Business
Update on the Avion Agreement
Update on the Avion Agreement.
About this update from Immupharma Plc
[{"type":"text","content":"\n \nRNS Number : 1295C Immupharma PLC 06 February 2020 \n\n06 February 2020\nImmuPharma PLC\n(\"ImmuPharma\" or the \"Company\")\n \nImmuPharma provides an update on the Avion Agreement in relation to\nLupuzor™'s new international Phase III trial \nImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM), a specialist drug discovery and development company, announces an update on activities with Avion Pharmaceuticals LLC (\"Avion\") following the successful licence and development agreement signed with Avion in November 2019 for the exclusive rights to Lupuzor™ in North America (United States). \nA summary of key activities completed since November 2019\n· First joint steering committee (\"JSC\") completed in December 2019 to identify and agree the optimised Phase III study design for Lupuzor™ including a focus on those patients presenting with the biomarker anti-dsDNA autoantibody positive\n· Confirmation that the JSC wish to progress Lupuzor™ into its second international Phase III clinical trial as soon as possible this year\n· Avion and ImmuPharma to meet with the FDA in Q1 2020 to discuss guidance on a new optimised international Phase III trial protocol\n· Positive discussions with a number of potential commercial partners of Lupuzor™ outside of the US\nSummary of the Avion Agreement\n· ImmuPharma retains all the rights to commercialise Lupuzor™, outside of the US, either through distribution partnerships or directly by ImmuPharma\n· Avion will fund the full expected costs of the new Phase III trial up to $25 million\n· ImmuPharma will receive milestone payments of up to $70 million. A $5 million milestone payment will be paid on regulatory approval of Lupuzor™ in lupus, and $65 million will be based on achievement of overall sales targets\n· ImmuPharma will also receive $5 million for each additional approval, other than lupus, as Avion also has the rights, for the US, to explore further opportunities within Lupuzor™'s peptide platform for other auto-immune indications outside of lupus\n· ImmuPharma will receive from Avion tiered double-digit royalties up to 17 percent, according to pre-specified annual US sales targets\n· Avion has the right to use rel...