Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs, has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking marketing approval for its lead compound, emapalumab, for the treatment of patients with primary Hemophagocytic Lymphohistiocytosis (HLH).
Primary HLH typically arises in pediatric patients, is lethal if untreated, and has a 40% mortality rate with current best available care. The secondary form of the disease typically arises later in life, and is also associated with significant mortality. HLH is an orphan disease for which no drugs have been approved, representing a high unmet need.
Cristina de Min, Novimmune’s Chief Medical Officer, said, “We are delighted that the emapalumab research and development program has now advanced to the product registration phase also in Europe. We look forward to working with the EMA during the review process for the first targeted therapy for primary HLH.”
Acquisition of rights by Biovitrum
On 20th July 2018, Novimmune announced an agreement with Swedish Orphan Biovitrum (Sobi) of Sweden for Sobi to acquire the global commercialization and development rights to emapalumab. Following approvals from relevant competition authorities, SOBI has completed the acquisition of the perpetual global rights to emapalumab from Novimmune SA today. Novimmune will receive an upfront payment of CHF 50 M in cash, with a total of CHF 400 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.
(SK)
Picture: Kateryna Kon, Fotolia
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