Pharmaceutical Market Europe • March 2024 • 8-9

NEWS

Erectile dysfunction drugs could reduce risk of Alzheimer’s

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Researchers from University College London have suggested that drugs used to treat erectile dysfunction could be linked to a reduced risk of developing Alzheimer’s disease (AD).

Published in the journal Neurology, the study saw the team look at the medical records of nearly 270,000 men aged over 40 years with erectile dysfunction.

The researchers discovered that those who were prescribed drugs known as phosphodiesterase 5 inhibitors (PDE5Is) were 18% less likely to develop AD compared to those who were not – there were 8.1 cases of AD among those treated with PDE5Is and 9.7 cases in those who did not take them.

PDE5Is work to relax smooth muscle in vessels in the penis to increase blood flow by raising levels of cyclic guanosine monophosphate (cGMP), a nucleotide secondary messenger.

In the brains of AD patients, previous studies have shown that cGMP is present at lower-than-usual levels.

The researchers also found that individuals who were issued the most prescriptions over the five-year study period had a 44% reduction. However, the team warned that it does not have information on whether participants actually used the drugs.


AbbVie’s Parkinson’s drug made available by NHS England

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AbbVie’s Produodopa (foslevodopa-foscarbidopa) is being rolled out by NHS England for patients living with advanced Parkinson’s disease (PD) who are experiencing movement-related symptoms and whose condition is not responding to oral medicines.

The wearable, 24-hour infusion is set to benefit hundreds of NHS patients in England living with the neurodegenerative condition.

Currently, many patients living with PD take large numbers of tablets to manage their symptoms, which can be difficult to maintain, can sometimes cause side effects including impulse control disorders and excessive movement, and can lose effect in the middle of the night.

Delivered through an under-the-skin cannula that releases a combination of medications into the body, the treatment is controlled by a small automatic pump worn 24 hours a day to manage patients’ symptoms with less side effects.

Patients also have the option to manually give themselves a boost in dose at any point during the day if needed.

The roll-out follows the recommendation of Produodopa by the National Institute for Health and Care Excellence in October to treat patients with advanced stages of the disease.


Sanofi’s frexalimab shows promise for relapsing forms of MS

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Sanofi has announced that its investigational anti-CD40L antibody frexalimab has shown potential as a “high-efficacy therapy” for relapsing multiple sclerosis (MS), according to mid-stage results published in The New England Journal of Medicine.

Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease.

Sanofi frexalimab has “a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion,” the company said.

The phase 2 study of the candidate randomised 129 patients to receive one of two doses of frexalimab or matching placebo. After week 12, patients receiving placebo switched to respective frexalimab arms and entered the open-label part B, which is currently ongoing.

Following 12 weeks of therapy, the number of new gadolinium-enhancing T1-lesions was reduced by 89% and 79% in the high- and low-dose treatment arms, respectively, versus placebo, meeting the study’s primary endpoint.

The effects on the primary endpoint were sustained over time across both treatment arms, Sanofi said, with an even greater reduction seen in the high-dose frexalimab treatment arm.


ICR researchers reveal findings on advanced breast cancer

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Researchers from the Institute of Cancer Research (ICR) have revealed why some advanced oestrogen receptor (ER)-positive breast cancers become resistant to hormone therapy.

The study used blood samples from the plasmaMATCH clinical trial to analyse traces of cancer DNA in the blood.

Experts from the ICR’s Breast Cancer Now Toby Robins Research Centre analysed the blood samples to identify genetic mutations in the circulating tumour DNA of advanced ER-positive breast cancer patients and observed how they responded to fulvestrant.

The widely used hormone therapy, fulvestrant, is usually given to people with ER-positive breast cancer as either a first-line treatment or once other drugs have stopped working.

However, in some cases, patients’ cancer will often progressively develop resistance to the treatment.

The team found that 4% of ER-positive breast cancer patients with mutations in F404, combined with specific pre-existing mutations, caused overt resistance to fulvestrant hormone therapy.

These new mutations only occurred in patients with already existing mutations in ESR1 prior to treatment.

Researchers confirmed that the combined effect of these pre-existing and new mutations created profound resistance to hormone therapy.


PACE announces partnership with UKHSA to tackle AMR

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Pathways to Antimicrobial Clinical Efficacy (PACE) has announced its first partnership with the UK Health Security Agency (UKHSA) to support the development of new antimicrobials to tackle antimicrobial resistance (AMR).

Founded last year by LifeArc, the Medicines Discovery Catapult and Innovate UK with £30m in funding, PACE aims to remove the barriers and connect the AMR research and development ecosystem to accelerate the preclinical pipeline.

Designated as one of the top ten global public health threats by the World Health Organization, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time.

The partnership will utilise the UKHSA’s AMR platform to support the evaluation of new antimicrobial candidates from other PACE-funded projects to create new scientific breakthroughs, while PACE aims to help advance a diverse pipeline of preclinical projects to treat bacterial infections with high unmet needs.

All successful PACE projects will gain access to the UKHSA’s facilities to test panels of clinical strains of bacteria, which will be expanded to provide additional bacterial strains that portray the challenges faced by clinicians in the UK and internationally.


Pfizer/BioNTech’s COVID-19 vaccine available to buy in UK

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Pfizer and BioNTech have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a change to the licence of their Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine.

The vaccine will be available for supply to UK high street pharmacies, occupational health providers and private healthcare companies from March 2024.

Prior to this, COVID-19 vaccines in the UK have only been made available via the COVID-19 NHS national immunisation programme (NIP), to provide vaccinations free of charge to the groups who are at the highest risk of serious illness, as determined by the Joint Committee on Vaccination and Immunisation.

UK individuals who are not eligible to receive the free COVID-19 vaccination through the NIP will now be able to decide whether or not they would like to purchase it.

There have been more than 25 million confirmed cases of COVID-19 in the UK as of January 2023, with the nation holding the highest death toll from the virus in western Europe.

Between 11 September 2023 and 4 February 2024, the NHS administered autumn COVID-19 vaccinations to over 11,000,000 individuals as part of the NIP.