Biogen enters into a license and collaboration agreement with Alcyone Therapeutics to develop the ThecaFlex DRx system.
Biogen aims to use this delivery system to improve the patient experience when undergoing treatment for neurological disorders such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS). increase.
Under the agreement, the company will make an upfront payment of $10 million (€9.5 million) to Alcyone in exchange for exclusive global licenses to SMA and ALS systems. Partners also have a joint exclusive global license with non-specific attribution.
Alcyone is eligible to receive an additional $41 million if certain milestones are achieved. The agreement can also be expanded to include additional therapies in Biogen’s pipeline.
ThecaFlex is an implantable intrathecal catheter, catheter anchorage device and subcutaneous port system designed to deliver therapy to the cerebrospinal fluid.
Alcyone positions its drug delivery device as a means of bypassing, in some cases, the lumbar puncture procedure, a standard care approach for delivering therapy to the spine.
The company also said the system could facilitate a safer alternative treatment for patients with anatomical challenges or those who require multiple anesthesia and radiation exposures for repeated lumbar punctures. says.
Both partners will initially work on developing a system for use with SPINRAZA (nusinersen) in SMA before transitioning to Biogen’s portfolio of investigational antisense oligonucleotide (ASO) therapies.
Through this collaboration, the two companies will work on the clinical development of ASO therapeutic systems, while Alcyone will be solely responsible for the manufacturing and commercialization of the delivery device.
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 may be the first implantable device designed to allow regular subcutaneous administration of his ASO therapy into the cerebrospinal fluid.
All the changes at Biogenna
A day after the Biogen-Alcyon partnership was announced, the former company announced that it would split its R&D division into two divisions.
As a result, the current head of research and development, Priya Singhal, takes over the role of head of development and the company begins searching for a new head of research.
In explaining the decision, CEO Christopher Viehbacher said that two dedicated leaders “Increase productivity”,while guaranteeing “Improving risk and resource management”na
Viehbacher himself just joined from Sanofi in November 2022 as CEO. The CEO change comes as the company charts a path forward after a rocky start to the commercialization of his Alzheimer’s drug Aducanumab.