Pharmaceutical Market Europe • July/August 2023 • 8-9
NEWS
Researchers have genetically altered oral polio vaccines to significantly reduce the likelihood of the weakened virus mutating into a dangerous form that can cause outbreaks and paralysis.
The development of the two new candidates has been detailed in the journal Nature by the team from the University of California and the UK’s National Institute of Biological Standards and Control.
The two vaccines were tested in mice and found to be effective, safe and stable, and are now being tested in clinical trials to ensure that they are both effective and do not revert to dangerous forms in humans.
Cases of polio have decreased by over 99% since 1988, and more than 20 million people who would otherwise have been paralysed are able to walk today thanks to vaccines.
Endemic ‘wild’ poliovirus remains in border areas of Pakistan and Afghanistan, according to the World Health Organization, and oral vaccines play a crucial role in the attempt to eradicate polio.
However, if allowed to circulate in places where vaccine coverage is low, or replicate in an immunodeficient individual, the weakened live poliovirus contained in oral polio vaccine can mutate to a form that causes illness and paralysis.
The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century.
The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults.
The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be tested to see how well it prevents latent TB from becoming active TB and causing illness.
The candidate has already been shown in a phase 2b trial to prevent active TB from developing in around half of those who received it.
It has been in development since the early 2000s by GSK in partnership with non-profit Aeras and the International AIDS Vaccine Initiative.
In 2020, the UK-based drugmaker announced that it would partner with the Gates Medical Research Institute for continued development and potential use of M72 in countries with a high TB burden, with GSK continuing to provide the adjuvant for the candidate’s further development and potential launch.
Bayer and its subsidiary, BlueRock Therapeutics, have announced positive top-line results from an early-stage study of an experimental Parkinson’s disease stem cell therapy.
In the phase 1 study of bemdaneprocel, the treatment was shown to be well-tolerated in all 12 patients involved in the study, and transplanted cells grew as intended in the patients’ brains at one-year post-transplant.
The companies said that, based on these positive results, planning is already underway for a phase 2 study that is expected to begin enrolling patients in the first half of 2024.
Parkinson’s disease is caused by nerve cell damage in the brain, which leads to decreased levels of dopamine and the subsequent progressive decline of motor function.
Bemdaneprocel is comprised of dopamine-producing neurons derived from pluripotent stem cells that, when transplanted into the brains of patients with Parkinson’s disease, have the potential to reform neural networks and restore motor and non-motor function.
Bayer acquired US-based BlueRock in 2019 in a bid to boost its cell therapy business, with the president of Bayer’s pharmaceutical division, Stefan Oelrich, describing the deal as a “major milestone” on the company’s path towards a “leading position” in cell therapy.
The World Health Organization (WHO) has published its first global research agenda for scientists to address the ‘most urgent’ human health priorities to tackle antimicrobial resistance (AMR), which has been declared by the organisation as one of the top ten threats to global public health.
Associated with the deaths of 4.95 million people in 2019, AMR occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time.
The WHO Global Research Agenda for AMR in human health outlines 40 research topics on drug-resistant bacteria, fungi and Mycobacterium tuberculosis that the organisation said “must be answered by 2030”.
WHO said the aim of the agenda is to guide key stakeholders, including policymakers, researchers and funders, in generating new evidence to inform AMR policies and interventions as part of efforts to address AMR, particularly in low-and-middle-income countries.
The research agenda was developed in close collaboration with a large group of AMR experts, WHO said, and is based on a review of over 3,000 relevant documents published over the past decade. More than 2,000 unanswered questions or knowledge gaps were identified in the review, which were further consolidated and prioritised to conclude with the 40 research topics.
Merck & Co – known as MSD outside the US and Canada – has filed a lawsuit against the US government over the Medicare drug price negotiation element of President Biden’s Inflation Reduction Act (IRA).
The Act, which became law last year, allows Medicare – the government health plan for older adults – to negotiate lower prices for a selected group of prescription medicines.
Merck argues that this violates the part of the Fifth Amendment to the US Constitution that requires the government to pay just compensation if it takes private property for public use.
The lawsuit, filed in the US District Court for the District of Columbia, also argues that companies will be forced to sign agreements conceding that the prices are fair, which the drugmaker claims is a violation of the First Amendment’s protections of free speech.
“These constitutional violations cannot be swept under the rug by pretending that manufacturers have voluntarily subjected themselves to the programme by accepting reimbursements from Medicare and Medicaid,” the complaint said.
A list of the first ten Medicare Part D drugs selected for negotiation is expected to be published by the government in September, with the new prices set to be effective in 2026.
A new report from the medicines manufacturing alliance has found that if the UK is to realise its ‘life sciences superpower’ ambition, it must not only discover and develop new medicines, but must manufacture a significant share of them too.
The report from the Medicines Manufacturing Industry Partnership (MMIP), entitled Follow the green, high-tech road: A path to UK growth, net zero and health resilience from innovation in medicines manufacturing, reveals how, with the right policies in place, the UK could attract £15bn in company investment over ten years and create more than 116,000 new jobs.
Medicines manufacturing is the largest economic contributor within the UK life sciences sector, according to MMIP, providing almost 45% of the £36.9bn delivered by the life sciences industry in 2019. However, the UK’s position as a manufacturing leader has declined in recent years, the alliance said.
The report sets out nine key recommendations to reverse this decline and make the UK the ‘best global location’ for innovative and environmentally sustainable medicines manufacturing.
This includes a call for £1.1bn from the government over four years to provide ‘sustained, predictable and accessible’ innovation funding and investment incentives, as well as a five-year digital innovation in medicines manufacturing technology roadmap.