News

Interim data from an open-label extension study of bimekizumab, a treatment for plaque psoriasis, showed that a majority of patients who responded to the therapy at Phase 3, continued to benefit from the drug after two years. Bimekizumab is currently under review by the US Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis, a chronic inflammatory skin disease for which there is no cure. In June, it was given a positive opinion by the European Medicines Agency.

AstraZeneca Plc is discontinuing a Phase 3 trial of Ultomiris (ravulizumab), a newly acquired antibody therapy being investigated in amyotrophic lateral sclerosis, due to lack of efficacy. The decision was taken following a recommendation of the trial’s independent data monitoring committee. The trial did not throw up any new safety findings, the company announced on 20 August.

The loss of patent protection for Northera, a core hypotension product, depressed sales at H. Lundbeck A/S in the first half year and also affected its revenue forecast for the year. Partially offsetting this were sales gains for four medicines targeting neurological disorders as healthcare activity gradually recovered from the worst of the pandemic.

A new version of a Covid-19 vaccine being developed by CureVac NV and GlaxoSmithKline Plc has shown an improved immune response and protection in a preclinical study, compared with an earlier version of the vaccine, the two companies announced on 16 August.

The US Food and Drug Administration has approved a new indication for Xywav for the treatment of idiopathic hypersomnia, a chronic sleep disorder. The disorder causes people to be excessively sleepy during the day, even after a sound sleep the night before.

Xywav is already approved for excessive daytime sleepiness in patients with narcolepsy. The active ingredient of the drug is oxybate which is a controlled substance. Given its potential risks, Xywav will be subject to strict safety controls, the FDA said in an announcement on 12 August.

The accelerated approval pathway, a regulatory procedure used by the Food and Drug Administration to speed drugs to market that promise to treat serious medical conditions, is to be reviewed by the Office of Inspector General (OIG), the largest oversight body in the US government. Announced in early August, the review was triggered by the FDA’s accelerated approval on 7 June of Aduhelm, a treatment for Alzheimer’s disease. This decision led to the resignation of three members of an FDA advisory committee who argued that data presented in the drug’s application was inadequate.

A bidding contest between Philip Morris and Carlyle, a private equity firm, for ownership of Vectura Group Plc has ended with the cigarette company winning control of the UK pharma group. On 12 August, the Vectura board accepted a final offer from Philip Morris of 165 pence per share to acquire the company, giving a total enterprise value of £1.1 billion.

Mission Therapeutics Ltd has reached an important threshold in a three-year old collaboration with AbbVie Inc aimed at degrading the toxic proteins in Alzheimer’s and Parkinson’s diseases. The event was the selection of two enzyme targets for the development of new small molecule drugs for these diseases, which are the most common neurological disorders worldwide. It triggered a $20 million milestone payment to Mission, announced on 9 August.

Evotec SE continued to build its global service business in the first half of 2021 with the completion of a new biologics plant in the US, ownership of an R&D site in Verona, Italy, and new and expanded partnerships with pharma companies to co-develop compounds for multiple diseases. At the end of the first half, the company had more than 130 co-owned assets in its portfolio, potentially capable of delivering income in the form of royalty payments from 2024 onwards.

Novo Nordisk A/S reported turnover of DKK 66.8 billion (€8.98 billion) in the first half, up by 5% from the previous year, lifted by sales of its glucagon-like peptide-1 (GLP-1) medicines for diabetes. The three medicines in this group, Rybelsus, Ozempic and Victoza, had sales of DKK 23.4 billion, or more than a third of total group revenue.