Following approvals from relevant competition authorities, Swedish Orphan Biovitrum AB has completed the acquisition of the perpetual global rights to emapalumab from Novimmune SA. That Sobi had entered into an exclusive licence agreement for the acquisition of the perpetual global rights to emapalumab was announced on 20 July 2018.
Emapalumab is a late-stage orphan drug candidate for the treatment of primary Haemophagocytic lymphohistiocytosis, developed by Novimmune SA, a privately-held, pre-commercial drug discovery and development company focused on rare inflammatory diseases, immune disorders and immuno-oncology.
Highlights of the acquisition
- Strategic partnership to develop and commercialise emapalumab, a highly attractive late stage orphan drug candidate that addresses a high unmet medical need in primary Haemophagocytic lymphohistiocytosis.
- Emapalumab provides an attractive near-term commercial opportunity for Sobi with sales potential from 2019 onwards, and with an estimated annual SEK 2.5-3.0 B peak sales potential.
- Emapalumab application for US regulatory approval was filed with the FDA in March 2018 with a regulatory decision expected towards the end of 2018. Breakthrough Designation has been granted by the FDA. In Europe, emapalumab has been granted eligibility for the PRIME (PRIority MEdicine) scheme by the EMA. Novimmune submitted a Marketing Authorisation Application for emapalumab to EMA in August 2018.
Emapalumab has potential therapeutic value in other serious medical conditions, with studies in secondary HLH and haematopoietic stem cell transplant ongoing or being planned. - 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.
- A non-binding letter of intent for a possible subsequent acquisition of all emapalumab assets has been signed.
Date: August 27, 2018
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Source: BioSpace
