GlobeNewswire

Janssen announces submission of New Drug Application to the U.S. FDA for ponesimod for treatment of adults with relapsing multiple sclerosis

Share
  • New Drug Application (NDA) based on data from the head-to-head OPTIMUM Phase 3 study, presented in September 2019 at the 35th Congress of The European Committee for Treatment and Research in Multiple Sclerosis Conference (ECTRIMS) in Stockholm, Sweden
  • Idorsia Pharmaceuticals Ltd and Actelion Pharmaceuticals Ltd, a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, have a revenue-sharing agreement in respect to ponesimod

Allschwil, Switzerland – March 19, 2020
Idorsia Ltd (SIX: IDIA) today informed that the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS).

For further details please read the full announcement available here:
https://www.janssen.com/janssen-submits-ponesimod-new-drug-application-us-fda-treatment-adults-relapsing-multiple-sclerosis

About the Revenue Sharing Agreement
Idorsia Pharmaceuticals Ltd and Actelion Pharmaceuticals Ltd, a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, have entered into the revenue-sharing agreement in respect to ponesimod. Under the terms of the revenue-sharing agreement, Idorsia Pharmaceuticals Ltd is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion Pharmaceuticals Ltd.

Notes to the editor

About Idorsia
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.

For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
www.idorsia.com

The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Attachment

About GlobeNewswire

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

https://globenewswire.com

GlobeNewswire 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

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

Latest releases from GlobeNewswire

Nordisk næringsliv fokuserer på innovasjon og forbedring av kundeopplevelsen27.1.2020 10:00:00 CETPressemelding

Rapporten ISG Provider Lens™ viser at selskaper i regionen henvender seg til leverandører av digitale forretningstjenester for hjelp med analyse, kunstig intelligens og andre teknologier STOCKHOLM i Sverige, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Næringslivet i de nordiske landene fokuserer på å forbedre kundeopplevelsen og innovasjonen, og kontakter leverandører av digitale forretningstjenester for å nå målene sine. Dette viser en ny rapport som ble publisert i dag av Information Services Group ( ISG ) (Nasdaq: III ), et verdensledende teknologisk forsknings- og rådgivningsselskap. Rapporten 2019-2020 ISG Provider Lens™ Digital Business – Solutions and Service Partners for Norden viser at bedrifter i regionen omfavner teknologier som dataanalyse, kunstig intelligens, tingenes internett og blokkjeder for å levere kvalitetstjenester til kundene sine og for å skille ut seg fra konkurrenter. «Nordiske bedrifter søker transformasjonstjenester fra IT-leverandører for ikke bare å bli veiledet gje

UPM commits to UN Business Ambition for 1.5°C to mitigate climate change27.1.2020 10:00:00 CETPress release

(UPM, Helsinki, 27 January 2020 at 11:00 EET) – UPM commits to the United Nations Global Compact’s Business Ambition for 1.5°C, joining leading companies in a promise to pursue science-based measures to limit global temperature rise to 1.5°C. UPM will strive to mitigate climate change and drive value creation through innovating novel products, committing to a 65% CO2 emission reduction and by practicing sustainable forestry. The 1.5°C ambition is a response to increasing concern about the severe consequences of a failure to stop global warming. UPM is among the first global forest industry companies making this commitment. “UPM has a unique opportunity to make a positive impact and contribute to mitigating climate change by tangible actions. We innovate climate-positive products and turn them into growing businesses. At the same time, we limit risks from climate mitigation policies and physical impacts of changing climate. This is important for the long-term value of the company,” says

Valmet to supply a board machine rebuild to Umka in Serbia27.1.2020 10:00:00 CETPress release

Valmet Oyj’s press release on January 27, 2020 at 11:00 a.m . EET Valmet will supply a board machine rebuild to Umka Cardboard Mill in Serbia. The main target of the rebuild is to increase the customer’s production capacity. The start-up of the rebuilt paper machine PM 1 is scheduled for the second half of 2021. The order is included in Valmet's orders received of the fourth quarter 2019. The value of the order will not be disclosed. The total value of an order of this type is typically around EUR 15-20 million. "This rebuild is one of the most important strategic decisions we have made in the course of 80 years long history of the mill. We are pleased that this project is going to be completed by Valmet, a global leader in the supply of process technology in the paper industry. I strongly believe in the success and bright future of Umka Cardboard Mill, with planned capacity of over 200,000 tonnes, further quality improvements and wider product portfolio,” says Milos Ljusic, Managing D

Nordic Enterprises Focus on Innovation and Improving Customer Experience27.1.2020 10:00:00 CETPress release

ISG Provider Lens™ report finds companies in the region turning to digital business services providers for help with analytics, artificial intelligence and other technologies STOCKHOLM, Sweden, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Enterprises in the Nordic countries are focused on improving customer experience and enhancing innovation, and they are turning to digital business service providers to achieve their goals, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2019-2020 ISG Provider Lens™ Digital Business – Solutions and Service Partners Report for the Nordics finds enterprises in the region embracing technologies such as data analytics, artificial intelligence, the Internet of Things and blockchain to deliver quality services to their customers and to differentiate themselves from competitors. “Nordic enterprises are seeking transformation services from IT providers to not only ta

Nordiska företag fokuserar på innovation och förbättrar kundupplevelsen27.1.2020 10:00:00 CETPressemelding

Rapport från ISG Provider Lens™ visar att företag i regionen vänder sig till leverantörer av digitala företagstjänster för hjälp med analys, artificiell intelligens och annan teknik STOCKHOLM, Sverige, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Företag i Norden är inriktade på att förbättra kundupplevelse och innovation, och de vänder sig till leverantörer av digitala företagstjänster för att uppnå sina mål, enligt en ny rapport publicerad idag av Information Services Group ( ISG ) (Nasdaq: III ), ett ledande företag inom global teknikforskning och -rådgivning. Rapporten Digital verksamhet – lösningar och servicepartners2019–2020 från ISG Provider Lens™ för Norden visar att företag i regionen anammar teknik som dataanalys, artificiell intelligens, sakernas internet och blockkedja för att leverera kvalitetstjänster till sina kunder och för att utmärka sig bland konkurrenterna. ”De nordiska företagen söker transformationstjänster från IT-leverantörer för att inte bara ta dem genom sina digitala r

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer27.1.2020 07:00:00 CETPress release

·Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Basel, 27 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial. “Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tece