PHARMACY

Mar 21 2020

Profiles of Major Products under Development, Clinical Development, Research and Development, Sumitomo Dainippon Pharma, dainippon sumitomo pharma.

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Profiles of Major Products

*as of October 30, 2017

LATUDA В® (lurasidone hydrochloride)гЂЂAtypical antipsychotic

  • Developed in-house
  • LATUDA В® (lurasidone hydrochloride) is an atypical antipsychotic agent that is believed to have an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine H1 or muscarinic M1 receptors.
  • Approved country and area:

Schizophrenia 2010: U.S., 2012: Canada, 2013: Switzerland, 2014: Europe and Australia,

2016: Taiwan, Russia, Singapore, Thailand and Hong Kong, 2017: Brazil

Bipolar I depressionгЂЂ 2013: U.S., 2014: Canada, 2017: Russia and Brazil

  • Development stage:
  • glycopyrronium bromide (SUN-101)гЂЂChronic obstructive pulmonary disease (COPD)

    • Developed in-house (Sunovion Pharmaceuticals Inc., from the former Elevation Pharmaceuticals)
    • SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow closed system nebulizer. It is a portable, hand-held nebulizer system and is designed to deliver the medication in approximately two to three minutes. A standard jet nebulizer typically takes up to 10 minutes. Currently, there are no LAMAs delivered via nebulizer that are approved by the U.S. Food and Drug Administration (FDA). SUN-101 is a nebulizer delivered LAMA for COPD at the most advanced development stage.
    • Development stage: NDA submitted in the U.S. in July 2016. NDA resubmitted in June 2017.

    dasotraline (SEP-225289)гЂЂAttention-deficit hyperactivity disorder (ADHD), Binge eating disorder (BED)

    • Developed in-house (Sunovion Pharmaceuticals Inc.)
    • SEP-225289 is a dopamine and norepinephrine reuptake inhibitor (DNRI). SEP-225289 has an extended half-life (47-77 hours) that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval.
    • Development stage:

    Adult and pediatric attention-deficit hyperactivity disorder (ADHD): NDA submitted in the U.S. in August 2017.

    Binge eating disorder (BED): Phase 3 in the U.S.

    napabucasin (BBI608)гЂЂCancer

    • Developed in-house (Boston Biomedical, Inc.)
    • BBI608 is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. BBI608 has been shown to inhibit STAT3 pathways, Nanog pathways and ОІ-catenin pathways in the pre-clinical studies.
    • Development stage:

    *1 Phase 2 : Ovarian cancer, Brest cancer, Melanoma, etc.

    *3 FOLFOX: Combination therapy with fluorouracil, leucovorin, oxaliplatin

    CAPOX: Combination therapy with capecitabine, oxaliplatin

    FOLFIRI: Combination therapy with fluorouracil, leucovorin, irinotecan

    FOLFIRINOX: Combination therapy with fluorouracil, leucovorin, irinotecan, oxaliplatin

    apomorphine hydrochloride (APL-130277)гЂЂParkinson’s disease

    • Developed in-house (Sunovion Pharmaceuticals Inc., from former Cynapsus Therapeutics)
    • APL-130277 is a sublingual film formulation of apomorphine, a dopamine agonist, which is the only molecule approved in the United States for acute intermittent treatment of OFF episodes associated with Parkinson’s disease. It is designed to rapidly, safely and reliably convert a Parkinson’s disease patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine.
    • Development stage: Phase 3 in the U.S.

    vatiquinone (EPI-743)гЂЂMitochondrial disease

    • In-licensed from BioElectron Technology Corporation (former Edison Pharmaceuticals, Inc.)
    • EPI-743 is expected to show efficacy by removing the oxidative stress which is generated excessively by decreased mitochondrial function. It is expected to be the world’s first treatment for mitochondrial diseases, which there is no effective therapy, beginning with Leigh syndrome.
    • Development stage: A Phase 2/3 study for Leigh syndrome in Japan completed, development strategy under consideration

    obeticholic acid (DSP-1747)гЂЂNonalcoholic steatohepatitis (NASH), Primary biliary cholangitis (PBC)

    • In-licensed from Intercept Pharmaceuticals Inc. (Intercept’s product code: INT-747)
    • DSP-1747 is an agonist for farnesoid X receptor (FXR) whose ligand is the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist. The compound is expected to be effective for hepatic dysfunction and hepatic fibrosis associated with an increase of bile acid in the liver.
    • Development stage: Phase 2 in Japan for NASH, Phase 2 for PBC is under consideration.

    DSP-6952гЂЂIBS with constipation, Chronic idiopathic constipation

    • Developed in-house
    • DSP-6952 is an enterokinetic agent with a high affinity for serotonin 5-HT4 receptor where it has partial agonist effects. DSP-6952 is expected to be effective for IBS with constipation and chronic idiopathic constipation by increasing complete spontaneous bowel movement.
    • Development stage: Phase 2 in Japan

    amcasertib (BBI503)гЂЂCancer

    • Developed in-house (Boston Biomedical, Inc.)
    • BBI503 is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. BBI503 has been shown to inhibit multiple kinases in pre-clinical studies.
    • Development stage:

    * Phase 2 : Colorectal cancer, Head and Neck cancer, Ovarian cancer, etc.

    SB623гЂЂStroke

    • In-licensed from and co-developed with SanBio, Inc.
    • SB623 is an allogeneic cell product, derived from bone marrow stromal cells isolated from healthy donors. SB623 is expected to be effective for chronic stroke that has no effective treatments available, by promoting regeneration of central nerve cells. Unlike autologous cell therapies that require individualized cell preparation at the clinical site, SB623 production can be scaled up from a single donor’s cells, enabling delivery of uniform-quality products to a large number of stroke patients.
    • Development stage: Phase 2 in the U.S.

    EPI-589гЂЂNeurodegenerative diseases

    • In-licensed from BioElectron Technology Corporation(former Edison Pharmaceuticals, Inc.)
    • EPI-589 is expected to show efficacy by removing the oxidative stress which is generated excessively by decreased mitochondrial function. It is expected to be developed for neurodegenerative indications arising through redox stress.
    • Development stage:

    Parkinson’s disease: Phase 2 in the U.S. by BioElectron Technology Corporation

    Amyotrophic lateral sclerosis (ALS): Phase 2 in the U.S. by BioElectron Technology Corporation

    SEP-363856гЂЂSchizophrenia, Parkinson’s disease psychosis

    • Developed in-house (Sunovion Pharmaceuticals Inc.)
    • SEP-363856 is an antipsychotic agent with a novel mechanism of action, and doesn’t show affinity to dopamine D2 receptors. The molecular target(s) responsible for the profile of effects is unknown, but may include agonist effects at serotonin 5-HT1A and TAAR1 (trace amine-associated receptor 1) receptors. Results obtained with the preclinical models suggest that SEP-363856 may be able to treat the positive and negative symptoms of schizophrenia as well as Parkinson’s disease psychosis. SEP-363856 is expected to have high efficacy in the treatment of schizophrenia and Parkinson’s disease psychosis, while improving patients’ QOL.
    • Development stage:

    Schizophrenia: Phase 2 in the U.S.

    Parkinson’s disease psychosis: Phase 2 in the U.S.

    Schizophrenia: Phase 1 in Japan



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