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Drug Names(s): PN401
PN401 is an orally bioavailable prodrug of uridine that enables delivery of therapeutic concentrations of 20 - 200 uM plasma uridine in humans. PN401 has shown neuroprotective activity in models of Parkinson's disease, Huntington's disease in addition to models of stroke and neuroinflammation.
The mechanism of action may include reduced oxidative stress. In vitro studies also indicate that uridine can increase secretion of amyloid precuror protein processed by alpha secretase (rather than beta secretase, which leads to the formation of amyloid beta) and enhance neurite outgrowth.
BioMedTracker maintains two separate profiles for uridine triacetate:
- Xuriden is uridine triacetate 2g packets for the treatment of hereditary orotic aciduria (HOA).
- Vistograd is uridine triacetate 10g packets for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
In July 2011, BTG acquired US commercial rights to uridine triacetate for use as a treatment for accidental overexposure to the chemotherapeutic 5-fluorouracil (5-FU). Under the terms of the agreement, BTG will have exclusive rights to market, sell and distribute uridine triacetate for this indication in the US for up to 10 years from marketing approval. Wellstat will be responsible for completing development and regulatory filings and for product manufacture. BTG will pay Wellstat an upfront fee of $7.5 million as well as milestone payments upon NDA acceptance and approval and transfer pricing payments based on manufacturing costs and a significant percentage of net sales.
In May 2012, BTG acquired rights to distribute uridine triacetate on a named patient supply basis in Europe for an upfront payment of $3.0m, together with an option to market uridine triacetate following EU regulatory approval, under pre-agreed financial terms including a multi-million dollar exercise fee...See full deal structure in Biomedtracker
Partners: Wellstat Therapeutics Corporation
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