EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR JYSELECA® (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE ACTIVE RHEUMATHOID ARTHRITIS
-- Jyseleca® Demonstrated Durable Efficacy Combined with a Consistent Safety Profile in Rheumatoid Arthritis Through 52 Weeks in Phase 3 Clinical Development Program --
Foster City, Calif., & Mechelen, Belgium, September 25, 2020, 19.00 CET – Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).1
RA is a chronic, progressive, systemic, inflammatory disease that can lead to significant and irreversible joint destruction, pain and functional impairment.2 Almost 3 million people in Europe are living with RA,3 many of whom do not achieve long-term symptom control, which can lead to more frequent symptom flares and disease progression and can significantly impact their quality of life.4,5
“Despite the availability of existing therapies, new treatment options are still needed to help optimally manage the impact of RA on patients’ daily lives. Jyseleca has demonstrated robust symptom control and prevention of disease progression with a consistent safety profile across the clinical development program. This marketing authorization provides a welcome new option for people in Europe living with this debilitating and complex disease,” said Peter C. Taylor, MA, BM, BCh, PhD, FRCP, Professor of Musculoskeletal Sciences at the University of Oxford.
The EC’s decision is supported by data from more than 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs.6 In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX.7-8910111213
A significantly higher proportion of patients treated with Jyseleca 200 mg plus MTX or other conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARD) achieved low disease activity and/or remission (DAS28-CRP≤3.2 and DAS28-CRP<2.6) at Weeks 12 and 24 compared with placebo or MTX.7-13
In patients who had an inadequate response to MTX, treatment with Jyseleca plus MTX achieved statistically significant inhibition of progression of structural joint damage compared with placebo plus MTX, as assessed using the modified Total Sharp Score (mTSS) at Week 24. In the DARWIN 3 Phase 2, open-label, long-term extension study, durable ACR20/50/70 responses were maintained for up to three years in patients who received Jyseleca 200 mg as monotherapy or with MTX.1
Across the FINCH and DARWIN trials,14 the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness.1 Rates of herpes zoster and pneumonia were uncommon.1 The frequency of serious infections in the Jyseleca 200 mg group was 1.0 percent compared with 0.6 percent in the placebo group.1
In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with Jyseleca were comparable to placebo.6 The rates of serious infections remained stable with long-term exposure.1
“Jyseleca, the first medicine from Galapagos to obtain regulatory approval is the result of a strong commitment to addressing unmet medical need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to making continued progress through our collaboration with Galapagos so we can help to deliver many new solutions for patients in the future.”
“Today’s announcement is a proud day for everyone at Galapagos, recognizing years of research and commitment to make a meaningful change in the lives of patients struggling with the symptoms of RA,” said Onno van de Stolpe, Chief Executive Officer, Galapagos. “This news further affirms the efficacy and safety profile of Jyseleca, and we look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.”
Under the collaboration agreement, Galapagos will now receive a milestone payment of $75 million in recognition of the approval of Jyseleca by the European Commission.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety of Jyseleca 200 mg and 100 mg once-daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 was a 52‑week, randomized, placebo- and adalimumab-controlled trial in combination with MTX, enrolling 1,759 adult patients with moderate to severe active RA who had inadequate response to MTX. The primary endpoint in FINCH 1 was ACR20 at Week 12. The trial included radiographic assessment at Weeks 12, 24 and 52. FINCH 2 was a global, 24-week, randomized, double-blind, placebo-controlled, Phase 3 study evaluating Jyseleca on a background of csDMARDs among 449 adult patients with moderate to severe active RA who had not adequately responded to biologic DMARDs (bDMARDs). The primary endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate Jyseleca 200 mg alone and Jyseleca 200 mg or 100 mg combined with MTX versus MTX alone in MTX-naïve patients. The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial included radiographic assessment at Weeks 24 and 52.
About the Filgotinib Collaboration15
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in RA and other inflammatory indications. The companies are conducting global studies investigating the potential role of Jyseleca in a variety of diseases, including the previously reported Phase 3 SELECTION trial in ulcerative colitis.
More information about clinical trials with Jyseleca can be accessed at: www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Galapagos NV discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. There is also the possibility of unfavorable results from ongoing and additional clinical trials involving ﬁlgotinib. Further, it is possible that the parties may make a strategic decision to discontinue development of ﬁlgotinib, and as a result, ﬁlgotinib may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to diﬀer materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Galapagos Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to diﬀer materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of additional regulatory authorities approval of marketing authorization for filgotinib, such additional regulatory authorities requiring additional studies, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
# # #
Full European Summary of Product Characteristics for Jyseleca are available from the EMA website at www.ema.europa.eu.
Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
Elizabeth Goodwin Carmen Vroonen
VP IR Global Head of Communications & Public Affairs
+1 781 460 1784 +32 473 824 874
Sofie Van Gijsel Anna Gibbins
Senior Director IR Senior Communications Director – Therapeutic Areas
+32 485 19 14 15 +44 (0) 7717 801900
Douglas Maffei, PhD Jennifer Wilson
+1 650 522-2739 +44 7920 266-582
1Summary of Product Characteristics for Jyseleca®, Foster City, USA: Gilead Sciences.
2Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Available at: https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html. Accessed: September 2020.
3National Rheumatoid Arthritis Society (NRAS). European Fit for Work report. Available at: https://www.nras.org.uk/european-fit-for-work-report. Accessed: September 2020.
4Claxton, L. et al. An economic evaluation of tofacitinib treatment in rheumatoid arthritis after methotrexate or after 1 or 2 TNF inhibitors from a US payer perspective. Journal of Managed Care & Specialty Pharmacy. 2018;13:1-8. doi: 10.18553/jmcp.2018.17220.
5Smolen, J.S. et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Annals of Rheumatic Disease. 2017;79:685-699. doi: 10.1136/annrheumdis-2019-216655.
6Genovese, M C et al. Integrated safety Analysis of Filgotinib Treatment for Rheumatoid Arthritis from 7 Clinical Trials. Abstract European Congress of Rheumatology (EULAR) 2020.
7Kivitz, A. et al. Filgotinib provided rapid and sustained improvements in functional status, pain, health-related quality of life, and fatigue in patients with rheumatoid arthritis and inadequate response to methotrexate: results from the FINCH 1 study. Abstract European Congress of Rheumatology (EULAR) 2020.
8Combe, B. et al. Efficacy and safety of Filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 52-week results. Abstract ACR/ARP Annual Meeting 2019.
9Combe, B. et al. LB0001 efficacy and safety of Filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 primary outcome results. Annals of the Rheumatic Diseases. 2019;78:77-78.
10Genovese, M. et al. Effect of Filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: the FINCH 2 randomized clinical trial [published correction appears in JAMA. 2020 Feb 4;323(5):480]. JAMA. 2019;322(4):315‐325. doi:10.1001/jama.2019.9055.
11Westhovens, R. et al. Efficacy and safety of Filgotinib in methotrexate-naïve patients with rheumatoid arthritis: FINCH 3 52-week results, Annals of the Rheumatic Diseases 2020;79:1019-1020.
12Alten, R. et al. Filgotinib provided rapid and sustained improvements in functional status, pain, and health related quality of life, and reduced fatigue over time in patients with rheumatoid arthritis who are methotrexate-naïve: results from the FINCH 3 study. Abstract European Congress of Rheumatology (EULAR) 2020.
13Westhovens, R. et al. LB0003 efficacy and safety of Filgotinib for patients with rheumatoid arthritis naïve to methotrexate therapy: FINCH 3 primary outcome results. Annals of the Rheumatic Diseases. 2019;78:259-261.
14Frequency based on placebo controlled pre rescue period (week 12) pooled across FINCH 1 and 2, and DARWIN 1 and 2, for patients who received Filgotinib 200 mg. Summary of Product Characteristics for Jyseleca® (table 2). Foster City, USA: Gilead
15 Gilead & Galapagos Filgotinib Clinical Program Trial Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3 (NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839).
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
ProMIS Neurosciences Offers its Perspective on the Likelihood of Regulatory Approval of Aducanumab21.10.2020 12:30:10 CEST | Press release
Regulatory progress is spurring the development of safe and effective therapies for Alzheimer’s disease TORONTO and CAMBRIDGE, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, released a white paper today that offers its perspective on aducanumab’s likelihood of regulatory approval in advance of its U.S. Food and Drug Administration Advisory Committee (AC) review on November 6. The white paper, available at www.promisneurosciences.com, chronicles aducanumab’s history, regulatory support, positive data outcomes and potential impetus for development of improved second-generation therapies. If approved, aducanumab would be the first disease-modifying treatment for Alzheimer’s disease, offering a therapeutic option for the millions of Americans living with the disease. A
Orion Group Interim Report 1-9/202021.10.2020 11:00:00 CEST | Press release
ORION CORPORATION INTERIM REPORT 1-9/2020 21 OCTOBER 2020 at 12:00 noon EEST Orion Group Interim Report 1-9/2020 This is a summary of Orion’s Interim Report 1-9/2020. The complete report is attached to this stock exchange release and is available at https://www.orion.fi/en/Orion-group/investors/financial-reviews-and-presentations/ Net sales were EUR 823 million (EUR 776 million in January–September 2019).Operating profit was EUR 246 (198) million.Both net sales and operating profit include a total of EUR 37 (47) million milestone payments.Profit before taxes was EUR 245 (196) million.Equity ratio was 70% (78%).ROCE before taxes was 40% (32%).ROE after taxes was 34% (28%).Basic earnings per share were EUR 1.38 (1.10).Cash flow per share before financial items was EUR 1.52 (1.28).Outlook for 2020 was updated after the review period on 19 October 2020. Orion estimates that in 2020 net sales will be at a similar level as in 2019 or slightly higher than in 2019 (net sales in 2019 were EUR 1
Prosafe SE: Q3 2020 results and audio webcast on 5 November 202021.10.2020 10:34:42 CEST | Press release
Prosafe SE will release its third quarter 2020 results on 5 November 2020 at approx. 07:00 a.m. CET. The Q3 2020 report and the Q3 2020 presentation will be published on www.newsweb.no and on Prosafe’s website www.prosafe.com Jesper Kragh Andresen, CEO and Stig H. Christiansen, Deputy CEO & CFO will the same day at 10:00 a.m. CET host an audio webcast. The audio webcast can be followed at www.prosafe.com It will be possible to submit questions during the presentation by using the Q&A tool embedded in the audio webcast. These questions will be answered after the presentation. A replay of the audio webcast will be made available at www.prosafe.com shortly after. Prosafe is a leading owner and operator of semi-submersible accommodation vessels. The company is listed on the Oslo Stock Exchange with ticker code PRS. For more information, please refer to www.prosafe.com Stavanger, 21 October 2020 Prosafe SE For further information, please contact: Jesper K. Andresen, CEO Phone: +47 51 65 24
Result of Riksbank´s purchases of Commercial Paper21.10.2020 10:00:00 CEST | Press release
Auction date201021 Requested volume, SEK mln4,000 Credit rating class1Term3MFixed purchase rate0.45 %Total bid amount, SEK mln0,000Prel. accepted volume, SEK mln0,000Percentage alloted0.00 %Number of bids0 Credit rating class1Term6MFixed purchase rate0.55 %Total bid amount, SEK mln0,000Prel. accepted volume, SEK mln0,000Percentage alloted0.00 %Number of bids0 Credit rating class2Term3MFixed purchase rate0.75 %Total bid amount, SEK mln0,000Prel. accepted volume, SEK mln0,000Percentage alloted0.00 %Number of bids0 Credit rating class2Term6MFixed purchase rate0.85 %Total bid amount, SEK mln0,000Prel. accepted volume, SEK mln0,000Percentage alloted0.00 %Number of bids0
Recovery mitigates pandemic’s impact on central government finances21.10.2020 09:30:00 CEST | Press release
Recovery mitigates pandemic’s impact on central government finances The Swedish economy is recovering after the historically large fall in GDP in the second quarter of 2020. This helps to support central government finances, reduce the borrowing requirement compared with the previous forecast and dampen the debt increase resulting from the pandemic. The Swedish National Debt Office’s new forecast shows a central government budget deficit of SEK 256 billion this year, an improvement in the budget balance by SEK 146 billion over the previous forecast from May. The reduced deficit means the Debt Office is lowering borrowing and that central government debt is not expected to increase as much as previously forecast. “The virus outbreak has had a major impact on the Swedish economy and state finances, but the development in recent months indicates it is less than we forecast in May. Not least the trend in tax income points to the start of an increasingly more apparent economic recovery, alt
Återhämtning mildrar pandemins effekter på statsfinanserna21.10.2020 09:30:00 CEST | Pressemelding
Återhämtning mildrar pandemins effekter på statsfinanserna Svensk ekonomi återhämtar sig efter det historiskt stora BNP-tappet under det andra kvartalet 2020. Det bidrar till att understödja statsfinanserna, minska statens lånebehov jämfört med tidigare prognos och dämpa ökningen av statsskulden till följd av pandemin. Riksgäldens nya prognos visar ett underskott i statsbudgeten på 256 miljarder kronor i år, en förbättring av budgetsaldot med 146 miljarder kronor jämfört med föregående prognos från maj. Det minskade underskottet innebär att Riksgälden drar ned statens upplåning och att statsskulden inte väntas öka lika mycket som tidigare förutspåtts. – Virusutbrottet har haft stora effekter på svensk ekonomi och statens finanser, men de senaste månadernas utveckling indikerar att de blir mindre än vi bedömde i maj. Inte minst utvecklingen av skatteinkomsterna pekar på att ekonomin har börjat återhämta sig allt tydligare, men osäkerheten är fortfarande stor, säger riksgäldsdirektör Han