaccine for the prevention of dengue disease. In addition, the company highlighted the continued momentum of global brands like Entyvio® and the commercial skills that will help make the launch successful.
Offer patients a highly innovative pipeline for sustainable growth
Takeda has built a state-of-the-art, world-class research and development engine and has established a diverse and dynamic pipeline of approximately 40 new molecular units in clinical stage starting to ship. All 12 NMEs in the Wave 1 pipeline expected short-term milestones in late development, important data readings or important study starts. Takeda has expanded its global capabilities, including data discovery and analysis, patient services, and evidence generation, to enhance commercial excellence for delivering these life changing therapies to patients around the world.
Beyond the Wave 1 pipeline, Takeda’s research engine, comprised of in-house research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline for fiscal 2025 and beyond will ensure sustainable growth. These Wave 2 pipeline programs are designed to offer transformative or curative potential for target groups with high unmet needs in all core therapeutic areas. They are based on targets with strong human validation, represent different modalities, and leverage new platform capabilities in cell therapy, gene therapy, and data science.
ABOUT TAK-721 and TAK-003
TAK-721 (budesonide oral suspension)
Takeda’s TAK-721 is a mucoadhesive, topical, viscous formulation of budesonide that has been specially formulated as a test treatment for (EoE). When TAK-721 is approved, it will be the first FDA-approved treatment for EoE. Takeda plans to use the trade name Eohilia (budesonide oral suspension). To date, it has received both the Breakthrough Therapy and Orphan Drug designations from the FDA. The development program is the first and largest EoE phase 3 clinical trial program in the US to publish results. It comprises the core phase 3 studies ORBIT1 and ORBIT2, in which the safety and efficacy of TAK-721 were assessed in adolescent and adult patients (11 to 55 years old) with EoE. The terms “breakthrough therapy” and “orphan drug” do not guarantee approval or commercial availability.
Takeda’s dengue tetravalent vaccine candidate (TAK-003) has the potential to help manage the massive global dengue burden, including key dengue control priorities such as protecting seronegative individuals (individuals who have not previously been exposed to dengue fever) and the prevention of hospitalization. TAK-003 is based on a live attenuated dengue serotype 2 virus, which forms the genetic “backbone” for all four vaccine viruses. The TAK-003 development program includes the Phase 3 Tetravalent Immunization Against Dengue Effectiveness Trial (TIDES), a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of two doses of TAK-003 in the prevention of laboratory tests. confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES study will continue and the safety and effectiveness will be assessed over a total of four and a half years. Dengue fever is the fastest-spreading mosquito-borne viral disease and was recognized by WHO as one of the top ten major threats to global health in 2019.
To access a replay of today’s Wave 1 Pipeline Market Opportunity Call, including presentation slides with the latest data and updates on TAK-721 and TAK-003, please visit https://www.takeda.com/investors/ir-events/.
Takeda plans to host Part 2 of the Wave 1 pipeline update on April 6, 2021 (subject to change). This includes an in-depth look at TAK-925/994, maribavir and an update on oncology assets.