Business Wire

Janssen Announces European Commission Approval of Darzalex®▼ (daratumumab) Split Dosing Regimen

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted marketing authorisation to provide healthcare professionals with the option to split the first infusion of Darzalex® (daratumumab) over two consecutive days.

“We are committed to the development of new treatments, combinations, and formulations that will support people living with multiple myeloma across the full disease spectrum,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “This is an important decision for healthcare professionals and patients, as it provides flexibility in administration that may help address individual patient needs.”

The decision was based on data from the Phase 1b EQUULEUS (MMY1001) clinical trial, which demonstrated daratumumab pharmacokinetics concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma.1 The safety profile of daratumumab was comparable when administered initially as a split or single dose.1

The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 19 November 2018.2

#ENDS#

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.3 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.4 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.4 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.5,6,7,8,9,10,11,12 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.13,14 For more information, please see www.clinicaltrials.gov.

In Europe, daratumumab is indicated for use in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy, and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.4 For further information on daratumumab, please see the Summary of Product Characteristics at https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.15

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.16 More than 45,000 people were diagnosed with multiple myeloma in Europe in 2016, and more than 29,000 patients died.17 Up to half of newly diagnosed patients do not reach five-year survival,18 and almost 29% of patients with multiple myeloma will die within one year of diagnosis.19

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.20 Refractory multiple myeloma is when a patient’s disease progresses within 60 days of their last therapy.21,22 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.23 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.24 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.25

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea . Follow us at www.twitter.com/janssenEMEA for our latest news.

Janssen Biotech, Inc., Janssen-Cilag International NV, and Janssen-Cilag Limited are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a recommendation to broaden the existing marketing authorisation for daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen-Cilag Limited, Janssen Biotech, Inc., any of the Janssen Pharmaceutical Companies of Johnson & Johnson and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References


1 Chari A, et al. Daratumumab in Combination With Carfilzomib and Dexamethasone (D-Kd) in Lenalidomide-refractory Patients With Relapsed Multiple Myeloma: Subgroup Analysis of MMY1001*. Available at: https://ir.genmab.com/static-files/327f79f7-98d7-4639-8267-a8be9e7e5e1d Last accessed December 2018.

2 Genmab: CHMP Issues Positive Opinion on Split Dosing Regimen for DARZALEX® (daratumumab). Available at: https://ml-eu.globenewswire.com/Resource/Download/9832c10e-4ef4-455e-bdf8-d0823a665de6 Last accessed December 2018

3 Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687.

4 Darzalex summary of product characteristics, October 2018. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf Last accessed December 2018.

5 ClinicalTrials.gov. A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009 Last accessed December 2018.

6 ClinicalTrials.gov. Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma. NCT02136134. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134 Last accessed December 2018.

7 ClinicalTrials.gov. A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NCT02541383. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383 Last accessed December 2018.

8 ClinicalTrials.gov. A study of combination of daratumumab and Velcade (bortezomib) melphalan-prednisone (DVMP) compared to Velcade melphalan-prednisone (VMP) in participants with previously untreated multiple myeloma. NCT02195479. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479 Last accessed December 2018.

9 ClinicalTrials.gov. Study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in participants with previously untreated multiple myeloma. NCT02252172. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172 Last accessed December 2018.

10 ClinicalTrials.gov. A study of Velcade (bortezomib) melphalan-prednisone (VMP) compared to daratumumab in combination with VMP (D-VMP), in participants with previously untreated multiple myeloma who are ineligible for high-dose therapy (Asia Pacific region). NCT03217812. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812 Last accessed December 2018.

11 ClinicalTrials.gov. Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736 Last accessed December 2018.

12 ClinicalTrials.gov. Study of carfilzomib, daratumumab and dexamethasone for patients with relapsed and/or refractory multiple myeloma (CANDOR). NCT03158688. Available at: https://clinicaltrials.gov/ct2/show/NCT03158688 Last accessed December 2018.

13 ClinicalTrials.gov. A study to evaluate 3 dose schedules of daratumumab in participants with smoldering multiple myeloma. NCT02316106. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106 Last accessed December 2018.

14 ClinicalTrials.gov. An efficacy and safety proof of concept study of daratumumab in relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. NCT02413489. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489 Last accessed December 2018.

15 Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 30, 2012. Available at: https://www.jnj.com/media-center/press-releases/janssen-biotech-announces-global-license-and-development-agreement-for-investigational-anti-cancer-agent-daratumumab Last accessed December 2018.

16 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed December 2018.

17 Cowan AJ, Allen C, Barac A, et al. Global burden of multiple myeloma: a systematic analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4:1221-1227 + data supplement.

18 De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.

19 Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

20 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–207.

21 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245 Last accessed December 2018.

22 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.

23 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866 Last accessed December 2018.

24 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf Last accessed December 2018.

25 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

PHEM/DAR/1218/0004

December 2018

Contact information

Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com

Investor Relations:
Christopher DelOrefice
Phone: +1 732-524-2955

Lesley Fishman
Phone: +1 732-524-3922

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Fishawack continues to build best-in-class service offering with Dudnyk acquisition20.3.2019 16:00:00 EETTiedote

Fishawack, a leading independent healthcare communications specialist, is excited to announce its acquisition of Dudnyk, the Philadelphia-based healthcare communications agency. Dudnyk is an award-winning, full-service agency that specializes in creating insight-driven, authentic brand experiences that unite specialty physicians and their patients. They leverage strategic, scientific, and creative capabilities to serve clients in the biotech, pharmaceutical, and medical device industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005204/en/ Dudnyk leadership team includes Christopher Tobias, PhD, President; Laurie Bartolomeo, EVP, Creative Director; Drew Desjardins, EVP, Chief Strategy Officer; Annemarie Armstrong, EVP, Director of Client Services; John Kemble, EVP, Creative Producer. (Photo: Business Wire) Fishawack’s goal is to increase the range of healthcare communications services that it can offer to commerc

ExaGrid Nominated in Six Categories for the 2019 Network Computing Awards20.3.2019 15:00:00 EETTiedote

ExaGrid ®, a leading provider of intelligent hyperconverged storage for backup, today announced that it has been nominated in six categories for the 2019 Network Computing Awards. ExaGrid has become a finalist for Data Centre Product of the Year, The Return on Investment Award, Hardware Product of the Year, Product of the Year, The Customer Service Award, and Company of the Year. Voting to determine the winner in each category is underway now and closes on April 23. The results will be revealed at an evening award ceremony in London on May 2. ExaGrid’s model EX63000E backup storage appliance with data deduplication is a nominee in four categories. The model provides the largest scale-out system and offers up to a 2PB full backup with an ingest rate of 432TB/hr, which is three times faster than any other backup storage on the market. “We are thrilled to be nominated by IT staff, and recognized by Network Computing, in six prestigious categories this year,” said Bill Andrews, CEO and Pre

Eos Biosciences Issued Patent for New Approach to Shuttle Therapeutics Across the Blood-Brain Barrier to Treat Brain Diseases20.3.2019 14:30:00 EETTiedote

Eos Biosciences, Inc. (Eos), a nanomedicines company developing an efficient and versatile nanobiologic particle-based platform technology (Eosomes), announced that the U.S. Patent and Trademark Office has granted Eos Biosciences Patent No. 10,183,078, relating to a novel approach of using HER3-targeted Eosomes as a shuttle system for transporting various classes of therapeutics across the blood-brain barrier for treatment of brain disorders, including brain cancer. The patent is owned by Cedars-Sinai Medical Center and is exclusively licensed to Eos Biosciences. Details of the system will be highlighted in an upcoming manuscript from Lali Medina-Kauwe, PhD, Professor, Department of Biomedical Sciences, Cedars-Sinai. Omar Haffar, Ph.D., Founder, President and Chief Executive Officer, commented, “We’re very excited by the issuance of this pivotal patent and look forward to receiving similar approvals in other countries. This patent adds to Eos’ considerable IP portfolio covering the Eos

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics20.3.2019 13:45:00 EETTiedote

Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease. Wilson disease is a devastating, rare, chronic, and potentially life-threatening liver disorder of impaired copper transport that causes serious copper poisoning. In patients with Wilson disease, a monogenetic mutation disables the normal copper biliary excretion pathway leading to excess copper accumulation in the liver and other organs including the central nervous system. Untreated, Wilson disease results in various combinations and severity of hepatic (fibrosis and cirrhosis), neurologic and psychiatric symptoms, which can b

Fintech Company Rimilia Appoints Kevin Kimber as CEO20.3.2019 13:00:00 EETTiedote

Rimilia, a fintech company helping finance departments simplify the complex, has appointed Kevin Kimber as CEO. The news follows another strong year for Rimilia. In 2018, Rimilia opened offices in Central London and Denver, Colorado in the U.S., and reported significant revenue growth on the previous year. Rimilia was founded in 2008 and its platform, created by finance professionals, uses RPA (robotic process automation) technology to help finance teams fast-track their cash flow by providing clearer information and better control. It has quickly become the industry leader, trusted by a number of global brands from HSBC to DHL and Santander, to provide visibility, improve efficiencies and guarantee cash flow. Rimilia works with any currency, any bank and in any language, and on average delivers 70% cost-savings and an 80% reduction in manual effort to its customers. Kevin joins Rimilia from Eight Roads Ventures (one of Rimilia’s investors), where he was a Venture Partner, advising its

Knopp Biosciences Enters Collaboration with Leading UK Investigators to Commence Phase 2 Clinical Trial of Dexpramipexole in Severe Eosinophilic Asthma20.3.2019 13:00:00 EETTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet need, today announced a collaboration with a consortium of leading medical researchers in the United Kingdom to evaluate the ability of Knopp’s lead drug candidate, dexpramipexole, to reduce exacerbations in people with severe eosinophilic asthma. The project is chiefly funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC) of the UK. The Chief Investigator for the Phase 2 multi-center, 52-week trial is Professor Salman Siddiqui, Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals. Dexpramipexole is an orally available small molecule shown to selectively reduce eosinophil levels in multiple clinical trials, including in a Phase 2 study in hypereosinophilic syndrome (HES) and a Phase 2 trial in chr

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme