CA-GILEAD-SCIENCES,-INC.
11.10.2019 00:02:07 CEST | Business Wire | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis (RA) are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191010005875/en/
“We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences. “These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.”
“These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib’s profile in RA patients. In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
A Marketing Authorization Application (MAA) for filgotinib for the treatment of adults with rheumatoid arthritis is now under evaluation by the European Medicines Agency (EMA) and a New Drug Application (NDA) for filgotinib has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.
Filgotinib is an investigational agent and is not approved anywhere. Its efficacy and safety have not been established by any regulatory authorities.
About the FINCH 1 and FINCH 3 Programs
The FINCH Phase 3 program investigated the efficacy and safety of 100 mg and 200 mg filgotinib 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 methotrexate (MTX) enrolling 1,759 adult patients with moderately to severely active RA who had inadequate response to MTX. The primary endpoint was ACR20 at week 12. The trial included radiographic assessment at weeks 24 and 52. FINCH 3 was a 52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate filgotinib 200mg alone and filgotinib 100 mg or 200 mg combined with methotrexate versus methotrexate alone in methotrexate-naïve patients. The primary endpoint was ACR20 at week 24. Radiographic progression was also assessed.
More information about clinical trials with filgotinib can be accessed at: www.clinicaltrials.gov .
About the Filgotinib Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The FINCH Phase 3 studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA Phase 2 study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.
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. Our pipeline comprises Phase 3 through to discovery 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 .
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 Forward-Looking Statements
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 Galapagos’ product candidates. 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 that the final efficacy, safety and tolerability results from these studies differ materially from those reported in this press release, the possibility of unfavorable results from other clinical trials involving filgotinib, and the risk that the EMA, FDA and other regulatory agencies may not approve filgotinib for the treatment of RA in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191010005875/en/
Link:
About Business Wire
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
Ruler of Ras Al Khaimah Inaugurates the First Ras Al Khaimah’s Business Consultancy in China, Strengthening Ties With Guangdong21.10.2026 23:46:00 CEST | Press release
HH Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, inaugurated the Emirate’s first business consultancy in China, marking a new chapter of cooperation and partnership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021542126/en/ His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, inaugurated the Emirate’s first business consultancy in China, located in Guangzhou, Guangdong Province, stating that the launch reflects a long-term commitment to strengthening ties with partners in China and to creating new avenues for investment, trade and collaboration. (Photo: AETOSWire) Located in the industrial hub of Guangzhou, the consultancy will serve as a leading platform dedicated to strengthening Ras Al Khaimah’s engagement with Chinese businesses, facilitating expanding cooperation across key sectors. The inauguration builds on a relationship t
Octane AI Launches Phoenix, an AI Quiz Builder That Builds, Checks and Improves Quizzes for Shopify Brands21.10.2026 19:15:00 CEST | Press release
Phoenix builds a full quiz from a prompt or a document, catches broken logic before shoppers do and shows what every answer earns in Shopify revenue. Octane AI, the quiz and zero-party data platform for Shopify brands, launched Phoenix in October, its biggest release to date. Merchants describe the quiz they want or upload what they already have, and Phoenix builds it, checks it, personalizes the results and keeps improving it with experiments. One beta customer turned a single document into a complete product-launch quiz: “I attached it to Phoenix, and it built the whole thing, all the pages. It understood everything, not just the text but the logic behind it.” Across all live Octane AI quizzes, 15% of shoppers who finish a quiz place an order. Yet building one has meant hours of writing rules by hand, custom code for design and clicking through every path to find broken results. Phoenix handles those hard parts, from building a quiz to improving it after launch. “Since day one, we've
Cognite Earns Corporate Supplier of the Year Award from Marathon Petroleum Corporation21.10.2026 19:06:00 CEST | Press release
Cognite today announced it has been named Corporate Supplier of the Year winner in Marathon Petroleum Corporation’s 11th Annual Supplier Recognition Awards. The Supplier Recognition Awards is a program sponsored by Marathon Petroleum Corporation to honor suppliers that positively impacted the company’s business throughout the previous calendar year. “There’s a reason ‘Impact’ is one of Cognite’s most important core values,” said Girish Rishi, CEO of Cognite. “For us, the ultimate measure of our performance is delivering quantifiable value for our customers. From that perspective, the Corporate Supplier of the Year award from Marathon is particularly meaningful. Marathon Petroleum is an innovator, and to receive this recognition is a great honor to the Cognite community.” The Supplier of the Year Award from Marathon is the latest honor Cognite has received in 2026: In May, Cognite ranked 15th on CNBC’s Disruptor50 list, honoring venture-backed companies innovating across industries, exp
The Estée Lauder Companies Inc. to Webcast Capital Markets Experience: China Ecosystem Immersion Presentations on November 4, 202621.10.2026 18:48:00 CEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced that it will webcast presentations from its Capital Markets Experience: China Ecosystem Immersion in Shanghai, China, on Wednesday, November 4, 2026. The event will feature presentations from Stéphane de La Faverie, President and Chief Executive Officer, and Akhil Shrivastava, Executive Vice President and Chief Financial Officer, as well as members of the Company’s Executive Leadership Team and local leaders. The presentations will highlight the Company’s strategy and capabilities in China, Beauty Reimagined in action, and how China serves as a blueprint for deploying the Company’s global capabilities to drive sustainable growth and stronger profitability. Due to limited capacity, in-person attendance is by invitation only. Interested parties can access the live webcast on Wednesday, November 4th, beginning at 1:00 p.m. China Standard Time (12:00 a.m. ET) at Investors – The Estée Lauder Companies Inc. A replay of the webcast wi
Future Health and Bridge for Billions to Launch Programme Strengthening Health Entrepreneurship in Emerging Markets21.10.2026 17:50:00 CEST | Press release
New programme will support locally rooted health entrepreneurs to build stronger ventures and deepen their impact in the communities they serve The programme responds to persistent gaps in capital and specialist support for promising health innovation across emerging markets First phase will target around 50 entrepreneurs leading late-incubation to early-acceleration ventures in Africa and Asia Entrepreneurs will receive tailored support, with selected groups later having the opportunity to access Abu Dhabi’s health innovations ecosystem Future Health – A Global Initiative by Abu Dhabi and Bridge for Billions will launch a new entrepreneurship programme designed to strengthen promising health ventures in emerging markets and help locally-developed solutions reach more people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021719421/en/ The first phase of the programme will target around 50 entrepreneurs leading late-incub
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
