Johnson & Johnson has listed the pipeline prospects it expects to drive the growth in its biopharma business for years to come. The company is hoping to get 11 potential blockbusters ready for market by 2021, starting with regulatory green lights for psoriasis candidate guselkumab and rheumatoid arthritis prospect sirukumab.
J&J filed for approval of anti-IL-23 monoclonal antibody guselkumab and anti-IL-6 drug sirukumab last year, putting them at the tip of its pipeline plans. The Big Pharma has reached further back into its pipeline to identify the next nine candidates in which it sees blockbuster potential.
Nonsteroidal antiandrogen apalutamide, CD123-targeting talacotuzumab, FGFR inhibitor erdafitinib, PARP inhibitor niraparib and oligonucleotide imetelstat all made J&J’s list. That means more than half of its top nine development-stage prospects target cancers.
The rest of the list is made up of mix of neuroscience and infectious disease candidates. Major depressive disorder prospect JNJ-7922 and treatment-resistant depression candidate esketamine make up the neuroscience part of the list. The top infectious disease prospects are influenza A drug pimodivir and RSV candidate lumicitabine.
William Hait, M.D., Ph.D., global head of research and development at Janssen, thinks the list of drugs gives J&J “one of the most robust and sustainable pipelines in the industry.” To Joaquin Duato, worldwide chairman, pharmaceuticals at J&J, that pipeline represents an opportunity to pull off the lofty ambition of redefining “the cyclical nature of our industry.”
J&J has had more success than some in the clinic in recent years but plenty of pitfalls await it that could undermine Hait and Duato’s bullish outlooks.
If J&J succeeds in getting the 11 assets through development and onto the market—or sees some of them fail but also brings through less-heralded drugs—it will beat its historic rate of approvals. Of J&J’s last 11 new molecular entities approved by FDA, the oldest got a regulatory nod in 2011. That means J&J is currently averaging around a respectable two approvals a year.
J&J unveiled a similar filing target in 2015. Back then, J&J listed 10 potential blockbusters it hoped to file for approval of within four years. Now, halfway through that period, J&J has trimmed its target to nine filings.
The rate of attrition in late-phase development suggests other programs may fall away and never come to market, or suffer setbacks that push their approval dates out beyond the window targeted by J&J. Those that do succeed in winning FDA approval may encounter a commercial environment less conducive to delivering blockbuster sales than the one in which J&J operates today.