Takeda’s Pipeline Has Potential to Contribute Significantly to Revenue Growth Over Next Decade
As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade. The company also shared its PTS adjusted2 view for FY2019-FY2030 revenue CAGR (low single-digit), as well as its goal for FY2019-FY2030 revenue CAGR (mid-single-digit), amounting to JPY5 trillion ($47 billion) by FY2030.3
The majority of this revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique New Molecular Entities (NMEs), representing potential best-in-class/first-in-class therapies, and its existing 14 global brands. Of the Wave 1 programs, five have received Breakthrough Therapy designation and three were granted fast track designation by the U.S. Food and Drug Administration (FDA). In addition, one program received designation under the SAKIGAKE Designation System by the Japanese Ministry of Health, Labour and Welfare and another program was the first breakthrough designation granted by the China Food and Drug Administration to a multinational biopharmaceutical company.
“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said Christophe Weber, Takeda president and chief executive officer. “Our Wave 1 pipeline is reflective of the high bar we have set to focus solely on finding treatments, preventions and cures for targeted populations with high unmet medical needs, and bringing them to patients around the world.”
During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease. In addition, the company highlighted the sustained momentum of global brands such as Entyvio®, and the commercial capabilities that will help to ensure launch success.
Bringing a Highly Innovative Pipeline to Patients for Sustained Growth
Takeda has built a world-class, state-of-the-art R&D engine and has generated a diverse and dynamic pipeline of approximately 40 clinical-stage new molecular entities that is beginning to deliver. All 12 Wave 1 pipeline NMEs have anticipated near-term late-development milestones, pivotal data readouts or pivotal study starts. Takeda has expanded its global capabilities including data insights and analytics, patient services, and evidence generation to enhance commercial excellence for delivering these life-transforming therapies to patients around the world.
Beyond the Wave 1 pipeline, Takeda’s research engine, comprised of internal research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline that will provide sustained growth in FY2025 and beyond. These Wave 2 pipeline programs are designed to provide transformative or curative potential for targeted populations with high unmet need across core therapeutic areas. They are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.
ABOUT TAK-721 and TAK-003
TAK-721 (budesonide oral suspension)
Takeda’s TAK-721 is a mucoadherent, topical, viscous formulation of budesonide, formulated specifically as an investigational treatment for (EoE). If approved, TAK-721 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 Breakthrough Therapy designation and Orphan Drug designation from the FDA. Its development program is the first and largest EoE Phase 3 clinical trial program in the U.S. to report results, and includes the pivotal Phase 3 trials ORBIT1 and ORBIT2 which investigated the safety and efficacy of TAK-721 in adolescent and adult patients (11 to 55 years of age) with EoE. Breakthrough Therapy designation and Orphan Drug designation do not guarantee approval or commercial availability.
Takeda's tetravalent dengue vaccine candidate (TAK-003) has the potential to help address the massive global burden of dengue including key priorities for dengue control such as protection of seronegative individuals (persons not previously exposed to dengue) and prevention of hospitalization. TAK-003 is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses. The TAK-003 development program includes the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), a double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES trial is continuing, and safety and efficacy will be assessed over a total of four and a half years. Dengue is the fastest spreading mosquito-borne viral disease and was recognized by WHO to be one of the top ten 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, visit https://www.takeda.com/investors/ir-events/.
Takeda plans to host part 2 of the Wave 1 pipeline update on April 6, 2021 (date subject to change). This will include a deep dive into TAK-925/994, maribavir and an update on oncology assets.
ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.
Takeda Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified 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/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
1 Includes incremental revenues on a non-PTS (probability of technical success) basis (i.e., figures represent best case scenarios, including technical success that Takeda does not currently consider probable to occur and should not be seen as a forecast or target figure).
2 PTS (Probability of Technical Success) adjusted figures represent Takeda’s base case, i.e. its estimate of revenue based on technical milestones it believes it is probable to achieve.
3 Does not include any potential impacts imposed by the Most Favored Nation Model interim final rule issued by the U.S. Centers for Medicare & Medicaid Services (CMS) on November 20, 2020, which are currently being assessed.
+81 (0) 3-3278-2095
Media Outside Japan
+81 (0) 3-3278-3684
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Thales NS50 Radar to Equip the Belgium Navy and the Royal Netherlands Navy Next Generation Mine Counter Measures Vessels (MCMV)20.1.2021 12:00:00 EET | Press release
The navies of Belgium and the Netherlands rely on Thales, Naval Group and KERSHIP shipyard to equip the 12 next generation Mine Counter Measures Vessels with NS50 radars for Air & Surface Surveillance with Fire Control capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210120005024/en/ NS50 radar © Thales The NS50 provides for the first time a complete and superior level of self-protection capability against air and surface threats for this category of high value MCM vessels. A strategic choice for small to medium vessels, the NS50 offers dual functions between air and surface surveillance and fire control. The nature of threats faced by Navies has never been more varied nor more challenging, ranging from next generation anti-ship missiles, robotic warfare and swarm attacks, to electronic warfare (jamming) as well as, overall, having to operate in a simultaneously conventional, asymmetric and hybrid threat environm
SmartStream Reveal Their Latest API Suite With a Complete Range of Reference Data Services20.1.2021 12:00:00 EET | Press release
SmartStream Technologies, the financial Reference Data Utility (RDU) solutions provider, today announces the launch of its Application Programming Interface (API) suite – for quicker access to services providing accurate data, with improved customer service, operational efficiency, greater agility and competitiveness. The new fully comprehensive API service will benefit financial institutions by saving huge amounts on infrastructure costs, as well as an affordable service which is straightforward to deploy. Financial institutions are now realising the need for change, with many currently engaging in digital transformation projects including the implementation of APIs. RDU services currently fall into two categories: security reference data and regulatory reference data. Security reference data solutions available on an API basis will include a listed derivatives service, with data sourced from over 100 exchanges and comprehensive coverage for options, futures, options on futures and ca
ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer20.1.2021 10:00:00 EET | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.1,2,3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.1 “One in five women with breast cancer have HER2 positive disease and those with previously-treated metastatic disease often progress quickly,” said Professor Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. “One of the biggest challenges in this setting has been identifying treatment strategies that produce
Bureau Veritas Further Expands Cybersecurity Offer by Joining Forces With Secura20.1.2021 10:00:00 EET | Press release
Bureau Veritas , a world leader in testing, inspection and certification, announced today that it has completed the acquisition of Secura B.V. (starting with a majority stake), an independent service company specializing in cybersecurity services. Secura will be a cornerstone in the cybersecurity strategy of Bureau Veritas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006117/en/ Rising demand in digital security and new regulations drive a growing need for conformity assessments. As a result, Testing, Inspection and Certification (TIC) services for cybersecurity are an emerging market with substantial expected growth and significant momentum. In this promising new conformity market, Secura is a recognized cybersecurity player with a strong orientation toward TIC activities. Established in 2000 in the Netherlands, Secura has 100 employees located in two technological centers in Eindhoven and Amsterdam. The company pos
Wiztopic and Euronext Corporate Services Sign a Commercial Partnership20.1.2021 10:00:00 EET | Press release
Wiztopic, the cloud-based provider of software solutions for corporate communications, public relations and investor relations professionals, today announced a commercial partnership with Euronext Corporate Services, a subsidiary of Euronext, providing companies with innovative solutions and tailor-made advisory services in the areas of governance, compliance, communication, and investor relations. This strategic alliance will simplify the access to highly complementary solutions for their respective customers. The combination of Euronext Corporate Services and Wiztopic’s solutions constitutes a suite of best-in-class digital communication solutions to satisfy the increasingly sophisticated needs of time-poor corporate communication, PR and IR professionals. Euronext Corporate Services’ clients will benefit from Wiztrust’s blockchain certification platform to secure their financial communications and avoid fake news. "This partnership solidifies Wiztrust as the European platform for ce
CYNORA Announces Availability of Industry’s First Device Test Kits for TADF Deep Green Emitters for Next-Generation OLED Displays20.1.2021 09:00:00 EET | Press release
Marking a new innovation trajectory for the OLED industry, CYNORA today announced that device test kits for its Thermally Activated Delayed Fluorescence (TADF)-based Deep Green emitter for next-generation OLED displays are now available to customers. The development is an industry-first milestone for TADF technology, and validates CYNORA’s roadmap commitment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006159/en/ cyUltimateGreen™ - CYNORA's TADF Deep Green Emitter Device Test Kit (Photo: Dr. Harald Flügge, CYNORA) Known as the cyUltimateGreen™, the product delivers efficiency of more than 20 percent, which meets current industry specifications of 150cd/A in top emission devices. It demonstrates lifetime of 400h LT95@15mA, and color point and spectra that match today’s DCI-P3 standard. In addition, the product shows compatibility with BT2020, a color standard that requires greater color purity than DCI-P3, and one th
Ipsen Appoints Gwenan White as Executive Vice President, Communications and Public Affairs20.1.2021 09:00:00 EET | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119005966/en/ Gwenan White, Executive Vice President, Communications and Public Affairs, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) announced today the appointment of Gwenan White as Executive Vice President, Communications and Public Affairs, effective March 2021. Based in Boulogne, France, she will be responsible for designing, implementing and managing the communications and public affairs strategy for Ipsen at global level, reporting directly to David Loew, CEO, Ipsen. Gwenan will serve on the Executive Leadership Team. “Along with the ELT, we are very pleased to welcome Gwenan to Ipsen. She will be critical to the implementation of our new strategy, Focus. Together. For patients & society. Her background in communications and public affairs will help reinforce Ipsen’s position as partner and employer of choice and will contribute to d
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom