EUSA Pharma Announces Acquisition of Global Rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC for $115 Million
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.
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.
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.
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.
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)
Tel: +44 (0)330 5001140
Om Business Wire
(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
AURAK Gains SACSCOC Accreditation15.12.2018 10:49 | Pressemelding
The Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) officially announced the accreditation of the American University of Ras Al Khaimah (AURAK) at its 2018 Annual Meeting which was held in New Orleans, Louisiana, in the United States of America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181215005017/en/ AURAK delegation during the SACSCOC conference in New Orleans” (Photo: AETOSWire) SACSCOC, the regional body for the accreditation of degree-granting higher education institutions in the Southern United States, has a membership of more than 800 institutions in the Southern states and other international sites approved by SACSCOC that award associate, baccalaureate, master’s, and/or doctoral degrees. SACSCOC also awards accreditation to other international institutions of higher education that satisfy all its requirements and demonstrate compliance with its accreditation standards. AURAK now
Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 17:41 | Pressemelding
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 17:00 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl
Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 15:42 | Pressemelding
Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00
Henley & Partners Enlarges Executive Committee to Manage Expansion and Growth14.12.2018 14:00 | Pressemelding
Residence- and citizenship-by-investment programs have firmly established themselves over the past few years as the new frontier in terms of freedom, flexibility, and future-readiness, both for the countries issuing these programs and for the individual investors participating in them. The societal and economic value these programs generate is undisputed. The investment migration industry as a whole is currently grossing roughly USD 18 billion per year, with an expectation that it will hit the USD 20 billion mark very soon. Foreign direct investment (FDI) is now considered the lifeblood of economic growth for many developing and recovering smaller countries around the world. As such, the number of investment migration programs has been increasing rapidly, from just a handful of programs in the 1980s and 1990s to over 100 countries that now have investment migration provisions in their laws. There are more than 60 active programs today, with Moldova and Montenegro — both fast-growing Eu
Vargatef® plus docetaxel could be an option after failure of immunotherapy in lung cancer14.12.2018 09:07 | Pressemelding
Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef® plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3 The addition of nintedanib to docetaxel ha