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Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.

Takeda Pharmaceuticals: Global Homepage

A person in a wheelchair is participating in a panel discussion at an event.

# Engaging patients at the Healthcare Café



* ***ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease***

**OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024** – Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1 The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).*

The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1 The primary endpoint was clinical remission*** at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150. 

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”

In VISIBLE 2, a total of 409 patients were randomized at Week 6 in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by SC injection or placebo every 2 weeks.1 Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders). 

A statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission*** compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical studies, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for ENTYVIO SC. The most common adverse reactions reported with ENTYVIO IV (incidence ≥3% and ≥1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

*Please refer to “U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.

 

**Clinical response is defined as a ≥70-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline (Week 0).1

 

***Clinical remission is defined as CDAI score of ≤150 at Week 52.1

Takeda does not expect a material impact on the consolidated financial statements as a result of this approval.

## About ENTYVIO (vedolizumab) 

Vedolizumab is a biologic therapy and is approved for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market).1,2 Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.3 Vedolizumab is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).4 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.5 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.4 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn’s disease.4,6,7 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.4 

### IMPORTANT SAFETY INFORMATION 
 
#### CONTRAINDICATIONS 

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. 
 
#### WARNINGS AND PRECAUTIONS

* **Infusion-Related and Hypersensitivity Reactions:** Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment. 
 
*	**Infections:** Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice. 

* **Progressive Multifocal Leukoencephalopathy (PML):** PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.

* **Liver Injury:** There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury. 

* **Live and Oral Vaccines:** Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks. 

#### ADVERSE REACTIONS 

The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration. 
 
#### DRUG INTERACTIONS 

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed. 
 
#### INDICATIONS 

**Adult Ulcerative Colitis (UC):**

ENTYVIO is indicated in adults for the treatment of moderately to severely active UC. 
 
**Adult Crohn’s Disease (CD):**

ENTYVIO is indicated in adults for the treatment of moderately to severely active CD. 
 
**DOSAGE FORMS & STRENGTHS:**

* ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab 
* ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab 

***Please click for [Full U.S. Prescribing Information](https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&documentnumber=1).***

## About Ulcerative Colitis and Crohn’s Disease

Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).8 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract.9,10 UC only involves the large intestine as opposed to CD, which can affect any part of the GI tract from mouth to anus.11,12 CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine.11,12 UC can present with symptoms of abdominal discomfort or loose bowel movements, including blood.11,13 CD can present with symptoms of abdominal pain, diarrhea, and weight loss.12 The cause of UC or CD is not fully understood; however, research suggests that an interplay between environmental factors, genetics, and intestinal microbiota may contribute to the development of UC or CD.11,14,9

## Takeda’s Commitment to Gastroenterology

With this latest milestone, Takeda continues to demonstrate a commitment to meeting the very real needs of those living with gastrointestinal (GI) diseases. We believe that GI and liver diseases are life-disrupting conditions. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With more than 35 years of experience in gastroenterology, Takeda has made significant strides in addressing patient needs with treatments for inflammatory bowel disease (IBD), eosinophilic esophagitis (EoE), acid-related diseases, short bowel syndrome (SBS) and motility disorders. We are making significant strides toward closing the gap on new areas of unmet need. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

## About Takeda 

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com/). 

### Media Contacts:

#### Japanese Media

Jun Saito

[jun.saito@takeda.com](mailto:jun.saito@takeda.com)

+81 3-3278-2325

#### U.S. and International Media

Amy McCarthy

[amy.mccarthy@takeda.com](mailto:amy.mccarthy@takeda.com)

+1 781-496-7761

## 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](https://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.

## References

1. ENTYVIO (vedolizumab) Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.
2. ENTYVIO Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf. Last updated: April 2023. Last accessed: January 2024.
3. Data on file. Takeda Pharmaceuticals. 
4. Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.
5. Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151:97 110.
6. Eksteen B, Liaskou E, Adams DH. Inflamm Bowel Dis. 2008;14:1298 1312.
7. Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10(12):1437-1444.
8. Baumgart DC, Carding SR. Lancet. 2007;369:1627-1640.
9. Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Lancet. 2017; 389(10080):1741-1755.
10. Krugliak N, Torres J, Rubin DT. Gastroenterology. 2022;162:1396-1408.
11. Ordas I, Eckmann L, Talamini M, et al. Lancet. 2012;380:1606-1619.
12. Feuerstein JD, Cheifetz AS. Mayo Clin Proc. 2017;92:1088-1103.
13. Sands BE. Gastroenterology. 2004;126:1518-1532.
14. Kobayashi T, Siegmund B, Le Berre C, et al. Nat Rev Dis Primers. 2020;6(74).

Takeda receives FDA approval of subcutaneous ENTYVIO (vedolizumab) for maintenance therapy in adults with moderate to severe Crohn’s disease

U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

**OSAKA, Japan, and CAMBRIDGE, Massachusetts, April 18, 2024** – Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) today announced that it will host its earnings call on Thursday, May 9, 2024, to present the financial results for fiscal year 2023. Details below:

<table><tr><td>Date/Time</td><td>Thursday, May 9, 19:00-20:30 (JST) / 11:00-12:30 (BST) / 06:00-07:30 (EDT)</td></tr><tr><td>Participants (planned)</td><td>
 Christophe Weber, President and Chief Executive Officer 
 Milano Furuta, Chief Financial Officer 
 Andy Plump, President, Research & Development 
 Other executive leadership
 </td></tr><tr><td>Content</td><td>Presentation, Q&A session - presented in English and Japanese with simultaneous interpretation.</td></tr><tr><td>Webinar platform and registration</td><td>
 The call will be held using the Zoom platform and Zoom simultaneous interpretation function. Kindly pre-register from the below link: <a href="https://zoom.us/webinar/register/WN_XGJPbWtZT022ljqb1Ro5tA">https://zoom.us/webinar/register/WN_XGJPbWtZT022ljqb1Ro5tA</a>. If you wish to ask questions during the Q&A session, please join from the above link.
 </td></tr><tr><td>Presentation material</td><td>Presentation material will become available on <a href="https://www.takeda.com/investors/financial-results/quarterly-results/">Takeda’s website</a> on Thursday, May 9.</td></tr><tr><td>On-demand Replay</td><td>An on-demand replay will be made available on <a href="https://www.takeda.com/investors/financial-results/quarterly-results/">Takeda’s website</a> after the conclusion of the event.</td></tr><tr><td>Notes</td><td>For optimal performance of simultaneous interpretation and raise-hand functions, please upgrade your Zoom application to the latest version <a href="https://zoom.us">here</a>.</td></tr></table>

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R\&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](http://www.takeda.com).

### Media Contacts:

#### U.S., Japanese and International Media

Brendan Jennings

[brendan.jennings@takeda.com](mailto:brendan.jennings@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/](https://www.takeda.com/investors/sec-filings-and-security-reports/) or at[ www.sec.gov](https://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.

Takeda today announced that it will host its earnings call on Thursday, May 9, 2024, to present the financial results for fiscal year 2023.

Takeda to Hold Fiscal Year 2023 Earnings Call on May 9

* ***Process Performance Qualification (PPQ) Shortened by 50 Percent for Takeda’s New Prefilled Syringe Filling Line in Linz, Austria, for ENTYVIO® Subcutaneous (vedolizumab)***
* ***Recognition Illustrates Takeda’s Patient-Centric Investment in Supply Flexibility and Demonstrates Build-up of Supply Chain Resilience***
* ***Awarded Project Sets New Standard for PPQ for New Production Lines Helping to Shorten Time to Market***

**OSAKA, Japan and CAMBRIDGE, Massachusetts, April 16, 2024** - Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) today announced that the International Society for Pharmaceutical Engineering (ISPE) has awarded the company top honors in the category Operations with the 2024 Facility of the Year Awards (FOYA). The awarded project demonstrates Takeda’s continuous patient-focused process improvements in its manufacturing operations. The project was executed at Takeda’s manufacturing site in Linz, Austria, where Takeda managed to reduce the process performance qualification (PPQ) time by 50 percent for its prefilled syringe filling line for ENTYVIO Subcutaneous (SC) formulation. With this project, the foundation is laid to reduce PPQ timelines for new production lines while further improving supply chain resilience for the organization. The shorter PPQ time increases the flexibility to supply the markets with larger quantities in a shorter period of time.

“Projects like the one at our Linz site help us to respond in a much more flexible way to patients’ needs. At the same time, it helps our entire manufacturing network apply the learnings to future projects. This award reinforces our mission and the potential for innovation that exists in pharmaceutical manufacturing,” says Thomas Wozniewski, global manufacturing and supply officer, Takeda. “We are proud to be recognized by ISPE and will continue to challenge the status quo in pharmaceutical manufacturing by embracing digitalization and Pharma 4.0 for the benefit of patients.”

The implementation of the pre-filled syringe filling line in Linz for ENTYVIO SC was run under a designated “Warp Speed” program with the aim to significantly reduce the time required to perform Process Performance Qualification (PPQ). Takeda was able to reduce the time to 24 months compared to the conventional process of approximately 36 months. The faster process required to run many preparation activities in parallel. 

The PPQ is a prerequisite to verify and document that manufacturing in a new production facility is done effectively and reproducibly in accordance with approved manufacturing techniques and standards. It is a key milestone that must be reached before a new facility can be put into operation. 

Pharma 4.0 technologies in the area of automation and digitalization played a key role in the execution of this project. In scope was the integration of the manufacturing execution system and the historian system over a single automation integration layer for the availability of data for electronic batch recording and external applications. A complete 3D planning model for the aseptic filling line within its future facility was also completed in order to check all requirements in the model and address challenges before the installation.

"By successfully completing the project in Linz in such a short time, we have reached a significant milestone in our endeavour to shorten strategic projects timelines at our manufacturing sites. This project was initiated under our Warp Speed program, aimed at accelerating product launches in the future. Through robust cross-functional collaboration and strong vendor partnerships, we established new standards for efficiency, speed, and success in deploying new production lines," said Gunter Baumgartner, head of global engineering, Takeda. "This achievement serves as evidence of the transformative impact on pharmaceutical manufacturing, laying the groundwork for future progress and accomplishments within our organization."

The main focus of the Takeda site in Linz is the production of biologics for the treatment of chronic inflammatory bowel diseases in various forms, including ENTYVIO. Site investments of around 100 million euros will be made until 2025 to expand the production. The awarded project is part of this investment. Once fully operational, the Linz site will fill and finish 70 percent of the global demand of ENTYVIO SC. 

With a strong focus on sustainability, about 20 new freezers have been installed to store the active ingredient, shortening global supply chains. Innovative sustainable solutions are regularly evaluated and implemented along the entire value chain, such as renewable energy supply. 

## About the ISPE Facility of the Year Awards 

Established in 2004, the Facility of the Year Awards (FOYA) recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operations, while sharing the development of new applications of technology and cutting-edge approaches. For more information, visit [ispe.org/facility-year-awards](https://ispe.org/facility-year-awards).

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com/).
 
### Media Contact

#### Japanese Media

Kumi Iiyama

[Kumi.iiyama@takeda.com](mailto:kumi.iiyama@takeda.com)

#### U.S. and International Media

Megan Ostrower

[Megan.ostrower@takeda.com](mailto:megan.ostrower@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-and-security-reports/](https://www.takeda.com/investors/sec-filings-and-security-reports/) or at [www.sec.gov](https://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. 


Takeda awarded 2024 FOYA by ISPE for reducing process qualification time by 50 percent for new production line in Linz, Austria.

Takeda Recognized with 2024 ISPE Facility of the Year Awards in Category Operations

**OSAKA, Japan, April 15, 2024** – Takeda Pharmaceutical Company Limited (Head Office: Chuo-ku, Osaka; ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/)), “**Takeda**”) today announced that it will issue its 2nd Unsecured, Interest Deferrable and Early Redeemable Subordinated Bonds (“the 2nd Hybrid Bonds”) in the form of a public offering in Japan to refinance the whole or part of the 1st Unsecured, Interest Deferrable and Early Redeemable Subordinated Bonds (“the 1st Hybrid Bonds”) that were issued on June 6, 2019. In preparation for the upcoming issue in 2024, Takeda today filed an Amended Shelf Registration Statement for the issuance of the 2nd Hybrid Bonds with the Director of the Kanto Local Finance Bureau.

**1. Purpose and Background of the 2nd Hybrid Bonds Issuance:** 
Takeda issued the 1st Hybrid Bonds of JPY 500 billion in June 2019 after the acquisition of Shire plc. As a result, hybrid bonds have formed an important part of Takeda’s capital structure, and this importance remains unchanged. With the 1st Hybrid Bonds approaching their First Call Date on October 6, 2024, Takeda plans to replace the 1st Hybrid Bonds with the proceeds from the issuance of the 2nd Hybrid Bonds and (if needed) Hybrid Loans having similar terms.

**2. Features of the 2nd Hybrid Bonds:** 
The 2nd Hybrid Bonds will contain features of debt and equity. As a debt instrument they will carry an interest coupon and have a final maturity date. As an equity instrument they will be subordinated to Senior Notes and other debt instruments, allow interest coupon deferral, and have a very long maturity of up to 60 Years. Given such hybrid debt / equity features, we expect that the 2nd Hybrid Bonds will receive an equity acknowledgement of 50% from Rating Agencies. We note that despite the equity like features, the 2nd Hybrid Bonds are not convertible to equity and will never cause a dilution of equity holders.

**3. Schedule:** 
The 2nd Hybrid Bonds are expected to be priced and issued in mid-2024 subject to market conditions and investor demand. Details will be announced as soon as the terms are determined.

## Disclaimer

This announcement has been prepared to publicly disclose the proposed offering of the 2nd Hybrid Bonds and is not intended to, and does not, constitute, represent or form part of any offer, invitation or solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities whether pursuant to this announcement or otherwise.

This document does not constitute an offer to sell or a solicitation of an offer to purchase any securities within the United States. The 2nd Hybrid Bonds have not been and will not be registered under the U.S. Securities Act of 1933 (the “Act”) and may not be offered or sold in the United States, absent registration or an applicable exemption from the registration requirements. No 2nd Hybrid Bonds will be offered in the United States.

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R\&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](http://www.takeda.com).

## Contacts

**Investor Relations** 
Christopher O’Reilly 
<christopher.oreilly@takeda.com> 
+81 (0) 3-3278-2543

**Media Relations** 
Brendan Jennings 
<brendan.jennings@takeda.com> 
+81 (0) 80-2705-8259

## 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-and-security-reports/> or at [www.sec.gov](http://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.

Takeda Pharmaceutical Company Limited today announced that it will issue its 2nd Unsecured, Interest Deferrable and Early Redeemable Subordinated Bonds in the form of a public offering to refinance the whole or part of the 1st Unsecured, Interest Deferrable and Early Redeemable Subordinated Bonds that were issued on June 6, 2019.

Notice Regarding Issuance of JPY Hybrid Bonds

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