Canadian News

    Nov 2017
    TOKYO, JAPAN

    TOKYO, JAPAN – November 4, 2017 Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced detailed results from the Phase 3 REPRISE trial of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). Trial results showed that tolvaptan showed greater reduction on the primary endpoint, the rate of change in estimated glomerular filtration rate (eGFR) compared to placebo. Estimated GFR, the primary endpoint of the trial, is a key measure of kidney function. Change in estimated eGFR from pre-treatment baseline to post-treatment follow-up, adjusted by the duration of the trial for each patient and expressed per year was 2.34 mL/min/1.73 m2 /year with tolvaptan versus 3.61 mL/min/1.73 m2/year with placebo, representing a 35% reduction of 1.27 mL/min/1.73 m2/year (95% CI 0.86 to 1.68; P<0.001). These data were presented today as a late breaking oral abstract at the American Society of Nephrology (ASN) 2017 Kidney Week in New Orleans, and were simultaneously published online in the New England Journal of Medicine.

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    Nov 2017
    Montreal, Quebec

    Montreal, Canada, November 2, 2017– Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for ABILIFY MAINTENA (aripiprazole for prolonged release injectable suspension), approving a new indication for the maintenance monotherapy treatment of bipolar I disorder in adult patients.

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    Feb 2017
    Health Canada Approves Otsuka and Lundbeck’s REXULTI™ (brexpiprazole) as a Treatment for Schizophrenia in Adults
    Montreal, QC

    Tokyo, Japan and Montreal, Canada, February 16, 2017– Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for REXULTI™ (brexpiprazole) for the treatment of schizophrenia in adults. REXULTI™ was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become commercially available in Canada this spring.

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    Jun 2015
    Now Available in Canada: First-ever treatment for adults living with a life-threatening kidney disease (ADPKD)
    Montreal, Quebec

    MONTREAL, QC, June 3, 2015 Today, Otsuka Canada Pharmaceutical Inc. announced that JINARC™ (tolvaptan), is now commercially available for use in Canada. JINARC™ is indicated to slow the progression of kidney enlargement in adults with autosomal dominant polycystic kidney disease (ADPKD).

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    Feb 2015
    First-ever treatment approved in Canada for adults living with ADPKD, a life-threatening kidney disease
    Canada, Japan

    Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that Health Canada has approved JINARC™ (tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease (ADPKD). JINARC™ is indicated to slow the progression of kidney enlargement by targeting the underlying pathophysiology of the disease.

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    May 2014
    NEW ONCE-MONTHLY TREATMENT FOR SCHIZOPHRENIA, ABILIFY MAINTENA™ (aripiprazole for prolonged release injectable suspension), NOW AVAILABLE IN CANADA
    Montreal, Quebec

    Canadians living with schizophrenia now have a new option to help treat their disease. Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc. announce today that ABILIFY MAINTENA™ (aripiprazole for prolonged release injectable suspension), indicated for the maintenance treatment of schizophrenia in stabilized adult patients, is now commercially available for use in Canada.

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    Feb 2014
    The Otsuka and Lundbeck Alliance Announces Once-Monthly ABILIFY MAINTENA (ARIPIPRAZOLE for prolonged release injectable suspension) Now Approved in Canada for the Maintenance Treatment of Schizophrenia in Stabilized Adult Patients
    Montreal / Japan

    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce Health Canada's issuance of a Notice of Compliance for ABILIFY MAINTENA™, an intramuscular (IM) once-monthly injectable formulation indicated for the maintenance treatment of schizophrenia in stabilized adult patients.

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    Oct 2010
    Otsuka Opens First Office in Canada
    Montreal / Japan

    Otsuka Canada Pharmaceutical Inc. (OCPI) has opened its first Canadian office, in the Montreal suburb of Saint-Laurent. This marks a major milestone in the continued growth of Otsuka in North America.

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International News

    May 2015

    OTSUKA’S JINARC® THE FIRST-EVER TREATMENT APPROVED IN EUROPE FOR ADULTS LIVING WITH ADPKD, A CHRONIC GENETIC KIDNEY DISEASE

    TOKYO, JAPAN, 27

    Otsuka Pharmaceutical Co., Ltd. announced today that the European Commission has granted marketing authorisation for JINARC® (tolvaptan) for the treatment of ADPKD in adults who have chronic kidney disease (CKD) stage one to three at initiation of treatment with evidence of rapidly progressing disease. In receiving this marketing authorisation, tolvaptan becomes the first pharmaceutical therapy to be licensed in Europe for the treatment of the underlying pathophysiology of ADPKD.

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    Dec 2014
    Japan

    Takeda Pharmaceutical Company Limited (Head office: Chuo-ku, Osaka; President and COO: Christophe Weber; “Takeda”) and Otsuka Pharmaceutical Company, Limited (Head office: Chiyoda-ku, Tokyo; President and Representative Director: Taro Iwamoto; “Otsuka”) announce today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application submitted by Takeda (“NDA”) of TAKECAB® (generic name: Vonoprazan fumarate, hereafter “TAKECAB”), a drug for treating acid-related diseases.

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    Dec 2014
    Japan

    ARIAD Pharmaceuticals, Inc.(ARIAD) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that they have entered into an agreement for Otsuka to commercialize ARIAD’s Iclusig® (ponatinib) in Japan and nine other Asian countries and to fund future clinical trials in those countries. ARIAD will lead the completion of the Japanese New Drug Application (NDA) for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL) in 2015. Iclusig is an approved BCR-ABL inhibitor in the United States and Europe.

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    Dec 2014
    U.S.

    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the presentation of Phase III study results evaluating the effects of an investigational compound, brexpiprazole, as monotherapy in adult patients with schizophrenia at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in two poster presentations, “A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for the Treatment of Adults with Acute Schizophrenia” and “Brexpiprazole for the Treatment of Acute Schizophrenia: A Randomized, Controlled Trial.” (December 10, 2014, US)

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    Jul 2014
    E Keppra® Injectable Receives Marketing Authorization in Japan Will Contribute to Uninterrupted Treatment of Epilepsy Patients Aged Four and Over
    Japan

    Approval of E Keppra® IV Drip Infusion use will enable uninterrupted treatment of patients temporarily unable to swallow oral E Keppra® formulations. This product has been approved in over 40 countries and regions including in the EU and US in 2006.

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    Jul 2014
    After 40 Years, A New Drug For The Treatment Of Tuberculosis In Japan Deltyba® (delamanid) Is The First Drug Approved In Japan Specifically For Pulmonary Multidrug-Resistant Tuberculosis (MDR-TB)
    Japan

    Otsuka’s Deltyba is the first tuberculosis (TB) drug approval in Japan in over 40 years, and the only drug approval with an indication for MDR-TB.*1 Regulatory approval in Japan follows granting of a marketing authorization in Europe in April.

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    Jun 2014
    Regulatory Approval Received in Japan For L-Cartin® FF Tablets
    Japan

    Only Otsuka Pharmaceutical has marketed in Japan the therapeutic agent, L-Cartin® tablets (non- free form) for carnitine deficiencies. L-Cartin free-form (FF) tablets have now been approved as an additional tablet form with the same active ingredient levocarnatine in free form as the oral solution and injection approved in 2013.

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    Jun 2014
    Meptin®, a Fast-acting Bronchodilator to Treat Asthma and COPD, Will Become Available in Japan on July 2 in a New Form as Meptin® Swinghaler® 10μg 100Puffs
    Japan

    Meptin achieves rapid onset of action, targeting beta 2 adrenergic receptors and thereby causing smooth muscle relaxation and dilation of bronchial passages in the lungs. Meptin is widely used for asthma attacks and has a market share in Japan exceeding 50%. The new Meptin® Swinghaler® fits in the palm of the hand and enables fast inhalation by patients with asthma and chronic obstructive pulmonary disease (COPD).

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    May 2014
    Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD), an Orphan Disease
    Japan

    Samsca Tablets were approved in Japan on March 24, 2014 as the first therapeutic medication in the world for autosomal dominant polycystic kidney disease (ADPKD). Otsuka Pharmaceutical is launching an additional tablet formulation, "Samsca 30 mg Tablets," that will reduce the number of tablets patients with ADPKD need to take.

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    Apr 2014
    “QuickNavi Strep A” April 14 Market Launch in Japan Test Kit for the Rapid Detection of Group A Beta-hemolytic Streptococcal Antigen
    Japan

    Rapid (five minutes) and highly sensitive test for the detection of infection with group A beta-hemolytic Streptococcus – approximately 90 percent of positive infections can be detected within two minutes. Preparation of the test sample is a simple one-step process.

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    Mar 2014
    Otsuka Acquires Rights to Hematological Cancer Treatment Dacogen® From Eisai (U.S.)
    Japan

    Otsuka has acquired rights from Eisai Inc. to develop and sell in the US, Canada and Japan the DNA methylation inhibitor Dacogen®. In addition, Otsuka has acquired licensing rights worldwide, excluding Mexico. The drug is an intravenous formulation of decitabine (generic name) used in the treatment of myelodysplastic syndrome (MDS), in which ineffective or abnormal production of the myeloid class of blood cells occurs, and in the treatment of acute myeloid leukemia (AML).

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    Mar 2014
    Otsuka and Takeda Announce a Co-promotion Agreement in Japan of TAK-438 For the Treatment of Acid-related Diseases in the Gastrointestinal Therapeutic Area
    Japan

    Otsuka and Takeda Announce a Co-promotion Agreement in Japan of TAK-438 For the Treatment of Acid-related Diseases in the Gastrointestinal Therapeutic Area

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    Mar 2014
    IBM and Otsuka Develop Transformative Care Coordination Solution
    Japan / USA

    BM and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced they are teaming to deliver a novel solution intended to improve care coordination in the mental health community.

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    Mar 2014
    Otsuka Pharmaceutical’s Samsca® Approved in Japan as the World’s First Drug Therapy for ADPKD, a Rare Kidney Disease
    Japan

    Samsca, discovered and developed by Otsuka Pharmaceutical Co., has been approved in Japan as the first drug treatment in the world to slow the progression of autosomal dominant polycystic kidney disease (ADPKD).

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    Mar 2014
    Anti-Epileptic Drug E Keppra® Filed in Japan for Additional Indication of Monotherapy for Partial-Onset Seizures
    Japan

    E Keppra® (brand name outside Japan: Keppra®) was launched in Japan in 2010 as adjunctive therapy with existing anti-epileptic drugs for partial-onset seizures and it now holds the largest value market share among anti-epileptic drugs in Japan*1.

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    Feb 2014
    Meptin Swinghaler, Easy-to-inhale Bronchodilator for COPD and Asthma Patients, Approved in Japan
    Japan

    Meptin is a short-acting beta agonist with rapid onset of pharmacological effect, widely used for asthma attacks. Newly approved Meptin Swinghaler is a smaller device than the inhaler currently marketed by Otsuka, making inhalation easier.

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    Jan 2014
    Otsuka Pharmaceutical Submits Marketing Authorization Application in Japan for Abilify Once-Monthly Injectable Form for the Treatment of Schizophrenia
    Japan

    Aripiprazole Extended Release Injectable, a once-monthly IM depot formulation of Abilify, provide uninterrupted medication coverage for one month, providing schizophrenia patients with stable blood concentration of the active drug that remain at a therapeutic range for an extended period of time, which delays timing to relapse without having to take the treatment on a daily basis.

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    Feb 2013
    Otsuka’s Antipsychotic Aripiprazole Awarded the 60th Okochi Memorial Prize
    Japan

    Otsuka Pharmaceutical Co., Ltd. (Otsuka) was awarded the 60th Annual Okochi Memorial Grand Technology Prize from the Okochi Memorial Foundation, for the development of aripiprazole, an antipsychotic medication. The award ceremony will take place at the Industrial Club of Japan on March 26, 2014.

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Otsuka Pharmaceutical Co., Ltd. (OPC) is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. 

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. 

Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardiovascular health, oncology and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec.

 

OCPI is part of Otsuka Pharmaceutical Co., Ltd., a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately CAD 14.5 billion (USD 11 billion) in 2016.

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