PHARMACEUTICALS
GMP kilo lab working at up to 3 kg batches , with potential to double this .
Broad positivity
CDMOs who spoke with SCM during DCAT Week 2024 generally concurred that business was very strong through COVID , with some running at full capacity to meet demand . It was actually “ too good ” for a while , said Lihong Yu , president of PHT International , and inevitably took a dip once the demand spike for COVID drug starting materials faded and customers destocked .
Most agreed that business has seen a recovery on the back of the return in biotech funding and legislation in the US and the expectation is generally of strong demand in 2024 or in some cases 2025 . This naturally varies , of course , depending on the projects they managed to capture .
Nick Shackley of Veranova agreed that he saw early promising signs around biotech funding . There is always a lag between that and RFPs going to CDMOs but the trend is positive . He expects continuing investment in potent molecules , notably ADCs , and for M & A to continue apace in this field .
“ The money is following these molecules and that creates opportunities for Veranova because we are active in these drugs in clinical development and also in supplying commercially , such as in the linker payloads for ADCs ,” he said . Protein degraders are also an area of growth at the clinical stage .
Because of the company ’ s platform and experience , Shackley added , it is well placed to meet demand where APIs are being modified in ways such that they all into the banding for controlled substances . It has been holding and expanding its position in some well-established generics in fields like opioid analgesics and stimulants , some of which are in short supply .
In addition to what it announced at DCAT Week , CordenPharma is also investing in other fields , notably injectables , fill-finish and LNPs from early-stage to GMP manufacturing , and closing gaps in its capabilities , such as polymorphism screening and bioavailability enhancement . Oligonucleotides and high potency OSD are other “ hot areas ”, according to CEO Michael Quirmbach .
The company will not , however , enter into biologics or ADCs . There are many well-established players here , but relatively few innovators , so the marketplace is crowded . “ In this business , you need to be good at what you do and to focus ,” Quirmbach said . “ You can ’ t be good at everything . Customers value us for scientific knowledge and top-notch execution in our six defined areas of focus . These are worth over $ 1 billion already .”
Anil Kane , global head of technical and scientific affairs , highlighted cell and gene , plasmids and viral vectors among the technologies Thermo Fisher has been supplying . “ We strongly believe that outsourcing is the key and it will only grow ” Kane said . “ The trend is to outsource to stable and reliable partners like us , be it bits and pieces or end-to-end .”
Fat chance
Shortly before DCAT Week , the largest ever transaction in the CDMO sector took place , when Novo Nordisk ’ s holding company acquired Catalent for $ 16.5 billion . This was an almost unprecedented example of Big Pharma buying a CDMO and led some to wonder if it could be the start of a trend .
Novo made the move to ensure supply of fill-finish capabilities for Wegovy ( semaglutide ), its blockbuster GLP-1 agonist for obesity and diabetes . The sale also created a headache for Eli
Lilly , who had also relied on Catalent for capacity for its rival blockbuster Zepbound ( tirzepatide ).
These two drugs have been so successful , indeed , that they have made Novo Nordisk and Lilly the top two pharma companies by market capitalisation . Novo has actually been removed from official GDP calculations for Denmark because its recent growth skews the figure so much .
Headline speaker Graham Lewis of IQVIA described the rise of obesity drugs as potentially the most farreaching and deep-seated change he had seen in his very long career in the industry , more than COVID or even AIDS . As he wryly observed , anyone can self-diagnose obesity : only a mirror and / or a set of scales are needed . And many patients are ready to pay the amount at which these drugs are priced within a standard healthcare reimbursement scenario .
“ That patient-driven , out-of-pocket demand is absolutely massive relative to conventional thoughts about how we behave in the clinical arena ,” Lewis said . No one had expected this and it is a prime example of patient advocacy in action . Moreover , there is already a small cohort of patients for whom there is tangible evidence that a reduction in obesity could yield better lifetime results .
Obesity is unquestionably a major healthcare problem – on average it is linked to two co-morbidities per patient , a figure that shoots up in older patients . As a result , a lot of recalculations are going on about how healthcare systems can afford to treat it and it could fundamentally change our approach to cardiovascular conditions , which are still the biggest killer in the Western world .
MAY / JUN 2024 SPECCHEMONLINE . COM
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