L-DOPA

BioVie Announces Pipeline Update and Near-Term Clinical Priorities

Retrieved on: 
Monday, March 11, 2024

CARSON CITY, Nev., March 11, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that its recently completed funding round provides opportunity to further the Company’s clinical priorities in Parkinson’s Disease (PD), Alzheimer’s Disease (AD), and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators. 

Key Points: 
  • The Company continues to explore longevity and aging in conjunction with external collaborators.
  • The trial targets enrolling 100-150 patients in a 6-month trial with the Part 3 (motor) score on the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as the primary endpoint.
  • Only one Phase 3 trial is potentially needed as BIV201 has already received Orphan and Fast Track designations.
  • BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete.

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheime

Retrieved on: 
Friday, March 1, 2024

CARSON CITY, Nev., March 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal.

Key Points: 
  • These findings complement previously reported improvement in motor symptoms in patients treated with NE3107 and demonstrate potential intrinsic, levodopa-enhancing activity of NE3107 that is consistent with data from animal models.
  • NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159).
  • Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259).
  • More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.

NEW PAPER: Parkinson's Patients Struggle to Access Optimal Treatment

Retrieved on: 
Thursday, February 1, 2024

WASHINGTON, Feb. 1, 2024 /PRNewswire/ -- Coverage delays, restrictive insurance policies and a lack of specialized health care providers often prevent Americans with Parkinson's disease from receiving optimal treatment, explains a new physician-authored policy paper from the Movement Disorders Policy Coalition.

Key Points: 
  • Parkinson's Disease: Improving Treatment While Working Toward a Cure ," describes the highly individualized nature of the disease and the importance of having accessible options to tailor treatment.
  • For example, newer formulations of the first line Parkinson's treatment levodopa can prolong patients' relief from symptoms and are available in multiple forms – oral, inhaled or infused – to accommodate patients' individual needs.
  • Health plan restrictions like step therapy can block patients from getting the medication that works best for them.
  • Long delays between when the FDA approves a new medication and when health plans begin covering the treatment can also undermine treatment.

AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson's Disease in the European Union

Retrieved on: 
Tuesday, January 9, 2024

NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results.1

Key Points: 
  • The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA received Conformité Européenne (CE) Mark in November of 2023.
  • Parkinson's disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally3 and is expected to double by 2040.
  • "This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson's disease, their families, and care partners."
  • "It is vital that the Parkinson's community have more options that can help them manage their symptoms."

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 32, Status: Authorised

Retrieved on: 
Thursday, January 4, 2024

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 32, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 32, Status: Authorised

Cerevel Therapeutics to Host Investor Webcast on Tavapadon in Parkinson’s Disease

Retrieved on: 
Wednesday, November 29, 2023

CAMBRIDGE, Mass., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced it will host a tavapadon investor webcast on Monday, December 11, from 10:00 to 11:30 a.m. ET.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced it will host a tavapadon investor webcast on Monday, December 11, from 10:00 to 11:30 a.m.
  • Cerevel will lead an in-depth discussion of tavapadon, its D1/D5 partial agonist currently in Phase 3 development for the treatment of Parkinson’s disease.
  • Tavapadon is currently being studied for Parkinson’s disease in the Phase 3 TEMPO program.
  • Following the live webcast, an archived version of the event will be available on the website.

IntelGenx Receives Approval to Conduct ’MONTPARK’ Montelukast VersaFilm® Phase 2 Clinical Trial in Patients with Parkinson's Disease

Retrieved on: 
Tuesday, November 14, 2023

The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa.

Key Points: 
  • The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa.
  • Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer’s Disease.
  • The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm® or placebo twice daily for 18-months, followed by a 3-month washout period.
  • 3 Wallin, J; Svenningsson, P. Potential Effects of Leukotriene Receptor Antagonist Montelukast in Treatment of Neuroinflammation in Parkinson’s Disease.

Cerevance Doses First Patient in ASCEND Phase 2 Clinical Study of CVN424, a First-in-Class, Non-Dopaminergic Therapy for the Treatment of Parkinson’s Disease

Retrieved on: 
Monday, November 13, 2023

The ASCEND (A novel Selective Compound to ENable Individuals with Parkinson’s Disease) study will explore the potential use of CVN424 as a novel and innovative treatment option for individuals with early-stage Parkinson’s disease.

Key Points: 
  • The ASCEND (A novel Selective Compound to ENable Individuals with Parkinson’s Disease) study will explore the potential use of CVN424 as a novel and innovative treatment option for individuals with early-stage Parkinson’s disease.
  • "We are delighted to announce the commencement of our ASCEND study in individuals who have recently been diagnosed with Parkinson's disease and not yet received levodopa treatment," stated Craig Thompson, chief executive officer of Cerevance.
  • "This study aims to build upon the promising results from our previous Phase 2 trial of CVN424 as an adjunctive therapy for later-stage Parkinson's disease.
  • The Phase 2 ASCEND study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of CVN424 in individuals with early, untreated Parkinson’s disease.

Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)

Retrieved on: 
Thursday, December 7, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.
  • Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s.
  • ONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time.
  • The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance.