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Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting


Takeda (TSE:4502/NYSE:TAK) today announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP. These findings will be presented in a poster session on Sunday, June 23, 2024 at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.

HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, approved earlier this year by the U.S. Food and Drug Association (FDA) as maintenance therapy in adults with CIDP and by the European Commission for patients of all ages with CIDP post-stabilization with intravenous immunoglobulin (IVIG). HYQVIA's hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle. This allows high-volume IG administration (equivalent to volumes administered intravenously) into the subcutaneous tissue over a short time. As a result, HYQVIA can be infused up to once monthly (every two, three or four weeks). HYQVIA can be self-administered after appropriate patient or caregiver training or administered by a healthcare professional in a medical office, infusion center or at a patient's home.1

"The long-term data from the ADVANCE-CIDP 3 clinical trial allow us to further characterize the safety, efficacy and tolerability profile of HYQVIA and reinforces its role as a long-term, up-to once monthly maintenance treatment for this complex, chronic condition," said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit. "These results reflect our continued commitment to bringing the benefits of our differentiated immunoglobulin therapies to patients with neuroimmunological disorders, and providing a range of effective treatment options that address the individual needs of a broad range of patients."

The ADVANCE-CIDP 3 clinical trial is the longest extension study ever performed within context of a clinical trial in CIDP to date. The study, which enrolled 85 patients from the ADVANCE-CIDP 1 clinical trial, evaluated the safety, tolerability and immunogenicity of HYQVIA. The primary outcome measure was safety/tolerability and immunogenicity. The median duration of HYQVIA treatment was 33 months (0 to 77 months) with a cumulative overall follow-up time of 220 patient years. The findings were consistent with the known safety and tolerability profile of HYQVIA and no new safety concerns were observed.2 Key findings showed:

"Results of the ADVANCE-CIDP 3 study help provide additional confidence to those living with CIDP and their healthcare providers regarding the potential for extended maintenance of their condition with a facilitated subcutaneous immunoglobulin," said Dr. Robert Hadden, MD, Consultant Neurologist, Neurology Department, King's College Hospital, London, UK and Department of Basic & Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK and ADVANCE-CIDP 3 presenting author. "This treatment allows the convenience of potential self-treatment at home, typically only once every four weeks."

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in the extremities.3 The role of IG therapy for CIDP has been well-established4 and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects.5 Nearly a quarter of all IG therapy is used in the treatment of CIDP.6

About HYQVIA®
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. In addition, it is approved by the EMA as maintenance therapy in adults, children and adolescents (0-18 years) with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG). In the United States it is approved to treat adults and children two years of age and older with PI as a well as a maintenance therapy for adult patients with CIDP. HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body's immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI).

About the ADVANCE-CIDP 3 Clinical Trial
ADVANCE-CIDP 3 was a long-term extension of ADVANCE-CIDP 1, a Phase 3, double-blind, randomized, placebo-controlled study.7 All patients entering ADVANCE-CIDP 3 received open-label HYQVIA and continued to receive the same dose and dosing regimen from ADVANCE-CIDP 1 (mean monthly dose equivalent of 1.1 g/kg).7 The primary objective was to analyze long-term safety, tolerability and immunogenicity. Efficacy was an exploratory outcome, including evaluation of CIDP relapse.

Further information about the ADVANCE-CIDP 3 clinical trial is available at ClinicalTrials.gov under study identifier NCT02955355.

HyQvia® (Human normal immunoglobulin) 100 mg/ml solution for infusion for subcutaneous use European PRESCRIBING INFORMATION

Always refer to the Summary of Product Characteristics (SmPC) and the local prescribing information of your country before prescribing.

Presentation: HyQvia is a dual vial unit consisting of one vial of 10% human normal immunoglobulin (Ig) and one vial of recombinant human hyaluronidase (see the SmPC for details).

Indications: Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes (PID) with impaired antibody production; secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/l. PSAF is a failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

Dosage and administration: For subcutaneous use only. Therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency/CIDP. The product should be brought to room temperature before use. Inspect both vials for discolouration and particulate matter before administration. Do not use heating devices including microwaves. Do not shake or mix the components of the two vials. Suggested infusion site(s) are the middle to upper abdomen and thighs. The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by Ig 10%. Please see the SmPC for infusion rates. The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full contents of the Ig 10% vial is administered. Longer needles may be used under medical supervision to prevent infusion site leakage. Home treatment should be initiated and monitored by a physician experienced in the guidance of patients for home treatment. Posology: Dose and dosage regimen may need to be individualised for each patient dependent on the response. The dose and dose regimens are dependent on the indication. Dose based on body weight may require adjustment in underweight or overweight patients. Replacement therapy in PID: Patients naïve to Ig therapy: The dose required to achieve a trough level of 6 g/L is approximately 0.4-0.8 g/kg body weight/month. The dose interval to maintain steady state levels varies from 2-4 weeks. IgG trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels (>6 g/l). At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1-week dose to up to a 3- or 4-week dose. Patients previously treated with intravenous (IV) Ig: For patients switching directly from IV Ig, or who have had a previous IV dose that can be referenced, the medicinal product should be administered at the same dose and at the same frequency as their previous IV Ig treatment. Patients previously treated with Ig administered subcutaneously: the initial dose of HyQvia is the same as for subcutaneous treatment but may be adjusted to 3- or 4-week intervals. The first infusion should be given one week after the last treatment with the previous Ig. Replacement therapy in SID: the recommended dose is 0.2-0.4 g/kg every 3 to 4 weeks. IgG levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free. Immunomodulatory therapy in CIDP: Before initiating therapy, the weekly equivalent dose should be calculated by dividing the planned dose by the planned dose interval in weeks. The typical dosing interval range for HyQvia is 3- to 4-weeks. The recommended subcutaneous dose is 0.3 to 2.4 g/kg body weight per month, administered in 1-or 2-sessions over 1-or 2-days. The patient's clinical response should be the primary consideration in dose adjustment. The dose may need to be adapted to achieve the desired clinical response. In clinical deterioration, the dose may be increased to the recommended maximum of 2.4 g/kg monthly. If the patient is clinically stable, periodic dose reductions may be needed to observe whether the patient still needs IG therapy. A titration schedule that permits gradual dose increase over time (ramp-up) is recommended to ensure the patient's tolerability until the full dose is reached. During the titration schedule, the calculated HyQvia dose and recommended dose intervals must be followed for the first and second infusions. Depending on the treating physician's discretion, in patients who tolerate the first 2 infusions well, subsequent infusions may be administered by gradually increasing doses and dose intervals, considering the volume and total infusion time. An accelerated titration schedule may be considered if the patient tolerates the SC infusion volumes and the first 2 infusions. Doses less than or equal to 0.4 g/kg may be administered without a titration schedule, provided acceptable patient tolerance. Patients must be on stable doses (Variations in the dosing interval of up to ±7 days or monthly equivalent dose amount of up to ±20% between the subject's IgG infusions are considered a stable dose) of IVIg. Before initiating therapy with the medicinal product, the weekly equivalent dose should be calculated by dividing the last IVIg dose by the IVIg dose interval in weeks. The starting dose and dosing frequency are the same as the patient's previous IVIg treatment. The typical dosing interval for HyQvia is 4-weeks. For patients with less frequent IVIg dosing (greater than 4-weeks), the dosing interval can be converted to 4-weeks while maintaining the same monthly equivalent IgG dose. The calculated one-week dose (1st infusion) should be administered 2 - weeks after the last IVIg infusion (see Table 1 of the SmPC). One week after the first dose, the next weekly equivalent dose (2nd infusion) should be administered. A titration schedule can take up to 9-weeks (see Table 1 of the SmPC), depending on the dosing interval and tolerability. On a given infusion day, the maximum infusion volume should not exceed 1200 mL for patients weighing ?40 kg or 600 mL for <40 kg. Suppose the maximum daily dose limit is exceeded or the patient cannot tolerate the infusion volume. In that case, the dose may be administered over multiple days in divided doses with 48-to 72-hours between doses to allow absorption of infusion fluid at the infusion site(s). The dose can be administered up to 3 infusion sites with a maximum infusion volume of 600 mL per site (or as tolerated). If using three sites, the maximum is 400 mL per site. Paediatric population: Replacement therapy and Immunomodulatory therapy: follow adult dosage guidance.

Contraindications: Hypersensitivity to any ingredient or human IG especially in patients with antibodies against IgA; systemic hypersensitivity to hyaluronidase or human recombinant hyaluronidase; HyQvia must not be given IV or intramuscularly.

Warnings and precautions: If HyQvia is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate given in the SmPC should be adhered to. Infuse slowly and monitor closely throughout the infusion period, particularly patients starting therapy. Patients may require monitoring for up to 1 hour after administration. Manage infusion related events by slowing the infusion rate or stopping the infusion. Treatment will depend on the nature and severity of the adverse event. Patients should be reminded to report chronic inflammation and nodules which occur at the infusion site or other locations. For home treatment, patients should have the support of another responsible person in case of adverse reactions. Record treatment with HyQvia and batch number in patients' notes.

Hypersensitivity: Hypersensitivity reactions are possible in patients with anti-IgA antibodies who should only be treated with HyQvia if alternative treatments are not possible and under close medical supervision. In case of hypersensitivity, shock or anaphylactic-like reactions, discontinue the infusion immediately and treat the patient for shock. Rarely, human normal IG can induce a fall in blood pressure with anaphylactic reaction. In high-risk patients HyQvia should only be administered where supportive care is available for life threatening reactions. Patients should be informed of the early signs of anaphylaxis/ hypersensitivity. Pre-medication may be used as a preventative measure.

Hypersensitivity to recombinant human hyaluronidase: Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary.

Immunogenicity of recombinant human hyaluronidase: Development of non-neutralising antibodies and neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.

Thromboembolism: Thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been observed with IG treatment and cannot be excluded with use of HyQvia. Ensure adequate hydration prior to treatment. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk. Patients should be informed about initial symptoms and advised to contact their physician immediately upon onset.

Haemolytic anaemia: IG products contain antibodies to blood groups (e.g. A, B, D) which may act as haemolysins. Monitor for signs and symptoms of haemolysis.

Aseptic meningitis syndrome: has been reported, symptoms usually begin within several hours to 2 days following treatment. Patients should be informed about initial symptoms. Discontinuation of IG treatment may result in remission within several days without sequelae.

Interference with serological testing: After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing. Passive transmission of antibodies to erythrocyte´s surface antigens may interfere with some serological tests for red cell antibodies. Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of ?-D glucans for diagnosis of fungal infections.

Transmissible agents: Infectious diseases due to the transmission of infective agents cannot be totally excluded.

Sodium content: The recombinant human hyaluronidase component contains 4.03 mg sodium/mL. To be taken into consideration by patients on a controlled sodium diet. Traceability: The name and the batch number of the administered product should be clearly recorded.

Interactions: Live attenuated virus vaccines ? postpone vaccination for 3 months after treatment with HyQvia. For measles vaccine, impairment may persist for up to 1 year, so check antibody status. Please see the SmPC for details.

Fertility, pregnancy and lactation: Safety during pregnancy has not been established and immunoglobulins are excreted into the milk, therefore use with caution in pregnant and breastfeeding mothers.

Effects on ability to drive and use machines: The ability to drive and operate machines may be impaired by some adverse reactions e.g., dizziness associated with this medicinal product. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.

Undesirable effects: Very common (?1/10 patients): Headache, Blood pressure increased and Hypertension, Nauseam Diarrhoea, Vomiting, Arthralgia, Local reactions (Infusion site discomfort, Infusion site pain, Injection site pain, Puncture site pain and Tenderness; infusion site erythema and Injection site erythema; Infusion site oedema, Injection site oedema, infusion site swelling, Injection site swelling and Swelling (local), Feeling hot, Asthenia, Fatigue, Lethargy and Malaise.

Common (?1/100, <1/10 patients): Migraine, Tremor, Paraesthesia, Sinus tachycardia and Tachycardia, Hypotension, Dyspnoea, Abdominal distension, Erythema, Pruritus, Rash, Rash erythematous, Rash macular, Rash maculo-papular and Rash popular Urticaria, Myalgia, Limb discomfort and Pain in extremity, Back pain, Joint stiffness, Musculoskeletal chest pain, Groin pain, Hemosiderinuria, Infusion related reaction, Infusion site bruising, Injection site bruising, Infusion site haematoma, Injection site haematoma, Infusion site haemorrhage and Vessel puncture site bruise, Infusion site reaction, Injection site reaction and Puncture site reaction, Infusion site mass, Injection site mass and Infusion site nodule, Infusion site discoloration, Infusion site rash and Injection site rash, Infusion site induration and Injection site induration, Infusion site warmth, Infusion site paraesthesia and Injection site paraesthesia, Infusion site inflammation, Chills, Oedema, Oedema peripheral and Swelling (systemic), Localised oedema, Peripheral swelling and Skin oedema, Gravitational oedema, Oedema genital, Scrotal swelling and Vulvovaginal swelling, Hyperhidrosis, Coombs direct test positive and Coombs test positive.

Uncommon (? 1/1 000 to < 1/100): Cerebrovascular accident and Ischaemic stroke, Burning sensations.

Other undesirable effects (rare or unknown frequency): Meningitis aseptic, Hypersensitivity, Direct Coombs' test positive, Infusion site leakage, Influenza-like illness.

Refer to the SmPC for details on full side effect and interactions.

Marketing Authorisation (MA) numbers: 2.5g EU/1/13/840/001, 5g EU/1/13/840/002, 10g EU/1/13/840/003, 20g EU/1/13/840/004, 30g EU/1/13/840/005. Name and address of MA holder: Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna, Austria. HyQvia is a registered trade name.

PI approval code: PI-02941

Date of preparation: June 2024.

Further information is available on request

Adverse events should be reported to the authorities in your country as required by local law. Adverse events should also be reported to Takeda at: [email protected].

For Full U.S. Prescribing Information, please visit: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.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.

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.

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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.

References
___________________________________
1 European Medicines Agency. HyQvia 100 mg/mL solution for infusion for subcutaneous use Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf.
2 Hadden R et al. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% for chronic inflammatory demyelinating polyradiculoneuropathy: final results from a long-term safety and tolerability study. Poster presented at: Peripheral Nerve Society (PNS) Annual Meeting, 22?25 June 2024, Montréal, Canada. P89.
3 Dalakas MC; Medscape. Advances in the diagnosis, pathogenesis and treatment of CIDP. Nat Rev Neurol. 2011;7(9):507-517.
4 Eftimov F, et al. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013;(12):CD001797.
5 Van den Bergh PYK, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision [published correction appears in J Perpher Nerv System. 2022 Mar;27(1):94].
6 Adivo 2020 data (incl. US, Canada, France, Germany, UK, Italy, Spain, Sweden, Netherlands, Japan, Taiwan, Australia, Brazil, Turkey, Russia, Argentina, Egypt, Kazakhstan, Saudi Arabia, Colombia) represents ~84% of Global IG Consumption (excl. China and India)
7 ClinicalTrials.gov. Long-Term Tolerability and Safety of HYQVIA/?HyQvia in CIDP. July 24, 2023. Last accessed May 2024 from https://clinicaltrials.gov/study/NCT0295535


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