Takeda, Halozyme Global Collaboration on Vedolizumab

Takeda Announces Global Collaboration and License Agreement with Halozyme to Continue Advancing Vedolizumab with ENHANZE® Drug-Delivery Technology

January 8, 2026

Strategic partnership represents continued focus on patient care and long-term potential of vedolizumab

OSAKA, Japan and CAMBRIDGE, Massachusetts, January 8, 2026 – Takeda (TSE:4502/NYSE:TAK) today announced a global collaboration and license agreement with Halozyme Therapeutics, Inc., granting Takeda exclusive access to Halozyme’s innovative ENHANZE® drug delivery technology for use with vedolizumab. This partnership underscores Takeda’s commitment to advancing patient care and unlocking new possibilities for vedolizumab, which is marketed under the trade name ENTYVIO®*. Entyvio is approved for the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn's disease.

Ulcerative colitis and Crohn’s disease, the two most prevalent forms of inflammatory bowel disease (IBD), are chronic, complex, and unpredictable conditions. Each patient’s journey is unique, often requiring multiple treatment approaches over time.^1,2 With IBD prevalence projected to surpass 10 million globally by 2032,^3,4 Takeda recognizes the urgent need for ongoing innovation. This collaboration demonstrates Takeda’s continued commitment to directly address these challenges, expand its GI and Inflammation portfolio and broaden access to vedolizumab worldwide.

“For more than a decade, vedolizumab has played a pivotal role in helping patients to manage ulcerative colitis and Crohn’s disease. This collaboration marks another significant step in our dedication and leadership within the IBD community, including relentless pursuit of research and development addressing important patient needs,” said Robert Hollowell, M.D., Head of Global Product and Launch Strategy, GI and Inflammation at Takeda. “By integrating ENHANZE technology, we aim to offer greater flexibility in vedolizumab treatment, improve patient experience, and continue our focus on high-impact partnerships that deliver value for patients, health care providers, and the broader healthcare community.”

Dr. Helen Torley, President and Chief Executive Officer of Halozyme, added: “Our partnership with Takeda demonstrates our ongoing commitment to delivering innovative solutions that improve the patient experience. By leveraging ENHANZE, a commercially validated solution that facilitates the subcutaneous delivery of injected drugs, we aim to help patients spend less time managing their therapy and more time living their lives. This collaboration further highlights the broad applicability and value of ENHANZE across multiple therapeutic areas.”

Under the terms of the agreement, Takeda will provide Halozyme with an upfront payment, as well as potential future development and commercial milestone payments. Halozyme will also be eligible to receive royalties on sales of products containing vedolizumab in combination with ENHANZE®.

Halozyme’s proprietary ENHANZE® drug delivery technology is the leading recombinant human hyaluronidase PH20 enzyme (rHuPH20) and has touched more than one million patient lives through ten commercialized products across over 100 global markets.

About vedolizumab

Vedolizumab is a biologic therapy marketed under the trade name ENTYVIO®* for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market). Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.⁵

*In most markets worldwide.

U.S. 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: Reports of elevations of transaminase and/or bilirubin have occurred. Discontinue ENTYVIO 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.

Please click for the EU SmPC.

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.

Media Contacts:

Takeda Media Relations
[email protected]

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. 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

Crohn's & Colitis Foundation. Inflammatory Bowel Disease vs. Irritable Bowel Syndrome. 2019.
Vieujean S, Jairath V, Peyrin-Biroulet L, et al. Nat Rev Gastroenterol Hepatol. 2025;22:371–394.
Santiago M, Stocker F, Ministro P, et al. Clin Transl Gastroenterol. 2022;13(5):e00481.
Agrawal M, Jess T. United European Gastroenterol J. 2022;10(10):1113-1120.
Data on file. Takeda Pharmaceuticals.

* Strategic partnership represents continued focus on patient care and long-term potential of vedolizumab **OSAKA, Japan and CAMBRIDGE, Massachusetts, January 8, 2026 –** Takeda (**[TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)**) today announced a global collaboration and license agreement with Halozyme Therapeutics, Inc., granting Takeda exclusive access to Halozyme’s innovative ENHANZE® drug delivery technology for use with vedolizumab. This partnership underscores Takeda’s commitment to advancing patient care and unlocking new possibilities for vedolizumab, which is marketed under the trade name ENTYVIO®*. Entyvio is approved for the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn's disease. Ulcerative colitis and Crohn’s disease, the two most prevalent forms of inflammatory bowel disease (IBD), are chronic, complex, and unpredictable conditions. Each patient’s journey is unique, often requiring multiple treatment approaches over time.1,2 With IBD prevalence projected to surpass 10 million globally by 2032,3,4 Takeda recognizes the urgent need for ongoing innovation. This collaboration demonstrates Takeda’s continued commitment to directly address these challenges, expand its GI and Inflammation portfolio and broaden access to vedolizumab worldwide. “For more than a decade, vedolizumab has played a pivotal role in helping patients to manage ulcerative colitis and Crohn’s disease. This collaboration marks another significant step in our dedication and leadership within the IBD community, including relentless pursuit of research and development addressing important patient needs,” said Robert Hollowell, M.D., Head of Global Product and Launch Strategy, GI and Inflammation at Takeda. “By integrating ENHANZE technology, we aim to offer greater flexibility in vedolizumab treatment, improve patient experience, and continue our focus on high-impact partnerships that deliver value for patients, health care providers, and the broader healthcare community.” Dr. Helen Torley, President and Chief Executive Officer of Halozyme, added: “Our partnership with Takeda demonstrates our ongoing commitment to delivering innovative solutions that improve the patient experience. By leveraging ENHANZE, a commercially validated solution that facilitates the subcutaneous delivery of injected drugs, we aim to help patients spend less time managing their therapy and more time living their lives. This collaboration further highlights the broad applicability and value of ENHANZE across multiple therapeutic areas.” Under the terms of the agreement, Takeda will provide Halozyme with an upfront payment, as well as potential future development and commercial milestone payments. Halozyme will also be eligible to receive royalties on sales of products containing vedolizumab in combination with ENHANZE®. Halozyme’s proprietary ENHANZE® drug delivery technology is the leading recombinant human hyaluronidase PH20 enzyme (rHuPH20) and has touched more than one million patient lives through ten commercialized products across over 100 global markets. ## About vedolizumab Vedolizumab is a biologic therapy marketed under the trade name ENTYVIO®* for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market). Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.5 *\*In most markets worldwide.* ## U.S. 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:** Reports of elevations of transaminase and/or bilirubin have occurred. Discontinue ENTYVIO 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).*** *Please [click for the EU SmPC](https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf).* ## 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: **Takeda Media Relations** [[email protected]](mailto:[email protected]) ## 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. ## 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. Crohn's & Colitis Foundation. Inflammatory Bowel Disease vs. Irritable Bowel Syndrome. 2019. 2. Vieujean S, Jairath V, Peyrin-Biroulet L, et al. Nat Rev Gastroenterol Hepatol. 2025;22:371–394. 3. Santiago M, Stocker F, Ministro P, et al. Clin Transl Gastroenterol. 2022;13(5):e00481. 4. Agrawal M, Jess T. United European Gastroenterol J. 2022;10(10):1113-1120. 5. Data on file. Takeda Pharmaceuticals.