Business Wire

Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

Share

Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.

Approximately 600,000 to 1 million people are living with RA across Japan, and despite available options, many still do not experience disease remission. In the global Phase 3 FINCH studies, filgotinib demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve.

“We are very pleased to announce this important new partnership with Eisai, which brings together our complementary expertise and commitment in inflammation, to deliver this important new option to patients living with inflammatory diseases in Japan,” said Luc Hermans, M.D., President and Representative Director, Gilead Japan.

“We have extensive clinical development and commercialization experience spanning more than 20 years in RA and have established a solid RA franchise in Japan,” said Hidenori Yabune, President of Eisai Japan, Senior Vice President of Eisai. “With this agreement, we look forward to contributing more to patients living with RA by adding filgotinib to our product line-up.”

Global studies investigating filgotinib in additional diseases are also underway, including the Phase 3 SELECTION trial in ulcerative colitis, 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 NV (Mechelen, Belgium) have entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Filgotinib is an investigational drug whose efficacy and safety have not been established. Filgotinib is pending regulatory approval in Japan, Europe and the United States, based on global Phase 3 trials evaluating its efficacy and tolerability.

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 Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.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 the Japanese Ministry of Health, Labour and Welfare and other regulatory agencies may not approve filgotinib for the treatment of RA or other potential indications, and any marketing approvals, if granted, may have significant limitations on its use. As a result, filgotinib may never be successfully commercialized. In addition, Gilead and Eisai may not realize the potential benefits of this partnership. 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. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 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.

Contact information

Gilead Sciences, Japan
Seiko Noma
+81-3-6837-0790

Gilead Sciences, US
Sonia Choi
+1 650-425-5483

Eisai Co., Ltd.
Public Relations Department
+81-3-3817-5120

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells3.8.2020 20:03:00 EESTPress release

NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) “Relief” today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes. RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted. The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND

Panasonic Corporation announces verification of inhibitory effect of hydroxyl radicals contained in water (nano-sized electrostatic atomized water particle) on novel coronavirus (SARS-CoV-2)3.8.2020 18:47:00 EESTPress release

Panasonic Corporation today announced that, in collaboration with Mayo Yasugi, Associate Professor, Department of Veterinary Science, Graduate School of Life and Environmental Sciences, Osaka Prefecture University, it has verified the inhibitory effect of the hydroxyl radicals contained in water (nano-sized electrostatic atomized water particle) on the novel coronavirus (SARS-CoV-2). Hydroxyl radicals contained in water are particulate ions containing hydroxyl radicals that are generated by applying a high voltage to moisture in the air. They are characterized by being strongly oxidative and highly reactive. Panasonic has been conducting research on this technology over the past 20 years since 1997, and has verified its effectiveness in a variety of areas, including inhibiting pathogenic microorganism (bacteria, fungi, and viruses) and allergens, breaking down PM 2.5 components that have adverse effects on the human body*1. In 2012, Panasonic conducted a virus clearance test with a thi

OpenGate Capital Strengthens Management Team with Tenured Chief Financial Officer3.8.2020 17:43:00 EESTPress release

OpenGate Capital, a global private equity firm, announced today that their senior leadership team has expanded with the addition of Heather Malloy who joined the firm today as Chief Financial Officer based in the firm’s Los Angeles office. Malloy is a tenured, private equity finance executive with an extensive background in corporate strategy, structuring, and systems. She is experienced in control buyouts, senior, junior, and mezzanine debt, structured finance, and asset-backed securities. Prior to joining OpenGate, Malloy was a management consultant at Riva Ridge Management, and she previously served as Chief Operating Officer and Chief Financial Officer at Strattam Capital for six years. In her role at OpenGate Capital, Malloy is responsible for the financial and administrative matters of OpenGate Capital, the funds under OpenGate’s management, and the financial supervision of OpenGate’s global portfolio companies. Andrew Nikou, OpenGate’s Founder and Chief Executive Officer stated,

Alpega Partners with project44 to Deliver Advanced Visibility in North America and Europe3.8.2020 17:15:00 EESTPress release

Alpega, a global provider of cloud-based transportation management systems (TMS), today announced as part of its growing value-adding partner ecosystem, it has partnered with project44, a global leader in supply chain visibility for shippers and logistics service providers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200803005311/en/ Alpega Partners with project44 to Deliver Advanced Visibility in North America and Europe (Photo: Business Wire) The partnership delivers real-time truckload tracking integration and serves Alpega customers of all industries and verticals across North America and Europe. “We are happy to join efforts with Alpega to serve our global community of customers,” said Tommy Barnes, Head of Global Network Partnerships at project44. “We want to enable supply chain professionals all over the world to make informed decisions based on high quality, real-time data, and drive more operational efficiencies

 JEOL: Release of the New Scanning Electron Microscope JSM-IT700HR3.8.2020 17:00:00 EESTPress release

JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new scanning electron microscope (SEM), the JSM-IT700HR for unprecedentedly high throughput in August 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200803005011/en/ Note: The photo of the instrument is JSM-IT700HR/LA. (Photo: Business Wire) Development background Scanning electron microscopes are used in various fields, such as nanotechnology, metals, semiconductors, ceramics, medicine, and biology. In addition, SEM applications are expanding to include quality control as well as basic research. The demands are increasing for faster data acquisition of higher-quality SEM images and for easier confirmation of compositional information. Based on our award-winning predecessor of “InTouchScope™” series SEMs, the JSM-IT700HR is equipped with our in-lens Schottky field emission electron gun (FEG). This new powerful SEM satisfies the needs for obser

Immervision Orders Investigation by Ad Hoc Research to Clearly See Smartphone Camera Performance from End Users Point of View3.8.2020 16:00:00 EESTPress release

Immervision, the Montreal-based developer and licensor of patented, wide-angle optics and imaging technology, today announced its 2020 Smartphone Camera survey results in cooperation with Ad Hoc Research. Amid confusing end-user comments on photos and videos and disagreement between phone makers on what has to be done, Immervision decided to investigate what end-user like or don’t like from their phone’s cameras. It revealed no smartphone brand, even the flagship brands, is performing well in consumers’ experience in taking photos. The survey included 1,557 consumers located in California, China and South Korea who selected pictures they preferred amongst 10 images for each of the four scenes comprising city landscape and people. Photos were taken on settings from the same angle and under the same environmental conditions. Results were based on region, age, gender. Data was collected February 20 - March 5, 2020. Ad Hoc Research said, “Our study showed that with current functionalities,

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