TORONTO, Jan. 24, 2020 /CNW/ - Takeda Canada Inc. is pleased to announce that effective January 31, Ontario will publicly reimburse INTUNIV XR® (guanfacine hydrochloride extended-release tablets) for the treatment of attention deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents (6 to 17 years old) in the following settings: As an adjunctive therapy to psychostimulants;

As monotherapy in patients who have significant intolerance to psychostimulants and who have had an inadequate response to either atomoxetine or other non-stimulant alternative(s). INTUNIV XR® is a selective alpha 2A -adrenergic receptor agonist.1 In Ontario, this funding provides an additional treatment option for children and adolescents (6 to 17 years old) in whom response to stimulant therapy has been suboptimal.1 "ADHD is a complicated and chronic disease, and I've seen first-hand how challenging it is for parents and their children to find a treatment plan that works for them," said Heidi Bernhardt, President and Executive Director of the Centre for ADHD Awareness Canada. "I applaud the government of Ontario for granting families access to an additional treatment option to help their children manage their ADHD." ADHD is among the most prevalent mental health conditions in childhood.2 Five to nine per cent of children and adolescents in Canada are living with ADHD,3 a condition that can cause poor school performance, behavioural challenges, and difficulties at home and with friends.2 Medication plays an important role4 in managing common symptoms including inattention, hyperactivity and impulsivity.2 "Takeda is committed to providing innovative treatment options to Canadians with ADHD," said Gamze Yüceland, General Manager, Takeda Canada Inc. "We are pleased to learn that the Ontario government will improve access for patients by listing INTUNIV XR® as both a standalone and combination therapy on the Ontario Drug Formulary." To learn more about the eligibility criteria for reimbursement of INTUNIV XR® visit http://www.health.gov.on.ca/en/pro/programs/drugs/odbf_mn.aspx About INTUNIV XR®

INTUNIV XR® (guanfacine hydrochloride extended-release tablets) is an oral, once-daily treatment for attention deficit/hyperactivity disorder (ADHD). Its active ingredient, guanfacine, is a selective alpha 2A -adrenergic receptor agonist.1 INTUNIV XR® was approved by Health Canada in July 2013 as monotherapy for the treatment of ADHD in children aged 6 to 12 years, and as adjunctive therapy to psychostimulants for the treatment of ADHD in children, aged 6 to 12 years, with a sub-optimal response to psychostimulants.5 In September 2015, Health Canada extended both indications for INTUNIV XR® to include adolescents aged 13-17.6 The efficacy of INTUNIV XR® in the treatment of ADHD was established in two placebo-controlled monotherapy pivotal trials in pediatrics, and in one placebo-controlled monotherapy trial in adolescents (aged 13-17 years). A fourth study further evaluated the safety and efficacy of INTUNIV XR® as adjunctive therapy to psychostimulants.1 INTUNIV XR® is also publicly reimbursed in the province of Quebec as part of the RAMQ (Régie de l'assurance maladie du Québec) "Exceptional medications" section of the List of Medications,7 in association with a psychostimulant, for the treatment of children and adolescents suffering from attention deficit disorder with or without hyperactivity, for whom it has not been possible to properly control the symptoms of the disease with methylphenidate and an amphetamine used as monotherapy. Before it can be concluded that the effectiveness of these drugs is sub-optimal, they must have been titrated at optimal doses.8 About ADHD

Attention deficit/hyperactivity disorder is a neurodevelopmental disorder characterized by the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years.1 For an ADHD diagnosis, the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work), and at home.1 Approximately 75 per cent of patients continue to meet the diagnostic criteria as the child moves into adolescence, and over half of patients will continue to present with clinically significant impairment into adulthood.2 About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. 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. Additional information about Takeda Canada is available at www.takeda.com/en-ca *INTUNIV XR® is a registered trademark of Shire LLC, a Takeda company. References __________________________ 1 INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, January 23, 2019. 2 Statistics Canada. Childhood Conditions. Available at: https://www150.statcan.gc.ca/n1/pub/82-619-m/2012004/sections/sectionc-eng.htm. Accessed January 2020. 3 Canadian ADHD Resource Alliance (CADDRA): Canadian ADHD Practice Guidelines, Fourth Edition, Toronto ON; CADDRA, 2018. 4 Cutler AJ, Mattingly GW. Beyond the pill: new medication delivery options for ADHD. CNS Spectr. 2017;22(6):463-474. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149449/. Accessed January 2020. 5 INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, July 5, 2013. 6 INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, September 8, 2015. 7 Régie de l'assurance maladie du Québec (RAMQ). Pharmaceuticals; Exceptional Drugs. Available at: http://www.ramq.gouv.qc.ca/fr/professionnels/pharmaciens/medicaments/medicaments-patient-exception/Pages/index-formulaires-mc.aspx#I. Accessed January 2020. 8 Régie de l'assurance maladie du Québec (RAMQ). List of Medications. Available at: http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_12_18_en.pdf. Accessed January 2020. SOURCE Takeda Canada