- Celgene on Friday won U.S. approval for Inrebic, a treatment for myelofibrosis that is one of five drugs Bristol-Myers Squibb regarded as particularly valuable in its $74 billion deal to buy Celgene.
- Before Inrebic's approval, only one other drug was cleared in the U.S. to treat myelofibrosis, a rare bone marrow disorder that disrupts the production of blood cells.
- Celgene paid just over $1 billion upfront in January 2018 to acquire Inrebic's latest developer, Impact Biomedicines. As part of that deal, Impact shareholders are entitled to up to $1.4 billion in milestone payments for regulatory approvals in myelofibrosis and other indications.
Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline.
While Celgene's top-selling blood cancer drug Revlimid (lenalidomide) was a key draw for Bristol-Myers, the pharma also made a case to skeptical investors that Celgene's experimental drugs could give it a foundation for the future.
Among the five drugs highlighted by Bristol-Myers, Wall Street sales estimates for Inrebic are the lowest, ranging between $300 million to $500 million by 2028, according to an activist investor which opposed the Celgene deal.
Much more important are the multiple sclerosis drug ozanimod and the CAR-T cancer therapies bb2121 and lisocabtagene maraleucel.
All told, Bristol-Myers expects the five drugs plus one of its own to eventually generate more than $15 billion in annual revenue.
Six pipeline assets crucial to Bristol-Myers' deal for Celgene
|Previous Celgene peak sales forecast
|Filed with FDA, approval expected in 2020
|$4 billion to $6 billion
|Myelodysplastic syndrome and beta-thalassemia
|Filed with FDA, initial approval expected in December
|Approval expected in 2020
|Approval expected in 2020 or early 2021
|Phase 3 readouts in 2020
*TYK2 inhibitor is from Bristol-Myers' pipeline; estimate of $15 billion plus in total peak revenue is from Bristol-Myers and Celgene SOURCE: Company presentations
Inrebic is cleared for adult patients with primary or secondary myelofibrosis classified as either intermediate-2 or high risk.
Clinical results supporting Inrebic's approval showed treatment with the drug led to a 35% or greater reduction in spleen volume, one of the consequences of myelofibrosis, in 35 of the 96 patients given the recommended dose of the drug.
A similar number also experienced a reduction by half in disease-related symptoms including night sweats, itching, pain under the ribs and abdominal discomfort.
Inrebic is approved with a Boxed Warning, however, cautioning of the risk of serious and potentially fatal brain damage or dysfunction. Doctors are advised to monitor patient thiamine levels, as well as for gastrointestinal and liver toxicity.
Neurological concerns for the drug led the Food and Drug Administration in 2013 to place a clinical hold on testing. Impact, which bought rights to the drug from Sanofi, convinced the agency to lift the hold in 2017, and data later showed only one of the eight flagged cases of Wernicke's encephalopathy actually presented a clear case.
Prior to Inrebic, treatment for myelofibrosis patients was limited to Incyte's Jakafi (ruxolitinib), first approved in 2011. Both drugs inhibit a protein known as Janus Associated Kinase, or JAK.
Jakafi, though, does not carry a Boxed Warning and costs less than the $21,000 a month at which Celgene priced Inrebic, according to RBC Capital Markets analyst Brian Abrahams. Celgene did not respond to BioPharma Dive's requests for confirmation on Inrebic's price.
Perhaps reflecting that, Incyte shares rose by 2.5% Friday, while Celgene's were up 1%.