EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to Sylvant (siltuximab) for USD 115 million in cash.
Sylvant is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma. The disease can affect individuals at any age, with iMCD representing one-third to half of all multicentric Castleman’s disease (MCD).
Sylvant is the only approved treatment for iMCD in the United States and Europe. It first received approval in the United States in 2014, with subsequent approvals occurring in a number of countries thereafter. Since then, Sylvant has achieved rapid revenue growth.
The approval of Sylvant was based on the MCD2001 study (NCT01024036); an international, randomised, double blind, placebo-controlled trial including 79 subjects. More than one-third of subjects in the Sylvant arm had a durable tumour and symptomatic response to treatment plus best supportive care (BSC), compared to none of the subjects who received placebo plus BSC (34% versus 0% according to stringent criteria; 95% CI: 11.1, 54.8; p=0.0012).