Celgene gives up on lucrative new use for linchpin drug Revlimid, clouding hopes for $1B-plus revenue boost

Celgene’s best-selling drug Revlimid fell short in a lymphoma trial, putting its hopes for a $1 billion revenue boost in danger. And if the blood cancer med doesn’t pull through in other lymphoma trials set to read out next year, the company could have a tough time hitting its ambitious 2020 sales targets, analysts said.

The superstar in Celgene’s galaxy, Revlimid is expected to deliver $6.7 billion in sales this year, and the company sees new indications adding another $1 billion to $1.5 billion to that total over the next few years.

But a new use as maintenance therapy for lymphoma patients won’t be one of them. With Monday’s data release, Celgene said it wouldn’t pursue that new approval.

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In the new study, Revlimid did delay progression of diffuse large B-cell lymphoma in patients who’d responded to previous treatment with Rituxan and standard chemo. But it didn’t help extend patients’ lives--and performance on that score would be key to winning a maintenance therapy approval.

Expanding into maintenance therapy can be a lucrative proposition for cancer drugs. Patients take maintenance meds to prevent relapse, which means they’re used indefinitely, rather than episodically. And that means a steady stream of sales.

Evercore ISI analyst Mark Schoenebaum said this particular indication in DLBCL isn’t critical to Celgene’s 2020 sales goal. But “it puts pressure on the other Revlimid expansion trials to show clear success," Schoenebaum wrote in a Monday note. "The largest remaining indication under investigation is follicular lymphoma ... which is now likely to be necessary to meet their 2020 guidance."

Celgene is testing Revlimid in another DLCBL study, but as Leerink Partners analyst Geoffrey Porges points out, it’s designed differently, with Revlimid as an add-on to Rituxan and CHOP chemo. Patients there have also been sifted with a diagnostic, focusing the trial on a particular subtype where Revlimid shows more promise.

Celgene is aiming for $21 billion in sales by 2020, with its hematology franchise surpassing $14.8 billion. Revlimid is the linchpin of that franchise, but the company also fields other meds, including Pomalyst, now approved in later lines of multiple myeloma treatment but aiming for a broad range of uses. That med brought in $983 million last year.

On its own, Revlimid has been expected to bring in more than $10 billion in 2020 sales, according to a report from EvaluatePharma. That could change as the drug either delivers, or fails to deliver, on the new indications Celgene is shooting for.

Meanwhile, past 2020, Celgene will be looking at competition from Revlimid generics. Under a patent settlement with Natco Pharma finalized late last year, the company will allow earlier-than-expected copycats, but on a phased-in schedule, beginning in 2022. As of 2026, Natco can sell Revlimid generics at will, about 18 months before the drug's last patent expires.

- see the Celgene release

Special Reports: Top 20 drugs by 2020 - Revlimid, Celgene | Top 10 most expensive drugs in 2013 - Revlimid, Celgene

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