Biogen ( BIIB ) and Ionis Pharmaceuticals ( IONS ) are unlikely to see a competitor to Spinraza in 2018, an analyst said after rival AveXis ( AVXS ) outlined a significant delay for its competing drug, AVXS-101.
[ibd-display-video id=3065146 width=50 float=left autostart=true] Late Thursday, AveXis said it plans to submit data to the Food and Drug Administration for its investigational new drug application for AVXS-101 on an ongoing basis. AVXS-101 is being developed to treat spinal muscular atrophy in young children.
The announcement missed expectations from the Street that AveXis would announce the initiation of a rolling biologics license application, Instinet analyst Christopher Marai said in a note to clients. A biologics license application would be another step closer to approval.
AveXis said it now plans to request a pre-biologics license application meeting with the FDA in the second quarter. This meeting would outline what information is to be submitted in the application and how that information will be submitted.
Credit Suisse analyst Alethia Young notes there’s a 60-day window between the request and the meeting. That would put the meeting on the schedule for the third quarter. If AveXis files its application in the latter half of 2018, the gene therapy likely would come on the market in the first half of 2019.
“Based on the next steps AveXis needs to take, we think it is unlikely that Biogen sees commercial competition for Spinraza in 2018,” she said.
IBD’S TAKE: Innovators will score big in 2018 as a number of large-cap franchises face patent cliffs over the next 10 years. Head to the Industry Snapshot for how that setup could play out this year.
Spinraza is approved in the U.S. to treat pediatric and adult patients. AVXS-101 is in a pivotal trial in Type 1 spinal muscular atrophy patients and in a Phase 1 trial in Type 2 patients. Type 1 is evident in infants. Type 2 occurs between six and 18 months of age, AveXis said.
“Overall, AveXis is ultimately moving closer to a potential approval, so it still remains a risk for Biogen’s Spinraza franchise ,” she said. “Of course, there remains the potential Biogen could acquire this company for their differentiated approach and gene therapy platform that is heading toward being commercially read at some point.”
By the closing bell on the stock market today , AveXis dropped 2.5% to close at 102.08. Biogen rose 0.7% to 342.49.
Can Biogen, Ionis’ Spinraza Keep Up With Expectations After Q4?
Biogen, Ionis Sink As Competitor Plans Rival Drug To Spinraza
Beware: Price Wars For Big Pharma, Biotech Companies On Horizon
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.