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After a couple of years of mainly bad news, Celgene (NASDAQ: CELG) is enjoying a streak of good news so far in 2019.
The biotech won U.S. Food and Drug Administration (FDA) approval for a combination of Revlimid and Rituxan in May as a second-line treatment for follicular lymphoma or marginal zone lymphoma. It received FDA approval in June for Otezla in treating Behcet's disease. And on Friday, Celgene announced that the FDA approved Inrebic (fedratinib) in treating myelofibrosis.
Just how big is Celgene's latest good news? Maybe a $1 billion-per-year kind of big.
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Another option in myelofibrosis
Celgene's press release about the FDA approval for Inrebic trumpeted that it marked the "first new treatment in nearly a decade for patients with myelofibrosis." That statement was correct. The last FDA approval for a myelofibrosis treatment came in 2011, when Incyte (NASDAQ: INCY) picked up its first approved indication for Jakafi.
Ann Brazeau, CEO and founder of patient advocacy group MPN Advocacy and Education International, stated that "Inrebic is a much-welcomed new treatment for the myelofibrosis community." She added, "This FDA approval marks an important milestone for people living with myelofibrosis as we embark on making greater strides in the diagnosis, understanding, and treatment of this disease."
The FDA approval for Inrebic was based on Celgene's Jakarta phase 3 clinical study. In this study, 37% of patients treated with a 400 mg dose of Inrebic experienced spleen volume reduction of 35% or greater compared to 1% of patients on placebo. In addition, 40% of patients taking Inrebic had a total symptom score (a measurement of myelofibrosis symptoms) improvement of 50% or higher compared to 9% of patients on placebo.
Inrebic does have some concerning potential safety issues, though. The drug has a black-box warning for serious and fatal brain disease encephalopathy. Serious encephalopathy was reported in eight of the 608 patients treated with Inrebic in clinical studies. Serious adverse reactions were reported for 21% of the patients treated with Inrebic in the Jakarta study, with cardiac failure occurring in 5% of patients.
Great expectations
Celgene picked up fedratinib with its 2018 acquisition of Impact Biomedicines. The big biotech paid $1.1 billion up front and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. This deal could pay off nicely for Celgene if fedratinib lives up to expectations. Celgene estimates that the drug will deliver peak annual sales of $1 billion.