Rare Daily Staff

Sobi said it entered into a strategic partnership with Novimmune to develop and commercialize emapalumab, a late-stage experimental drug being developed to treat primary hemophagocytic lymphohistiocytosis, a rare and life-threatening syndrome involving extreme immune activation.

Primary HLH mainly occurs in infants and young children and the secondary form of the disease (sHLH) is acquired from or associated with infection, autoimmune diseases or malignancy. The estimated patient population in the United States, European Union, and Japan amounts to around 5,000 people across both primary and secondary HLH. There is currently no approved drug therapy for HLH, with a current treatment protocol consisting of immuno-chemotherapy being used to suppress the immune reaction.

Emapalumab is an anti-interferon-gamma monoclonal antibody currently under U.S. Food and Drug Administration review for the treatment of primary HLH. In the United States, emapalumab has received Orphan Drug designation, Breakthrough Therapy designation and Rare Pediatric Disease designation from the FDA. Novimmune will be eligible to receive a Priority Review Voucher upon approval.

A regulatory decision in the United States is expected towards the end of 2018. In Europe, emapalumab has been granted Orphan Drug designation and PRIME (PRIority MEdicine) status by the EMA. The EMA filing is expected to be submitted later in 2018.

Emapalumab has potential therapeutic value in other serious medical conditions, with studies in secondary HLH and hematopoietic stem cell transplant ongoing or being planned. Sobi said emapalumab has sales potential from 2019 onwards, with an estimated annual $282.6 million (SEK 2.5-3.0 B) peak sales.

Under terms of the agreement, Novimmune will grant Sobi an exclusive global license for emapalumab in exchange for an upfront payment of $50.8 million (SEK 450 Million) in cash and additional payments of $42.1 million (CHF 400 million) over eight years. The additional payments may be accelerated by either party at any time after July 1, 2019. Upon payment of the final fixed amount, all intellectual property related to emapalumab will be transferred to Sobi. Sobi will have full responsibility for all future development and commercialization costs from September 2018.

Sobi has also 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 commercialization 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 of expanding our commercial Specialty Care portfolio, strengthening our geographic footprint, particularly in the U.S., and building our R&D pipeline,” said Guido Oelkers, Sobi president and CEO. “Our strategic goal is to build our Specialty Care business area as a complement to Hemophilia, allowing Sobi to advance our position to become global leaders in rare diseases.”

July 20, 2018
Photo: Guido Oelkers, Sobi president and CEO

 

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