💊 The UK’s new life sciences accelerator; Novartis’ bet to pay off; Eli Lilly shoots for the stars

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Hello hello. Welcome back to The Kable for an edition that begins with a very promising update. The Saudi Food and Drug Authority (SFDA), which is the national regulatory authority (NRA) of Saudi Arabia, has achieved maturity level four (ML4) for medicines and vaccines regulation! This is the highest level in the WHO’s classification of regulatory authorities for medical products. This achievement is particularly significant because the SFDA is now the first in the Eastern Mediterranean region to attain ML4, and only the third in the world. The NRAs of Singapore and the Republic of Korea are the other two.

Not much good news from Malawi, however, where the infectious skin disease scabies is making a comeback. As a heatwave, high humidity, and water shortages make people in Malawi highly vulnerable to disease outbreaks, this one, too, is being linked to climate change. It follows close on the heels of a cholera outbreak which killed over 1,800 people just a few months ago. Hospitals are struggling to cope with the rise in scabies cases - 4,000 have been recorded across the Nsanje district, with 1,600 in school-age children.

Meanwhile, the Agence Française de Développement, or AFD, is providing Rwanda with a €75 million loan. These funds will contribute towards the modernisation of Rwanda’s Ruhengeri Level Two Teaching Hospital. AFD is also providing a €4 million grant for capacity building and trainings for medical staff. A further €16 million loan will support infrastructure development in 16 rural districts. These agreements are key to upholding France’s commitment of €500 million in cooperation with Rwanda.

What’s an edition of The Kable without a mention or two of AI? In the UK, a new £100 million fund has been established to accelerate the use of AI in the life sciences. The AI Life Sciences Accelerator Mission aims to improve clinical outcomes and further research into the major health challenges plaguing us today. It will focus on treatments for previously incurable diseases, like cancer and dementia, where AI has the greatest potential to generate breakthroughs. The government intends to invite proposals bringing together academia, industry, and clinicians to develop innovative solutions.

An expensive Novartis bet looks like it will pay off. In June this year, the Big Pharma company announced that it was acquiring the biotech Chinook Therapeutics for $3.2 billion. In the process, Novartis also got its hands on Chinook’s kidney disease drug candidates, one of which was already in phase 3 trials. Now the trial for Atrasentan, designed to treat IgA nephropathy (IgAN), has met its primary endpoint in a 36-week interim analysis. No treatment-related serious adverse events have been reported. Novartis intends to file for accelerated approval in the US in 2024. In the meantime, it will continue to assess the kidney function of participants over 136 weeks to generate data for a full approval. 

Swooping in while important data and decisions are still pending appears to be a pattern with Novartis. bluebird bio is expecting the US FDA’s decision on its biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) for sickle cell disease in December. It also hopes to be granted a rare paediatric disease priority review voucher (PRV) – the US FDA awards these to sponsors of certain rare paediatric disease product applications, allowing them to receive priority review of a subsequent marketing application for a different product. Already, bluebird has entered an agreement with Novartis to sell the pharma biggie its PRV, if received, for $103 million. If it closes, this will be bluebird’s third PRV sale in about a year.

Merck KGaA is shelling out €160 million (~$169 million) upfront in a licensing and option agreement for two oncology assets from China-based Jiangsu Hengrui Pharmaceuticals. One asset is a PARP1 inhibitor, while the other is an antibody-drug conjugate. Merck will receive exclusive worldwide rights (ex-China) to the former and an option for ex-China rights to the ADC. The German company also has the option to co-promote the two assets in China. Merck may end up paying up to €1.4 billion (~$1.48 billion) in milestone and royalty payments. This deal puts Merck in competition with Gilead and AstraZeneca in the cancer medicine arena.

Meanwhile, Eli Lilly is shooting for the stars. Lilly intends to be the first to test Redwire Corporation’s in-space drug manufacturing platform, PIL-BOX. The platform provides drugmakers with flexible services to grow small-batch crystals of protein-based pharma products and other molecules for research in space. Lilly intends to conduct three experiments to develop diabetes, cardiovascular disease, and pain meds. Previous such spaceflight investigations have suggested that growing crystals in space could yield more uniform products with fewer imperfections, improving the drug discovery and development process. Eli Lilly is not the first to make such a trip into space though.

The life sciences venture capital group Abingworth has raised $356 million in its new Clinical Co-Development Co-Investment Fund to invest in late-stage drug development by pharma and biotech companies. This new fund is part of Abingworth’s clinical co-development strategy, under which it has supported 14 programmes to date with Eisai, AstraZeneca, Pfizer, and other partners.

The DNA testing firm 23andMe has inked a new non-exclusive data licensing agreement with GSK, extending their existing partnership. The $20-million-upfront agreement will allow GSK to access the former’s database for one year to conduct drug target discovery and other research.

Sanofi has made a $30 million strategic investment in the clinical-stage gene therapy company MeiraGTx Holdings.

Implementing its announcement from earlier this month that it would cut $3.5 billion in costs, Pfizer has shut down sites in New Jersey and North Carolina.

And finally, the Indian Council of Medical Research (ICMR) will soon unveil the outcomes of a comprehensive study conducted to understand the unexpected rise in cardiac events following Covid-19 infections.