2020

19.03.2020 – Idorsia Ltd

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

  • 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


schliessen