In a process arguably crueller than a penalty shootout, one hand in a goldfish bowl decided that Amsterdam, rather than Milan, would claim the honour of being the new home for the European Medicines Agency.
Relocation to Amsterdam should mean that some of the gloomier predictions of a mass exodus of staff will be avoided. But even with employees’ favoured city coming out on top, the sheer logistics of moving close to 1,000 people will cause disruption that could hit the drug approval process. EP Vantage has identified the biggest products approaching the European regulator (see table below).
Yesterday’s decision will mean that planning can begin for a smooth transition towards March 2019. The agency has acknowledged that its activities will be affected, and believes that 19% of employees might choose not to make the move. At this stage there is no way of knowing if the departures will be spread evenly across the agency or will fall disproportionately on individual departments.
For the companies below and others, even minimal disruption could cause a delay to valuable sales. Most are big groups that could absorb this, but there is a notable exception.
Bluebird Bio’s prospects are heavily dependent on the success of its beta-thalassaemia and sickle cell disease gene therapy, Lentiglobin. European sales of $210m make up 36% of its total revenue projection in 2022.
Other smaller companies that have a lot riding on their lead pipeline projects include GW Pharmaceuticals, with its rare epilepsy candidate Epidiolex, and Sage Therapeutics’ depression contender Sage-547. Both just missed out on the top 10, with 2022 European sales forecasts of $173m and $164m respectively.
|At risk? European sales of late-stage projects|
|Project||Company||Lead indication(s)||Global||Europe||2022e Europe sales ($m)|
|Apalutamide||Johnson & Johnson||Prostate cancer||Phase III||Phase III||338|
|Rova-T||Abbvie||Small-cell lung cancer||Phase III||Phase III||239|
|Bevespi Aerosphere||Astrazeneca||COPD||Marketed||Phase III||213|
|Calquence||Astrazeneca||Chronic lymphocytic leukaemia||Marketed||Phase III||213|
|Lentiglobin||Bluebird Bio||Beta-thalassaemia||Phase III||Phase III||210|
|Ozanimod||Celgene||Multiple sclerosis||Phase III||Phase III||208|
|Luspatercept||Celgene||Myelodysplastic syndromes, beta-thalassaemia||Phase III||Phase III||193|
|BAF312||Novartis||Multiple sclerosis||Phase III||Phase III||182|
|Upadacitinib/ABT-494||Abbvie||Rheumatoid arthritis||Phase III||Phase III||175|
|Source: EvaluatePharma October 2017.|
This list was previously published in a longer-depth look at this issue (Vantage Point – European approvals face delay from agency move, October 25, 2017).