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Novimmune SA is a privately held, Swiss biopharmaceutical company founded in 1998 by the renowned immunologist Pr. Bernard Mach. More than 140 employees operate from two sites, Geneva and Basel, Switzerland, to discover and develop antibody-based drugs targeted for the treatment of inflammatory diseases, immune-related disorders and cancer.
Since our foundation, we have built a significant R&D pipeline of drug candidates, four of which are at various stages of clinical development. The most advanced of them, emapalumab, a fully human monoclonal antibody, to treat Hemophagocytic Lymphohistiocytosis (HLH). HLH is a life-threatening syndrome of extreme immune activation which mainly occurs in children and still carries a high mortality rate. There is no approved drug for HLH.
Novimmune has been granted Breakthrough therapy designation for emapalumab by the US Food and Drug Administration (FDA) and was also selected for PRIME (PRIority MEdicine) by the European Medicines Agency (EMA). The submission of the Biologics License Application (BLA), to the FDA, for emapalumab in primary HLH has been done in March 2018. The submission of the Marketing Authorization Application (MAA), to the EMA, is planned for the second quarter 2018. Emapalumab is currently in development also for secondary HLH and the development program for non-HLH indications is about to start.
Novimmune has signed two exclusive partnering agreements with Genentech, a member of the Roche Group: in 2010 on an anti-IL17 and in 2016 on an anti-TLR4 monoclonal antibody. Novimmune is currently performing a phase 2 study in Rheumatoid Arthritis, with this latter molecule, with results expected in the third quarter 2018.
In 2014 and 2016, the exclusive rights for the development of an anti-CD3 and an anti-IL-6R monoclonal antibody, were granted to Tiziana Life Sciences.
Our company has also developed monoclonal and bispecific antibody generation platforms designed to streamline the identification, production and characterization of fully-human antibodies. In 2015, Novimmune signed an international bispecific antibody research collaboration with Baxalta Inc. which after the acquisition by Shire in 2016, continued as per the agreed plan. In July 2017, we entered into a licensing agreement with Shire granting them exclusive worldwide rights to develop and commercialize an innovative bispecific antibody, currently in preclinical development, for the treatment of hemophilia A.
Novimmune’s highly skilled researchers and drug developers are committed to continue to provide innovative, antibody-based medicines to patients suffering from rare and devastating diseases in need of more effective and safer treatments.
Eduard E. Holdener
Chairman and CEO
