An audit of Celgene’s R&D over the last five years has revealed that two-thirds of its programs failed—and it made no difference whether the project originated in-house or externally.
The analysis by analysts at Leerink looked at Celgene's R&D presentations in 2013 and 2014 and found that only one out of 20 programs has resulted in a marketed product, namely Otezla (apremilast) for psoriasis. Furthermore, 14 out of 28 projects have disappeared from the portfolio in the last two years.
“This turnover raises questions about how much value to give to those programs still in development, and is consistent with our prior analysis suggesting that Celgene’s stock is discounting little or no value for its non-phase 3 pipeline,” the analysts wrote in a research note.
The company’s relatively weak stock value of late—pegged back by R&D setbacks such as a big delay for multiple sclerosis candidate ozanimod and an over-reliance on multiple myeloma drug Revlimid (lenalidomide)—suggests that investors have assigned very little value to its pipeline. Leerink said the productivity of Celgene's R&D activity in the past five years “suggests the current negative sentiment may be warranted.”
Celgene’s R&D strategy over the last few years has been to forge partnerships for early-stage programs while acquiring companies with promising later-stage drugs. The latter approach yielded acute myeloid leukemia Idhifa (enasidenib), which other than Otezla is Celgene’s only other launch in the last five years.
Overall, the company’s much-trumpeted strategy doesn’t seem to give a higher success rate in R&D than its peers, said the analysts.
“Celgene’s unique convention-defying strategy and structure have not necessarily yielded more new chemical entities (NCEs) or better success rates than more traditional (focused) approaches to product discovery and development,” they suggested.
While there still seems to be plenty of scope for growth with Revlimid—Leerink is estimating sales will rise from a little over $8 billion last year to $14.78 billion in 2022—the company has a lot of work to do to prepare for possible generic competition to its cash cow drug at the end of that forecast period.
“Celgene is invested in rights to a broad array of novel technologies and products in hematology, oncology, and inflammatory diseases,” Leerink said.“The potential of these products remains to be seen, but 2018 is shaping up to be a critical year for assessing the value, and likely return, from these investments.”