Swedish Orphan Biovitrum AB (Sobi) and Novimmune SA have entered into an exclusive licence agreement for the perpetual global rights to emapalumab, a late-stage orphan drug candidate for the treatment of primary Haemophagocytic lymphohistiocytosis (HLH), developed by Novimmune SA.
Further, Sobi has signed a non-binding letter of intent with the majority shareholders of Novimmune to explore a broader collaboration regarding a possible subsequent acquisition of all assets relating to emapalumab, which would also include the transfer of relevant employees, and options for exclusive development and commercialisation rights to NI-1801 and Novimmune’s interest in NI-170, two preclinical products in the field of immuno-oncology.
Emapalumab is an anti-interferon-gamma (IFN-ɣ) monoclonal antibody (mAb), currently under FDA review for the treatment of primary Haemophagocytic lymphohistiocytosis (HLH), a life-threatening syndrome of immune activation with high unmet medical need for which there is currently no approved drug therapy.
In Europe, emapalumab has been granted orphan designation and PRIME (PRIority MEdicine) status by the EMA. The EMA filing is expected to be submitted later in 2018. In the US, emapalumab has received Orphan Drug Designation, Breakthrough Designation and Rare Pediatric Disease Designation from the FDA. A regulatory decision in the US is expected towards the end of 2018.
Novimmune SA is a privately held, Swiss biopharmaceutical company focused on discovering and developing antibody-based drugs targeted for the treatment of inflammatory diseases, immune-related disorders and cancer. Founded in 1998 by the renowned immunologist Professor Bernard Mach, Novimmune has more than 150 employees and operates in two sites in Geneva and Basel (Switzerland).
Sobi™ is an international biopharmaceutical company dedicated to rare diseases. Its product portfolio is primarily focused on treatments in Haemophilia and Specialty Care. Sobi has pioneered in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. Headquartered in Stockholm (Sweden), the organisation now spans 24 countries, delivering treatments to patients in over 60 countries across the globe. Europe is the core market for our haemophilia franchise.