Business Wire

Takeda’s Pipeline Has Potential to Contribute Significantly to Revenue Growth Over Next Decade

Share

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.

TAK-003
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.

Medical information

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.

Contact information

Media:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media Outside Japan
Holly Campbell
holly.campbell@takeda.com
+1 617-588-9013

Investor Relations:
Atsushi Seki
Atsushi.seki@takeda.com
+81 (0) 3-3278-3684

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Servier announce updated overall survival results of exploratory TASCO1 phase II study of LONSURF ® + bevacizumab in a first-line setting for patients with unresectable mCRC non-eligible for intensive therapy16.1.2021 22:15:00 CETPress release

Servier announced today updated results from the exploratory phase II TASCO1 study evaluating LONSURF® (trifluridine/tipiracil) + bevacizumab and capecitabine + bevacizumab (C-B) in a first-line setting for patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for intensive therapy.1 The data were announced today during an oral presentation at the 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI). Patients with mCRC who are not eligible for chemotherapy face a large unmet need, with fewer treatment options available to them and lower survival rates. Colorectal cancer (CRC) makes up 9.7% of total global cancer cases, with almost 1.4 million new cases of CRC each year.2 In Europe, CRC is the second most common cause of death due to cancer, and those with a metastatic disease have a 5-year survival rate of just 11%.3 “For patients with metastatic colorectal cancer, those non-eligible for standard combination therapy have few options left and we are conti

H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 09:00:00 CETPress release

H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas

Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 07:30:00 CETPress release

Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa

TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport ® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 07:00:00 CETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit

Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 21:58:00 CETPress release

Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and

Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 202014.1.2021 19:15:00 CETPress release

Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe. "Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world." Ve

MANSCAPED™ Continues Its Rapid International Expansion, Launching in Norway and Switzerland14.1.2021 18:00:00 CETPress release

The booming grooming brand that never sleeps is at it again, wasting no time in the new year to add two new countries to its international roster. MANSCAPED™, theglobal leader in men’s below-the-waist grooming and hygiene announced today its launch into Norway and Switzerland. The addition of these regions follows a successful 2020 filled with unprecedented expansion into more than 30 countries across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005831/en/ The premier and leading brand in below-the-waist grooming and hygiene announces exciting expansion. (Graphic: Business Wire) “Our launch into Norway and Switzerland rounds out MANSCAPED’s regional European expansion, which is a true milestone for the brand,” said Casey Gee, Senior International Business Manager at MANSCAPED. “We’re proud to augment our European presence and can’t wait to get our products into the hands of this new set of sharp and savvy