Pivotal readouts threatened by Covid-19 represent a $20bn investment

Last week Vantage highlighted 315 pivotal trials that are approaching readout and that could face delays caused by the new coronavirus pandemic. These studies of unapproved, novel medicines, due to end this year and seeking 172,104 subjects, represent years of invested time and money, and test some of the industry’s biggest new hopes. A further analysis seeks to put a figure on exactly how much cash is being put to work here: $20bn is the figure that EvaluatePharma Vision* estimates it will cost to run these 315 studies. Delays to much of this clinical work seem unavoidable as Covid-19 causes global lockdowns – and longer trials means more expense. This is before considering the knock to the profitability of a project, lengthening the time it takes to get to market. At this stage it is impossible to estimate the real cost of the pandemic, but the sums committed to trials detailed below illustrate what is at stake to various developers. Lilly announced a pause to much of its research work this week, and others will surely follow. Smaller companies reaching critical stages, like Satsuma and Axsome, below, will be under especially intense pressure.

Commercially sponsored pivotal trials of novel projects due to read out this year   
Stage Trial count Total enrolment  Estimated total cost of running these studies ($bn)
Active, not recruiting  147 107,248 11.75
Recruiting  168 64,856 8.45
Total  315 172,104 20.19
Source: EvaluatePharma Vision*. 


Blockbusters under threat? The costs committed to pivotal programmes approaching conclusion   
Project and trial info Company  2024e sales ($m) Estimated cost of running study/ies ($m)*
Tirzepatide: Surpass 3 trial in type 2 diabetes Lilly 1,619 130
Bardoxolone: Catalyst trial in PAH Reata 1,608 36
Sacituzumab govitecan: Ascent trial in TNBC Immunomedics 1,365 75
BMS-986165 (Tyk2 inhibitor): 4 psoriasis trials  Bristol-Myers Squibb 1,178 384
Filgotinib: Selection1 trial in UC  Gilead/Galapagos 1,031 218
Ozanimod: 4 trials in MS, UC and Crohn's Bristol-Myers Squibb 966 1112
Efgartigimod: Adapt trial in myasthenia gravis Argenx 964 29
Mirikizumab: 2 trials in UC and psoriasis Lilly 848 361
AXS-05: 2 depression trials, incl Stride-1 Axsome 753 46
Fintepla: 3 epilepsy trials, in Dravet and LGS Zogenix 694 126
*For study IDs relating to these costs please see Clinical trial delays become reality as Covid-19 risk spreads. LGS=Lennox-Gastaut syndrome; UC=ulcerative colitis; TNBC=triple-negative breast cancer; PAH=pulmonary arterial hypertension. Source: EvaluatePharma Vision. 

*EvaluatePharma Vision’s R&D cost model estimates the cost of individual clinical programmes using real-world data. Company disclosed product-level spend and clinical trial patient numbers are combined to create cost per patient benchmarks by technology and therapy type. Utilising a matching algorithm these benchmarks are applied to all commercially relevant clinical trials to estimate their cost, which can then be aggregated by product to estimate the cost of development of all products. 

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