EUSA Pharma has signed a definitive agreement to purchase global rights for the drug Sylvant (siltuximab) from Janssen Sciences Ireland for a cash consideration of $115m.
Discovered and developed by Janssen, Sylvant is a monoclonal antibody designed to inhibit the high levels of interleukin-6 (IL-6) cytokine found in idiopathic multicentric Castleman’s disease (iMCD) patients.
iMCD is an inflammatory lymphoproliferate disorder that causes abnormal overgrowth of immune cells and shares many features with lymphoma.
The drug is said to be the only therapy approved by the US Food and Drug Administration (FDA) and European Commission to treat the rare disease with five-year survival rates of 65%.
In addition, Sylvant has approvals in about 40 other countries, including Canada and the Republic of Korea.
The approval was based on results obtained from the international, randomised, double-blind, placebo-controlled MCD2001 clinical trial with 79 subjects.
Data showed around 34% of patients administered with Sylvant experienced a durable tumour and symptomatic response along with best supportive care, compared with 0% in placebo arm.
EUSA Pharma CEO Lee Morley said: “The acquisition of Sylvant represents a significant opportunity for EUSA Pharma. As the only approved treatment for this orphan condition, Sylvant highlights the importance of ongoing research and development in areas where there are few patients yet high unmet medical needs.
“Sylvant is a perfect fit with our ambitious plans to roll out innovative biopharmaceutical treatments to serve the oncology and rare disease community worldwide.”
The drug has also been evaluated for the treatment of other diseases, including non-hodgkin lymphoma, renal cell carcinoma, prostate cancer and type 1 diabetes.
It has been additionally assessed as an immunosuppressive agent to reduce symptoms of cytokine release syndrome (CRS), which is caused as a side effect to CAR-T cell therapies.
Sylvant is further being studied in high-risk smouldering multiple myeloma.