Astellas Pharma Inc is to pay $5.9 billion to acquire Iveric Bio Inc of the US giving it an ophthalmology asset under review at the US Food and Drug Administration. The asset, avacincaptad pegol, has been developed for geographic atrophy secondary to age-related macular degeneration. The FDA is expected to take a decision on marketing in August.
Health technology assessment (HTA) bodies in the US, Canada and the UK have reached a consensus about how confidential clinical data should be handled in their public assessments of new medicines. Each of the groups operates in a different healthcare environment, but they agree that more transparency is required in the future.
Roche, a company whose oncology portfolio traditionally drives sales, saw growth in the first quarter from several different therapy types. Although a decline in sales of Covid-19 products pulled revenue in the diagnostic division down, the pharma division continued to advance. Diagnostics had sales of CHF 3.6 billion, down by 31% in Swiss francs from a year earlier, but pharma had sales of CHF 11.7 billion, up by 5%. The sharp fall in diagnostic sales drove group sales down by 7% to CHF 15.3 billion ($17.1 billion).
Sanofi SA was further buoyed by its best-selling drug Dupixent in the first quarter as sales reached €2.3 billion and the path was cleared for a possible new indication in the US. The Food and Drug Administration is to review Dupixent for the treatment of chronic spontaneous urticaria, also known as hives. If approved, it would be the drug’s eleventh US indication since it was first approved for eczema in 2017.
US regulatory approval has been given to MaaT Pharma SA of France to start a Phase 3 trial of an experimental microbiome therapy in patients with graft-versus-host-disease, a potential complication from an allogeneic stem cell transplantation. The therapy, MaaT013, is an enema formulation consisting of samples of faeces from multiple healthy donors. The goal of the treatment is to restore gut microbiome diversity in order to help the body fight the disease.
The US Food and Drug Administration has approved the first oral microbiota product to prevent the recurrence of Clostridioides difficile (C. difficile) infection in individuals suffering repeat infection after treatment with an antibiotic. The product is made from human faeces. This is the second microbiota product targeting C. difficile infection to get a US approval in just five months. The first was a faecal transplant therapy developed by Ferring Pharmaceuticals Inc.
Novartis has raised its forecast for revenue growth in 2023 against a backdrop of double-digit sales increases for key cardiovascular, oncology and multiple sclerosis medicines. Group sales are now expected to grow by a mid-single digit figure, a mark-up from the previously forecast low-to-mid single digit increase. The Switzerland-based company also expects to complete the spin-out of Sandoz, its generics and biosimilar medicines business, before the end of the year.
AstraZeneca Plc expects revenue to increase by a low-to-mid single-digit percentage this year on the strength of its oncology portfolio and a continued penetration of the emerging markets. Revenue for the first quarter was $10.9 billion, unchanged from a year earlier at constant exchange rates, and down by 4% on a reported basis. While the US remains the company’s most important market, with sales of $4.3 billion in the quarter, the emerging markets including China were second, contributing $3.2 billion. China alone generated $1.6 billion or 15% of total group revenue.
GSK Plc highlighted progress with its vaccine portfolio in presenting its first quarter financial results on 26 April. Shingrix, its vaccine for shingles, produced sales of £833 million during the quarter or 12% of total group turnover. This exceeded total sales from respiratory and immunology products and was well above revenue from oncology medicines.
Just a year after closing a €60 million Series B financing, Tubulis GmbH of Germany has concluded a licensing agreement with Bristol Myers Squibb Company to develop antibody-drug conjugates (ADC). Announced on 20 April, the deal will give BMS rights to Tubulis’ technology platform to develop ADCs for solid tumours. The number of products to be developed wasn’t disclosed.