Zevra Therapeutics (NASDAQ:ZVRA) announced Monday it has entered into an exclusive distribution agreement with Ireland-based Uniphar to broaden access to MIPLYFFA® (arimoclomol).
The partnership targets "select territories" outside of Europe and the United States, utilizing Uniphar’s extensive global supply chain to reach patients through reimbursed named-patient programs.
The move comes as Zevra builds on the momentum of its U.S. commercial launch.
MIPLYFFA, which is used in combination with miglustat, became the first FDA-approved treatment for the neurological manifestations of NPC in September 2024.
NPC is an ultra-rare, progressive, and fatal genetic disorder often referred to as "childhood Alzheimer's" due to its neurodegenerative nature.
While MIPLYFFA is already commercially available in the U.S., it is currently in the middle of a high-stakes regulatory review in Europe.
The European Medicines Agency (EMA) recently validated Zevra’s Marketing Authorisation Application (MAA), with a decision expected in early 2026.
By partnering with Uniphar, Zevra can immediately address unmet medical needs in regions where the drug is not yet formally registered but can be imported on a per-patient basis.