Updated on 15 January 2013
Clostridium Difficile Toxoid Vaccine, for the prevention of primary symptomatic Clostridium Difficile infections (CDI), is expected to enter phase III in Q3 2013 in patients at high risk of CDI. In the US, a Fast Track Development Program designation was granted by CBER (Center for Biologics Evaluation and Research). CDI is the most common cause of healthcare related infections in the developed world and is increasingly reported globally.
SAR231893 (collaboration with Regeneron), an anti IL-4Rα monoclonal antibody with dual IL-4/IL-13 cytokine antagonism, will enter phase IIb in mid-2013 in asthma and atopic dermatitis following positive proof-of-concept data for both indications. These data will be submitted for presentation at medical conferences in 2013.
SAR302503: In December, Sanofi announced that the phase II trial evaluating its JAK2 inhibitor in myelofibrosis met its primary endpoint. The data was presented during the 2012 Annual Meeting of the American Society of Hematology. Recruitment of the phase III Jakarta study is completed.
Aubagio (teriflunomide): Sanofi has discontinued the Teracles study. This decision is based on recruitment challenges and an assessment of changing market dynamics which suggests that combining oral and injectable immunomodulatory platform multiple sclerosis therapies may not be a preferred treatment option. This decision is not related to any safety concern.
Ombrabulin: Results of the phase III study in sarcoma did not demonstrate sufficient clinical benefit to support regulatory submissions despite reaching its primary endpoint of progression free survival and the phase II study in ovarian cancer was terminated early based on an interim analysis. There were no substantial safety concerns in these studies. We have informed our partner Ajinomoto of our decision to discontinue this project.