Business Wire

Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721

Share

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.1

The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback.

“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” said Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization, Takeda. “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”

About TAK-721 (budesonide oral suspension)

TAK-721 (budesonide oral suspension) is an oral viscous formulation of budesonide, formulated as an investigational treatment for eosinophilic esophagitis. It entered the Takeda pipeline through the company’s acquisition of Shire.

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 Genetics 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 and regions. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; 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/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 Hirano I, Futura GT. Gastroenterology. 2020;158(4):840-851.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Japanese Media
Ryoko Matsumoto
ryoko.matsumoto@takeda.com
+81 (0) 3-3278-3414

U.S. and International Media
Megan Ostrower
megan.ostrower@takeda.com
+1 772-559-4924

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

Sermo Barometer Reveals Growing Concern Among Global Physicians Regarding Monkeypox8.8.2022 16:00:00 CEST | Press release

With the spread of monkeypox on the rise and the World Health Organization (WHO) declaring a global health emergency, findings from a recent survey conducted by Sermo, a physician-first online community and leader in global HCP insights, show there is high concern about public misinformation spreading. The survey also found that while 71% of respondents would recommend vaccination as a preventative measure to a patient who was concerned about contracting monkeypox, 65% of doctors say their country does not have enough vaccines. The barometer survey included 1,011 physician respondents from 20 countries, with key findings including: Concerns About Misinformation Seventy-eight percent of physician respondents are concerned about the spread of monkeypox misinformation and 60% are concerned that monkeypox is being categorized incorrectly as a sexually transmitted disease, such as syphilis or HPV. Based on lessons from the COVID-19 pandemic, 36% feel public health authorities should priorit

Advent Technologies and the Greek Natural Gas Company, DEPA Commercial, sign MoU to collaborate on Hydrogen Projects8.8.2022 15:00:00 CEST | Press release

Advent Technologies Holdings, Inc., an innovation-driven leader in the fuel cell and hydrogen technology space, today announced the signing of a Memorandum of Understanding ("MoU") with DEPA Commercial S.A., the leading importer of pipeline gas and liquefied natural gas (“LNG”) in Greece to enter into a strategic collaboration on hydrogen projects of common interest. The MoU sets out the framework for a forthcoming mutually binding agreement. The parties have preliminarily agreed to the following actions: Collaborate on the production of environmentally friendly hydrogen as a fuel with the participation of other major industrial partners. Co-develop a proprietary and highly differentiated CHP system ready for mass production with efficiency approaching 90% and with multi-fuel operating capabilities (hydrogen, natural gas, efuels) that can address the key current, future, and on-grid, off-grid operation modes and business cases. Create an innovation hub for the Greek hydrogen and fuel c

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital8.8.2022 10:50:00 CEST | Press release

Pharma Tech Holding SA (“PTH”) announced today it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries. Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA (“BSS”) a JV between PTH and listed company IGEA PHARMA NV (“Igea”), IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extractio

Smile Hair Clinic Named 'Hair Transplant Clinic of the Year'8.8.2022 09:30:00 CEST | Press release

The Smile Hair Clinic took two awards in the ‘Highest Quality Hair Transplantation Clinic’, and the 'Hair Clinic of the Year' categories at the 13th Annual Quality of Magazine Klass Award Ceremony. Dr. Gokay Bilgin and Dr. Mehmet Erdoğan founded the Smile Hair Clinic in 2018 and have since overseen its successful and award-winning growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005053/en/ Smile Hair Clinic named 'Hair Transplant Clinic of the Year' (Graphic: Business Wire) Award Ceremony: https://www.youtube.com/watch?v=0TvUp2FxRII Accepting the award Dr. Bilgin said, "Our country holds an important position in medicine globally; patients from all over the world come to Turkey for treatment." Award winners Dr. Bilgin and Dr. Erdoğan have many years of experience in follicular unit extraction (FUE) techniques. Located on Istanbul’s Anatolian neighborhood of Ataşehir, the clinic has more than 100 trained personnel

Teckro Partners with Reforestation Non-profit “One Tree Planted”5.8.2022 15:04:00 CEST | Press release

Teckro, creator of the only digitally interconnected clinical trial platform for real-time decision-making at the point of patient care, today announced a partnership with One Tree Planted to support native reforestation in Ireland. Teckro will plant trees quarterly to celebrate new clinical research sites and studies live on the Teckro platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220805005165/en/ “Working with One Tree Planted aligns with Teckro’s ethos of making an impact in the world,” said Gary Hughes, co-founder and chief executive officer. “Digitally interconnected clinical trials are good for the environment with less paper and a reduced need for in-person monitoring visits. This partnership enables us to plant trees in recognition of the sustainable gains achieved with our platform.” Planting trees is one of the best ways to combat the damaging effects of climate change. Trees help clean the air we breath