PHARMACEUTICALS
Small molecule remains more than 95 % of what the company does and that will not change in the foreseeable future .
Much of Sterling ’ s investment is going into complementary capabilities to traditional chemistry , like flow chemistry , biocatalysis and micronisation , as well as to create backup capacity . It has added considerable lab and commercial capacity , notably in smallerscale GMP and commercial sites in Cary , North Carolina , and Germantown , Wisconsin .
At the latter , Sterling is looking to increase manufacturing capacity and capabilities and adding a high potency chromatography skid , all with a view to supporting more toxin linker synthesis alongside its ADC offer from the UK . The company completed its first GMP conjugation project in this field in 2023 .
Navin Molecular has just approved a capex investment of $ 35 million to nearly double capacity at its site in Dewas , India , to 420 m 3 in order to support existing small molecule projects . The company needs capacity just to “ stay in the game and cater to future demand growth ”, according to chief commercial officer Jordi Robinson .
“ Our target is now to be double the size we are now in the next three years ,” Robinson said . “ Although that sounds crazy , it has a basis in fact . We expect five to six molecules over the next three years that support commercial manufacturing and the forecasts for some of them are huge . There ’ s still life in these small molecules .” ●
entirely plausible . There were unconfirmed reports that WuXi AppTec had closed , or was intending to close , a plant , despite its continued heavy investment across the board .
PHT International , which is US-based but manufactures in China , is also seeing the effects of customer wariness of placing projects in China despite the cost advantages . “ There is the ideology and the reality , and companies need to find a balance ,” said president Lihong Yu . “ We are not governmentfunded and we respect IP , but still , people are talking .”
At the same time , she said , the talent available in China has boomed , not least because of Chinese chemists returning to start businesses after starting their careers in the US . A significant proportion of the drug innovation is now coming from China , such as in ADCs and large molecules generally . Big Pharma , in her view , will find it hard to ignore that part of the supply chain .
Don ’ t believe the hype
The talk about biologics taking over completely in healthcare is unjustified , according to Jordi Robinson , chief commercial officer at Navin Molecular . The hype goes right back to the Human Genome Project , where researchers talked of finding a gene for every imaginable condition but found no such thing . And the cost remains prohibitive .
“ Apart from in extremely rare diseases , I can ’ t see them ever becoming first-line therapies ,” he said . “ Even where there is an antibody for oncology , you will still get chemotherapy , radiotherapy and small molecule treatment first . No healthcare provider is going to fund , straight away , a $ 400,000 / year treatment .”
The other key issue for Robinson is delivering the drugs to the right place in the body and keeping them there . The science behind them is extraordinary but getting them to work longterm is quite another matter .
Moreover , the potential patient populations are not always that large because the cost excludes lower and middle-income countries . Many biologics will remain ‘ lifestyle ’ drugs that at best will give older patients in First World countries a few more years of life .
That raises many questions , some of them political , of how much providers are willing to pay for the additional benefits biologics may bring . As Graham Lewis of IQVIA put it : “ Large molecules do not help health systems manage their budgets as effectively as they would like .”
Nonetheless , the perceived ‘ sexiness ’ of biologics means that funding seeks them out . This has unlikely and unfortunate results . Anecdotally at least , most pharma companies keep biologics in the pipeline even when they are too far behind the leading products to win FDA approval and even when cheaper cures are possible , because investors are enticed by the prospect of winning the proverbial golden ticket .
MAY / JUN 2024 SPECCHEMONLINE . COM
29