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Idorsia presents at the 40th J.P. Morgan Healthcare Conference – Ready for first product launches – QUVIVIQ (daridorexant) approved by the US FDA

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Idorsia presents at the 40th J.P. Morgan Healthcare Conference – Ready for first product launches – QUVIVIQ (daridorexant) approved by the US FDA

  • QUVIVIQ™ (daridorexant) – 25 and 50 mg – approved by the US FDA for the treatment of adults with insomnia after demonstrating an improvement on objective measures of sleep onset and sleep maintenance, as well as an improvement in patient reported total sleep time

Allschwil, Switzerland – January10, 2022
Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive Officer of Idorsia, will present at the 40th J.P. Morgan Healthcare Conference on January 12, 2022 at 10:30 Eastern Time / 16:30 Central European Time. The conference will take place virtually.

Jean-Paul will describe the progress Idorsia is making to deliver on the company’s strategic priorities and how 2022 will be a transformative year for the company. The presentation will cover the launch preparations for the company’s first products, clazosentan in Japan and the newly approved QUVIVIQ (daridorexant) in the US. He will also present opportunities for future growth with important clinical development results expected in the near-term. Follow this link to access the audio stream.

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“The first approval of QUVIVIQ is a pivotal moment for both Idorsia as a company and adults in the US who live with insomnia. I’m particularly pleased that the 50 mg dose was approved, as it was the dose giving greatest efficacy and therefore the greatest benefit. I’m very proud of every member of the Idorsia team, who have worked with a great sense of urgency since “Day 1” of Idorsia in 2017, to ensure that we can build the company into the leading biopharmaceutical company we are destined to be. At Idorsia, with QUVIVIQ, we are going to help millions of patients and impact a wide-spread societal problem.”

Highlights to look for in 2022

  • QUVIVIQ (daridorexant) approved by the US FDA for the treatment of adults with insomnia
  • Upcoming publication of daridorexant Phase 3 clinical trials in a peer-reviewed journal
  • Conclusion of the review for clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) with the Japanese PMDA and subsequent launch, subject to approval
  • Conclusion of the review for QUVIVIQ (daridorexant) for the treatment of insomnia with other health authorities
  • Commercial launch of QUVIVIQ (daridorexant) in the US, following scheduling by the US Drug Enforcement Administration
  • Results of PRECISION, the Phase 3 registration study with aprocitentan for difficult-to-control hypertension
  • Results of the proof-of-concept study with our selective orexin 1 receptor antagonist in binge eating disorder
  • First European launches of QUVIVIQ (daridorexant), subject to approval
  • Initiation of the Phase 3 study with cenerimod for the treatment of SLE
  • Conclusion of REACT the Phase 3 registration study with clazosentan

Jean-Paul commented on the outlook for 2022:
“This is the start of a transformative year for Idorsia where we expect to launch two products in the two largest pharmaceutical markets at the same time. This will transform Idorsia into a fully-fledged biopharmaceutical company and put sustainable profitability within reach. All eyes will be on the US launch of QUVIVIQ to see how Idorsia intends to disrupt the treatment paradigm in insomnia. I have absolute confidence in the launch preparation, we have a fantastic product, a world-class team – hand-picked and focused on delivering success – and an ambitious launch plan which focusses on the consumer, communicating the importance of a good night sleep – and better days.”

Jean-Paul concluded:
“We will achieve all this whilst continuing to expand our product portfolio, which will be key for our future growth trajectory.”

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 a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1’000 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
investor.relations@idorsia.com
media.relations@idorsia.com
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.


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