EUSA Pharma (EUSA), a global biopharmaceutical company focused on oncology and rare disease, announced today that it has successfully completed the acquisition of the worldwide rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC (Janssen) for $115 million in cash
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HEMEL HEMPSTEAD, England and BOSTON, /PRNewswire/ -- EUSA Pharma (EUSA), a global biopharmaceutical company focused on oncology and rare disease, announced today that it has successfully completed the acquisition of the worldwide rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC (Janssen) for $115 million in cash. SYLVANT® is approved in more than 40 countries for the treatment of idiopathic multicentric Castleman's disease (iMCD), and is the only approved treatment in the United States and Europe for the condition. EUSA intends to commercialize SYLVANT® through its worldwide commercial platform, which it plans to expand further into a number of new markets. Following the recent appointment of Jeff Hackman as the company's US President, EUSA has completed a significant expansion of its North American commercial operations and established new headquarters in Boston, MA. Its team of 30 specialist oncology representatives and medical science liaisons are currently undergoing training and EUSA plans to re-launch SYLVANT® across the United States during January. In addition, EUSA will re-launch the product immediately through its European commercial and medical infrastructure, as well as expanding its direct operations into a number of new territories, including the Republic of Korea, Canada and certain markets in South America and South East Asia. SYLVANT® is a monoclonal antibody that blocks the action of interleukin-6 (IL-6), a multifunctional cytokine detected at elevated levels in iMCD patients.1 iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells, and shares many symptomatic and histological features with lymphoma.2 iMCD can affect individuals at any age and has an estimated incidence of up to 1,900 patients in the United States with a similar number in Europe.3 Consequently, SYLVANT® has Orphan Market Exclusivity in both territories. EUSA is currently planning to invest in developing SYLVANT® in additional indications where IL-6 blockade may be indicated. Among these, the company is looking into Cytokine Release Syndrome associated with CAR-T therapy Lee Morley, EUSA Pharma's Chief Executive Officer, said, "SYLVANT® is a perfect fit with EUSA's oncology and rare disease focus, and provides the company with a major opportunity to continue its rapid growth. As the only approved treatment for the devastating disorder iMCD, we have ambitious plans to bring SYLVANT® to patients around the world. As part of this strategy we plan to use our established commercial platform in Europe, develop new commercial operations in a number of new territories, and leverage our significantly expanded US commercial team to relaunch SYLVANT® in the United States. We are also excited to begin clinical development in new indications with high unmet need, as part of our plans to enable as many patients as possible to benefit from SYLVANT®." About EUSA Pharma SYLVANT® PRESCRIBING INFORMATION HIGHLIGHTS These highlights do not include all the information needed to use SYLVANT® safely and effectively. See full prescribing information for SYLVANT.4 For more information visit https://www.sylvant.com/. Limitations of Use DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS The most common adverse reactions (>10% of patients) were rash, pruritus, upper respiratory tract infection, increased weight, and hyperuricemia. To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. References:
Contacts Lee Morley Rob Budge
SOURCE RJB Communications Ltd |
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