EUSA Pharma Announces Acquisition of Global Rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC for $115 Million

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.¹ The disease can affect individuals at any age, with iMCD representing one-third to half of all multicentric Castleman’s disease (MCD).²

“iMCD is a devastating disorder with few treatment options for patients, because the underlying mechanisms are so poorly understood,” said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Translational Medicine and Human Genetics, and Associate Director, Patient Impact, Orphan Disease Center, at the Perelman School of Medicine at the University of Pennsylvania.

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).³

“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”, said Lee Morley, EUSA Pharma’s Chief Executive Officer. “Following the recent divestment of our critical care portfolio, EUSA Pharma has transformed into a rapidly growing biopharmaceutical company focused solely on oncology and rare disease, backed by leading life science investor EW Healthcare Partners. SYLVANT^® is a perfect fit with our ambitious plans to roll out innovative biopharmaceutical treatments to serve the oncology and rare disease community worldwide.

Janssen discovered and developed SYLVANT^®.

Rothschild & Co. advised EUSA Pharma on the Transaction.

Fajgenbaum has received research funding from Janssen for the ACCELERATE registry.

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NOTES TO EDITORS

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has commercial operations in the United States and Europe, and a wider distribution network in approximately 40 countries around the world. 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.

About SYLVANT®

SYLVANT^® (siltuximab) is a monoclonal antibody that blocks the action of interleukin-6 (IL-6), a multifunctional cytokine detected at elevated levels in patients with iMCD. Although the cause is unknown, the dysregulated production of IL-6 plays a key role in the pathophysiology of the disease. Idiopathic MCD is an inflammatory lymphoproliferative disorder that causes the abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.¹ Symptoms of this orphan condition include fever, night sweats, fatigue, weight loss, lymphadenopathy, anaemia, flu-like symptoms, and multiple organ system failure.^2,4 It is a challenge to diagnose iMCD accurately due to the paucity of specific diagnostic biomarkers and the significant overlap with other conditions such as lymphoma and autoimmune disorders, and patients are therefore often misdiagnosed.² Idiopathic MCD is a disease that affects individuals at any age, representing one-third to one-half of all MCD cases.² The five-year survival for MCD is approximately 65%⁵, as a result, the disease represents a significant unmet clinical need. The limited number of therapeutic options for iMCD means that SYLVANT^® is the only approved treatment in the United States and Europe. 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 patients who received placebo plus BSC (34% versus 0% according to stringent criteria; 95% CI: 11.1, 54.8; p=0.0012).³

This rare disease has an estimated incidence of up to 1,900 patients in the United States with a similar number in Europe, and consequently SYLVANT^® benefits from Orphan Market Exclusivity in both the United States and Europe.

SYLVANT^® has been studied in other indications such as Renal Cell Carcinoma, Non-Hodgkin Lymphoma, Prostate Cancer & Type 1 Diabetes, and is undergoing active assessment in high-risk smouldering multiple myeloma. SYLVANT^® has also been investigated as an immunosuppressive agent to alleviate symptoms of cytokine release syndrome (CRS), a serious side effect of CAR-T cell therapies.⁶

HIGHLIGHTS OF PRESCRIBING INFORMATION FOR SYLVANT^®

These highlights do not include all the information needed to use SYLVANT^® safely and effectively. See full prescribing information for SYLVANT⁷. For more information visit https://www.sylvant.com/.

Indications and Usage

SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. 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.

Contradictions

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.

Adverse Reactions

The most common adverse reactions (>10% of patients) were rash, pruritus, upper respiratory tract infection, increased weight, and hyperuricemia.

¹ American Cancer Society, Castleman’s Disease. Last viewed June 2018. Available at https://www.cancer.org/cancer/castleman-disease/about/what-is-castleman-disease.html

² Fajgenbaum et al (2017). International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman Disease. Blood; 23; 129(12): 1646-1657.

³ Van Rhee et al (2014). Siltiuximab for multicentric Castleman’s disease: a randomised, double blind, placebo-controlled trial. Lancet Oncology; 15(9): 966-74.

⁴ Van Rhee et al (2010). Castleman Disease in the 21^st Century: An update on diagnosis, assessment, and therapy. Clinical Advances in Hematology & Oncology; 8(7):486-98.

⁵ Dispenzieri et al (2012). The clinical spectrum of Castleman’s disease. American Journal of Hematology; 87(11):997-1002

⁶ Chen et al (2016). Measuring IL-6 and sIL-6R in serum from patients treated with tocilizumab and/or siltuximab following CAR T cell therapy. Journal of Immunological Methods; 434:1-8.

⁷ http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SYLVANT-pi.pdf (accessed 2nd July 2018)

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