Pharmaceutical Market Europe • April 2024 • 8-9
NEWS
NeuroDerm’s results for investigational Parkinson’s disease therapy
NeuroDerm has announced positive phase 3 results for its investigational ND0612 in Parkinson’s disease (PD) patients living with motor fluctuations.
The BouNDless trial, published in the Lancet Neurology, evaluated the efficacy, safety and tolerability of ND0612 in 381 PD patients aged 30 years or older.
ND0612 is a continuous, 24-hour-a-day subcutaneous infusion of liquid levodopa/carbidopa (LC/CD).
Caused by a positive or therapeutic response to dopaminergic therapy and a declining or absent response to dopaminergic therapy, motor fluctuations are alterations in movement function.
Results from the BouNDless trial demonstrated that ND0612 met its primary endpoint and the first four secondary endpoints, which showed that it was superior to oral immediate-release LD/CD at increasing ‘on’ time in patients without causing dyskinesia and reducing ‘off’ time, after 12 weeks.
In addition, the systemic safety profile of ND0612 was consistent with that of the oral standard of care.
The safety and efficacy of investigational ND0612 in PD is currently under review by the US Food and Drug Administration, which previously assigned a Prescription Drug User Fee Act target action date for the second quarter of 2024.
BMS shares positive long-term results for Zeposia in relapsing MS
Bristol Myers Squibb (BMS) has shared promising long-term data from an open-label extension study evaluating Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (RMS).
Approximately 2.9 million people worldwide are affected by MS, a disabling and unpredictable neurological disease that disrupts communication between the brain and other parts of the body.
Relapsing forms of MS account for the majority of disease cases and are characterised by episodes of new or worsening signs or symptoms followed by periods of recovery.
Results from the phase 3 DAYBREAK open-label extension trial, presented at this year’s Americas Committee for Treatment and Research in Multiple Sclerosis Forum, demonstrated sustained efficacy of BMS’ Zeposia in RMS, with an annualised relapse rate of 0.098 and 67% of patients being relapse-free at six years.
Safety was consistent with prior findings and the established safety profile of Zeposia, the company said.
Additionally, a separate analysis of the study showed that almost 97% of the followed patients were relapse-free at 90 days post-Zeposia discontinuation and those who did relapse showed no evidence of a rebound effect.
Novo Nordisk’s semaglutide data for diabetes and chronic kidney disease
Novo Nordisk has announced positive results from a phase 3 trial evaluating semaglutide for the prevention of kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD).
Announced in October, the kidney outcomes FLOW trial was stopped early due to the efficacy of semaglutide in preventing kidney disease-related incidences.
An estimated 40% of people living with type 1 or type 2 diabetes will go on to develop CKD, a gradual loss of kidney function over time, during their lifetime.
The double-blind trial evaluated injectable semaglutide 1mg in comparison to placebo as a potential alternative standard-of-care treatment for the prevention of the progression of kidney impairment and the risk of kidney and cardiovascular mortality.
Results showed that semaglutide was safe and well tolerated, and achieved its primary endpoint after demonstrating a statistically significant reduction of 24% in kidney disease progression, cardiovascular and kidney death for people treated with semaglutide.
The company now intends to file for regulatory approvals of a label expansion for semaglutide in the US and the EU this year.
AstraZeneca to invest £650m in UK’s life sciences sector
AstraZeneca (AZ) has announced its plans to invest £650m to boost the life sciences sector in the UK, grow the economy, enhance public health protection and improve pandemic preparedness.
The company intends to invest a total of £450m at its manufacturing site in Speke, Liverpool, to boost the research, development and manufacturing of vaccines, in alignment with the site’s current role in supplying the childhood vaccination programme.
In addition, AZ and the UK Health Security Agency (UKHSA) will work in partnership to advance science for developing and evaluating vaccines to further boost the UK’s resilience for future pandemics and global health threats.
The company also intends to expand its presence at Europe’s life sciences cluster in Cambridge with a further £200m investment.
Set to provide 1,000 jobs, the facility will build on AZ’s £1.1bn global Research and Development Discovery Centre, which currently hosts 2,300 researchers and scientists.
Later this year, AZ plans to open a new manufacturing facility for one of its cancer medicines in Macclesfield, Cheshire, following the announcement of a £380m investment in 2021.
University of Liverpool reveals new framework to tackle AMR
Researchers at the University of Liverpool and partners have set out a new framework in an effort to tackle antimicrobial resistance (AMR) in the UK.
Published in Lancet Microbe, the framework was supported by the National Institute of Health and Care Research’s (NIHR) Clinical Research Network and the NIHR Infection Specialty Group.
Designated by the World Health Organization as one of the top ten global public health threats, AMR occurs when bacteria, fungi and parasites change and adapt over time.
The article, System-Wide Approaches to Antimicrobial Resistance in the UK: the AMR-X Framework, highlights the work of multiple authors from several UK institutions and stakeholders.
AMR-X combines traditional AMR discovery, experimental research and applied research with continuous analysis of pathogens and antimicrobial uses.
In addition, the new model utilises clinical outcomes that are routinely provided to practitioners, policymakers, patients and the public to advance practice and outcome changes.
The model builds on previous years of research conducted by University of Liverpool researchers and seeks to reveal the global impact of AMR, the discovery and development of new antibiotics and the optimisation of antimicrobial therapy worldwide.
US drugmakers submit counter-offers to Medicare pricing negotiations
The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counter-offers.
The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act.
First selected in August last year, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants.
The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban).
The Biden-Harris Administration has confirmed that all ten of the selected drugs will continue to be included in drug price negotiations, with new prices set to be announced by 1 September 2024 and going into effect at the beginning of 2026.