Business Wire

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

Del

EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, announced today that it 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 $115 million in cash. The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions.

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.

-Ends-

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 21st 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)

Contact information

EUSA Pharma
Lee Morley
Chief Executive
Tel: +44 (0)330 5001140
www.eusapharma.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Gemalto Instant Connect Signals New Era in Effortless Mobile Connectivity for Consumer eSIM-equipped Devices  26.6.2019 23:00:00 CESTPressemelding

Thales announces the launch of Gemalto Instant Connect, a pioneering connectivity solution to simplify the connection of eSIM-enabled devices on a mobile network. While users are spared the inconvenience of establishing a Wi-Fi or Bluetooth connection to kick-start their mobile experience, OEMs and mobile operators can now provision devices with mobile connectivity at their first use, and not during manufacturing, saving both time and cost. Connected PCs and laptops will be the first devices to integrate this faster and more efficient approach to out-of-the-box connectivity for eSIMs. Going forwards, a wide array of OEMs and mobile operators stand to benefit from the solution, which is fully compliant with the latest GSMA Remote SIM Provisioning specifications. Between 2018 and 2022, an estimated 2.3 billion eSIM-compliant consumer devices will be shipped worldwide 1 . To date, eSIM-equipped devices have had to rely on some form of primary connectivity before they are able to activate

Quanterix Announces Agreement to Acquire UmanDiagnostics, World’s Leading Neurofilament Light (Nf-L) Antibody Supplier26.6.2019 20:00:00 CESTPressemelding

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced that it has entered into a definitive agreement to acquire privately held UmanDiagnostics AB for $22.5 million, comprised of $16 million in cash plus $6.5 million in Quanterix common stock. Uman is widely recognized to possess the leading antibodies available today to measure neurofilament light (Nf-L) and has become the provider of choice for biopharmaceutical and diagnostic applications. Uman, based in Umeå, Sweden, supplies Nf-L antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions. Nf-L has seen a dramatic growth in the last three years since Quanterix developed the first assay using Uman’s antibodies that could relia

Elliott Statement on Bayer26.6.2019 16:44:00 CESTPressemelding

Elliott Advisors (UK) Limited (“Elliott”), which advises funds that collectively hold shares of Bayer A.G. (“Bayer” or “the Company”) and economic equivalents with an aggregate value of €1.1 billion, acknowledges Bayer’s announcement to create a special litigation committee of the Supervisory Board (the “Special Committee”), and the retention of Mr. John Beisner of Skadden, Arps, Slate, Meagher & Flom LLP, as legal advisor to the Supervisory Board and Special Committee. Elliott welcomes these steps, and is confident that today’s statement marks a step change in Bayer’s approach to addressing the legal challenges currently facing the Company. Elliott believes that the creation of the Special Committee will provide a new level of oversight and a fresh perspective to a litigation strategy in need of a radical overhaul, and help guide the Company towards a rational, fair and swift settlement. The appointment of Mr. John Beisner not only provides Bayer with relevant litigation expertise, bu

Louisiana Launches Hepatitis C Innovative Payment Model With Asegua Therapeutics, Aiming to Eliminate the Disease26.6.2019 15:30:00 CESTPressemelding

Today, Governor John Bel Edwards joined Secretary Rebekah Gee of the Louisiana Department of Health, Secretary James LeBlanc of the Louisiana Department of Corrections, and Asegua Therapeutics LLC, a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), to announce a deal that will allow the implementation of an innovative payment model for hepatitis C treatment, part of Louisiana’s plan to eliminate the disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005539/en/ “This new model has the potential to save many lives and improve the health of our citizens. It is an important day for our state, for our partner Asegua Therapeutics, for providers, but most importantly for the patients and their families who will benefit from treatment,” said Governor Edwards. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this five year partnership. Ultim

Nextflow Software Introduces Nextflow Studio, Its Newest Fluid Simulation Software26.6.2019 14:00:00 CESTPressemelding

Nextflow Software is an Independent Software Vendor (ISV) based in Nantes, France. Nextflow Software is one of the leaders in innovative Computational Fluid Dynamics (CFD) methods. The startup exhibits at the NAFEMS World Congress in Quebec City, Canada, on June 17-20, featuring live demos if its latest product Nextflow Studio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005482/en/ Nextflow Studio conception simulation (Photo: Nextflow Software) A full environment covering all stages of CFD simulation Nextflow Studio is a software platform that covers the entire CFD flow, from pre-processing, to computation and post-processing. This environment lets engineers manage easily their simulation projects and provides a Graphical User Interface (GUI) based on the latest software technologies. Nextflow Studio offers an experience that allows users to accelerate the resolution of their field-specific design objectives. Main

BrandSafway Selects Rimini Street Application Management Services for Salesforce26.6.2019 13:00:00 CESTPressemelding

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that BrandSafway, a global leader in access, industrial services and forming and shoring solutions for the industrial, commercial and infrastructure markets, has selected Rimini Street Application Management Services (AMS) for Salesforce for its Salesforce Sales Cloud system. BrandSafway has been leveraging Rimini Street support for its Oracle Database, E-Business Suite and JD Edwards software products since 2014, and now, BrandSafway is expanding its support service scope with Rimini Street to maximize the value and business impact of Salesforce and the Salesforce Sales Cloud system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005022/en/ BrandSafway Selects Rimini Street Application Management Servi