Novartis has agreed to buy U.S.-based gene-therapy company AveXis for $8.7 billion, as the drugmaker works to refresh its drug development pipeline.
According to Novartis, AveXis’ lead product candidate, AVXS-101, has potential to be first-ever one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong disability. The U.S. FDA has granted AVXS-101 Orphan Drug designation for the treatment of SMA as well as Breakthrough Therapy designation for SMA Type 1. A BLA filing with the FDA for AVXS-101 is expected in the second half of 2018 and approval and launch in the U.S. is expected in 2019. PRIME and Sakigake designations have been secured in Europe and Japan, respectively.
AveXis also offers state of the art AAV9 gene therapy manufacturing capabilities and valuable R&D capabilities, which in addition to AVXS-101, includes other pipeline products for Rett Syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS).
This deal comes shortly after Novartis agreed to sell its consumer healthcare joint venture stake to GlaxoSmithKline for $13 billion, giving Novartis cash for “bolt on” deals aimed at replenishing the pipeline.
Read the Novartis press release