#27 - Mistletoe, gut feelings, and frosty receptions

The coffee break biotech roundup, by SomX.

Season’s greetings my festive friends,

This week’s newsletter delivers a stocking full of stories to keep your brain buzzing: scientists are hoping to swap surgical glue for mistletoe, the US is outpacing Europe in the drug approval race, amyloid Alzheimer’s therapies are facing a frosty reception, biopharma’s 2024 M&As has been a bit of a turkey this year, and finally, a gut-focused approach to antidepressants could be the gift that keeps on giving.

Stay merry and bright,

Dodo

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💋 Sealed with a kiss – scientists study if mistletoe can be used as surgical glue (Phys.org): Scientists are examining mistletoe – yes, that very same festive orchestrator of awkward seasonal snogging – as nature's answer to surgical adhesive. The University of Essex has rather cleverly partnered with a British grower to decode this parasitic plant's sticky proclivities. While they've managed to grow it in the lab and discovered it has the UK's largest sequenced plant genome, commercial viability remains a bit of a head-scratcher.

Our take: I must say, it's rather amusing how mistletoe might graduate from staging awkward Christmas encounters to the operating theatre. While surgeons currently rely on synthetic or animal-derived adhesives (not exactly ideal for one's insides) this festive fellow could offer a rather elegant solution. Interestingly, this science is far from new as the Romans, clever lot that they were, noticed its adhesive properties back in 50BC – though I dare say they weren't thinking about surgery while using it to catch songbirds.

✅ Drugs are approved – and made available – faster in US than most of EU, data show (Endpoints): It seems our cousins across the pond are showing us up. IQVIA's latest number-crunching reveals that between 2014 and 2022, 79% of novel active substances got the nod stateside first – on average, almost 5 months earlier. While Germany and Denmark lead the way with prompt access, other European nations face delays stretching from 8 to a staggering 56 months. The EMA admitted to their tardiness in October, citing late and incomplete applications as the culprits.

Our take: When nearly half of first-in-class neurology and oncology treatments are caught in Europe's regulatory quicksand, one can't help but wince at its impact on innovation. The country-by-country reimbursement negotiations are proving particularly troublesome for smaller biotechs, who lack the resources for such drawn-out proceedings. While the EMA's reform promises are encouraging, America's streamlined approach continues to make it the premier destination for ambitious drug developers.

💭 Amyloid hypothesis in doubt as newly approved drugs hit hurdles (BioSpace): Those much-lauded amyloid-targeting Alzheimer's drugs seem to be navigating a rather frosty reception. Despite FDA nods for Biogen and Eisai's Leqembi, and Eli Lilly's Kisunla, some of the medical community are raising their collective eyebrows at the theory behind their mechanism. In a Reuters survey, 20 neurologists and geriatricians cite concerns about toxicity and if patients experience any meaningful difference. Though interestingly enough, AbbVie seems undeterred: spending $1.4B on Aliada Therapeutics and their amyloid-targeting approach.

Our take: I must say, the amyloid hypothesis is rather like that relative who overstays their welcome at Christmas – one's not entirely sure whether to embrace them or show them the door. Proponents of this theory believe amyloid beta deposits in the brain causes memory loss and a decrease in cognitive ability. It’s high stakes for pharma: the billions poured into amyloid-targeted approaches highlight a potential breakthrough, but only if the science evolves beyond its current limits.

📉 Industry M&A volume declined 8% this year compared to '23: PwC (Fierce Biotech): Well, well, what do we have here? Rather tepid M&A numbers for biopharma in 2024, with deal volume down 8% and value dipping 2% from last year's figures. While Novo Holdings made the grandest splash with their £16.7 billion Catalent acquisition, Vertex kept the biotech end up with their £4.9 billion Alpine purchase. PwC's number-crunchers, ever the optimists, are betting on a livelier 2025 – with radiopharmaceuticals and immunology tipped as the areas to watch.

Our take: Despite a modest showing this year, the M&A landscape remains quietly hopeful; it’s all about timing and knowing when to strike. For early to mid-stage biotechs, it’s a case of sitting pretty – like a perfectly roasted turkey, primed for carving by larger players with deep pockets and even deeper appetites (cranberry sauce strictly optional). And with the IPO market starting to thaw, 2025 might just deliver.

And finally…

💊 SSRI antidepressants may cause fewer side effects when targeted to the gut (GEN): It seems that, for widely prescribed selective serotonin reuptake inhibitor (SSRI) antidepressants, we may have been focusing on the wrong place all along. Rather than targeting the brain directly, boosting serotonin levels in the gut could improve anxiety and depression symptoms without bothering the blood-brain barrier. This approach looks promising in animal studies and human data, with the rather appealing bonus of potentially fewer side effects.

Our take: This gut-focused approach offers a rather elegant solution to several long-standing challenges in antidepressant development, as keeping the medication's activity confined to the gut epithelium might address those bothersome cognitive side effects while maintaining therapeutic benefits. It’s a great reminder that the body’s regulatory networks are not unidirectional and that the gut epithelium – a once-overlooked site in this therapy area – may come to yield the best gains for our brains.

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