Takeda Canada, Inc.

HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option TORONTO, June 21, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in pediatric patients 2 years of age and older. HyQvia is the only subcutaneous immune globulin (SCIG) infusion that can be administered every three or four weeks.1 "This approval is significant as it gives children and adolescents living with immunodeficiencies another treatment option," said Whitney Ayoub Goulstone, Executive Director, ImmUnity Canada. "Children living with immunodeficiencies can be severely impacted as it affects them physically, emotionally and socially. Our organization welcomes treatment options for patients in Canada as this is to the benefit of better health outcomes and patient preference." There are more than 300 genetic defects and disorders of the immune system that are recognized as PI. These forms range widely in severity and symptoms. On average, 1 in every 1,200 individuals are affected by this disease and early diagnosis and treatment are vital in saving lives. Approximately 29,000 Canadians suffer from PI and over 70% are undiagnosed.2 "The pediatric indication for HyQvia provides another treatment option for patients impacted by immunodeficiency disorders," said Jefferson Tea, Vice President, Medical & Scientific Affairs, Takeda. "We are committed to creating innovative solutions for Canadians living with immunodeficiency and are excited that parents and caregivers will have the option to support administration of this treatment to their children in their own home." Authorization for the treatment of pediatric patients was based on two pivotal studies in 66 patients ranging in age from 2 to 16 years. HyQvia was shown to be efficacious and no new safety signals were detected when compared to the adult population. Based on evidence from the pivotal, prospective, open-label, non-controlled Phase 3 clinical study in 44 pediatric patients with PI, there were no clinically meaningful differences in trough IgG levels across age groups. During the 12-month trial period, it was shown to be efficacious with respect to the occurrence of acute serious bacterial infections (ASBIs), a primary endpoint.1 The mean rate of ASBIs per subject-year was 0.04 and was statistically significantly lower (p<0.001) than the threshold rate of 1.0 ASBI per subject-year favoring efficacy of this treatment in pediatric subjects with PI. The efficacy of the treatment in this study was further demonstrated by the overall rate of infections per subject, which is consistent with results obtained in the pivotal clinical study. The mean rate of all infections per subject-year was 3.20, with an upper limit of the 95% CI of 4.05. The results of Study 161503 indicated similar safety profiles to adults.1 About HyQvia® HyQvia is indicated as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult and pediatric patients 2 years of age and older.1 This therapy is used in patients who do not have enough antibodies in their blood or have a weakened immune system and get frequent infections.1 Consult the product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical information department. About Immunodeficiency Primary immunodeficiency disorder (PID) refers to a large heterogeneous group of disorders that result from defects in immune system development and/or function. PIDs are broadly classified as disorders of adaptive immunity (i.e., T cell, B-cell or combined immunodeficiencies) or of innate immunity (e.g., phagocyte and complement disorders). Although the clinical manifestations of PIDs are highly variable, many disorders involve an increased susceptibility to infection.2 Secondary immune deficiencies or acquired deficiencies, more frequent than primary immune deficiencies, are problems of the immune system that are not genetic and which are caused by external factors including viruses (such as HIV), severe malnutrition, certain chronic diseases such as diabetes, immunosuppressive medication or chemotherapy, certain cancers such as leukemia, and the absence of the spleen.3 About Takeda Canada Inc. Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: References SOURCE Takeda Canada Inc. Company Codes: NYSE:TAK, Tokyo:4502

Funding to attract and advance Canadian clinical research in inflammatory bowel disease TORONTO, Feb. 13, 2024 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium's (CIRC) $1 million PIONEER Grant in its second year. This grant, with Takeda contributing $500,000 of the $1,000,000 award, will continue to support high-quality, impactful Canadian clinical research to improve patient outcomes and quality of life for people living with inflammatory bowel disease (IBD). "At Takeda, our unwavering dedication lies in making a tangible difference in the lives of Canadians struggling with inflammatory bowel disease," said Rute Fernandes, President & General Manager, Takeda in Canada. "In order to do this, we must continue to invest in scientific research that address the needs of patients, and that is why we are pleased to continue to support this important program." For the second PIONEER grant, a prospective, multi-site, randomized controlled trial (RCT) will be given priority, but one or multiple non-RCT designs will be considered, and to involve CIRC members. Investigators who have pilot data and partner support are encouraged to share those details. Requests for up to $1 million in funding will be considered, which can be dispersed over a minimum of two and a maximum of five years. "The purpose of CIRC is to advance the care of people living with Crohn's disease and Ulcerative Colitis, through research," said Dr. Talat Bessissow, President of CIRC and Gastroenterologist at McGill University. "We are immensely proud of our research community, this program and are grateful for Takeda partnership and dedication to advancing research in Canada." The inaugural PIONEER grant was awarded to Dr. Christopher Ma, Associate Professor of Medicine and Community Health Sciences, for his PATHFINDER study, a randomized, multi-centre pragmatic trial that will investigate which class of biologics is the optimal first-line treatment for patients with high-risk ileal Crohn's disease. "In Canada, there is significant competition for high-impact clinical research funding and a huge appetite amongst researchers, physicians, and patients to advance the field," said Dr. Ma. "The PIONEER Grant, established through $1,000,000 in support from Takeda, gives Canadian IBD researchers an amazing and truly unique opportunity to conduct practice changing investigator-initiated research. We are seeing firsthand the impact of this grant on our research community, with recruitment having already kicked off and most sites for the PATHFINDER study being set to open in 2024." Inflammatory bowel disease – the main forms of IBD being Crohn's disease and ulcerative colitis – causes chronic inflammation of the gastrointestinal (GI) tract which impacts food digestion, nutrition absorption and waste elimination for those affected. More than 300,000 Canadians live with this disease for which there is currently no cure.i ii Letters of intent are now being accepted and are due March 26th, 2024, at 12:00 am EST. Further details including information on how to submit a letter of intent can be found at: . About CIRC With the support of Crohn's and Colitis Canada, CIRC was established in 2017 to attract and facilitate clinical studies in Canada by creating a collaborative network of clinician scientists and offering research support. Now in its sixth year, CIRC has continued to grow and is currently running nine multi-centre investigator-initiated studies designed to answer important clinical questions, including four multi-centred randomized controlled trials. To learn more about CIRC, visit circ-ccrm.ca About Crohn's and Colitis Canada Crohn's and Colitis Canada is on a relentless journey to find the cures for Crohn's disease and ulcerative colitis and improve the lives of children and adults affected by these chronic diseases. We are the country's largest volunteer-based organization with this mission and are one of the top two health charity funders of Crohn's and colitis research in the world, investing over $135 million in research to date. We are transforming the lives of people affected by Crohn's and colitis through research, patient programs, advocacy, and awareness. For more information, visit crohnsandcolitis.ca and follow us @getgutsycanada on Twitter, Facebook, and Instagram. About Takeda Canada Inc. Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: takeda.com/en-ca SOURCE Takeda Canada, Inc.

BYK Additives starts 2024 with a significant investment at the Deventer site in the Netherlands. On Jan. 11, 2024, BYK Netherlands B.V. celebrated the groundbreaking ceremony for the construction of a new factory in Deventer, the Netherlands. The new production facility will manufacture solvent based wax dispersions and replace the current facility with a state-of-the-art process installation which will meet current as well as future demands from customers – of course also in line with current and future regulatory demands. BYK is investing a double-digit million euro amount in the plant. “The significant investment in the solvent-based wax business shows our commitment to our key customers who have an ever-growing need for these specialties. With this investment we are excellently positioned to continue to be a reliable and sustainable development partner to our global customer base,” said Dr. Jörg Hinnerwisch, BYK Division president. “Everything that we have learned about producing wax dispersions in the last 50 years has been transferred to the project and construction team. The new facility ensures that we continue to provide a safe and ergonomic working place for our employees, to remain a reliable and sustainable supplier for our customers and a good and compliant neighbor, ” said Steef Bouwmeester, managing director of BYK Netherlands B.V. The solvent-based wax dispersions are used by can & coil producers, automotive paint producers, printing inks, wood- and industrial coating customers worldwide. The new facility aims to start commercial production end of 2026.