A new chapter for argenx
Monday 22 February 2021
In just 12 years – the time it takes to develop a new chemical entity – argenx NV has grown from Dutch start-up into an internationally recognised biopharma enterprise. The company has a portfolio of wholly-owned and partnered antibody therapeutics, the first of which has been submitted for review to the US Food and Drug Administration. On 5 February, it announced gross proceeds of $1.15 billion from a global share offering, managed by J.P. Morgan and three other leading US financial institutions.
With cash and cash equivalents of $2 billion on 31 December 2020, added to receipts from the share offering, argenx is preparing to create infrastructure for a global roll-out of its lead product efgartigimod, once regulatory approval is secured. An FDA authorisation would be followed by a regulatory application in China. Applications are also being prepared for Japan and the EU, with a filing to the European Medicines Agency expected in the second half of 2021.
In preparation for a European roll-out, argenx has appointed Anant Murthy, formerly of Alnylam Pharmaceuticals, as general manager of argenx Europe.
The lead product, efgartigimod, is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies. It binds to the neonatal Fc receptor which is widely expressed throughout the body. Blocking this receptor reduces IgG antibody levels, potentially addressing several autoimmune diseases including myasthenia gravis, a disease of the muscles; pemphigus vulgaris, a disease characterised by blistering of the skin; and immune thrombocytopenia, a bleeding disorder.
Argenx is seeking FDA approval for efgartigimod in generalised myasthenia gravis.
In parallel, the company is investigating cusatuzumab, a CD70 directed monoclonal antibody, in acute myeloid leukaemia. The compound is currently in Phase 2 under a collaboration with Janssen, the pharmaceuticals division of Johnson & Johnson Inc.
Like many other European-based companies, argenx has taken steps to establish a footprint in China. On 6 January, it announced a collaboration with Shanghai-based Zai Lab Ltd to develop and commercialise efgartigimod in mainland China, Hong Kong, Taiwan and Macau. Argenx is to receive $75 million upfront in Zai Lab equity and $100 million in near-term milestone and other payments.
“We are excited to enter a new chapter for argenx as we look towards commercialisation and achieving our mission of reaching patients with debilitating rare diseases,” Tim Van Hauwermeiren, the chief executive, said on 8 January during a presentation of the company’s corporate priorities for 2021.
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