ImmuPharma PLC (LON:IMM), a specialist drug discovery and development company, has today announced an update on activities with Avion Pharmaceuticals LLC following the successful licence and development agreement signed with Avion in November 2019 for the exclusive rights to Lupuzor™ in North America (United States).
A summary of key activities completed since November 2019
· 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
· Confirmation that the JSC wish to progress Lupuzor™ into its second international Phase III clinical trial as soon as possible this year
· Avion and ImmuPharma to meet with the FDA in Q1 2020 to discuss guidance on a new optimised international Phase III trial protocol
· Positive discussions with a number of potential commercial partners of Lupuzor™ outside of the US
Summary of the Avion Agreement
· ImmuPharma retains all the rights to commercialise Lupuzor™, outside of the US, either through distribution partnerships or directly by ImmuPharma
· Avion will fund the full expected costs of the new Phase III trial up to $25 million
· 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
· 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
· ImmuPharma will receive from Avion tiered double-digit royalties up to 17 percent, according to pre-specified annual US sales targets
· Avion has the right to use relevant trademarks for the development, manufacture and commercialisation of products
Commenting on the announcement, Dimitri Dimitriou, ImmuPharma’s Chief Executive Officer and Robert Zimmer, President & Chief Scientific Officer, said: “We are delighted with the positive and proactive progress made since entering into this partnership with Avion in November last year. Both companies are focused on expediting Lupuzor™ into a new optimised international Phase III study as soon as possible this year after discussions with the FDA over the next period. In parallel, we have entered into positive discussions with a number of potential commercial partners for Lupuzor™ outside of the US. We are in a new chapter within ImmuPharma’s history, with the investment thesis for the Company and specifically Lupuzor™ being repositioned and we look forward to providing further updates on progress with shareholders over the next period.”
Art Deas, Chief Executive Officer, Avion Pharmaceuticals added: “Avion is extremely pleased with the partnership with ImmuPharma. We believe that Lupuzor™ has a unique position within lupus that sets it apart from competition, and we are delighted to be extending our footprint within this therapeutic area. We are committed on moving Lupuzor™ into a new Phase III trial as quickly as possible this year. We look forward to continuing to make successful strides in the relationship with ImmuPharma going forward.”
