Business Wire

Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint

Del

Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV (Euronext & NASDAQ:GLPG) today announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary efficacy endpoint in adults with moderately to severely active ankylosing spondylitis (AS). In the study, patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001). More patients receiving filgotinib also achieved an ASAS20 response compared to those treated with placebo (76 percent versus 40 percent, p<0.0001).

“People with ankylosing spondylitis face serious pain and disability, and, too often, their disease does not respond adequately to existing therapies,” said John McHutchison, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “These data are encouraging, suggesting filgotinib has the potential to play an important role in addressing this medical need.”

“We are excited to see that filgotinib showed strong activity across a wide range of parameters relevant for ankylosing spondylitis and was well tolerated in TORTUGA, which reinforces previous findings about the activity and tolerability profile of filgotinib in multiple inflammatory conditions,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.

Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups. Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event reported for a patient receiving filgotinib who experienced pneumonia and recovered after hospital-based antibiotic treatment. One patient randomized to filgotinib, with an inherited risk for thrombosis, experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, opportunistic infections or cases of Herpes zoster were observed in the study.

Detailed results from the TORTUGA trial will be submitted for presentation at a future scientific conference.

Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.

About the TORTUGA Study

TORTUGA was a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active AS. The trial was conducted in Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain and Ukraine. In total, 116 patients were randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12 weeks.

The primary objective of TORTUGA was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of AS, as assessed at Week 12 by ASDAS (a standard composite index for assessing the disease, which incorporates five disease activity variables).

About Ankylosing Spondylitis

AS is a systemic, chronic, and progressive seronegative spondyloarthritis that classically affects the spine and sacroiliac (SI) joints and may progress to spinal fusion, leading to permanent disability. Currently, there is no known cure for AS, but there are treatments and medications available to reduce signs and symptoms and manage pain.

About the Galapagos – Gilead Collaboration

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The Phase 2 TORTUGA trial in ankylosing spondylitis is one of several Phase 2 trials in inflammatory diseases in addition to the ongoing FINCH Phase 3 program in rheumatoid arthritis, 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) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 675 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.

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.

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 anticipated timing of clinical studies with filgotinib and the progression and results of such studies. 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 Galapagos’ product candidates. 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.

Gilead Forward-Looking Statements

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 parties’ ability to complete the clinical trial programs evaluating filgotinib for the treatment of ankylosing spondylitis, ulcerative colitis and other inflammatory diseases in the currently anticipated timelines, or at all. In addition, there is the possibility of unfavorable results from additional clinical trials involving filgotinib. Further, it is possible that the parties may make a strategic decision to discontinue development of filgotinib, and as a result, filgotinib may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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, 2018, 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

Galapagos Contacts
Investors:
Elizabeth Goodwin, +1-781-460-1784
VP IR & Corporate Communications
ir@glpg.com
Paul van der Horst, +31 71 750 6707
Director IR & Business Development
ir@glpg.com
or
Media:
Evelyn Fox, +31 6 53 591 999
Director Communications
communications@glpg.com
or
Gilead Contacts
Investors:
Sung Lee, +1-650-524-7792
or
Media:
Nathan Kaiser, +1-650-522-1853

Om 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.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

GSMA To Showcase Mobile’s Increasing Impact on Sustainable Development During UN General Assembly Week24.9.2018 12:00Pressemelding

The GSMA will represent the global mobile industry at the 73rd session of the UN General Assembly (UNGA) being held in New York this week, advancing the leading role the sector is playing in meeting the UN Sustainable Development Goals (SDGs). Over the coming week, the GSMA will be participating in a wide range of activities with several high-profile partners and providing a critical platform for dialogue between mobile industry leaders, heads of state, global leaders and governments to further accelerate mobile’s contribution to the SDGs. “The GSMA will be in UNGA for the third year running to demonstrate how the global mobile industry is strengthening its commitment to improving lives around the world, as we enter a critical period in the delivery of the UN’s ambitious 2030 Agenda,” said Mats Granryd, Director General of the GSMA. “As the leading forum for international political cooperation, UNGA give us a unique opportunity to showcase how mobile’s unprecedented global scale is con

BolySolar Announcing Launch of BolySolar Tree24.9.2018 11:00Pressemelding

Bolymedia Holdings Co. Ltd., a global high-tech company headquartered in Silicon Valley, is pleased to announce its fifth patented renewable energy product – BolySolar Tree - at the Anaheim, California SPI to be held on September 24-27, 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005050/en/ BolySolar Tree (Graphic: Business Wire) BolySolar is a complete set of solar technologies and products that will revolutionize the entire energy industry. At SPI this month, the company will be showcasing its fifth product from its growing line of solar technologies - the BolySolar Tree. The diagram shows the basic design of the BolySolar Tree. The basic idea of the BolySolar Tree is to allow double-sided solar energy utilization with the help of mirrors, thereby reducing solar energy system costs and generating electricity for a longer duration. Compared to the conventional fixed-mount PV panel systems or tracker-mounted P

The 9th Edition of Tour of China 2018 Comes to an End24.9.2018 10:45Pressemelding

The sixteen-day Tour of China 2018 is concluded in Anshun, Guizhou Province on 23rd September, as the 13th stage witnesses the victory of Jakub Mareczko from Wilier Triestina – Selle Italia. The last stage in Anshun is a circuit race of 127.8 kilometers with two sprints and one KOM of Category 4. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005421/en/ The riders are crossing the finishing line. (Photo: Business Wire) The stage remained exciting and unpredictable due to little difference between riders’ results after the 12th stage. No rabbit group was formed even after 40 kilometers, though riders had never stopped breaking out from the peleton since race started. As the peleton kept its pace, Luke Mudgway from H&R Block Pro Cycling Team led the rabbit group of four who worked together quite well, with the gap of 1 minute 50 seconds. The gap narrowed, however, as the peleton started to chase with 30 kilometers to go,

CONQUEST Completes the Financing of Its Sustainable Infrastructure Portfolio24.9.2018 10:18Pressemelding

CONQUEST Asset Management (“CONQUEST”) announced it completed, on behalf of the Sustainable Infrastructure fund it manages, the financing of its solar photovoltaic assets portfolio. The transaction was closed with a major financial institution following a competitive selection process. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005404/en/ Photo Credit: Istock Prior to this transaction, CONQUEST had increased the size of its assets under management to circa 70MW as a result of 3 transactions closed in less than a year. This portfolio, located in the South of France, benefits from up to 20-year secured and inflation linked power purchase agreements from local incumbent utility EDF. “The financing market remains competitive across Western Europe for sustainable infrastructure. We are pleased with the outcome of this process and the quality of the project finance lenders and teams we managed to attract, which confirmed

L&T Technology Services (LTTS) wins USD 40 million Engineering Content Management (ECM) Deal in Europe24.9.2018 08:20Pressemelding

L&T Technology Services Limited (NSE: LTTS), a leading global pure-play engineering services company, today announced that it has won a multi-year deal to provide digital content management services to a leading technology company’s industrial products segment. The deal is expected to run for a period of 5 years with an aggregate revenue potential of USD 40 million, covering Engineering Content Management (ECM) programs in the US and European regions. LTTS will leverage centers in Europe, US & India while assuming complete ownership and talent to manage content for all current and future product suites for the customer. This would include technical design specifications, diagnostic solutions for service engineers and product training for customers & engineers, thereby supporting the entire ECM cycle from product conceptualization to developing digital content platforms. “With engineering content becoming one of the cornerstones of digital transformation, this deal win highlights LTTS’

Prima Solutions Expands Product Offering and Geographical Reach Through the Acquisition of ICOD Inc.24.9.2018 08:00Pressemelding

As part of its continuing growth strategy, Prima Solutions (Prima), the premier software platform for Property and Casualty insurers, has agreed to acquire ICOD Inc. (ICOD), the Canadian provider of software solutions for Life and Health insurance. Recognized as an established leader with its SN Assurance suite, ICOD offers a best-in class solution deliverable in SaaS or on premise. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005019/en/ The transaction, which closed on September 20th, accelerates Prima’s expansion into the Life and Health insurance market which is still largely using legacy technologies. The ICOD acquisition offers many synergies including: complementing Prima’s existing product offering, diversifying its customer base and expanding the platform for rapid growth in both Europe and North America. Hugues Delannoy, Chairman of Prima Solutions, said: "This acquisition provides a unique opportunity to ac