HEMEL HEMPSTEAD, England and BOSTON, Jan. 9,2019 /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
Founded 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 Use
SYLVANT 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 ADMINISTRATION
For intravenous infusion only. Administer as an 11 mg/kg dose given over 1 hour by intravenous infusion every 3 weeks.
DOSAGE FORMS AND STRENGTHS
- 100 mg of lyophilized powder in a single-dose vial.
- 400 mg of lyophilized powder in a single-dose vial.
Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.
WARNINGS AND PRECAUTIONS
- Concurrent Active Severe Infections: Do not administer SYLVANT to patients with severe infections, monitor for infections, institute prompt treatment, and interrupt SYLVANT until resolution of infection.
- Vaccinations: Do not administer live vaccines because IL-6 inhibition may interfere with the normal immune response to new antigens.
- Infusion Related Reactions: Administer SYLVANT in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.
- Gastrointestinal (GI) perforation: Promptly evaluate patients presenting with symptoms that may be associated or suggestive of GI perforation.
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.
- Fajgenbaum et al (2017). International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman Disease. Blood; 23; 129(12): 1646-1657
- American Cancer Society, Castleman's Disease. Last viewed January 2019. Available at https://www.cancer.org/cancer/castleman-disease/about/what-is-castleman-disease.html
- EUSA Pharma, data on file
- http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SYLVANT-pi.pdf (accessed 7th January 2019)
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SOURCE RJB Communications Ltd