Swedish company to acquire Novimmune’s emapalumab assets

Based in Geneva, Novimmune is a pre-commercial drug discovery and development company focused on rare inflammatory diseases, immune disorders and immuno-oncology. The company has entered into an exclusive licence agreement with Sobi, an international biopharmaceutical company dedicated to rare diseases, for the perpetual global rights to emapalumab, a late-stage orphan drug candidate for the treatment of primary Haemophagocytic lymphohistiocytosis (HLH), developed by Novimmune.

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 the US, emapalumab has received Orphan Drug Designation, Breakthrough Designation and Rare Pediatric Disease Designation from the FDA.

According to the terms of their agreement, Novimmune will receive an upfront payment of CHF 50 M (SEK 450 M) in cash, with a total of CHF 400 M (SEK 3,600 M) in additional payments over an eight-year period. Upon payment of all additional amounts, the intellectual property related to emapalumab, including patent rights, data and know-how, will be transferred to Sobi. The additional payments may be accelerated by either party any time after 1 July 2019. Closing of the licensing deal is expected in Q3 2018, subject to customary approvals of the relevant competition authorities.

Furthermore, 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. This 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-1701, two preclinical products in the field of immuno-oncology.

“We believe this transaction is an excellent fit for Sobi and consistent with our strategy. The addition of emapalumab to Sobi’s portfolio is a natural fit that builds upon our expertise with Kineret (anakinra) and focuses our business in inflammation, immunology and immuno-oncology,” comments Sobi President and CEO Guido Oelkers.

Novimmune’s Chairman and CEO Eduardo Enrico Holdener adds, “We are delighted to announce this collaboration with Sobi. Novimmune has brought emapalumab all the way from discovery through development to the brink of regulatory approval. Now is the right time to bring in a partner with substantial commercial capabilities to take the next step of making the product available for patients in need. In Sobi we see a strong partner with a proven ability to further develop, commercialise and provide access to innovative treatments for rare disease patients across European and US markets. Pending approval by the FDA, this means that patients who suffer from HLH will be able to benefit from emapalumab, the only targeted medicine specifically developed for the treatment of HLH.”

Picture: Hemophagocytic lymphohistiocytosis, adapted from The American Society of Hematology

(Press release/ran)