Two years after abandoning an experimental treatment for Duchenne muscular dystrophy (DMD), Santhera Pharmaceuticals AG is close to achieving its treatment goal – this time with a different molecule. The Swiss rare disease company has completed regulatory applications in both the US and Europe for its newest DMD treatment vamorolone, an anti-inflammatory drug that is being positioned as a potential alternative to corticosteroids for treating the disease.
A new gene therapy company has been launched in the US and UK by a group of academic-entrepreneurs who aim to treat genetic diseases of the eye with therapies delivered by a herpes simplex virus (HSV) vector. The company, Eudora, plans to employ an HSV-1 vector as a delivery vehicle instead of the commonly used adeno-associated virus (AAV) vector. In an announcement on 31 October, Eudora said its HSV vehicle could deliver more drug than an AAV vector, one of the most widely used virus vectors in the industry.
Two Phase 3 trials of an experimental antibiotic for uncomplicated urinary tract infections in female adults and adolescents have been stopped early for efficacy, according to the developer GSK Plc. The trials were testing gepotidacin which inhibits bacterial DNA replication and independently binds to two different type 2 topoisomerase enzymes. The trials were halted on the recommendation of the programme’s independent data monitoring committee. GSK said it plans to submit a new drug application for the antibiotic to the US Food and Drug Administration in the first half of 2023.
GSK Plc reported a double-digit increase in sales for the third quarter and a pipeline of 65 potential vaccines and medicines as it transitioned to a new structure. On 18 July, it spun off its consumer healthcare business, Haleon, into an independently listed company. The new GSK retains a minority stake in the business, but going forward it will focus on specialty medicines, vaccines and new technologies.
Sanofi beat analyst sales forecasts for the third quarter with stronger than expected turnover for influenza vaccines and robust demand for Dupixent, its anti-inflammatory drug developed with Regeneron Pharmaceuticals Inc. Group sales were €12.48 billion for the quarter which was 5% above the consolidated forecast of the financial community. On a reported basis, this represented an increase of 19.7%. The increase at constant exchange rates was 9%.
Novartis saw its operating profit decline in the third quarter as it began execution of a new strategy that will focus on proprietary medicine development and the divestment of its Sandoz generics and biosimilar business. Operating income for the quarter was $2.2 billion, down by 33% due to higher impairment and restructuring costs. The decline was 4% when calculated on a non-IFRS basis. Net income for the quarter was $1.57 billion, down by 43%.
Negotiating the sale of a pharma asset, whether preclinical or clinical, involves skills in interpersonal relations as well as a thorough understanding of the asset itself, according to speakers at a panel discussion at BIO-Europe in Leipzig, Germany on 25 October.
Roche expects to report unchanged, or slightly increased, sales for 2022 as demand for new products offsets sales declines for Herceptin and other legacy medicines which are now competing against cheaper biosimilar products. The Swiss multinational said it expects to increase its dividend for 2022. As is customary, it did not report operating or net profit figures for the third quarter and the nine-month period.
France-based Andera Partners has closed its newest venture capital fund, BioDiscovery 6. At €456 million, it is the largest amount raised for any of the group’s funds directed at the life sciences sector. The fund was supported by new and existing investors.
Immunic Inc, which is co-located in the US and Germany, has raised approximately $60 million in an oversubscribed private equity financing to support clinical development of its small molecule drugs for chronic inflammatory and autoimmune diseases. The newest financing extends the company’s cash runway into the fourth quarter of 2024.