European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190815005605/en/
“We are excited about the validation of this application which is an important milestone in our ongoing work to improve the lives of people living with rheumatoid arthritis and other inflammatory conditions,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences.
The MAA for filgotinib is supported by 24-week data from the Phase 3 FINCH clinical trials in which once-daily treatment with filgotinib achieved improvements in clinical signs and symptoms, achievement of low disease activity and remission, and inhibition of structural damage for different sub-populations of patients living with RA. Across the FINCH program, safety data were consistent with previously reported results.
“We are very happy with the validation of the filgotinib MAA by the EMA, as this represents the latest step forward in our partnership with Gilead to bring filgotinib as a new treatment option to RA patients across Europe,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
The filgotinib filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, as well as Norway, Iceland and Liechtenstein. In early July, Gilead announced plans to submit a New Drug Application (NDA) for filgotinib for the treatment of RA in the United States before the end of the year.
Filgotinib is an investigational agent and is not approved anywhere globally. Its efficacy and safety have not been established by any regulatory authorities.
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.
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 study 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.
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. Its pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Galapagos’ 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, including the risk that EMA, the European Commission and other regulatory agencies may not approve filgotinib for the treatment of RA, and any marketing approvals, if granted, may have significant limitations on its use. As a result, filgotinib may never be successfully commercialized. There is also the possibility that Gilead may be unable to file an NDA for filgotinib in the United States in the currently anticipated timelines. Further, there is the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib. 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.
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 progression and results of clinical studies with filgotinib, the regulatory pathway for filgotinib and the timing of regulatory filings. 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.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Sung Lee, Investors
+1 (650) 524-7792
Arran Attridge, Media
+1 (650) 425-8975
Elizabeth Goodwin, Investors
+1 (781) 460-1784
Carmen Vroonen, Media
+32 473 824 874
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Velodyne Shows Velarray Lidar in Sleek Car Designs at IAA 2019 Conference14.9.2019 19:39:00 CEST | Press release
Velodyne Lidar, Inc. (Hall 8.0, Booth A13) is showcasing the pristine integration of Velarray lidar sensors into consumer vehicles to make currently available, high-end electric vehicles safer at the IAA 2019 Conference. Velodyne has addressed the market need for lidar technology that enables high-level Advanced Driver Assistance Systems (ADAS) for safe navigation and collision avoidance, all within a compact form factor. The lidar is situated behind the vehicle’s windshield for streamlined, flawless integration. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190914005023/en/ Can you see the lidar? The Velarray is embedded in a sleek electric car at IAA 2019 (Hall 8.0, Booth A13). (Photo: Velodyne Lidar) Velodyne booth visitors can see how the Velodyne Velarray™ sensors are beautifully integrated into sleek, high-end vehicles, maintaining their aerodynamic design. The Velarray’s small, embeddable form factor is a powerful so
Insurance Leaders and Visa Digitize Claims Payouts for Individuals and Businesses When They Need It Most13.9.2019 14:37:00 CEST | Press release
Emergencies like car collisions or natural disasters come when people least expect them, leaving individuals unprepared to complete insurance forms, confirm claim estimates, and pay repair shop and medical expenses. During these times, quick access to funds is critical. Visa is committed to working with innovative companies in the insurance industry to help turn outdated and time-consuming processes associated with insurance claim payouts into near real-time1 access to payments when individuals, families and businesses need them the most. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190913005323/en/ Visa Direct powers real-time insurance payouts, providing people access to their funds when they need it most. (Graphic: Business Wire) “Visa believes that money shouldn’t be a stressor in moments of crisis and waiting on average six to 10 days to access the money from insurance checks, is outdated, frustrating and costly to th
Wipro Positioned as a Leader in the IDC MarketScape for Utilities Customer Experience, Worldwide13.9.2019 12:55:00 CEST | Press release
Wipro Limited (NYSE: WIT) (BSE: 507685) (NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been positioned as a leader in the IDC MarketScape: Worldwide Professional Services Firms for Utilities Customer Experience 2019 Vendor Assessment (doc #US42713318, July 2019). Wipro has been recognised for key strengths including provider of fast as-a-service implementations of IT systems, for Utilities and cost-effective quality of service delivery models. The study evaluated the Utilities Customer Experience (CX) transformation and digital capabilities of 15 service providers and mapped them based on strategies, capability and market impact related parameters. Key Highlights include- The report notes Wipro’s internal program aimed at comprehensively addressing the challenges faced by utilities. Selected employees are assigned to one of six "domain tribes" — customer services, network operations, new energy servic
Jefferies to Hold Global Relief Day in Support of Hurricane Relief in the Bahamas, Monday, September 1613.9.2019 12:00:00 CEST | Press release
Jefferies confirmed that the firm’s global trading day for Hurricane Dorian relief efforts in the Bahamas will be held on Monday, September 16. Jefferies will offer investors around the world the opportunity to join efforts to assist those affected by the devastation of this event by trading with Jefferies. As previously announced, Jefferies will donate all net trading commissions on Monday, September 16, from U.S., European and Asia equity, fixed income and foreign exchange trading. In addition, Jefferies will donate an additional $1 million itself, and all 3,656 employees worldwide will be given the opportunity to personally donate to the relief effort. These contributions will be allocated to a series of charities with the goal of quickly getting funds to relief efforts directly involved in the rescue and recovery efforts. Rich Handler, Chairman and Chief Executive Officer of Jefferies, and Brian Friedman, Chairman of the Executive Committee, commented: "All of us at Jefferies are d
Knopp Biosciences to Present Data Characterizing Its Kv7 Technology Platform’s Potential for Delivering Precision Medicines to Treat Diverse Neurological and Smooth Muscle Diseases13.9.2019 10:00:00 CEST | Press release
Knopp Biosciences LLC today reports data demonstrating that compound subgroups from its proprietary library of potassium-channel modulators selectively target Kv7 channel subtypes associated with a wide range of neurological and smooth muscle diseases. The data is being presented at the International Kv7 Channels Symposium 2019 in Naples, Italy. Presentation Title: The Re-emergence of Kv7 Drug Discovery Presenter: Michael Bozik, M.D., CEO, Knopp Biosciences Date & Time: September 13, 4:35 pm CEST Michael Bozik, M.D., Chief Executive Officer of Knopp, will present the data derived from the Company’s proprietary library of more than 3,000 novel compounds directed to modulating the Kv7 channel, which regulates the flow of potassium ions across cell membranes. The data demonstrate that specific subgroups of Kv7 compounds selectively modulate different Kv7 channel subtypes across ranges of channel activation and inhibition, enabling selection of compounds capable of targeting neurological d
PenSam Selects Moody’s Analytics Economic Scenario Generator to Support New Risk Modeling Framework13.9.2019 09:00:00 CEST | Press release
Moody’s Analytics, a global provider of financial intelligence, announced today that its software has been selected by PenSam, one of Denmark’s leading labor market pension and insurance firms. PenSam will be using the Moody’s Analytics Economic Scenario Generator (ESG) for actuarial liability valuations, risk management, strategic asset allocation, and asset and liability management (ALM). The Moody’s Analytics ESG is an award-winning simulation framework which clients deploy in areas such as actuarial reporting, risk and capital calculation and analysis, and investment and ALM analysis. PenSam will also take advantage of the Moody’s Analytics Automation Module, which allows insurers to streamline their modeling processes by automating model set-up, execution, and validation, in turn reducing production time and cost. “The Danish pensions and insurance market is going through a period of change, with insurance companies across the country reassessing their risk management frameworks a