Company News

Transgene SA of France has appointed Alessandro Riva, the current chairman, as chairman and chief executive officer, and confirmed its commitment to its oncolytic virus portfolio. This follows a decision by AstraZeneca Plc to end a research and development collaboration with the company and hand back an oncolytic virus asset poised to start clinical development in the US. According to Transgene, AstraZeneca took the decision after a strategic review of its pipeline. The French company said the decision would have a “limited impact” on its financial guidance.

argenx SE of the Netherlands continued the expansion of its antibody treatment for autoimmune diseases, Vyvgart (efgartigimod), with regulatory filings for a new formulation of the product in the US, Japan and Europe. Vyvgart is a biologic that was approved by the US Food and Drug Administration in late 2021 and subsequently in the EU and Japan to treat generalised myasthenia gravis (gMG), a chronic autoimmune disease.

MorphoSys AG accelerated the clinical development of its two top cancer drugs in the first quarter whilst also stopping work on preclinical programmes and reducing the size of its workforce. Jean-Paul Kress, the chief executive, told investors on 4 May that the company’s strategic focus is to complete development of pelabresib, a small molecule drug for myelofibrosis, and expand indications for Monjuvi (tafasitamab), an approved antibody  which was launched in the US for second-line diffuse large B cell lymphoma (DLBCL) in 2020.

A vaccine developed by GSK Plc to protect older adults against infection from the respiratory syncytial virus (RSV) has been approved in the US and given a positive opinion in the EU – the first such treatment to be approved anywhere in the world. The vaccine, Arexvy, will be launched in the US before the next RSV season which typically starts in the autumn and peaks in the winter. Launch in Europe is expected to follow a formal decision on marketing authorisation, which will be taken by the European Commission.

Eli Lilly and Co reported positive results for its Alzheimer’s disease drug donanemab on 3 May saying that the Phase 3 TRAILBLAZER-ALZ 2 trial met the primary and all secondary endpoints measuring cognitive and functional decline. The company expects to make a regulatory submission to the US Food and Drug Administration by 30 June. Lilly submitted a regulatory application for donanemab to the FDA in January but the agency turned it back citing insufficient data.

Astellas Pharma Inc is to pay $5.9 billion to acquire Iveric Bio Inc of the US giving it an ophthalmology asset under review at the US Food and Drug Administration. The asset, avacincaptad pegol, has been developed for geographic atrophy secondary to age-related macular degeneration. The FDA is expected to take a decision on marketing in August.

Roche, a company whose oncology portfolio traditionally drives sales, saw growth in the first quarter from several different therapy types. Although a decline in sales of Covid-19 products pulled revenue in the diagnostic division down, the pharma division continued to advance. Diagnostics had sales of CHF 3.6 billion, down by 31% in Swiss francs from a year earlier, but pharma had sales of CHF 11.7 billion, up by 5%. The sharp fall in diagnostic sales drove group sales down by 7% to CHF 15.3 billion ($17.1 billion).

Sanofi SA was further buoyed by its best-selling drug Dupixent in the first quarter as sales reached €2.3 billion and the path was cleared for a possible new indication in the US. The Food and Drug Administration is to review Dupixent for the treatment of chronic spontaneous urticaria, also known as hives. If approved, it would be the drug’s eleventh US indication since it was first approved for eczema in 2017.

US regulatory approval has been given to MaaT Pharma SA of France to start a Phase 3 trial of an experimental microbiome therapy in patients with graft-versus-host-disease, a potential complication from an allogeneic stem cell transplantation. The therapy, MaaT013, is an enema formulation consisting of samples of faeces from multiple healthy donors. The goal of the treatment is to restore gut microbiome diversity in order to help the body fight the disease.

The US Food and Drug Administration has approved the first oral microbiota product to prevent the recurrence of Clostridioides difficile (C. difficile) infection in individuals suffering repeat infection after treatment with an antibiotic. The product is made from human faeces. This is the second microbiota product targeting C. difficile infection to get a US approval in just five months. The first was a faecal transplant therapy developed by Ferring Pharmaceuticals Inc.