HEMEL HEMPSTEAD, England and BOSTON, Jan. 9, 2019 /PRNewswire/ -- EUSA Pharma (EUSA), a global biopharmaceutical
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 PharmaFounded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit www.eusapharma.com.
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 UseSYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.
DOSAGE AND ADMINISTRATIONFor intravenous infusion only. Administer as an 11 mg/kg dose given over 1 hour by intravenous infusion every 3 weeks.
DOSAGE FORMS AND STRENGTHSFor injection
CONTRAINDICATIONSSevere hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.
WARNINGS AND PRECAUTIONS
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.
Lee MorleyChief ExecutiveEUSA PharmaTel: +44(0)330-5001140
Rob BudgeRJB CommunicationsTel: +44(0)1865-760969Mobile: +44(0)7710-741241
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SOURCE RJB Communications Ltd
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