UC is a chronic, idiopathic inflammatory disease affecting the colon and often involves periods of remission interspersed with periods of active disease. Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis -- Filgotinib 200 mg Demonstrated Greater Efficacy Compared with Placebo in the Induction and Maintenance of Remission in the SELECTION Trial -- Among biologic-experienced patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (11.5 percent, p=0.0103) compared with placebo (4.2 percent). Gilead and Galapagos will co-commercialize filgotinib in France, Germany, Italy, Spain and the United Kingdom and retain the 50/50 profit share in these countries that was part of the original filgotinib license agreement, and under the revised agreement, Galapagos will have an expanded commercial role. News via mail The Cohort A Induction Trial enrolled biologic-naive patients, and the Cohort B Induction Trial enrolled biologic-experienced patients. ● Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. ● For more information on Gilead Sciences, please visit the company’s website at www.gilead.com. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC). Despite EU and Japan approvals, forecast for Gilead and Galapagos’ Jyseleca (filgotinib) in the US less sunny than once hoped By Victoria Smith 30 Sep 2020 (Last Updated September 30th, 2020 08:57) GlobalData estimated the size of the 2019 market for rheumatoid arthritis in the eight major markets. 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 for the treatment of ulcerative colitis and other inflammatory diseases and the possibility that the parties may be unable to complete such trials in the currently anticipated timelines or at all. Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study -- Filgotinib 100 mg and 200 mg Doses Demonstrated Significantly Higher ACR20/50/70 Responses than Placebo in Patients with Prior Inadequate Methotrexate Response -- 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. +1 (650) 425-8975, Galapagos Under our collaboration agreement with Gilead, we are developing filgotinib in RA, UC, and CD. UC is often diagnosed in people of working age who can face debilitating flares in their symptoms and progression of disease overtime. Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-infectious uveitis following receipt of … Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. The SELECTION trial is one of multiple clinical studies of filgotinib in a range of inflammatory conditions, including the FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease. Gilead and Galapagos’ late-stage trial of their ulcerative colitis drug filgotinib has hit its target – but shares in both companies were … Filgotinib is approved for the treatment of RA by the EMA and PMDA. Of patients receiving filgotinib 100 mg, 23.8 percent achieved clinical remission at Week 58, compared with 13.5 percent treated with placebo (p=0.0420). Gilead will pay Galapagos 160 million ($195 million) to support ongoing development and accelerated commercial buildout in the European Union. Filgotinib is an investigational agent and is not approved anywhere. Gilead and Galapagos partnered to develop filgotinib as treatment for rheumatoid arthritis. In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications. Filgotinib was discovered and developed by Galapagos using our proprietary target and drug discovery technology platform. Gilead and Galapagos plan to award a total of approximately $5,000,000 in funds for these research proposals, dependent upon availability of funds and receipt of meritorious applications. Now, Galapagos is on its own with filgotinib in Europe. Among biologic-naïve patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (26.1 percent, p=0.0157) compared with placebo (15.3 percent). In the US, Gilead received a complete response letter (CRL) from the FDA in August 2020 in the context of the agency’s evaluation of the product’s marketing authorization for RA. This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation). Any proposal greater than Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. In the induction trial of biologic-naïve patients, the incidence of serious adverse events was similar across treatment groups (200 mg: 1.2 percent; 100 mg: 4.7 percent; placebo: 2.9 percent). The FDA is only one of the regulators reviewing filgotinib. ● First patients treated with filgotinib in Japan and the EU in 2020. Available at: https://bmjopen.bmj.com/content/bmjopen/7/8/e017544.full.pdf. Moderately to severely active UC was defined as a centrally read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and Physician Global Assessment (PGA) of ≥ 2 based on the MCS. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-infectious uveitis following receipt of the CRL and, without a viable path forward in the United States, the companies no longer believe it is feasible to continue the current global development program for filgotinib in these indications. Two deaths were observed in the filgotinib 200 mg treatment group in the maintenance trial. These and other risks are described in detail in Gilead’s Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. In the US, Gilead received a complete response letter (CRL) from the FDA in August 2020 in the context of the agency’s evaluation of the product’s marketing authorization for RA. Filgotinib is an investigational agent and is not approved by the FDA or any other regulatory authority for any use. Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. The reader is cautioned not to rely on these forward-looking statements. Patients with clinical remission or response at Week 10 of induction were subsequently re-randomized to the induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58. -- Some content on this site is not intended for people outside the United States. Gilead and Galapagos have released 52-week clinical trial data showing the durability of filgotinib in rheumatoid arthritis patients. Our. 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. Gilead and Galapagos anticipate that 6-10 awards will be granted. The SELECTION trial comprises 2 Induction Trials and a Maintenance Trial. BMJ Open 2017: Adapting to ulcerative colitis to try to live a ‘normal’ life. Gilead was very tightly interwoven with GLPG, but recent setbacks with filgotinib have required O’Day & co to become firefighters. One patient with pre-existing asthma died due to asthma exacerbation, and the second patient with pre-existing atherosclerosis died due to left ventricular heart failure per autopsy report. ii Gilead & Galapagos Filgotinib Clinical Program Trial Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3 (NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839), View source version on businesswire.com: The primary objectives of SELECTION are to evaluate the efficacy of filgotinib compared with placebo in establishing EBS clinical remission as determined by the Mayo Clinic endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 and Week 58. Disclaimer Gilead and filgotinib partner Galapagos have framed safety as a positive differentiator for filgotinib over other JAK1 inhibitors, which so far have all come with a black box warning. FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Douglas Maffei, PhD, Investors In the maintenance trial, 4.5 percent of patients treated with filgotinib 200 mg experienced a serious adverse event, compared with none for their corresponding placebo; 4.5 percent of patients treated with filgotinib 100 mg experienced a serious adverse event, compared with 7.7 percent for their corresponding placebo. The efficacy and safety of filgotinib have not been established. Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis, and other inflammatory indications. At Week 58, 37.2 percent of biologic-naïve and biologic-experienced patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2 percent treated with placebo (p˂0.0001). “We are encouraged by the early response as an induction therapy and the durable efficacy as a maintenance therapy observed in the SELECTION trial,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. Cookie policy Under the terms of the agreement, the companies will collaborate jointly on the global development of filgotinib starting with the initiation of Phase 3 trials in rheumatoid arthritis (RA). This press release features multimedia. +1 (781) 460-1784 Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. 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