This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.

Start Date22 Jan 2020

Sponsor / Collaborator

Proteus Digital Health, Inc.

NCT04088955 / Unknown statusNot Applicable

A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer

DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.
The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

Start Date06 Sep 2019

Sponsor / Collaborator

Proteus Digital Health, Inc.

NCT03418675 / CompletedPhase 2IIT

A Double-Blind, Placebo-Controlled Study of Brexpiprazole in the Treatment of Borderline Personality Disorder.

The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.

Start Date26 Nov 2018

Sponsor / Collaborator

The University of Chicago

[+1]

100 Clinical Results associated with Otsuka America Pharmaceutical, Inc.

0 Patents (Medical) associated with Otsuka America Pharmaceutical, Inc.

160

Literatures (Medical) associated with Otsuka America Pharmaceutical, Inc.

01 Jul 2024·Influenza and Other Respiratory Viruses

Economic Burden of Medically Attended Respiratory Syncytial Virus Infections Among Privately Insured Children Under 5 Years of Age in the USA

Article

Author: Diaby, Vakaramoko ; Nduaguba, Sabina O ; Tran, Phuong T ; Finelli, Lynn ; Winterstein, Almut G ; Choi, Yoonyoung ; Wang, Yanning

ABSTRACTBackgroundThe cost of medically attended RSV LRI (lower respiratory infection) is critical in determining the economic value of new RSV immunoprophylaxes. However, most studies have focused on intermittent RSV encounters, not the episode of care that captures the entirety of RSV illness.MethodsWe created age‐ and condition‐specific cohorts of children under 5 years of age using MarketScan® data (2015–2019). We contrasted aggregating healthcare costs over RSV‐LRTI episodes to ascertaining costs based on RSV‐specific encounters only. Economic burden was estimated by multiplying costs per encounter or per episode by their respective incidence rates.ResultsAverage cost was higher per episode than per encounter regardless of settings (inpatient: $28,586 vs. $18,056 and outpatient/ED: $2099 vs. $407 for infants). Across ages, the economic burden was highest for infants and RSV‐LRTI requiring inpatient care, but the burden in outpatient/ED settings was disproportionately higher than costs due to higher incidence rates (for inpatient vs. outpatient episodes: $226,403 vs. $101,269; for inpatient vs. outpatient encounters: $151,878 vs. $38,819 per 1000 infant‐years). For high‐risk children, cost and burden were up to 3–10 times higher, respectively.ConclusionsWith a comprehensive stratification by settings and risk condition, the encounter‐ versus episode‐based estimates provide a robust range for policymakers' economic appraisal of new RSV immunoprophylaxes.

01 Dec 2023·Alzheimer's & Dementia

A Culturally Competent Approach to the Lived Experience of Dementia

Author: Michael, Mary Chi

AbstractBackgroundIn 2021, the Global Council on Alzheimer’s Disease (GCAD) conducted research of the lived experience and care partner journey. In 2022 and 2023, GCAD expanded this research to focus on the experiences of individuals from historically underrepresented populations, specifically the LGBTQ+, Black, Latinx, and Asian communities."A Culturally Competent Approach to the Lived Experience of Dementia” seeks to explore the key differentiating factors in the journey for each population, how and when behavioral symptoms are identified and managed, and how the burden of care shifts among each community.MethodTo understand the experiences of each community living with dementia, we undertook qualitative primary research, complemented by secondary research. Primary research consisted of dozens of one‐on‐one interviews with people living with dementia and their care partners. Secondary research consisted of a review of existing literature on each community’s experiences with dementia.ResultResults account for the journey that each community experiences. It maps not only the challenges they face, but also the resources the community has built, and how they manage care along the disease progression.ConclusionThe research identifies several key differences in the dementia experience among each community. For instance, medical inequity includes a history of exploitation, discrimination, and distrust, which impacts how care is managed. Additionally we found that there is potential for a lack of a traditional family care structure, stigma surrounding dementia, and lack of resources and tools for living well with dementia.This research also highlights the ways in which the communities are responding to those challenges. For instance, advocating for fair treatment within medical systems, raising awareness around dementia within their community, and creating systems of support and practices of careFinally, it provides calls to action for how the broader dementia community can better support those from the underrepresented communities living with dementia. Addressing bias, discrimination, and inequity in healthcare settings, and creating resources that account for the specific needs and challenges of Black, LGBTQ+, Latinx, and Asian people living with dementia.

01 Nov 2023·Journal of the American Society of Nephrology

ESKD and CKD Progression Among a Diverse Immunoglobulin A Nephropathy (IgAN) Population

Author: Schachter, Asher D. ; Mathur, Mohit ; Sim, John J. ; Bhattacharjee, Sandipan ; Chang, John M. ; Chen, Qiaoling ; Fernandes, Ancilla ; Cannizzaro, Nancy ; Pinto, Cibele S. ; Makhija, Dilip

124

News (Medical) associated with Otsuka America Pharmaceutical, Inc.

22 Oct 2024

·pipelinereview.com

Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults

PRINCETON, NJ, USA & TOKYO, Japan I October 22, 2024 I Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka), today announce positive topline interim data from the ongoing Phase 3 clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults. Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting Gd-IgA1 production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 The pre-specified interim analysis review, conducted by an independent data monitoring committee, found that the Phase 3 VISIONARY study (NCT05248646) met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment. 5 The study, a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 530 adult patients (largest of its kind) with IgA nephropathy who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), was designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo. The primary efficacy endpoint was to evaluate the change in 24-hour uPCR at 9 months compared with baseline. 5 “The positive interim data from this trial suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We look forward to the completion of this study and reviewing the full results at a future timepoint. We are deeply appreciative to the patients with IgA nephropathy who participated in this trial, their caregivers, and investigators, all of whom continue to contribute greatly to this research.” Brian Pereira, M.D., CEO of Visterra, Inc., an Otsuka U.S. affiliate, which designed and engineered sibeprenlimab, said, “We are encouraged by sibeprenlimab’s continuing progress and its potential to provide a needed and possibly disease-modifying treatment option to IgA nephropathy patients.” The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgA nephropathy. Otsuka plans to review interim analysis results with the FDA to enable a potential regulatory submission for accelerated approval. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL ( A PR oliferation- I nducing L igand), that plays a key role in IgA nephropathy’s four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy and APRIL IgA nephropathy, also known as Berger’s disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over the lifetime of most patients. 4, 6, 7 It is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system.IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 APRIL ( A PR oliferation- I nducing L igand), a cytokine in the tumor necrosis factor (TNF) family, is integral to the development and progression of IgA nephropathy. It promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys. 8 About Otsuka Otsuka Pharmaceutical Co., Ltd. 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 products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. About Visterra Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra’s pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit www.visterrainc.com . References 1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov) 3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed.ncbi.nlm.nih.gov/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary.wiley.com/doi/full/10.1111/nep.13592 . SOURCE: Otsuka Pharmaceuticals

Phase 2Clinical ResultPhase 3Breakthrough Therapy

15 Oct 2024

·www.pharmaceutical-technology.com

Lundbeck to acquire Longboard Pharmaceuticals for $2.6bn

Lundbeck’s acquisition of Longboard Pharmaceuticals aims to bolster its neuro-rare conditions portfolio with the addition of bexicaserin. Credit: UnderhilStudio/Shutterstock. Lundbeck has signed an agreement to acquire Longboard Pharmaceuticals for $2.6bn equity value in a move set to enhance its capabilities within neuro-rare conditions. Lundbeck has initiated a tender offer for all outstanding shares of Longboard’s common stock. The transaction holds a net value of $2.5bn, calculated on a fully diluted basis. The acquisition is aligned with Lundbeck’s focused innovator strategy, marking a significant advancement by adding Longboard’s lead asset bexicaserin, which addresses developmental and epileptic encephalopathies (DEEs). The product is currently under evaluation in a global Phase III clinical programme known as DEEp SEA, which includes patients diagnosed with Lennox-Gastaut syndrome, Dravet syndrome and other DEE syndromes. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC Lundbeck president and CEO Charl van Zyl stated: “This transformative transaction will become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade. Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available.” Longboard president and CEO Kevin Lind said: “I would like to thank the entire DEE community, in particular bexicaserin’s study participants and their caregivers as well as the advocacy groups, investigators, sites and coordinators for their support and partnership. “Lundbeck’s remarkable capabilities will accelerate our vision to provide increased equity and access for underserved DEE patients with significant unmet medical needs.” The boards of directors of both Lundbeck and Longboard have given unanimous approval for the transaction. The expected closure of the deal is in the fourth quarter of 2024, contingent upon the tender of at least a majority of the total number of the outstanding voting shares of Longboard, along with the receipt of regulatory approvals and fulfilment of other customary conditions. In March 2024, Lundbeck and Otsuka Pharmaceuticals Europe’s Abilify Maintena received EU approval for treating schizophrenia.

Phase 3Drug ApprovalAcquisition

07 Oct 2024

·www.prnewswire.com

BioNJ's Prestigious Speaker Roster for Its 12th Annual C-Suite Summit

TRENTON, N.J., Oct. 7, 2024 /PRNewswire/ -- BioNJ is hosting its C-Suite Summit this Thursday, October 10, 2024, at the Bridgewater Marriott. In its twelfth year, the C-Suite Summit convenes executives from across the life sciences sector, representing a diverse array of companies — from early stage start-ups to established industry leaders, spanning both public and private sectors, as well as revenue-generating and pre-revenue enterprises. Together, they engage in insightful discussions on the critical issues shaping C-Suite decision-making as the industry strives to bring groundbreaking treatments to market. In the face of unprecedented change, the biopharmaceutical industry stands at a pivotal juncture. With the next wave of innovation on the horizon, this Summit offers a unique opportunity to reflect on the current landscape of life sciences and explore how companies can successfully navigate this dynamic era of transformation. "As shifts in policy and fluctuations in biopharma investment continue, the future of innovation in our industry continues to be closely scrutinized," said BioNJ President and CEO Debbie Hart. "The C-Suite Summit offers a vital platform for industry leaders to engage in open dialogue, exploring where the most promising opportunities exist and how to collectively navigate and shape the next frontier in life sciences and medical breakthroughs." The speaker roster, featuring world-class leaders, includes: Britt Byers, Sr. Vice President, Human Resources NA, Kyowa Kirin Jan Campbell, Managing Partner, Pharmaceuticals & Biotechnology, Korn Ferry Donna Conroy, Founder & CEO, SciMar ONE Vikki Conway, Sr. Vice President & Head, Human Resources US, Teva Pharmaceuticals Kiran Dattani, Customer Success, Transformation, Strategy & Architecture, Google Cloud Healthcare & Life Sciences, Google Tom Evegan, Principal, Strategy & Management Consulting; National Consulting Leader Life Sciences, RSM Hon. Jim Greenwood, Former Congressman & Former President & CEO, BIO Hisham Hamadeh , Ph.D., Sr. Vice President & Global Head, Data Science & AI, Genmab John Harlow, Chief Commercial Officer, Melinta Therapeutics Debbie Hart, President & CEO, BioNJ Paul Hunter, Vice President, Market Access & Commercial Operations, Halozyme Garrett Ingram, President & CEO, Cipla Therapeutics Christopher Jackson, Managing Member, The Law Office of Christopher S. Jackson Haripriya Jain, MS, MBA, Executive Director, Global Value & Access Consulting, Evidera, part of Thermo Fisher Scientific Rohan Jain, General Manager, Commercial, Nusano Harriet Keane, Partner, McKinsey & Company Sydney Klein, Chief Information Security Officer & Head, IT Core Services, Bristol Myers Squibb Keith Koharski, Executive Director, Global Development IT, Regeneron Emer Leahy, Ph.D., MBA, President & CEO, PsychoGenics & Chair, BioNJ Lisa LeCointe-Cephas, J.D., Partner, Compliance & Investigations & Global Chair, Life Sciences Sector, DLA Piper Will Lewis, J.D., MBA, Chair & CEO, Insmed Husseini Manji, M.D., F.R.C.P.C., Professor, Oxford University; Co-Chair, UK Govt MH Mission; Former Global Head, Neuroscience, Janssen/Johnson & Johnson Jake McDowell, Vice President & Head, Market Access, Pricing & Value, Partner Therapeutics Clive Meanwell, M.D., Chairman & Partner, Population Health Partners Aamir Mecklai, Managing Director, Healthcare Investment Banking, Bank of America Heather Meade, J.D., Principal, EY Christopher Mortko, Ph.D., MBA, Vice President, Business Development & Licensing, Merck Gina Murdoch, MBA, President & CEO, Multiple Sclerosis Association of America Brandon Parry, Sr. Partner, McKinsey & Company Tarek Rabah, President & CEO, Otsuka Pharmaceuticals Deiva Ramachandran, Ph.D., Partner, Generative AI-Automation Practice Leader, Healthcare, Life Sciences, State & Local Govt., IBM Arda Ural, Ph.D., Partner & Americas Industry Market Leader for Life Sciences and Healthcare, EY Monika Vnuk, M.D., Sr. Vice President, Global Partnering & Business Development, Sanofi Scott White, MBA, Chief Operations Officer, NA Innovative Medicine, Johnson & Johnson The action-packed agenda includes these topics: The Next Wave of Innovation in Life Sciences Harnessing Change to Deliver Impactful Innovation Policy Uncertainties in an Election Year Market Access & Reimbursement Topics in Talent: Attraction, Retention & Diversity Research & Development in Mental Health Continued Evolutions in Go-to-Market Models Including Patient Services Evolving Capital Markets & Implications for Innovation The Digital & AI Era in the Biopharma Industry: How Can Companies Across Functions Transition from Hype Into Reality? Click here for the full agenda. "From access, regulation and policy to talent and AI, our experts will dive into what the industry should be doing ― and how we can work together ― to foster medical innovation and ensure Patient access," added Hart. "We hope all stakeholders will join us for this very important discussion." Click here to register. Registration is $695 for BioNJ Members and $895 for future BioNJ Members. The C-Suite Summit is closed to media. Contact Randi Bromberg Sr. Vice President, Communications and Marketing O) 609-890-3185 C) 609-955-1067 [email protected] SOURCE BioNJ WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Otsuka America Pharmaceutical, Inc.

100 Translational Medicine associated with Otsuka America Pharmaceutical, Inc.

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Pipeline Snapshot as of 19 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Decitabine ( DNMT1 )	Refractory acute myeloid leukemia More	Phase 1
OPB-111077 ( STAT3 )	Relapsing acute myeloid leukemia More	Phase 1
Urea-13C	Helicobacter pylori infection More	Withdrawn
Aripiprazole ( 5-HT1A receptor x 5-HT2A receptor x D2 receptor x D3 receptor )	Bipolar I disorder More	Discontinued
Tolvaptan ( AVPR2 )	Cystinuria More	Pending

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