Biogen Plans to Acquire Alcyone Therapeutics, Boosting its Portfolio of Drug Delivery Solutions for Promising Products and Pipeline Contenders
In a significant move, Biogen Inc. has announced the acquisition of Alcyone Therapeutics. The deal, worth an initial $85 million with further payments upon achieving certain development milestones, aims to improve the delivery of RNA-based medicines. Upon closing, Alcyone's employees will join Biogen's product delivery solutions team.
The acquisition is part of Biogen's strategy to drive the end-to-end development, manufacturing, and commercialization of a promising new technology: ThecaFlex DRxTM. This innovative implantable device is being investigated for the intrathecal delivery of antisense oligonucleotides (ASOs).
ThecaFlex DRxTM has already received significant recognition, having received Breakthrough Device Designation from the FDA and a CE Mark in Europe. In the U.S., it has also secured an Investigational Device Exemption (IDE) from the FDA. The device is designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines.
One of the primary focuses of ThecaFlex DRxTM's development is its application with SPINRAZA, a drug that has a well-established safety profile based on data from patients treated up to 10 years. SPINRAZA is being evaluated with ThecaFlex DRxTM System in patients with spinal muscular atrophy.
The most common adverse events observed in clinical studies for SPINRAZA were respiratory infection, fever, constipation, headache, vomiting, and back pain. Biogen's website provides important safety information and full prescribing information for SPINRAZA in the U.S.
Biogen licensed the global rights to develop, manufacture, and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). SPINRAZA has shown efficacy across various ages and SMA types.
Biogen plans to introduce the new drug delivery system for SPINRAZA in early 2028, contingent upon the successful completion of clinical trials and regulatory approval. The company's commitment to this innovation is evident, as it also plans to introduce ThecaFlex DRxTM in the near future.
Laboratory tests can monitor for renal toxicity and coagulation abnormalities after administration of some ASOs. This underscores the importance of advancements in drug delivery systems like ThecaFlex DRxTM.
As Biogen moves forward with ThecaFlex DRxTM and SPINRAZA, it continues to push the boundaries of what is possible in the field of RNA-based medicines. The acquisition of Alcyone Therapeutics is a significant step in this journey, bringing together two companies dedicated to improving patient care.
