Business Wire

Janssen Receives Positive CHMP Opinion for Darzalex®▼ (daratumumab) as Frontline Treatment for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex® (daratumumab) for use as frontline (initial) therapy.1 The recommendation is for the use of daratumumab 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 (ASCT).1

“Multiple myeloma becomes harder to treat each time it returns, so the goal of initial therapy is to prevent the cancer from progressing for as long as possible,” said Dr Maria-Victoria Mateos, Ph.D., lead ALCYONE study investigator and Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL Salamanca, Spain. “Selecting the right treatment regimen for newly diagnosed patients is critical to their long-term survival, especially those who are transplant ineligible, so daratumumab could offer an important new standard of care in this indication.”

The CHMP’s recommendation is based on results from the randomised, open-label, multicentre Phase 3 ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine.2 Additional information about this study can be found at www.ClinicalTrials.gov (NCT02195479).3

“Clinical findings have consistently demonstrated the compelling benefit daratumumab offers across all lines of therapy in multiple myeloma, and this positive recommendation brings us one step closer to providing this ground-breaking option to more patients in Europe,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “Through our research and development efforts, we remain committed to identifying and treating patients earlier and earlier in their cancer journey, when they are healthier and have the best chance at lasting remission.”

In Europe, daratumumab is currently indicated for use 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 and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.4

A final decision regarding the approval of daratumumab for newly diagnosed patients is expected from the European Commission in the coming months.

In the U.S.A., daratumumab in the frontline setting was granted Priority Review by the U.S. Food and Drug Administration (FDA) in January this year,and was recently approved for use in this indication.6

#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.7-9 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.A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.Daratumumab is being evaluated in a comprehensive clinical development programme that includes nine Phase 3 studies across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.3,10-17 Additional studies are ongoing or planned to assess its potential for a solid tumour indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smouldering myeloma.18-23 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.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.24

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.25 MM is the second most common form of blood cancer, with around 40,570 new cases in Europe in 2015.26 MM most commonly affects people over the age of 65 and is more common in men than in women.27 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival.28 Almost 29% of patients with MM will die within one year of diagnosis.29

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.30 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.31 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.32

About the Janssen Pharmaceutical Companies

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.

Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, Inc. and Janssen-Cilag International NV 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, 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,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002994.jsp&mid=WC0b01ac058004d5c1 Last accessed July 2018.

2. Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan and prednisone for untreated myeloma. N Engl J Med. 2018;378:518-528.

3. 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 June 2018.

4. European Medicines Agency. DARZALEX summary of product characteristics, June 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.pdf Last accessed June 2018.

5. U.S. Food and Drug Administration. Priority review. Available at: https://www.fda.gov/forpatients/approvals/fast/ucm405405.htm Last accessed June 2018.

6. U.S. Food and Drug Administration. DARZALEX Prescribing Information, May 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s013lbl.pdf Last accessed June 2018.

7. 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.

8. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

9. Santoconito AM, Consoli U, Bagnato S, et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77.

10. 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 June 2018.

11. 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/results/NCT02136134 Last accessed June 2018.

12. 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 June 2018.

13. 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 June 2018.

14. 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 June 2018.

15. ClinicalTrials.gov. Compare progression free survival btw daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14) NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736 Last accessed June 2018.

16. ClincalTrials.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 June 2018.

17. ClinicalTrials.gov. A study of subcutaneous versus (vs.) intravenous administration of daratumumab in participants with relapsed or refractory multiple myeloma. NCT03277105. Available at: https://clinicaltrials.gov/ct2/show/NCT03277105 Last accessed June 2018.

18. 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 June 2018.

19. ClinicalTrials.gov. A study to assess the clinical efficacy and safety of daratumumab in participants with relapsed or refractory natural killer/T-cell lymphoma (NKTCL), nasal type. NCT02927925. Available at: https://clinicaltrials.gov/ct2/show/NCT02927925 Last accessed June 2018.

20. ClinicalTrials.gov. Study to separately evaluate the activity of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndromes (MDS) who are relapsed or refractory to erythropoiesis-stimulating agent (ESA) treatment. NCT03011034. Available at: https://clinicaltrials.gov/ct2/show/NCT03011034 Last accessed June 2018.

21. ClinicalTrials.gov. A study of subcutaneous daratumumab versus active monitoring in participants with high-risk smoldering multiple myeloma. NCT03301220. Available at: https://clinicaltrials.gov/ct2/show/NCT03301220 Last accessed June 2018.

22. ClinicalTrials.gov. A study to test the safety and effectiveness of nivolumab combined with daratumumab in patients with pancreatic, non-small cell lung or triple negative breast cancers, that have advanced or have spread. NCT03098550. Available at: https://clinicaltrials.gov/ct2/show/NCT03098550 Last accessed June 2018.

23. ClinicalTrials.gov. A study to evaluate the efficacy and safety of daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared to CyBorD alone in newly diagnosed systemic amyloid light-chain (AL) amyloidosis. NCT03201965. Available at: https://clinicaltrials.gov/ct2/show/NCT03201965 Last accessed June 2018.

24. Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 20, 2012. Available at: http://www.investor.jnj.com/releaseDetail.cfm?releaseid=703517 Last accessed June 2018.

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

26. GLOBOCAN 2012. Multiple myeloma. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Text-p=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Execute%C2%A0 Last accessed June 2018.

27. American Cancer Society. Multiple myeloma: causes, risk factors and prevention. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8739.00.pdf Last accessed June 2018.

28. 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.

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

30. 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.

31. 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 June 2018.

32. 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/0218/0003

JULY 2018

Contact information

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

SCG Chemicals Company chooses gPROMS modelling for digital design and operations22.3.2019 18:55:00 EETTiedote

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced that it has signed a long-term agreement with SCG, one of the largest integrated petrochemical companies in South East Asia, to standardise on PSE’s gPROMS® modelling technology for digital design and operations. SCG applies advanced process models within digital design initiatives to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer design and operating decisions. This help them to accelerate innovation and optimise the design and operation of their process plants. Dr Suracha Udomsak, SCG’s Emerging Business Director and R&D Director, says, “at SCG Chemicals, advanced process modelling (APM) is a key element in our Digital Manufacturing platform. APM accelerates innovation by making the development workflow ‘faster, cheaper & safer’, which are key considerations for us. It is a core technology building block that enables u

Logicor Announces Results for Year Ended 31 December 201822.3.2019 17:29:00 EETTiedote

Logicor announces strong financial performance for the year ended 31 December Net Operating Income (NOI): €639 million, which represents year on year growth of 2.5%, reflecting our strategic focus on increasing occupancy and capturing market rental growth. Over 60% of NOI is generated in the key markets of the UK (26%), Northern Europe1 (21%) and France (15%). Gross Asset Value: €12.5 billion, a 3.3% increase in valuation, which reflects the strong performance of our portfolio, in particular in Northern Europe. EPRA Occupancy: 94.4%, with physical occupancy up 70 bps over the year, underpinned by strong growth in each of our three largest regions of the UK (+120 bps), Northern Europe (+110 bps) and France (+220 bps). LTV: 51%, down from 52% at year end 2017 following increases in property values. At year end, our debt to EBITDA ratio was 11.3x. Capital Structure In 2018 Logicor (rated BBB (Stable) by S&P) established a Euro Medium Term Note (‘EMTN’) programme and raised €1.8 billion of

Delticom AG/Mytyres.co.uk: Buying Great Value Tyres Online Doesn’t Mean Missing out on Professional Fitting22.3.2019 17:15:00 EETTiedote

Spring is just around the corner, and it’s time for drivers to start thinking about changing to summer tyres. However, a tyre check may show that your current summer tyres are getting old, worn out, or have visible damage, such as cracks or bumps. If this is the case, then it's time for a new set of tyres. The legal minimum tread depth is 1.6 mm, however experts recommend significantly more – summer tyres should be replaced even if the tread depth is 3 mm. Regardless of mileage, you should change your tyres at least every eight to ten years. This is because the rubber starts to harden, the tyres lose grip on the road, and driving performance is affected. Of course, a set of four new tyres is a significant investment – authorised workshops can often charge between 250 and 350 pounds. If you want to save money, consider the alternatives: the result is an increasing number of customers turning to online shops such as Mytyres.co.uk to buy new tyres. The market share of tyres sold online ha

Trueman Man Clinic Achieves 10000 Surgery Milestone with Its SWITCH Operation22.3.2019 16:00:00 EETTiedote

Trueman Man Clinic Network announced that the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation), has been successfully completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190322005013/en/ Trueman Man Clinic Network has been successfully completed the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation). The SWITCH Premature Ejaculation Surgery (SWITCH operation) developed in 2010 by Dr. Yang, the chief director of the Trueman Man Clinic Network, can reduce the side effects of penile neurectomy and maintain the stable reduction of the glans sensation. The Trueman Man Clinic Network is the leading hospitals for male enhancement surgeries in Korea consists of 11 clinics, with 16 doctors working. As of 2019, more than 43,000 man clinic surgeries have been performed. (Photo: Business Wire) The Trueman Man Clinic Network is the leading hospitals for m

Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible22.3.2019 14:22:00 EETTiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We are incredibly grateful to the patients and investigators who participated in the MAIA clinical trial programme and look forward to working closely with the regulatory authorities to secure approval of this new combination.” The submission is supported by data from the Phase 3 MAIA (MMY3008) study, which were presented at the 60th Annual Meeting of the American

Bartek Ingredients Expands Leadership Team22.3.2019 01:35:00 EETTiedote

Bartek Ingredients Inc. recently completed a 4,000 ton/year capacity expansion for its malic and food-grade fumaric acid production facility, and today it announces the expansion of its leadership team, with the hiring of Jeff Billig as Vice President of Marketing & Business Development and Heinrich G. Schaefer as International Sales Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005785/en/ The global leader in malic and fumaric acid ingredients expands its leadership team. (Photo: Business Wire) Bartek’s investment in both its team and facilities reinforces its position as the leader in malic and fumaric acid globally and aligns with its mission to facilitate growth and increase global reach to better serve existing customers and markets while opening up new ones. Bartek’s addition of Billig and Schaefer lays the foundation for additional resource investment in the near future while rapidly increasing its sa

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