The company said it had submitted additional information on the therapy known as liso-cel, which was considered a major amendment to the marketing application by the agency
Bristol Myers Squibb said recently that the United States Food and Drug Administration (USFDA) has decided to extend the approval timeline for the drugmaker’s experimental blood cancer therapy that was acquired as part of the $74 billion buyout of Celgene.
The company said it had submitted additional information on the therapy known as liso-cel, which was considered a major amendment to the marketing application by the agency, which would now announce its decision by 16th November, 2020 versus its earlier deadline of 17th August, 2020.
As part of the buyout agreement, Celgene investors are eligible to receive a contingent value right (CVR) payment of $9 per share, if three experimental drugs, including liso-cel, achieve timely approvals.
The extended review for liso-cel does not alter the likelihood of approval, but narrows the window for the 31st December, 2020 CVR deadline for the therapy, said William Blair, Analyst, Matt Phipps.
The value of the CVR was down 11.5 per cent at $3.92 per unit in early trading, implying that investors give the company a roughly 40 per cent chance of meeting its approval deadlines.
Multiple sclerosis drug zeposia was the first of the three CVR treatments to be approved, but its launch has been delayed due to the coronavirus outbreak.
Bristol Myers has also submitted its marketing application for the final asset in the CVR, a CAR-T cell therapy for multiple myeloma known as ide-cel, with a CVR deadline by 31st March, 2021.
Liso-cel, developed for relapsed or refractory large B-cell lymphoma, belongs to a class of drugs known as CAR-T cell therapy. The treatment involves taking immune cells from a patient, engineering them to attack cancer and infusing them back into the patient.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Amy Caren Daniel and Shinjini Ganguli)
- Advertisement -