GlobeNewswire by notified

Jyseleca® approved in Japan for ulcerative colitis

Share

Approval of additionalindication based on Phase 2b/3 SELECTION study in patients with moderate-to-severe ulcerative colitis

Mechelen, Belgium;28 March 2022,08.01CET;Galapagos NV (Euronext & NASDAQ: GLPG) reports that Gilead Sciences K.K. (Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan) and EA Pharma Co., Ltd. (Tokyo, Japan) today announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), of a second indication for Jyseleca (filgotinib), a once-daily, oral, JAK1 preferentialinhibitor, for the treatment of patients with moderate-to-severe active ulcerative colitis (UC).

The approval of this second indication for Jyseleca in Japan is based on data from the randomized, double-blind, placebo-controlled phase 2b/3 SELECTION study. This study evaluated the efficacy and safety of Jyseleca for induction and maintenance of remission in patients with moderately to severely active ulcerative colitis who had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The study showed that Jyseleca 200mg was well-tolerated and efficacious as induction and maintenance therapy with no new safety findings reported. Jyseleca was approved in Japan in September 2020 for the treatment of rheumatoid arthritis (RA), including the prevention of structural joint damage, in patients who had inadequate response to conventional therapies.

Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply. Eisai will be responsible for product distribution, and together with EA Pharma, its subsidiary focused on gastrointestinal diseases, will jointly commercialize the medicine to make it available to physicians and patients across the country.

About filgotinib
Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). Filgotinib is also approved and marketed as Jyseleca (200mg tablets) in the European Union, Great Britain and Japan for the treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The Great Britain Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at www.emcmedicines.com/en-GB/northernireland. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. A global Phase 3 program with filgotinib is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.

Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

About the filgotinib collaboration
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos is responsible for the commercialization of filgotinib in Europe, while Gilead remains responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai.

About Galapagos
Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, 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.

Contact
Investors:
Sofie Van Gijsel
Head of Investor Relations
+1 781 296 1143

Sandra Cauwenberghs
Director Investor Relations
+32 495 58 46 63
ir@glpg.com

Media:
Marieke Vermeersch
Head of Corporate Communication
+32 479 490 603

Anna Gibbins
Senior Director Therapeutic Area Communications
+44 7717 801900

media@glpg.com

Forward-looking statements
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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. When used in this press release, the words “ongoing,” “may,” “who,” “will,” “plan” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to: statements regarding the global R&D collaboration with Gilead and product supply of filgotinib in moderate-to-severe UC in Japan; statements regarding product distribution by Eisai of filgotinib in moderate-to-severe UC in Japan; statements regarding joint commercialization in Japan of filgotinib in moderate-to-severe UC by Eisai and its subsidiary EA Pharma; and other statements and expectations regarding commercial sales for filgotinib and rollout in Europe. These risks, uncertainties and other factors include, without limitation, risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities, including the EMA’s planned safety review of JAK inhibitors used to treat certain inflammatory disorders, and the risk that the EMA’s planned safety review may negatively impact acceptance of filgotinib more widely by patients, the medical community, and healthcare payors, as well as the risk that the MHLW could undertake a similar review; the risk that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future; risks related to Galapagos’ reliance on third parties, and risks related to the ongoing COVID-19 pandemic. For a discussion of other risks and uncertainties and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC), as supplemented and/or modified by any other filings and reports that we have made or will make with the SEC in the future. All information in this press release is as of the date of the release, and Galapagos undertakes no duty to update this information unless required by law or regulation.

.


Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified 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 by notified

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

Latest releases from GlobeNewswire by notified

Changes in financial results publication18.5.2022 18:01:16 CEST | Press release

PRFoods AS declares that 2021/2022 financial year 9 months unaudited results will be published, according to Stock Exchange rules no later than two months after end of the reporting period, 31.5.2022. Although interim report will be unaudited, PRFoods has required a third party assessment of the impact of sale of Heimon Kala Oy, taking into account that final purchase price is dependent on certain conditions subsequent presumed to be met before publication. Indrek Kasela AS PRFoods Member of the Management Board Phone: +372 452 1470 investor@prfoods.ee www.prfoods.ee

PRESS RELEASE: NACON: WRC GENERATIONS: THE MOST COMPLETE RALLY GAME IS COMING IN OCTOBER!18.5.2022 17:46:00 CEST | Press release

WRC GENERATIONS: THE MOST COMPLETE RALLY GAME IS COMING IN OCTOBER! Lesquin, 18th May 2022 - NACON and the studio KT Racing are pleased to announce their new rally game, WRC Generations, the official video game of the FIA World Rally Championship, scheduled for release in Autumn 2022 on PlayStation®4, PlayStation®5, Xbox One, Xbox Series X|S, Nintendo Switch and Steam for PC. The result of 7 years of collaboration with legendary drivers, who have already made WRC 10 and WRC 9 the references of the genre, the latest entry in the series is an authentic and comprehensive rally racing simulation, giving players the chance to drive powerful cars in the most famous rallies of all time! Check out the announcement trailer for WRC Generations: [link] An unrivalled level of realism Never before have games come this close to the real-life World Rally Championship! Hailed by both critics and professionals, this year's WRC simulation has been reinforced with numerous improvements and optimisations

PRESS RELEASE: NACON PRESENTS AN AMBITIOUS LINEUP AND ANNOUNCES TWO NEW GAMES18.5.2022 17:45:00 CEST | Press release

NACON PRESENTS AN AMBITIOUS LINEUP AND ANNOUNCES TWO NEW GAMES NACON has confirmed its status as a major mid-publisher and creator of standard-setting accessories Paris (France), 18 May 2022 – The latest edition of Bigben Week opened its doors on Monday. This major event for the group is the perfect occasion to present its products and objectives to the media and international partners. NACON, the group's gaming brand, held a press conference to announce all of its news and to explain how it is changing. The last time the event was held – in 2019, due to the health crisis – BIGBEN presented its soaring ambitions for the years to come. Bigben Week is an opportunity to highlight the company's strong growth over the last three years along with the major changes it has undergone. AN EFFECTIVE STRATEGY NACON’s March 2020 listing on the stock market raised more than €100 million, reinforcing the company's ambitions and resources. Over the course of three years, NACON acquired no fewer than 9

FDA beviljar särläkemedelsstatus för tasquinimod vid behandling av myelofibros18.5.2022 15:00:00 CEST | Pressemelding

Lund 18 maj 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) meddelade idag att amerikanska Food and Drug Administration (FDA) har beviljat särläkemedelsstatus för tasquinimod vid behandling av myelofibros. "Särläkemedelsstatus som FDA tilldelat för tasquinimod i myelofibros utgör ett viktigt steg framåt för Active Biotech", säger Helén Tuvesson, VD Active Biotech. "Det öppnar en viktig regulatorisk väg och ger oss potential att snabbt avancera utvecklingen av tasquinimod i denna patientpopulation.” FDAs Orphan Drug Designation program ger särläkemedelsstatus för läkemedelskandidater avsedda för säker och effektiv behandling, diagnos eller förebyggande av ovanliga sjukdomar som drabbar färre än 200.000 människor i USA. Denna särläkemedelsstatus ger 7 års marknadsexklusivitet vid marknadsgodkännande samt vissa andra fördelar. I februari 2022 ingick Active Biotech ett exklusivt licensavtal med Oncode Institute i Nederländerna, som verkar på uppdrag av Erasmus University Medical Center (

FDA grants Orphan Drug Designation for tasquinimod in myelofibrosis18.5.2022 15:00:00 CEST | Press release

Lund May 18, 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) today announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis. “The Orphan Drug Designation awarded by the FDA for tasquinimod in myelofibrosis represents an important step forward for Active Biotech”, said Helén Tuvesson, CEO Active Biotech. “It opens an important regulatory pathway and provides us with the potential to rapidly advance the development of tasquinimod in this patient population.” The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that affects fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives. In February 2022, Active Biotech entered into an exclusive lice