Johnson & Johnson’s pharma engine is faltering, and it needs more fuel. But it is unclear whether its list of potential new blockbusters will give it the boost it needs.
Among the 11 projects highlighted – plus ponesimod, which it will gain when it closes the acquisition of Actelion – many are still in relatively early stages of development. It looks likely that J&J will still be heavily reliant on its marketed blockbusters and growth coming from the Actelion deal for a while longer, but at least here it is on firmer ground (see tables below).
J&J’s first quarter disappointed and growth is expected to slow to low-single digits this year as it faces greater impact from biosimilar Remicade as well as pricing pressure for the likes of Xarelto and Invokana.
But many projects on the expected blockbuster list, which J&J presented yesterday at its pharmaceutical business review day, are not a dead cert by any means. The company is taking a chance in some risky areas, with bets in depression and respiratory syncytial virus (RSV), both of which have proven tricky for drug development.
Another notable entry is the Parp inhibitor niraparib, which J&J licensed from Tesaro in prostate cancer last year – it is already approved as Zejula in ovarian cancer. However, J&J is not the only one looking at prostate cancer with this mechanism. Astrazeneca is ahead in this indication with Lynparza, which it is evaluating in the phase III Profound trial.
Niraparib is just one example of how much J&J depends on external innovation: only four of the 12 projects listed below were developed internally.
|J&J’s potential pipeline blockbusters|
|Project||Indication||Mechanism||Filing year||2022e sales ($m)||Source|
|Sirukumab||Rheumatoid arthritis||Anti-IL-6 MAb||2016||1,020||Internal|
|Apalutamide||Pre-metastatic prostate cancer||Anti-androgen||2017||1,424||University of California|
|Esketamine||Treatment-resistant depression||NMDA receptor antagonist||2018||436||Internal|
|Ponesimod||Multiple sclerosis||S1P agonist||2020||111||Actelion|
|Erdafitinib||Solid tumours||FGFR inhibitor||2018||83||Astex Therapeutics|
|Niraparib||Prostate cancer||Parp inhibitor||2018||76||Tesaro|
|Talacotuzumab||Acute myeloid leukaemia||Anti-IL-3/CD123 MAb||2018||-||CSL|
|Imetelstat||Myelofibrosis/myelodysplastic syndrome||Telomerase inhibitor||2019||218||Geron|
|Pimodivir||Influenza A||PB2 inhibitor||2020||18||Vertex Pharmaceuticals|
|Lumicitabine /JNJ-1575||RSV infection||Nucleoside analogue||2020||19||Alios BioPharma|
|JNJ-7922||Major depressive disorder/insomnia||Orexin 2 receptor antagonist||2021||6||Internal|
One of these, the multiple sclerosis candidate ponesimod originates from Actelion, which J&J agreed to buy in January for $30bn (J&J sets benchmark with massive Actelion price, January 26, 2017).
The deal looks pricey, but J&J is anticipating accelerating growth for Actelion’s two top products, Uptravi and Opsumit, which it highlighted yesterday as potential blockbusters alongside various other marketed products.
This list of blockbusters and mega-blockbusters – drugs bringing in over $4bn per year – does not contain any surprises. In fact, J&J is fairly conservative with its predictions compared with sellside consensus forecasts.
|J&J’s marketed blockbusters|
|Product||J&J peak forecast||Peak sales per EvaluatePharma ($bn)||EvaluatePharma 2022 forecast ($bn)|
|*Includes partner sales; Source: EvaluatePharma.|
But the fact that analysts have already taken these big guns fully into account just heaps more pressure on J&J’s pipeline to deliver.
Expectations are already high for guselkumab – now with the trade name Tremfya – and sirukumab, which are expected to be approved this year.
But timelines for other projects seem to be slipping, with a potential delay in store for the Zytiga follow-up apalutamide. Data from the phase III Spartan trial had been due earlier this year, but it now has a primary completion date of June and, being an event-driven study, this could be pushed back further. Filing might be put off until 2018, Wells Fargo analysts noted.
Even later-stage projects are not immune from hiccups. With J&J is pinning its hopes on many earlier-stage candidates, some in problematic diseases, expect at least a few of these to fall by the wayside.
This story has been updated to reflect the fact that imetelstat is in phase II.