Genmab A/S continued to derive significant revenue from partnerships with large pharma companies in 2022 while investing heavily in proprietary product development. Revenue grew to DKK 14.59 billion (€1.96 billion) in the year, up by 72% from a year earlier. The Danish company spent DKK 5.562 billion, or 38% of this revenue, on research and development.
Novartis has decided to divest a clinical-stage asset for the treatment of non-alcoholic steatohepatitis (NASH) in light of a corporate reorganisation that will see it spin-off its Sandoz generics unit and refocus its proprietary medicines business on a limited number of therapeutic areas. This will result in the ending of a collaboration with Pliant Therapeutics Inc of South San Francisco, US. Pliant disclosed the decision in a filing with the US Securities and Exchange Commission on 17 February.
UCB SA continued to invest significant sums in research and development in 2022 even as group revenue declined under the weight of patent expires. The Belgian-based company saw a 4% decline in revenue to €5.5 billion from a year earlier largely due to the loss of exclusivity for the epilepsy drugs Vimpat and Keppra. At the same time, the company maintained a high level of investment, spending 30% of revenue on new product development during the year, up from 28% in 2021.
Developers of cell and gene therapies will have more resources to conduct their research following a commitment by two financial groups to expand a campus located in Stevenage, UK. Stevenage is the home of the Cell and Gene Therapy Catapult, an independent incubator supported by the UK government.
The European Medicines Agency has issued a report summarising actions that it has taken over the past four years to improve the availability of medicines for children. This activity is regulated by a Paediatric Regulation which came into force in the EU on 26 January 2007. The regulation establishes a special committee to coordinate the agency’s work in this area. The committee in turn decides which studies companies must carry out on children, alongside studies for the same disease that are being investigated in the adult population.
Trodelvy (sacituzumab), an antibody drug-conjugate first approved for triple-negative breast cancer, has had its label expanded by the US Food and Drug Administration to include the treatment of metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer. The developer, Gilead Sciences Inc, said the approval was based on statistically significant and clinically meaningful progression-free survival and overall survival data from a Phase 3 study.
The US Food and Drug Administration has approved the first oral treatment for anaemia caused by chronic kidney disease in adults. The drug, Jesduvroq (daprodustat), was developed by GSK Plc and works by increasing the level of the hormone erythropoietin which signals the body to make red blood cells. These cells are deficient in anaemia. Jesduvroq has been approved for adults who have been on dialysis for at least four months. It is not authorised for patients who are not on dialysis. Other treatments approved in the US for this condition are injected into the blood or under the skin.
The US Food and Drug Administration has given a full approval to the cancer treatment Jemperli (dostarlimab), having received follow-up data confirming the drug’s effectiveness in treating endometrial cancer. Jemperli was given an accelerated approval in August 2021 for adult patients with mismatch repair-deficient recurrent or advanced solid tumours. Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell.
John Reed, the global head of research and development at Sanofi SA, has left the France-based multinational and will be replaced on an interim basis by Dietmar Berger, currently chief medical officer and global head of development. Dr Reed led R&D at Sanofi since joining the company in 2018. His departure was announced by Sanofi on 13 February. Shortly thereafter, Johnson & Johnson Inc announced his appointment as executive vice president for pharmaceutical R&D.
The UK medical research charity, LifeArc, is one of three donors of a £1 million award to researchers at University College London, UK, who are pioneering new therapies for motor neuron disease. This is a neurodegenerative disease that affects the nerve cells in the brain and spinal cord resulting in a person’s loss of voluntary movement. The two other donors are the Motor Neuron Disease Association and the My Name’5 Doddie Foundation.