News

Donanemab, an Alzheimer’s disease drug developed by Eli Lilly and Co, is set for a review by the US Food and Drug Administration in the wake of a recommendation by the agency’s outside panel of advisers on 10 June that the drug is both safe and effective. Neither the FDA nor Lilly would comment to MedNous on a date for the final review. Nevertheless analysts who followed discussions by the panel – the Peripheral and Central Nervous System Drugs Advisory Committee – expect that whatever the timing, a formal approval is likely.

A 2019 spin-out of the Max-Planck-Institute of Colloids and Interfaces has raised additional seed finance from a venture capital syndicate to progress antibody treatments for cancer.  Tacalyx GmbH announced the funding on 11 June which increases its seed finance to more than €14 million. The company is developing antibody therapeutics that target tumour associated carbohydrate antigens. These are glycan structures often found on cancer cells but which don’t usually appear on other tissues.

Eli Lilly and Co has reported positive data for tirzepatide, an approved drug for obesity and type 2 diabetes, which is now being investigated for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. Formerly known as non-alcoholic steatohepatitis, MASH results from an excess of fat in the liver which can lead to liver-related complications and death. The global prevalence of the disease is increasing.

ITM Isotope Technologies Munich SE has raised €188 million from a group of investors to prepare for the commercial launch of its lead radiopharmaceutical product and increase its manufacturing capacity for radioisotopes. The equity financing was led by Temasek Holdings Ltd, a Singapore-based investment group, and supported by four other entities including the Qatar Investment Authority. ITM has a pipeline of candidate radiopharmaceuticals and diagnostics for cancer as well as manufacturing agreements to supply medical radioisotopes to others, including Novartis.

Merck & Co Inc is to spend up to $3 billion to acquire a privately-held ophthalmology company and build a pipeline of candidate drugs for eye diseases. The company, Eyebiotech Ltd, was founded in August 2021 by two physicians and the venture capital group SV Health Investors. It has a lead drug poised to enter Phase 2b/3 for the treatment of patients with diabetic macular oedema. Merck will pay $1.3 billion upfront for the company, with future milestone payments amounting to up to $1.7 billion.

Johnson & Johnson Inc is to spend $1.25 billion to acquire the developer of a bi-specific antibody for atoptic dermatitis, a chronic and sometimes life-long skin disease. The antibody, NM26, was developed by a subsidiary of the Swiss biotech, Numab Therapeutics AG and is poised to enter Phase 2. Investors in the asset include the European venture capital companies Novo Holdings A/S and Forbion, which supported its development for autoimmune diseases. J&J will acquire the Numab unit Yellow Jersey Therapeutics.

Evotec SE has entered the obesity field under a new partnership with three French institutions where it will identify targets and diagnostic markers for the treatment of metabolic disorders, including over-weight and obesity. This is in response to the prevalence of obesity and the success of the first commercial medicines to treat it. Announced on 30 May, the partnership brings Evotec into an alliance with Inserm, the French National Institute of Health and Medical Research; Lille University Hospital; and Inserm Transfert, a private subsidiary of Inserm.

Calliditas Therapeutics AB is set to be acquired by the Japanese conglomerate Asahi Kasei Corp in a transaction that values the Swedish developer of drugs for rare diseases at SEK 11.8 billion ($1.1 billion). The bid comes just six months after Calliditas received full US Food and Drug Administration for its lead product, Tarpeyo (budesonide), for primary immunoglobulin A nephropathy (IgAN), a rare kidney disease.

Grey Wolf Therapeutics Ltd, a UK company with a subsidiary in Australia, has raised $50 million in a Series B round extension to support development of a candidate drug for solid tumours. The drug, GRWD5769, is a small molecule inhibitor of an enzyme in the endoplasmic reticulum that plays a key role in the presentation of antigen to the human immune system. Initial data from an ongoing Phase 1/2 trial will be presented at the annual meeting of ASCO which takes place from 31 March to 4 June.

The Roche Group has received a ‘breakthrough therapy designation’ from the US Food and Drug Administration for a new breast cancer treatment intended for patients with a PIK3CA mutation. The PIK3CA gene makes an enzyme which is involved in many important functions in a cell. Mutations can cause the enzyme to become overactive and cancer cells to grow.