GlaxoSmithKline Plc has negotiated rights to a candidate treatment for non-alcoholic steatohepatitis (NASH) from Arrowhead Pharmaceuticals Inc which uses RNA interference (RNAi) technology to reduce levels of the liver enzyme ALT and address the disorder. The candidate therapy, ARO-HSD, targets the protein-coding gene HSD17B13 which is involved in the metabolism of hormones, fatty acids and bile acids. NASH is a disorder in which excessive fat builds up in the liver, causing inflammatory damage and fibrosis.
Novo Nordisk A/S is to acquire Dicerna Pharmaceuticals Inc, a company developing candidate RNA interference (RNAi) therapeutics for multiple diseases including cardiometabolic, viral, and chronic liver indications. Under the terms of the agreement, Novo will acquire all of the outstanding shares of Dicerna for $38.25 per share for a total equity value of $3.3 billion.
Sanofi SA has announced an equity investment of $180 million in Owkin, a company with an AI platform which enables scientists to conduct research on diseases without having to pool data centrally. The model, called ‘federated learning,’ enables data scientists to securely connect to decentralised, multi-party data sets and create AI models for targeted drug discovery. Owkin is based in New York City, US but has scientific roots in France.
A preventive treatment for migraine, Vyepti (eptinezumab), has received a positive opinion from the European Medicines Agency – the first step towards getting an authorisation for the EU market. If approved, it will be the first and only intravenous treatment for migraine prevention in the region, the developer H. Lundbeck A/S, announced on 12 November.
A new drug has been approved by the US Food and Drug Administration for polycythemia vera, a rare disease that causes the bone marrow to make too many red blood cells, which can thicken the blood and cause clots. Besremi (ropeginterferon alfa-2b-njft) is the first approved medicine for this disease that patients can take, irrespective of their treatment history. It is also the first interferon therapy specifically approved for polycythemia vera.
Robert Califf, a professor of medicine at the Duke University School of Medicine, is to be nominated to lead the US Food and Drug Administration – a position he held during the final year of the Obama administration and will return to under the Biden presidency. A cardiologist, Dr Califf has been vice chancellor for clinical and translational research at Duke and was founding director of the Duke Clinical Research Institute, where he led many clinical trials.
Syncona Ltd has taken the lead in financing a new cell therapy company that is developing induced pluripotent stem cell (iPSC) derived medicines. Clade Therapeutics, located in Cambridge, US, has a platform technology that ‘cloaks’ human pluripotent stem cells and their adult derivatives enabling the development of immune compatible cell transplantation therapies. The company is initially focused on demonstrating the potential of cloaked immune cells as cancer treatments.
Johnson & Johnson Inc, whose Janssen business unit is active throughout Europe, is to split into two separate companies by spinning off its consumer healthcare products division from its more lucrative pharmaceuticals and medical devices business. Announced on 12 November, the demerger is expected to be completed in 18 to 24 months.
Evotec SE completed a public share offering on the US Nasdaq market on 9 November, raising a total of $435 million from the base offering and giving it more resources to pursue a strategy as development partner for the global biopharma industry. The share offering came after a third quarter during which revenue increased by 23% to €159.7 million on the strength of ongoing partnerships with large pharma companies.
MorphoSys AG increased spending on research and development by 88% in the third quarter and by 60% in the first nine months of 2021 as it continued to invest in new products and absorb programmes from Constellation Pharmaceuticals Inc, a developer of drugs in the field of epigenetics which it acquired in July. Constellation has two clinical-stage cancer programmes and several products in preclinical development.