05.02.2013 - The European Commission has granted EU market authorisation to Sanofi’s GLP-1 receptor agonist licisenatide as a diabetes therapy.
The first in class once-daily prandial GLP-1 (glucagon-like peptide-1) receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a second line therapy. The decision of the Commission to approve the drug for patients that do not respond to a combination of oral glucose-lowering medicinal products plus basal insulin as well as diet and exercise is based on results from the GetGoal clinical programme
In 11 studies on 5,000 patients, the Paris-based drug maker demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia (licisenatide) had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia, according to Sanofi.
The therapy, which was licensed from Danish Zealand Pharma A/S in a €170m deal, is indicated when first-line therapy proves no longer effective over time. It strengthens Sanofi’s leading position in the €12bn diabetes market. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells
16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.
10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.
05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.
03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.