Business Wire

Gilead and Galapagos to Present New Data on Filgotinib at 2019 ACR/ARP Annual Meeting


Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that new data from across the companies’ inflammatory disease research and development program will be presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta from November 8-13. The companies will present 20 abstracts at this year’s meeting, including key data on the investigational medicine filgotinib in rheumatoid arthritis (RA) and psoriatic arthritis (PsA), as well as real-world RA treatment outcomes and care.

This press release features multimedia. View the full release here:

“These latest data add to the growing body of evidence on the potential role of filgotinib in the management of rheumatoid arthritis and other inflammatory diseases,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences. “People living with RA may experience long-term symptoms that persist despite currently available treatment options. At Gilead, we are working to help improve the lives of people living with inflammatory conditions and look forward to sharing these latest data at ACR/ARP.”

“We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. “These results continue to show the potential for filgotinib in RA for patients who face significant challenges living with this disease. Further, we are particularly excited to embark on the PENGUIN Phase 3 trials in psoriatic arthritis, as filgotinib has the potential to address the important unmet medical need of patients living with this disease.”

New Filgotinib Efficacy and Safety Data in Rheumatoid Arthritis

Key presentations include multiple subgroup analyses from the FINCH 2 clinical trial that demonstrate the potential of filgotinib across specific RA populations who have experienced an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs), including those in this difficult-to-treat population with anemia, thrombocytopenia and leukopenia. Key data will also include pooled safety results from the Phase 3 FINCH program (NCT02889796, NCT02873936, NCT02886728), and safety outcomes from the long-term DARWIN-3 trial (NCT02065700).

  • A Subgroup Analysis of the Efficacy of Filgotinib in Demographic and Clinical Subgroups of Patients with Refractory Rheumatoid Arthritis (Poster, #504, Sunday, Nov. 10; 9:00am)
  • A Subgroup Analysis of Clinical Efficacy Response and Quality of Life Outcomes from Phase 3 Study of Filgotinib in Patients with Inadequate Response to Biologic DMARDs (Poster, #517, Sunday, Nov. 10; 9:00am)
  • Effects of Filgotinib on Anemia, Thrombocytopenia and Leukopenia: Results from a Phase 3 Study in Patients with Active Rheumatoid Arthritis and Prior Inadequate Response or Intolerance to Biologic DMARDs (Oral, #2875, Wednesday, Nov. 13; 9:00am)
  • Pooled Safety Analyses from Phase 3 Studies of Filgotinib in Patients with Rheumatoid Arthritis (Poster, #1329, Monday, Nov. 11; 9:00am)
  • Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study (Poster, #550, Sunday, Nov. 10; 9:00am)

In RA, biomarker research seeks to better characterize the molecular basis of the disease and identify populations that may benefit most from a treatment. Gilead is committed to helping drive forward this emerging area of innovation. Presented data will assess the relationship between a series of RA biomarkers and the therapeutic response of filgotinib.

  • bDMARD-Experienced Filgotinib-Treated Patient Samples Exhibit a Partial Reversion to the Peripheral Molecular Profile of a Demographically Matched Healthy Population (Poster, #45, Sunday, Nov. 10; 9:00am)
  • Key Inflammatory Biomarkers at Baseline are Associated with Filgotinib Response at Week 12 in Rheumatoid Arthritis Patients with Inadequate Response or Intolerance to Biologic DMARDs (Poster, #46, Sunday, Nov. 10; 9:00am)
  • A Composite IFN-Based Signature is Associated with a Filgotinib-Specific Clinical Response in bDMARD-Experienced Rheumatoid Arthritis Patients (Poster, #2012, Tuesday, Nov. 12; 9:00am)

Real-World Treatment Experiences in Rheumatoid Arthritis

In addition to therapeutic innovation, increased understanding of the real-world experiences of patients living with RA is needed. Select data will highlight results from multiple studies focused on the overall burden of RA within the U.S.

  • Treatment Patterns and Persistency Following First Biologic DMARD in Patients with Rheumatoid Arthritis: Real-World Analysis of 2012-2016 U.S. Medicare data (Oral, #953, Sunday, Nov. 10; 4:30pm)
  • Real-World Evidence: Clinical and Economic Burden of Anemia, Venous Thromboembolism, and Malignancy Among Rheumatoid Arthritis Patients Switching from First Biologic DMARD to Another Treatment in the U.S. (Poster, #204, Sunday, Nov. 10; 9:00am)
  • Real-World Evidence: Infections Among Rheumatoid Arthritis Patients Switching from First Biologic DMARD to Another Treatment in the U.S. (Poster, #1374, Monday, Nov. 11; 9:00am)

Filgotinib in Psoriatic Arthritis

Long-Term Safety with Filgotinib in PsA

It is important to understand the safety profile as well as the durability of response to new therapeutic options across potential indications. Results from a long-term safety analysis evaluating the safety of filgotinib for people with PsA will be presented.

  • Long-Term Safety of Filgotinib in Patients with Psoriatic Arthritis, Week 52 Safety Data from a Phase 2 Open-Label Extension Study (Poster, #1534, Monday, Nov. 11; 9:00am)

Initiation of PENGUIN Phase 3 Program with Filgotinib in PsA

The efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo will now be further investigated in the PENGUIN Phase 3 program. PENGUIN 1 (NCT04115748) will compare the efficacy and safety of filgotinib, adalimumab and placebo in approximately 1000 patients with active PsA who are naive to bDMARD therapy. PENGUIN 2 (NCT04115839) will measure efficacy and safety of filgotinib vs placebo in 390 patients with active PsA who have an inadequate response or are intolerant to bDMARD therapy. The primary endpoint of each trial is ACR20 response at week 12, with multiple secondary endpoints on signs and symptoms of PsA up to week 24 in PENGUIN 1, and week 16 in PENGUIN 2.

Filgotinib is an investigational agent and is not approved by the U.S. Food and Drug Administration or any other regulatory authority. Its efficacy and safety have not been established.

For more information, including a complete list of the abstracts being presented at the 2019 ACR/ARP annual meeting, please visit:

For information about clinical trials with filgotinib, please visit:

About the Filgotinib Collaboration

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The FINCH studies in rheumatoid arthritis are among several clinical trials of filgotinib in inflammatory diseases, which also include the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial (NCT02914561) in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies), the Phase 3 SELECTION trial (NCT02914522) in ulcerative colitis and the Phase 3 PENGUIN trial in psoriatic arthritis.

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) 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. Galapagos’ pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. The Company’s ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines.

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.

Galapagos Forward-Looking Statement

This release may contain forward-looking statements with respect to Galapagos, including statements regarding Galapagos' strategic ambitions, the mechanism of action and potential safety and efficacy of filgotinib, the anticipated timing of clinical studies with filgotinib and the progression and results of such studies. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of filgotinib due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner for filgotinib, Gilead), and estimating the commercial potential of filgotinib. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and subsequent filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

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, including the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, 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.

For more information on Gilead Sciences, please visit the company’s website at, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Greg Mann, Investors
(424) 322-1795

Arran Attridge, Media
(650) 425-8975

Elizabeth Goodwin, Investors
(781) 460-1784

Carmen Vroonen, Media
+32 473 824 874

About Business Wire

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

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Piper Sandler Advises Momentive Performance Materials on the Sale of its Consumer Sealants Business to Henkel Corporation7.8.2020 21:55:00 EESTPress release

Piper Sandler &Co., a leading investment bank and institutional securities firm, served as financial advisor to Momentive Performance Materials Inc. (Momentive) in the sale of its consumer sealants business to Henkel Corporation. The deal, which remains subject to customary closing conditions including regulatory clearances, is expected to close in 2020. Momentive’s consumer sealants business encompasses GE-branded consumer sealants sold under license from the General Electric Company and available through home-improvement centers, major retailers and hardware stores. Momentive will continue to manufacture consumer sealants through 2021 under a transition supply agreement. (Source: Momentive Performance Materials Inc.) “In the midst of a pandemic, we are delighted to have helped Momentive, reach this agreement and achieve the goals of the company and its shareholders,” said Telly Zachariades, managing director, chemicals and materials, at Piper Sandler. “We are looking forward to aidin

ENA Investment Capital Publishes Open Letter to Ontex Shareholders7.8.2020 14:00:00 EESTPress release

ENA Investment Capital (“ENA”), a long-term, value-oriented investment firm and the second-largest shareholder in Ontex Group NV (“Ontex” or the “Company”) owning c.15% of the Company’s outstanding shares, today issued the following public letter to Ontex’s shareholders. Dear Fellow Ontex Shareholders, ENA Investment Capital, owning c.15% of the voting shares of Ontex, has devoted considerable time and resources to conduct a thorough analysis of Ontex. This includes acquiring a comprehensive understanding of the personal hygiene segment and, more importantly, of the Company’s turnaround potential which we are convinced, if effectively executed, can deliver significant value for shareholders. As part of this extensive 18-month due diligence effort, we have consulted with former executives from Ontex as well as its main competitors, industry experts, investment bankers, lawyers and specialist consultants on a wide range of topics critical to Ontex’s business such as raw material trends a

Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan7.8.2020 12:28:00 EESTPress release

Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1. This press release features multimedia. View the full release here: “Takeda’s leading position in Japan, technical expertise,

SES S.A.: Half Year 2020 Results7.8.2020 08:30:00 EESTPress release

SES S.A. announced financial results for the six months ended 30 June 2020. This press release features multimedia. View the full release here: SES S.A.: Half Year 2020 Results (Photo: Business Wire) Solid H1 performance in line with expectations and continued underlying growth in Networks of +7.1% year-on-year(1,2) Revenue of EUR 947.5 million, -1.5% as reported with underlying revenue 2.4%(1,2) lower than H1 2019 Adjusted EBITDA(3) of EUR 582.0 million, -2.3% as reported (-3.5% at constant FX(2)) compared with H1 2019 and representing an Adjusted EBITDA(3) margin of 61.4% including a 2.2% year-on-year reduction in recurring operating expenses Limited COVID-19 impact in H1 reflecting business resilience with measures in place to mitigate increased headwinds in H2 2020 Updated FY 2020 group revenue outlook to EUR 1,860 - 1,900 million(4) in view of expected COVID-19 related revenue development FY 2020 Adjusted EBITDA(3) outlook

Western Union Stands in Solidarity with Lebanon6.8.2020 23:47:00 EESTPress release

Western Union, a leader in cross-border, cross-currency money movement and payments, today announced that it is offering zero-feei international money transfers paid out in U.S. dollars to Lebanon, as the country grapples with its recent tragedy amidst other economic and pandemic related threats. This press release features multimedia. View the full release here: Western Union Stands in Solidarity with Lebanon; Money Transfers to Lebanon Zero-Fee Paid out in US Dollars (Graphic: Business Wire) “We stand in solidarity with the people of Lebanon as they confront this latest tragedy following the horrific explosion in Beirut on August 4. Our thoughts and prayers are with families of those injured and have lost their lives,” said Jean Claude Farah, President, Global Network, Western Union. Farah said: “We know the people of Lebanon will stand strong as they grapple with this latest issue amidst other pressures of economic and COVID-

Pacific Drilling Announces Second-Quarter 2020 Results; Pacific Sharav Awarded a New 10-Well Contract in U.S. Gulf of Mexico6.8.2020 23:04:00 EESTPress release

Pacific Drilling S.A. (NYSE: PACD) (“Pacific Drilling” or the “Company”) today reported results for the second quarter of 2020. Net loss for second-quarter 2020 was $87.4 million or $1.16 per diluted share, compared to net loss of $61.0 million or $0.81 per diluted share in first-quarter 2020. Pacific Drilling CEO Bernie Wolford commented, “In the second quarter, our crews and leadership continued to exemplify our commitment to safe and efficient operations, including adopting measures to manage risks associated with COVID-19 transmission, delivering exceptional results for our clients, efficiently preserving the value of our assets and significantly reducing overhead costs.” Mr. Wolford continued, “Although oil prices began to rebound during the second quarter, clients have generally reduced their drilling investments, as evidenced by Equinor’s decision to cancel the previously exercised third firm well for Pacific Khamsin, and Murphy’s decision to cancel the two well Mexico contract

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom