Sobi Acquires Full Rights to Approved HLH Drug from Novimmune

Rare disease drug developer Swedish Orphan Biovitrum (SOBI) said it is acquiring from Novimmune emapalumab, an approved therapy for treating the rare condition hemophagocytic lymphohistiocytosis, for $517 million.

HLH is a condition in which the body makes too many activated immune cells that usually manifests within the first year of life and can rapidly become fatal unless diagnosed and treated. Symptoms include fever, enlarged liver or spleen, lower-than-normal number of blood cells, and neurological abnormalities. HLH may be inherited in an autosomal recessive manner or it can have non-genetic causes.

Emapalumab is the first and only medicine approved in the United States for primary HLH. It is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNγ) to reduce inflammation. The U.S. Food and Drug Administration granted Novimmune marketing approval for emapalumab in November 2018 for the treatment of HLH in pediatric and adult patients with refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy. It is currently marketed by Sobi under the name Gamifant.

Novimmune had licensed global rights to the treatment for the rare disorder HLH to Sobi in July 2018. The acquisition, which newly established company that owns supersedes the licensing deal.

“The acquisition of emapalumab and related assets is an important step in the transformation of Sobi in becoming a global leader in rare disease,” said Guido Oelkers, president and CEO of Sobi. “This will allow us to realize the full potential of emapalumab as an important treatment in the area of immunology and address a significant unmet medical need.”

Under the terms of the agreement, Sobi will acquire from Novimmune a newly formed company that holds emapalumab and related assets for $517 million. Of that amount, $402 million was previously committed in the licensing agreement to gain full rights to emapalumab in the field of immunology, including access to all intellectual property, patent rights, data, and know-how, as well as all of the employees involved in the clinical and biopharmaceutical development of the drug. The deal also includes options for shared financial rights to two Novimmune product candidates in the field of immune-oncology: NI-171 and NI-1801.

Following the announcement of the agreement, Sobi said it intended to reorganize its research and development operations to increase its focus on the late-stage development of its pipeline in hematology and immunology. It said this may include the acquisition of promising late-stage candidates. The plan includes establishing centers of excellence in Sweden and Switzerland.

“This planned structural alignment will sharpen the focus of the company on our two main areas: hematology and immunology,” said Oelkers. “The integration of the emapalumab organization makes this alignment possible.”

Sobi also intends to discontinue discovery, early research, and partner R&D programs outside its core focus areas.

Photo: Guido Oelkers, president and CEO of Sobi

Author: Rare Daily Staff