Netherlands-based argenx SE expects to report data from multiple clinical trials of its lead product Vyvgart (efgartigimod) this year and in 2024 in a bid to secure a pivotal position in the sector for severe autoimmune diseases. Specifically, the company aims to build a market position around its knowledge of how the blockade of a protein called the neonatal Fc receptor can help patients overcome a host of serious pathologies.
These pathologies range from generalised myasthenia gravis (gMG), a chronic autoimmune disease for which Vyvgart is approved, to thyroid eye disease, and lupus nephritis where the same product is under investigation. In a call with investors on 2 March, Tim Van Hauwermeiren, the chief executive, said that while 2022 was marked by the launch of Vyvgart, the coming years will focus on market expansion.
Vyvgart is an antibody fragment therapeutic that was approved by the US Food and Drug Administration in late 2021, and subsequently in the EU and Japan. The disease it treats, gMG, occurs when IgG autoantibodies disrupt communication between the nerves and muscles. This can cause debilitating and potentially life-threatening muscle weakness. Vyvgart works by binding to the neonatal Fc receptor, resulting in the reduction of circulating IgG. This mechanism is being investigated in multiple follow-up studies. Altogether, argenx expects that by the end of 2023, Vygart will be either approved, in regulatory review, or in trials for new indications for 13 severe autoimmune diseases.
In addition, the company has earlier projects where candidate therapies are being investigated against different targets and diseases. Two of the targets include the complement cascade and an epitope of the enzyme Galectin-10. A third candidate product is targeting a muscle specific kinase.
Founded in 2008, argenx has exploited a scientific finding that the Camelidae family, which includes the llama, have a unique set of antibodies ideally suited for human therapeutics. This finding, plus original target discovery work, led to the development of Vyvgart, which generated sales of $400.7 million in 2022. argenx reported total revenue for the year of $445 million, which also includes milestone income from one of its four partnered programmes. The company reported an operating loss of $720 million for the year, more than double the previous year’s loss of $349 million. This followed increased spending on both research and development and administration and sales. On 31 December 2022, the company had cash and financial assets of $2.2 billion, largely due to successful share offerings in the US. Mr Van Hauwermeiren told investors that the company has sufficient cash and product revenue to fund operations until it becomes profitable.
Separately, argenx has appointed Karen Massey, a former Roche executive, as chief operating officer. She replaces Keith Woods who is retiring but will remain a strategic advisor to the company’s board of directors. Ms Massey was most recently senior vice president of product development and global clinical operations at Genentech, a Roche company.
Argenx reported its 2022 results on 2 March 2023
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