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.
The US Food and Drug Administration has approved a new cell therapy to quicken the recovery of neutrophils, a subset of white blood cells in the body, and reduce the risk of infection in patients being treated for blood cancers. Called Omisirge (omidubicel), the product was developed by Gamida Cell Ltd of Israel.
GSK Plc has reached an agreement with BELLUS Health Inc under which it will acquire the Canadian company for $14.75 per share of common stock in cash giving a deal value of $2 billion. BELLUS is a specialty pharma company whose lead product, camlipixant, is in a Phase 3 programme for refractory chronic cough. The compound is an antagonist of P2X3, a protein which functions as a ligand-gated ion channel.
argenx SE and Genmab A/S, both developers of antibody therapeutics with listings on European stock exchanges and the US Nasdaq market, have announced a deal that will see them jointly discover, develop and commercialise new products. The deal will leverage each company’s expertise by adding immunology to Genmab’s set of skills while expanding argenx’s therapeutic reach into oncology. Financial terms of the partnership were not disclosed.