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Biogen expands its drug delivery solutions by acquiring Alcyone Therapeutics, enhancing patient-centered therapies with the innovative ThecaFlex DRx system.
The acquisition will also focus on advancing ThecaFlex DRx as part of an existing partnership between the two companies.
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Biogen acquired Alcyone Therapeutics with the intention to expand its drug delivery solution portfolio along with advancing ThecaFlex DRx, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides (ASOs).1
“For nearly three decades, Biogen has pioneered ASO development, and we are committed to continuing to improve patient experience and ease of administration," said Nicole Murphy, head of pharmaceutical operations and technology at Biogen. "We believe the acquisition of Alcyone Therapeutics offers a strategic opportunity to both expand the company’s capabilities and enhance the value proposition of our medicines by offering a meaningful, patient-centered solution.”
The ThecaFlex DRx System is a technology established in Alcyone’s Falcon Delivery Platform and is an investigational implantable intrathecal (IT) catheter fixation device and subcutaneous port system designed to provide access to the cerebrospinal fluid (CSF) for the infusion of therapies by IT bolus administration. Currently, lumbar puncture (LP) is the standard of care approach for delivering therapeutics into the CSF, with ThecaFlex’s design being an alternative to repeated LP. ThecaFlex received a CE Mark in Europe along with an Investigational Device Exemption from FDA, allowing Alcyone to conduct clinical investigations. Although ThecaFlex DRx hasn’t received commercial approval from FDA, it has been granted Breakthrough Device Designation.
Biogen and Alcyone began its collaborative efforts back in 2023 when the two companies elected to work together to develop ThecaFlex DRx through the Pierre and Pierre-Pk clinical studies for nusinersen. Nusinersen which is now marketed under the brand name Spinraza, is indicated for the treatment of spinal muscular atrophy (SMA) in both pediatric and adult patients, with Biogen planning to introduce its new drug delivery system for Spinraza upon its successful completion of clinical trial and regulatory approvals in early 2028.
Biogen is expected to handle end-to-end development, commercialization, and manufacturing of ThecaFlex DR, along with Alcyone employees becoming integrated into Biogen’s product delivery solutions team to build on Biogen’s existing portfolio following the agreements closure. Biogen is expected to evaluate the ThecaFlex DRx system along with Spinraza in patients with SMA to inform Biogen’s broader pipeline of therapy solutions.
“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-centered, chronic intrathecal delivery option for these important therapies,” said PJ Anand, founder, president, and chief executive officer of Alcyone Therapeutics. “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.”
Alcyone will receive an upfront cash payment of $85 million along with select milestones which are payable in accordance with the development and regulatory approval of ThecaFlex DRx, nusinersen and additional pipeline products. Biogen is anticipated to handle the transaction as an acquisition of an asset and will record the value of the transaction as acquired in-process research and development, while expensing the upfront milestone payments in the fourth quarter of this year. Alcyone’s remaining therapeutic assets, such as its Falcon precision intra-cerebrospinal fluid drug transport modeling, and intraparenchymal delivery will be divested into Neela Therapeutics.
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