Biogen enters into a licensing and collaboration agreement with Alcyone Therapeutics to develop the ThecaFlex DRx system.
Biogen aims to use the delivery system to improve patient experience when receiving treatments for neurological disorders, such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS).
The agreement sees the company make a $10m (€9.5m) upfront payment to Alcyone, in return for an exclusive global license to the system in SMA and ALS. The partners also have a co-exclusive global license in an unspecific indication.
Alcyone will be eligible to receive a further $41m, if certain milestones are met. The deal can also be expanded to include further treatments in Biogen’s pipeline.
ThecaFlex is an implantable intrathecal catheter, catheter fixation device, and subcutaneous port system that is designed to deliver treatments into the cerebrospinal fluid.
Alcyone is positioning the drug delivery device as a means of avoiding a lumbar puncture procedure, in certain cases, which is the standard of care approach to delivering treatments into the spine.
The company also states that the system could facilitate a safer treatment alternative for those with challenging anatomy and for those who would require multiple anesthesia and radiation exposures for repeat lumbar punctures.
Both partners will initially work on developing the system to be used with Spinraza (nusinersen) in SMA, before moving onto Biogen’s portfolio of investigational antisense oligonucleotide (ASO) therapies.
The collaboration will see both companies work on clinical development of the system for ASO therapies, and Alcyone will be solely responsible for the delivery device’s manufacturing and commercialization.
The ThecaFlex system has received breakthrough device designation from the US Food and Drug Administration (FDA), but is not yet approved. The drug delivery device could become the first implantable device designed to enable routine subcutaneous administration of ASO therapies to the cerebrospinal fluid.
All change at Biogen
A day after the partnership between Biogen and Alcyone was announced, the former company announced that it would be splitting its R&D development division into two separate divisions.
As a result, the current head of R&D, Priya Singhal, will take on the role of head of development, and the company will begin the search for a new head of research.
In explaining the decision, CEO, Christopher Viehbacher, outlined that it had been decided that two dedicated leaders would “enhance productivity”, while also assuring “better risk management and resource stewardship.”
Viehbacher is himself new to the role of CEO, after being appointed in November 2022, joining from Sanofi. The change of CEO comes as the company plots a path forward, after a rocky start to the commercialization of Alzheimer’s treatment, Aduhelm (aducanumab).