News & numbers
“The Commission [has] started legal action against AstraZeneca on the basis of breaches of the advanced purchase agreement.”
Stefan De Keersmaeker, European Commission spokesperson Shift to first-time launchers
The share of new drugs that are being launched by biopharma start-ups has more than tripled in the past decade, according to research by McKinsey & Company. Between 2016 and 2018, approximately 27% of all molecular entities submitted to the FDA have come from first-time launchers who have spurned the more established practice of seeking licensing, partnership or acquisition agreements with larger companies.
McKinsey & Company attributes the shift to small first-time launchers to a redistribution of talent due to larger companies’ focus on mergers and acquisitions, as well as the increased availability of funding for start-ups and the growth of specialist vendors that can
support commercialisation. Even so, the median first-time launcher reaches just 63% of expectations, compared with 93% for the experienced equivalent. Despite those difficulties, the trend is set to continue, with 22 of the 39 ‘blockbuster’ ($1bn+ in forecasted sales) launches due to take place by 2025 expected from first-time launchers. McKinsey recommends that small companies launching their own products build their commercialisation teams earlier in the development process, invest more in marketing and sales, and expand their market insight networks. By closely monitoring all data for deviations from the expected launch trajectory, they can also respond to problems as quickly as possible.
Malaria vaccine A malaria vaccine, developed by
researchers at Oxford University’s Jenner Institute, has shown an ‘unprecedented’ 77% efficacy in a phase II trial in Burkina Faso. It is the first vaccine to beat WHO’s 75% efficacy target, and could be vital to achieving the organisation’s goal of stopping 90% of annual malaria deaths by 2030. Globally, more than 400,000 people die of malaria every year – many of them children under five. The technology platform and manufacturing partnerships behind this malaria candidate also laid the foundation for the Oxford-AstraZeneca Covid-19 vaccine. Adrian Hill, the director of the Jenner Institute, believes there is a clear case for treating the new vaccine with the same urgency after it reports its phase III results, which are expected next year.
Vaccine blood clot concerns
Countries around the world have paused, restricted or recommended alternatives to using the Johnson & Johnson and Oxford- AstraZeneca Covid-19 vaccines due to their association with rare cerebral venous sinus thrombosis with low blood platelets. Pauses in the administration of the J&J vaccine have since been fully lifted in the US and EU, with regulators recommending the company add safety warnings to the product. The EMA had previously made the same recommendation for the AZ shot, although Denmark has dropped it entirely and numerous other countries have restricted its use to the highest risk populations. After the MHRA concluded that blood clots are a ‘possible’ and ‘extremely rare’ side effect of the AZ vaccine, the UK opted to offer under-30s a different product. It has not been approved for use in the US. US health authorities have identified 15 cases of blood clots, three fatal, in women under 50, among eight million recipients of the J&J vaccine. In recent days, the MHRA has more than doubled its count of UK cases
6
to 168, out of a total of more than 20 million AZ vaccine doses administered. Of those people, 19 have died.
Speaking of the UK decision to offer
under-30s an alternative to the AZ vaccine, which was made on a risk-benefit calculation comparing intensive care admissions with the risk of blood clots in that population, Anthony Harnden, deputy chair of the Joint Committee on Vaccination and Immunisation, emphasised that both the European Medicines Agency and the MHRA had found it to be “very safe and effective”. “There will be countries in the world where the AZ vaccine is the only choice and there would be countries in the world where the life expectancy of the population is very low indeed,” added Harnden. “Therefore, the risk-benefit equation for the younger age groups in those other countries in the world will be different than in the UK.” In the US, Anthony Fauci said that the J&J vaccine pause should increase public confidence by showing how seriously regulators take safety issues.
Rising falls Nearly every US adult over 65 was prescribed a drug that increased their risk of falling in 2017, up from 57% in 1999. Over the period of that increase, the risk of deaths from falls among older adults more than doubled. Each year, nearly $50 billion is spent on medical costs related to fall injuries among older adults, according to the Centers for Disease Control and Prevention.
25%
“Malaria killed at least four times as many more people in Africa last year as Covid did,” he told the PA News Agency. “Nobody for a moment questioned whether Covid should have an emergency use review and authorisation in Africa – of course it did, very quickly. So why shouldn’t a disease that firstly kills children rather than older people – certainly killed an awful lot more – be prioritised for emergency use authorisation in Africa?”
The increase in overall equipment efficiency pharma operations can achieve by using AI. This could equate to 80–90% lower conversion costs and 60% shorter lead times. McKinsey & Company
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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