After a second review, the main scientific committee of the European Medicines Agency has recommended approval of Leqembi (lecanemab) for the treatment of mild cognitive impairment due to early Alzheimer's disease in patients who have only one, or no copy, of the ApoE4 gene. The EMA opinion, announced on 14 November, will be forwarded to the European Commission for a decision.
Syncona Ltd, the UK investment group, has reaffirmed its goal of achieving £5 billion in net assets by 2032, but only after significant changes in the structure of its portfolio. With net assets per share down by 5.2% at the half year ended 30 September, the company has embarked on a two-pronged strategy. The first part of the plan is to rebalance the portfolio with an emphasis on companies with assets in clinical and late clinical-stage development.
AstraZeneca Plc is to increase its R&D and manufacturing presence in the US with a new investment of $2 billion at multiple sites across the country. Coupled with existing financial commitments, this will deliver total capital of $3.5 billion to the country by the end of 2026. The money will be invested in an R&D centre in Cambridge, Massachusetts; a biologics manufacturing plant in Maryland; specialty manufacturing in Texas; and cell therapy manufacturing at locations on the country’s west and east coasts.
A prospective drug for schizophrenia failed to show efficacy in two Phase 2 trials leaving the developer, AbbVie Inc, without a molecule to challenge one of its biggest competitors in the field. The drug, emraclidine, is a small molecule positive allosteric modulator of the muscarinic M4 receptor designed to harness the psychosis in schizophrenia. Current antipsychotic drugs target a direct blockade of dopamine receptors which are overactive in schizophrenia.
Mario Draghi, former president of the European Central Bank, has issued another appeal to policymakers to build an integrated capital market for the EU. In a commentary in the Financial Times on 2-3 November, Mr Draghi argues that a unified market would mobilise private capital to back projects in defence, the building of a digital infrastructure, and the mitigation of climate change. Currently the EU is home to more than 30 national and regional stock exchanges, each with its own regulations. A similar decentralised structure exists for bond markets.
Sanofi SA has become the latest pharma company to wind down its interest in consumer healthcare in order to focus on proprietary, prescription medicines. The French company is to sell a 50% controlling stake in Opella, its consumer business, to the US private equity group Clayton Dubilier & Rice. Under the deal, Sanofi will retain a significant interest in Opella, while increasing investment in new biopharma products and vaccines, according to Paul Hudson, the chief executive.
Evotec SE booked reorganisation costs of €62.3 million in the first nine months of 2024 in its ongoing effort to readjust its business model as a service company for the biopharmaceutical industry. The changes have been underway since January and the departure of Werner Lanthaler, the former chief executive. They affect the company’s global business in drug discovery and development as well as certain manufacturing activities.
Novartis more than doubled its operating income in IFRS terms in the third quarter on higher sales of its lead products for heart disease, breast cancer, plaque psoriasis, and multiple sclerosis as well as lower impairments for its portfolio assets. Research and development spending fell in the quarter from a year earlier, but still represented 18.7% of sales. R&D spending focused on six products that are in registration in the US, EU, Japan and China. A seventh product, a treatment for malaria, is being reviewed in Switzerland for distribution in the developing world.
GSK Plc is forecasting an increase in group turnover of 7% to 9% at constant exchange rates this year, but growth is expected to be powered by specialty medicines rather than vaccines. Vaccines for shingles and respiratory syncytial virus (RSV) put in a strong performance earlier this year but slumped in the third quarter following a raft of new regulatory measures.
The Roche Group expects to raise its dividend this year on the back of a recovery in sales led by strong demand for products treating multiple sclerosis, haemophilia A, and severe eye diseases. Group sales are expected to increase by a mid-single digit figure after rising by just 1% at constant exchange rates in 2023. The expected recovery reflects sales gains by newer products which are gradually offsetting the impact of competition from biosimilar versions of the company’s leading cancer medicines.