Biogen and Alcyone Therapeutics partner in deal worth over $50m

Biogen and Alcyone Therapeutics (Alcyone) have entered into a collaboration and licensing agreement to develop Alcyone’s ThecaFlex DRx System (ThecaFlex) to improve patient experience and access to neurological antisense oligonucleotide (ASO) therapies.

ThecaFlex, an implantable medical device intended for subcutaneous delivery of ASO therapies into the intrathecal space, has already received a CE Mark in Europe and Breakthrough Device Designation from the US Food and Drug Administration.

Under the terms of the agreement, Biogen will make an upfront payment of $10m to Alcyone, and Alcyone will also be eligible to receive up to $41m in potential milestone payments.

In exchange, Biogen will receive an exclusive global licence to ThecaFlex in spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS), as well as a co-exclusive global licence in an unnamed indication.

Clinical development of ThecaFlex for ASO therapies will be split between the two companies, with Alcyone solely responsible for its manufacture and commercialisation.

The deal also provides flexibility to expand the collaboration as additional ASO therapies progress through Biogen’s pipeline, the company said.

Biogen’s interim head of R&D, Priya Singhal, said: “Biogen looks forward to working with Alcyone to explore the potential of this device, which we believe will provide greater flexibility to people with SPA and other neurological disorders as well as their doctors in making the right treatment decisions.”

The current standard of care approach to delivering therapeutics into the cerebrospinal fluid (CSF) is lumbar puncture (LP), commonly known as a spinal tap, in which a needle is inserted between the bones of a patient’s lower spine.

ThecaFlex, designed to provide access to the CSF for the infusion of therapies by implantable intrathecal bolus administration, could provide patients with an alternative to LP, particularly for those with challenging anatomy or who require multiple anaesthesia and radiation exposures for repeat LPs.

“Alcyone designed ThecaFlex to be a therapeutic delivery alternative for patients with a chronic neurological condition whose current treatment requires repeat LP,” said PJ Anand, chief executive officer of Alcyone.

He continued: "This agreement underscores Alcyone’s expertise in CSF delivery technology which we believe will lead to an improved treatment experience for some people living with neurological conditions and their caregivers.”