Biogen has signed a definitive agreement to acquire Alcyone Therapeutics for advancing the development and commercialisation of ThecaFlex DRx drug delivery system.
The system is currently being evaluated with SPINRAZA (nusinersen) for spinal muscular atrophy treatment. Credit: CHUTTERSNAP on Unsplash.
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ThecaFlex DRx is an investigational implantable device to deliver antisense oligonucleotides (ASOs) intrathecally. The device administers medicines to patients with neurologic disorders.
It is designed to offer an alternative to repeated lumbar punctures, potentially improving patient experience and accessibility.
The acquisition will enable Biogen to take charge of the full spectrum of development, manufacturing, and commercialisation of ThecaFlex DRx.
The system is currently being evaluated with SPINRAZA (nusinersen) for spinal muscular atrophy treatment, which will guide the development of Biogen’s broader investigational therapy portfolio.
Since 2023, Biogen and Alcyone Therapeutics have collaborated on ThecaFlex DRx, with ongoing PIERRE and PIERRE-PK clinical studies for nusinersen.
Biogen aims to introduce the new drug delivery system for SPINRAZA by early 2028, subject to successful clinical trials and regulatory approval. The ThecaFlex DRx system has been under development since 2019 and is manufactured in Lowell, Massachusetts, US.
Upon completion of the agreement, employees from Alcyone joining Biogen will be integrated into the product delivery solutions team, enhancing Biogen’s capabilities in drug-device combination products.
Alcyone Therapeutics CEO, founder and president PJ Anand said: “Alcyone has been a pioneer in precision CNS delivery. With ThecaFlex DRx, following our productive partnership with Biogen, we now have the opportunity to further deliver what could be the first truly patient-centred, chronic intrathecal delivery option for these important therapies.
“We believe Biogen’s deep expertise in ASOs and its proven track record in advancing drug delivery innovations make it the ideal partner to bring this technology forward.”
Under the acquisition agreement, Biogen will pay $85m upfront in cash for Alcyone Therapeutics, plus additional milestone payments contingent on the development and regulatory approval of ThecaFlex DRx with nusinersen and other pipeline products.
Post-acquisition, Biogen will oversee the entire development process of ThecaFlex DRx, while Alcyone’s remaining therapeutic assets, Falcon precision intra-CSF drug transport modelling, and intraparenchymal delivery technology will be spun off into a new entity, Neela Therapeutics.
The deal will include convertible debt financing in Neela Therapeutics from current investors, including Biogen.
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