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

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 – January 10, 2022
Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive Officer of Idorsia, will present at the 40^th 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.”