News

H. Lundbeck A/S and its Japanese partner Otsuka Pharmaceutical Co Ltd expect to make a regulatory filing for a new indication for Rexulti, an approved drug for schizophrenia and depression, before the end of the year. The proposed indication, for agitation in patients with Alzheimer’s dementia, would be supported by positive data from a Phase 3 study showing a statistically significant reduction in agitation in patients receiving the drug compared with placebo. The trial results were reported in June.

Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration to treat non-small cell lung cancer whose tumours have activating HER2 mutations. The accelerated approval comes just a week after Enhertu, an antibody-drug conjugate (ADC), was authorised by the FDA for a new breast cancer indication. The decision, announced on 12 August, brings the total number of US regulatory approvals for the drug up to five, all of which are for cancers expressing the HER2 protein.

Verona Pharma Plc has raised $150 million from a public share offering on Nasdaq in order to support development of ensifentrine, its small molecule drug for chronic obstructive pulmonary disease. The UK company recently completed the first of two Phase 3 trials of ensifentrine in preparation for a possible regulatory submission to the US Food and Drug Administration in the first half of 2023.

A Phase 3 trial of canakinumab in patients with non-small cell lung cancer failed to meet its primary endpoint of disease-free survival compared with placebo despite earlier positive signals of the drug’s potential in the disease. The developer, Novartis, announced the results on 15 August. Canakinumab (Ilaris) is an approved treatment for arthritis and periodic fever syndromes and was being studied as an adjuvant treatment in patients with stages 2 to 3A and 3B lung cancer. The Phase 3 trial did not throw up any unexpected safety signals.

GlaxoSmithKline Plc has obtained an exclusive option to co-develop and commercialise an experimental antibody-drug conjugate (ADC) that is designed to activate the innate immune system in order to fight cancers expressing the HER2 protein. The partner is Mersana Therapeutics Inc of Cambridge, US which has a pipeline of clinical and preclinical ADCs.

Genmab A/S has raised its forecast for revenue and operating profit in 2022 after seeing a sharp increase in royalty income in the first half from Darzalex (daratumumab), a CD38 monoclonal antibody for multiple myeloma. Revenue is now expected to be between DKK 12,000 to 13,000 million and operating profit between DKK 3,800 to 5,400 million. In 2021, revenue was DKK 8,482 million (€1,140 million) and operating profit was DKK 3,018 million.

The US Food and Drug Administration has extended a clinical hold on a proposed Phase 3 clinical trial of a microbiome-based therapeutic developed by MaaT Pharma SA of France because it requires more information about the composition of the faecal-derived product. MaaT Pharma announced the clinical hold extension on 10 August.

Evotec SE increased revenue and expanded its drug discovery and development alliances in the first half of 2022 even as some sectors of the pharma industry experienced a slowdown. Group revenue was €336.9 million, up by 24% from a year earlier. More than three quarters of group revenue, or €258.8 million, was generated by the company’s fee-for-service business while €78 million came from partnered drug discovery.

Merck & Co Inc has entered into a multi-year research collaboration with Cerevance Inc, a six-year-old neuroscience company, to identify novel targets for Alzheimer’s disease. Cerevance was launched by Takeda Pharmaceutical Company Ltd and Lightstone Ventures in 2016 to develop novel therapeutics for neurological and psychiatric disorders.

Alnylam Pharmaceuticals Inc has reported positive Phase 3 data for its RNAi therapeutic patisiran which is being developed for ATTR amyloidosis with cardiomyopathy, a disease caused by the build-up of abnormal proteins in tissues of the heart. The therapy works by silencing the transthyretin messenger RNA, thereby inhibiting the synthesis of transthyretin protein. The disease affects the heart’s ability to function properly leading to shortness of breath and an irregular heart beat.