- Swedish rare disease specialist Sobi has added a late-stage inflammation drug to its pipeline through a deal with private biotech Novimmune that could be worth over SEK4,000 million (about $450 million).
- Under the deal, Sobi will develop and commercialize Novimmune's drug emapalumab, paying about $50 million upfront and lining up over $400 million in milestone payments to acquire exclusive global rights to the candidate.
- A human monoclonal antibody inhibitor of IFNγ, emapalumab is in a Phase 2 clinical trial in the immune disorder hemophagocytic lymphohistiocytosis (HLH). Novimmune has submitted a biologics license application (BLA) for approval in primary HLH in the U.S.
In one deal, Sobi has both expanded its rare diseases pipeline to include inflammation and got its hands on a drug that could reach the market as early as the beginning of 2019. Sobi has predicted annual peak sales potential of around $300 million for emapalumab, which is also being studied in secondary HLH and hematopoietic stem cell transplant.
"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," said Sobi CEO Guido Oelkers.
The Food and Drug Administration granted emapalumab's Biologics License Application priority review for primary HLH in March 2018, with a user fee goal date of Nov. 20. Emapalumab also has PRIME (PRIority MEdicine) status in Europe, and Sobi plans to submit an application for approval to the European Medicines Agency later in 2018.
"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," said Novimmune CEO Eduardo Enrico Holdener.
Once all additional amounts have been paid, Novimmune will transfer all emapalumab intellectual property over to Sobi, including patent rights.
As part of the deal, Sobi has also signed a non-binding letter of intent that would grant the company access to all emapalumab assets. This includes certain staff as well as options for rights to two other bispecific antibodies in preclinical development in immuno-oncology.