Celgene Corporation (NASDAQ:CELG) announced that it won’t be pursuing the approval of Revlimid, that was expected to be used as maintenance therapy for lymphoma treatment. The company made this announcement as it presented results from its clinical trial of Remar. Revlimid tested as maintenance for diffused large B-cell Lymphoma revealed that it did not improve the overall survival of patients, the most important metric for a cancer drug. Celgene will now not be pursuing approval for the indication but continue to study the drug in other lymphomas.
Celgene hoped to achieve a $1 billion revenue boost from Revlimid, but the current state puts this figure in doubt. If the blood cancer drug does not pull through in other lymphoma trials set to be conducted next year, the company will find it hard to achieve its ambitious 2020 sales targets that were set at $10 billion. According to analysts, Revlimid was projected to deliver $6.7 billion in sales this year, with the company seeing new indications that might add another $1 billion – $1.5 billion over the next few years. Revlimid is currently approved for multiple myeloma.
Past 2020, Celgene might find it hard to increase its sale of Revlimid since it will have to cope with competition from generics. Celgene entered into a patent agreement with NatcoPharma that will allow earlier than expected copycats, but on a phased-in schedule that begins in 2022. By 2026, Natco will be free to sell Revlimid generics, approximately 18 months before the drug’s patent expires.
Evercore ISI analyst, Mark Schoenebaum, noted that indication in DLBCL is not crucial to Celgene’s 2020 sales goal, but will make it a must for the other Revlimid expansion trials to deliver success. He further notes that the largest remaining indication under investigation is follicular lymphoma, which is most certain to meet Celgene’s guidance.