Amid pipeline woes, Celgene brings on Keytruda and Bavencio R&D executive in shake-up

celgene
This news comes after a recent withering R&D scorecard from analysts at Leerink. (Celgene)

Celgene has poached a new R&D executive as it hopes to shake off past problems with a shake-up of its research unit. 

Cue Alise Reicin, M.D., who has worked for both Mercks, German and U.S., helping with work on the latter’s immuno-oncology star Keytruda, to be parachuted in to lead the Big Biotech’s mid- to late-stage drug development across Celgene’s portfolio.

Reicin, meanwhile, will also lead “clinical operations, biostatistics, project leadership and project management,” according to Celgene, which is billing this as part of a “new organizational structure [that] enhances corporate strategy and focus on discovery, development and commercialization.” This leaves Dr. Rupert Vessey to continue work leading its early R&D projects.

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Reicin comes to Celgene from German Merck’s R&D arm, EMD Serono, where she was SVP and head of global clinical development. She was at the company for three years, working on its I-O projects, including the Pfizer-partnered PD-L1 Bavencio.

She went to Germany’s Merck in 2015 after leaving U.S. Merck, where she had been VP of project and pipeline leadership for the oncology franchise, as well as a key member of the Keytruda R&D team.

Celgene sees this as not just a new executive coming into the business, but part of a “deliberate strategy to strengthen Celgene for long-term success. This organizational change further establishes clinical development as another center of excellence and enhances strategic leadership in discovery, development and commercialization.”

This comes amid some turbulent times for the biotech’s pipeline. Back in May, an audit of Celgene’s R&D over the last five years revealed that two-thirds of its programs failed—and it made no difference whether the project originated in-house or externally.

The analysis by 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.

RELATED: After FDA rebuff, Celgene on track to refile ozanimod—in 2019

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 executive team will now hope to help turn things around, and get better R&D scorecards in the future. One of the hopes is that its $9 billion buyout of Juno and its CAR-T program will help, although it remains some way behind rivals Gilead/Kite and Novartis in this space.

“Dr. Reicin is an accomplished physician with an excellent record of developing important therapeutics for multiple cancer and inflammatory indications,” said Mark Alles, chairman and CEO of Celgene.  

“Led by Alise, our clinical development organization will be structured to more completely align with our strategy and mission to discover, develop and commercialize innovative therapies for patients with unmet need. She joins Dr. Rupert Vessey, president of research & early development, and Dr. Jay Backstrom, chief medical officer, as we deliver the potential of our deep and broad pipeline.”