Supported by $1 billion from a recent equity offering, Zealand Pharma A/S is planning to increase investment in its obesity portfolio and broaden its partnerships with other pharmaceutical companies. The Denmark-based company, which was founded in 1998 to produce peptide-based medicines, has already invented 10 medicines, two of which are on the market. Going forward it will progress three late-stage clinical candidates and invest in new assets.
Evotec SE simplified its structure and reduced staff in the first half of 2024 in response to a slowdown in its traditional drug services business. At the same time, there was an increase in its newer biologics manufacturing business with the result that group revenue rose by 2% to €390.8 million compared with €383.8 million a year earlier. Revenue from the service business, which accounts for 77% of total turnover, was down by 7% but income from biologics manufacturing was up by 50%.
Two clinical stage biotech companies with drug discovery platforms based on artificial intelligence are to merge, creating a company with a portfolio of wholly-owned assets as well as collaborations with five big pharma companies. Recursion Pharmaceuticals Inc of Salt Lake City, US, is to have a 74% stake in the new company, which will take the Recursion name and be led by Chris Gibson, the current Recursion chief executive. The partner is Exscientia Plc of Oxford, UK, a smaller AI company founded in 2017 to focus on small molecule drug design.
A new product designed to reduce proteinuria, a feature of a rare disease potentially affecting kidney function, has been given an accelerated approval by the US Food and Drug Administration. The product, Fabhalta (iptacopan), is a small molecule developed by Novartis and the first of several assets from its portfolio of drugs for rare kidney diseases. The FDA approval was announced on 8 August and is based on interim data from a Phase 3 trial investigating Fabhalta in comparison with placebo in patients with primary immunoglobulin A nephropathy (IgAN).
The US Food and Drug Administration has given an accelerated approval to a new therapy for synovial sarcoma, the first engineered cell therapy for a solid tumour to receive a marketing approval. The product, Tecelra (afamitresgene autoleucel), is directed against tumours that express the melanoma-associated antigen A4 (MAGE-A4), a marker for the disease. Synovial sarcoma is a rare type of soft tissue sarcoma which can occur in many parts of the body but most frequently in the extremities. The product was developed by Adaptimmune Therapeutics Plc.
The European Medicines Agency has issued a negative opinion for Leqembi (lecanemab), a treatment for Alzheimer’s disease, saying that the benefits of the drug do not outweigh the risks. The opinion, issued on 25 July, is in contrast to decisions by regulatory authorities in six other countries, including the US, which have all approved the treatment. Leqembi is currently being marketed in the US, Japan and China. Co-developer Eisai Co Ltd said that it will appeal against the decision.
Five years after raising €30 million in a Series A financing round, Confo Therapeutics NV has completed another fundraising – this time for €60 million to advance a pipeline of therapies that modulate G-protein coupled receptors, one of the most difficult set of targets for drug development. The new round was led by Ackermans & van Haaren and included participation from the new investors Driehaus Capital Management and Quest for Growth.
A US medical device company with a product designed to help patients at risk of heart failure has received $196 million in new finance to support the commercialisation of a wearable defibrillator product. Kestra Medical Technologies Inc, which is located in Kirkland, Washington, with a presence in Ireland, is a privately-held company established in 2014.
The Roche Group reported sales of CHF 29.8 billion ($33.7 billion) in the first half, unchanged from a year earlier on a reported basis but up by 5% at constant exchange rates. With product sales reviving and several regulatory approvals in hand, the company plans to increase its dividend in Swiss francs this year. Further details were not provided.
Sanofi SA ended the second quarter with sales of €10.7 billion, up by 7.8% from a year earlier and propelled by the continuing strong performance of Dupixent, the biologic co-developed with Regeneron Pharmaceuticals Inc. Dupixent generated €3.3 billion in the period, or nearly a third of group sales. Altogether, pharmaceutical products delivered €8.3 billion and vaccines, €1.14 billion. The company’s consumer business, which will be spun out in the fourth quarter, at the earliest, produced revenue of €.1.3 billion.