Company News

Genmab A/S of Denmark has revised upward its guidance for revenue and operating profit for 2022 following a strong performance of Darzalex (daratumumab), a monoclonal antibody therapy for multiple myeloma that is licensed to Janssen Biotech Inc. Genmab receives royalties on Darzalex sales which represent a significant proportion of group revenue. The company also receives royalties from Horizon Therapeutics Plc for Tepezza, a medicine for thyroid eye disease, and for Kesimpta (ofatumumab) for multiple sclerosis from Novartis.

Denmark-based H. Lundbeck A/S has raised its financial guidance for 2022 to show projected revenue in a range of DKK 17.9 billion to DKK 18.2 billion. This compares with revenue of DKK 16.299 billion (€2.19 billion) in 2021. The upgrade follows the strong performance of its four core products, which showed double-digit increases in sales for the first nine months of the year. The products are Rexulti and Brintellix for major depressive disorder; Abilify Maintena for schizophrenia; and Vyepti, a new product for migraine prevention.

The first gene therapy for adults with haemophilia B has been approved by the US Food and Drug Administration after showing that a single dose of the treatment was able to significantly reduce abnormal bleeding.

Haemophilia B is a genetic disease arising from missing or insufficient levels of blood clotting factor IX, a protein that is needed to produce blood clots to stop bleeding. Symptoms can include prolonged or heavy bleeding after an injury or surgery, or spontaneous bleeding without a clear cause. Most people affected by the disorder are men.

Facing stiff competition for its lead cancer product, MorphoSys AG is turning its attention to two Phase 3 trials that, if successful, could give it significant added momentum on the US market. This comes as the German company adjusts its US sales forecast for the  product, Monjuvi (tafasitamab), a second-line treatment for diffuse large B cell lymphoma (DLBCL). Sales for 2022 are now expected to be $90 million instead of the previously forecast $90 million to $110 million.

Gantenerumab, a candidate monoclonal antibody for the treatment of Alzheimer’s disease, has failed to slow progression of the disease in a large Phase 3 clinical programme involving 1,965 people across 30 countries, the developer Roche announced on 14 November. The company said it would share its learnings with the scientific community, while continuing to develop and test new diagnostics and prospective medicines for the disease.

A safety review of the Janus kinase (JAK) inhibitor group of medicines for chronic inflammatory disorders has concluded that the drugs should only be used in patients with certain risk factors if no suitable alternatives exist. The review was conducted by the pharmacovigilance risk assessment committee of European Medicine Agency and its conclusions were endorsed on 11 November by the agency’s main scientific committee, the CHMP. The recommendations now go to the European Commission for formal approval.

AstraZeneca Plc won 19 regulatory approvals for its portfolio of biopharmaceuticals in the four months to early November representing a step-change from the recent past. Approvals were evenly distributed across geographies and reflected the company’s global ambitions.

At the company’s third quarter press briefing on 10 November, Pascal Soriot, the chief executive, said AstraZeneca intends to spend a significant proportion of its revenue on R&D going forward as it has in the recent past.

New data have been reported for Jardiance (empagliflozin), a medicine approved to treat Type 2 diabetes in 2014 and subsequently also authorised to treat heart failure. A Phase 3 trial in 6,609 adults with chronic kidney disease has now shown that Jardiance can confer a significant kidney and cardiovascular benefit. When treated with the medicine, the risk of kidney disease progression or cardiovascular death was reduced by 28% compared with a placebo, according to the trial’s sponsors Eli Lilly and Co and Boehringer Ingelheim GmbH.

An experimental therapeutic vaccine for HIV that has been designed for use with other therapies to suppress the virus in the absence of antiretroviral medication has reported positive data from a Phase 1 study. The trial results were published online on 27 October in Nature Medicine. The vaccine’s developer is AELIX Therapeutics SL in Spain which collaborated on the study with Gilead Sciences Inc of the US and the IrsiCaixa AIDS Research Institute in Badalona, Spain.

A study of patients hospitalised for acute heart failure has shown that a strategy involving the rapid up-titration of medications and close follow-up resulted in a significant reduction in all cause death and hospital readmissions. The trial was stopped early for efficacy. The results of the study were published on line in The Lancet on 7 November. Separately, Roche announced that the trial had used one of its diagnostics to identify individuals suspected of having congestive heart failure.