Last checked at 6 Feb 2020 07:00
06 February 2020
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma provides an update on the Avion Agreement in relation toLupuzor™'s new international Phase III trial
ImmuPharma 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).
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."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")
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Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases, metabolic diseases and cancer. The lead program, LupuzorTM, is a first-in class autophagy immunomodulator which is in Phase III for the treatment of lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action. ImmuPharma and Avion Pharmaceuticals signed on 29 November 2019, an exclusive licence and development agreement and trademark agreement for Lupuzor™ to fund a new international Phase III trial for Lupuzor™ and commercialise in the US. For additional information about ImmuPharma please visit www.immupharma.com. ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Established in 2007, Avion is a US-based speciality pharmaceutical company formed to develop, acquire and market a portfolio of innovative pharmaceutical products in Women's Health and other therapeutic categories. Avion has a deep in-house expertise within medical and regulatory affairs and late-stage clinical development, together with a strong marketing and commercialisation operation. Avion's sales team reaches throughout North America with more than 100 sales representatives with significant specialist therapeutic experience. Since 2012, Avion has launched more than 55 New Drug Candidates (NDCs) and 20+ generic product extensions. Avion's launch earlier this year of a new gout product (Gloperba®) for adults is an excellent sales and marketing fit for the future commercialisation of Lupuzor™, as rheumatologists are the core prescribers and therapeutic influencers in both gout and lupus. For more information, visit www.avionrx.com.
Background to Lupuzor™ and Agreement with Avion
ImmuPharma announced top-line trial results from its pivotal Phase III trial of Lupuzor™ in lupus patients on 17 April 2018. Further data analysis, reported on 29 May 2018 demonstrated that in the European cohort (130 patients) Lupuzor™ plus standard of care ("Active Group") showed statistically significant reductions (71.1 percent vs 48.8 percent, p=0.0218) in disease activity compared to placebo plus standard of care ("Comparator Group") in 79 patients (60.8 percent) who were anti-dsDNA autoantibody positive ("Antibody Positive").
With important insights gained from this pivotal Phase III Lupuzor™ trial, a new Phase III clinical trial design has been identified. The ability to select the most responsive patients by biomarker profile has enabled Avion and ImmuPharma to agree the most robust way forward for Lupuzor™ in lupus patients. The Licence and Development Agreement allows completion of this new optimised international Phase III trial. Avion and ImmuPharma have assessed and agreed an expected level of funding required to complete the Phase III trial, which Avion has agreed to fund in full, in return for full licensing rights over the drug within the US. ImmuPharma will receive milestone payments upon achievement of certain milestones, and tiered double-digit royalties on future revenues generated by Avion.
Outside of lupus, the Licence and Development Agreement also includes the option for Avion to explore the peptide's potential in other auto-immune diseases for the US market.
Terms of the Avion Agreements
Licence and Development Agreement
The Licence and Development Agreement is between Avion and ImmuPharma (France) S.A, a subsidiary of the Company.
Avion Pharmaceuticals has licensed the exclusive rights to co-develop, with ImmuPharma, Lupuzor™ and the molecule forigerimod, to allow registration for marketing in the US, Europe and elsewhere and for Avion to commercialise Lupuzor™ for US territories. ImmuPharma retains all rights to commercialise Lupuzor™ outside of the US, either through distribution partnerships or directly by ImmuPharma. All existing clinical data and any future joint Intellectual Property will be shared between the two parties for their respective regions.
Avion has agreed to fund the full costs of the new optimised international Phase III trial for Lupuzor™ in lupus patients, based on an agreed level of expected costs up to $25 million. It is anticipated that this new Phase III trial will commence in 2020, following agreement of the trial design between Avion, ImmuPharma and the FDA. Following recruitment of patients (to include US, Europe and elsewhere), it is envisaged that this will be a 52-week trial. Both companies will jointly steer the clinical program.
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 tiered double-digit royalties up to 17 percent according to pre-specified annual US sales targets.
Avion will also have the right to explore clinical development for other auto-immune indications within US territories. Additional milestone payments of $5 million will be paid to ImmuPharma for each disease indication, outside of lupus, receiving regulatory approval.
Trademark Agreement
The Trademark Agreement is between Avion and ImmuPharma AG, a subsidiary of the Company.
The Trademark Agreement allows Avion to use various trademarks in connection with development, manufacture and commercialisation of products under the Licence and Development Agreement.