Company News

Evotec had operating loss for first nine months

Country
Germany

Evotec SE reported an operating loss for the first nine months of the year as costs associated with biologics manufacturing, drug research and development, and staff recruitment outpaced gains in revenue. The German drug developer and service provider had revenue of €510.8 million for the nine-month period, up by 19% from a year earlier. But the cost of sales and other expenses left it with an operating loss of €16.8 million. This compared with a year-earlier profit of €26.1 million.

Blenrep fails to meet endpoint in myeloma trial

Country
United Kingdom

The antibody-drug conjugate Blenrep (belantamab mafodotin), which was given an accelerated approval in the US for multiple myeloma in 2020, has failed to show superiority against a competitor molecule in a follow-up Phase 3 study. Announcing the trial results on 7 November, GSK Plc said the ADC did not meet its primary endpoint of progression-free survival. Blenrep was being tested against pomalidomide in combination with low dose dexamethasone.

New direction for Galapagos

Country
Belgium

Galapagos NV is to embark on a new strategic path that will combine its experience in immunology with a bold approach to cell-based therapies for cancer. The strategy was outlined by Paul Stoffels, the chief executive on 4 November, and involves changes to the company’s portfolio and its approach to commercialisation. Dr Stoffels is a former chief scientific officer at Johnson & Johnson Inc who became the Galapagos CEO on 1 April.

The strategy addresses both setbacks and opportunities.

Demand for Novo’s GLP-1 products strong

Country
Denmark

Demand for Novo Nordisk A/S’s glucagone-like peptide-1 (GLP-1) medicines for diabetes remained strong in the first nine months of the year, leading the Danish company to upgrade its financial forecast for 2022. Sales at constant exchange are now expected to increase by 14% to 17% this year, instead of the earlier predicted rise of 12% to 16%. In its latest financial report, Novo said the outlook takes into account periodic supply constraints at some of its manufacturing sites.

Santhera looks toward DMD approval

Country
Switzerland

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.

Gene therapy company launch

Country
United Kingdom

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.

GSK antibiotic trials stopped early for efficacy

Country
United Kingdom

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 grows pipeline

Country
United Kingdom

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 beats forecast

Country
France

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 executes new strategy

Country
Switzerland

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%.