Business Wire

European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

Share

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.

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. 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.

Contact information

Gilead
Sung Lee, Investors
+1 (650) 524-7792

Arran Attridge, Media
+1 (650) 425-8975

Galapagos
Elizabeth Goodwin, Investors
+1 (781) 460-1784

Carmen Vroonen, Media
+32 473 824 874

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Researcher John Craig Venter Is Awarded the 2020 Edogawa-NICHE Prize for His Accomplishment in Human Genome Research15.8.2020 08:00:00 CESTPress release

The Edogawa NICHE Prize for the year 2020 has been awarded to Dr. John Craig Venter for his contribution to research and development pertaining to the Human genome. This honor reflects Dr. Venter's lifetime accomplishments in the power of the genomics and specifically in the identification of the human genome which has radically transformed healthcare according to Prof. Gary Levy, chair, Edogawa NICHE awards committee (www.edogawanicheprize.org). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200814005092/en/ Dr. John Craig Venter, recipient of the 2020 - Edogawa NICHE Prize, for his contribution to research and development pertaining to the Human genome. (Photo: Business Wire) Edogawa NICHE Prize was Instituted in 2018, by the Jinseisha trust, and the Nichi-In Centre for Regenerative Medicine (NCRM), which honours scientists or clinicians whose contributions lead to the development of prevention, diagnosis or treatment of a

Eaton Launches New Line of Wireless Mobile Control Solutions for Heavy Machinery and Field Operations13.8.2020 23:51:00 CESTPress release

Power management company Eaton today announced its eMobility business has launched a new and improved line of Eaton OMNEX Trusted Wireless™ mobile control solutions for heavy machinery and field operations. The 900 MHz two-way remote-control units allow for the wireless control of high-value machinery in harsh environments, including mining, construction, agriculture, locomotive and marine markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200813005826/en/ Eaton's new OMNEX Trusted Wireless™ controllers can remotely operate heavy machinery, such as vacuum trucks, tow trucks, concrete mixers and cranes. (Photo: Business Wire) “Our next generation of rugged, weatherproof OMNEX wireless controllers were designed with customer input, and offer a number of benefits, including enhanced safety and productivity for machine operators,” said Scott Adams, president, eMobility, Eaton. “Overall, we’ve improved upon the reliability a

IFF to Hold Virtual Special Meeting of Shareholders on August 2713.8.2020 22:15:00 CESTPress release

Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition, announced today that the previously communicated special meeting of shareholders to consider and vote on the issuance of shares of IFF common stock in connection with the previously announced proposed merger of IFF and DuPont’s Nutrition & Biosciences (“N&B”) business pursuant to a Reverse Morris Trust transaction (the “special meeting”) has been changed to a virtual-only meeting due to the continued public health concerns over the COVID-19 outbreak and the health and safety of its shareholders and employees. Accordingly, the special meeting, to be held on Thursday, August 27, 2020 at 10:00 a.m. Eastern Time, will be held only virtually on the Internet at www.virtualshareholdermeeting.com/IFF2020SM. Shareholders will not be able to attend the meeting or vote physically in person. We have designed the format of the special meeting to provide shareholders the same right

PTC Makes Enterprise Version of Onshape Education Suite Available Free of Charge13.8.2020 22:00:00 CESTPress release

In advance of the 2020-2021 school year, PTC (NASDAQ: PTC) https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.onshape.com%2Feducation-enterprise%3Futm_source%3DPTC%26utm_medium%3Dpressrelease%26utm_campaign%3D2020Q4-EDUENT-pressrelease%26content_download_source%3DPTC-pressrelease&esheet=52266463&newsitemid=20200813005767&lan=en-US&anchor=has+made+the+Onshape%26%23174%3B+Education+Suite%26%238217%3Bs+newly-released+Enterprise+plan&index=2&md5=fd8157c151b59edaf50fef580aa6c650 has made the Onshape® Education Suite’s newly-released Enterprise plan available free-of-charge for K-12 schools and universities that register through November 20, 2020. The newest version of the cloud-based, remote learning suite is offered alongside the Onshape Education Standard plan to help alleviate the burden experienced by educational STEM programs during the COVID-19 pandemic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/202008

DeltaTrak Enhances Its Cold Chain Restart Program to Help Customers Battle COVID-1913.8.2020 18:00:00 CESTPress release

DeltaTrak®, a leading innovator of cold chain solutions, is enhancing its Cold Chain Restart Program to offer customers safer and more efficient methods to protect their employees and clients from the COVID-19 pandemic. The program was created to help companies reopen on a safe footing by providing access to critically needed PPE solutions. Following an extremely positive response, DeltaTrak has added the ThermoTrace Auto-Check Non-Contact Infrared Forehead Thermometer and Touchless Hand Sanitizer Dispenser to address the need for effective, contactless and hands-free options for temperature measurement and sanitization. “The increased demand for safety and sanitization equipment is driven by our customers’ need to conduct business safely without jeopardizing the health of employees and customers when it comes to using thermometers and hand sanitizers,” said Frederick Wu, President and CEO of DeltaTrak. “Gaining access to these solutions remains a major challenge and we are confident t

Verimatrix to Sponsor Virtual SportsPro Media INSIDER Series Featuring Broadcasting Experts From the NFL, Octagon, Astro, The FA, European Tour & More13.8.2020 17:35:00 CESTPress release

Regulatory News: Verimatrix (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Chief Revenue Officer Lu Bolden will join a lineup of sports broadcasting experts to speak on the future of the industry with today’s new need to protect ever-growing amounts of streamed sports and esports. Registration is free. Visit www.insider.sportspromedia.com. With an eye on highlighting the largely unchartered challenges that come with new methods of reaching all types of sports fans, the SportsPro Media INSIDER Series serves as a valuable venue for those seeking to protect revenues when fans are at home instead of stadiums. Traditional sports have found themselves facing the same new business model decisions that esports has organically addressed over the last several years. That makes for a big shift – where new revenue streams are created at warp speed with various streaming and broadcast options for countless typ