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.
A small molecule drug designed to improve lung function has met the primary and secondary endpoints in a Phase 3 trial of patients with chronic obstructive pulmonary disease (COPD), the developer Verona Pharma Plc announced on 9 August. The drug, ensifentrine, is a dual inhibitor of the enzymes phosphodiesterase 3 and 4, a mode of action that enables it to combine both bronchodilator and anti-inflammatory effects in a single compound.
Gilead Sciences Inc is to spend $405 million to acquire MiroBio Ltd, a 2019 University of Oxford spin-out, which has developed a group of medicines designed to restore balance to the immune system. The technology is based on antibodies that stimulate immune inhibitory receptors in order to suppress inflammation. The target diseases are autoimmune disorders.
The US Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for a new breast cancer indication while at the same time reclassifying a breast cancer subtype uniquely treated by the drug. Enhertu is an antibody-drug conjugate that combines a monoclonal antibody conjugated to the chemotherapy deruxtecan. The drug binds to a receptor on cancer cells after which it releases the antibody and toxin into cells to kill the cancer. Enhertu is being developed and commercialised by UK-based AstraZeneca Plc and Daiichi Sankyo Co Ltd of Japan.
F2G Ltd has raised $70 million in venture capital finance to advance its antifungal agent, olorofim, which has shown promise in treating invasive Aspergillosis, a fungal infection affecting high-risk immunosuppressed populations. Olorofim is completing a Phase 2b study and poised to start Phase 3. It has already received a breakthrough therapy designation from the Food and Drug Administration and plans to make a US regulatory filing by the end of 2022.
MorphoSys AG is poised to increase investment in its late-stage pipeline in order to strengthen its position in the treatment of haematological cancers. The Germany-based company has one product on the global market, Monjuvi (tafasitamab) for diffuse large B cell lymphoma (DLBCL). It aims to have two commercial products by 2025. In addition, Phase 3 data for two partnered products – one in Alzheimer’s disease and the second for rheumatoid arthritis – are expected to be reported by the end of the year.