News

A Phase 3 trial of a combination therapy intended to improve the standard of care for the most common type of liver cancer failed to meet its dual primary endpoints, Merck & Co Inc and Eisai Co Ltd announced on 3 August. The trial was investigating Keytruda (pembrolizumab) and Lenvima (lenvatinib) as a first-line treatment for patients with unresectable hepatocellular carcinoma versus Lenvima alone. In the trial, there were trends towards an improvement in overall survival and progression-free survival but these trends did not meet statistical significance, the companies said.

Germany-based Medigene AG ended the first half of 2022 with cash and cash equivalents of €39.4 million and a revenue-generating partnership with BioNTech SE to develop T cell receptor (TCR) based immunotherapies against cancer. Concurrently Selwyn Ho, an experienced business executive, took over the job of chief executive on 25 July, succeeding Dolores Schendel who will continue as chief scientific officer and head of research and development. Prof Schendel was previously both CEO and CSO.

A Phase 3 trial of an experimental checkpoint inhibitor for head and neck cancer has been ended for lack of efficacy, the developer Innate Pharma SA of France announced on 1 August. The drug, monalizumab was being studied in combination with cetuximab (Erbitux) versus placebo plus cetuximab in patients with metastatic disease who had previously had chemotherapy and another checkpoint inhibitor. Despite promising signals in an earlier Phase 1b/2 study, the Phase 3 trial did not meet a pre-defined threshold for efficacy.

Switzerland-based Addex Therapeutics Ltd has raised $4.2 million in equity finance in order to carry forward clinical and pre-clinical programmes directed at neurological disorders. The financing was arranged through Armistice Master Fund Ltd, an institutional investor, and was announced on 26 July. It makes a significant contribution to the company’s cash position which was CHF 8.8 million ($9.24 million) on 30 June, by extending cash well into 2023.

Pharming Group NV is to get an accelerated review from the European Medicines Agency for leniolisib, its candidate treatment for a rare primary immunodeficiency known as activated phosphoinositide 3-kinase delta syndrome (APDS). A marketing authorisation application is expected to be submitted to the EMA in October, the company announced on 1 August.

Sanofi SA generated sales of €10.1 billion in the second quarter with Dupixent, jointly developed with Regeneron Pharmaceuticals Inc, making the single biggest contribution to turnover. Sales for the company as a whole increased by 15.7%, while sales for Dupixent, an anti-inflammatory drug, rose by 58% to €1.96 billion.

AstraZeneca Plc reported a 31% increase in total revenue to $10.8 billion for the second quarter, driven by its cardiovascular and oncology medicines as well as income from Alexion Pharmaceuticals, a developer of drugs for rare diseases which it acquired in July 2021. The second quarter revenue figure includes three drugs with more than $1 billion in sales: Tagrisso for lung cancer; Farxiga, for diabetes, heart failure and kidney disease; and Alexion’s Soliris for myasthenia gravis and three other rare diseases.

GlaxoSmithKline Plc has revised upward its sales and adjusted operating profit guidance for 2022 – its first financial forecast since the demerger on 18 July of Haleon, its consumer products business. The new GSK is expected to produce sales growth of between 6%-8% this year, up from the previously forecast 5%-7%. Adjusted operating profit is expected to grow by between 13% to 15%, compared with a previous range of 12% to 14%.

The Roche Group is forecasting stable to modest sales growth this year as it transitions to new leadership and continues to launch more products to offset the impact of biosimilar competition for its legacy medicines. Severin Schwan, chief executive since 2008, will step down from his post on 14 March 2023 and be succeeded by Thomas Schinecker, currently CEO of the diagnostics division. Dr Schwan is to be nominated as chairman of the company’s board of directors.

AbbVie Inc of the US has formed an alliance with the Belgian company iSTAR Medical SA to further develop and commercialise a surgical device for treating patients with glaucoma. Glaucoma is a progressive disease estimated to affect more than 100 million people globally of which primary open-angle glaucoma is the most common form. The iSTAR device is designed to enhance natural fluid outflow from the eye, reducing intraocular pressure and the need for medication.