Press Release: Idorsia to debut at the 39th J.P. Morgan Healthcare Conference -- Major catalysts expected in the near-term -- Daridorexant NDA submitted to the US FDA

01/11/2021 | 01:00am
Jean-Paul Clozel
   --       Daridorexant new drug application (NDA) submitted to the US 
Food & Drug Administration (FDA) on January 8, 2021 
 
   Allschwil, Switzerland -- January 11, 2021 
 
   Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief 
Executive Officer of Idorsia, will present at the 39(th) J. P. Morgan 
Healthcare Conference on January 12, 2021 at 09:10 Eastern Time / 15:10 
Central European Time. The conference will take place fully virtual. 
 
   Jean-Paul will roll-out Idorsia's long-term vision and describe the 
progress made so far in delivering on the company priorities. He will 
also present why 2021 will be a key year for Idorsia with major 
catalysts expected in the near-term. Follow this 
https://jpmorgan.metameetings.net/events/healthcare21/sessions/35450-idorsia-pharmaceuticals/webcast?gpu_only=true&kiosk=true 
link to access the audio stream of the presentation. 
 
   Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented: 
 
   "We are very pleased to give our first presentation at J.P. Morgan and 
introduce Idorsia to a new audience. Building on our 20-year heritage 
from Actelion, Idorsia is reaching out for more! We have one simple 
vision: creating a sustainable mid-size pharma company based on science 
and innovation. In just a few years, Idorsia has gone from strength to 
strength and 2020 saw the company making progress on all fronts -- 
despite the COVID-19 pandemic." 
 
   Highlights of 2020 
 
 
   -- Positive results in the Phase 3 program of daridorexant, demonstrating 
      improved overall sleep and daytime functioning of patients with insomnia 
 
   -- Positive results in the Japanese registration program for clazosentan, 
      demonstrating a reduction in vasospasm-related morbidity and all-cause 
      mortality 
 
   -- US commercial operations established, with leadership team in place, and 
      Syneos Health selected as commercialization partner to launch 
      daridorexant in the US and effectively reach the primary care market 
 
   -- Neurocrine Biosciences entered into a license agreement for the 
      development and commercialization of Idorsia's novel T-type calcium 
      channel blocker 
 
   -- Successful capital increases secured over CHF 860 million of funding to 
      prepare for the launch of daridorexant and to develop our diversified 
      pipeline 
 
   Jean-Paul commented on the 2020 achievements: 
 
   "First and foremost, daridorexant gave outstanding results in insomnia 
both from an efficacy and safety perspective. Insomnia effects millions 
of people and there is no product that delivers on expectations of 
doctors or of the patients. Daridorexant has demonstrated improved 
nighttime sleep and, for the first time, improved daytime functioning, 
while keeping a favorable safety profile. Therefore, I truly believe 
that daridorexant can revolutionize the treatment of insomnia. 
Furthermore in 2020, the Japanese registration studies of clazosentan 
for patients suffering cerebral vasospasm also demonstrated excellent 
results. These are just two highlights from 2020, I'm very proud to say 
that -- even in difficult circumstances -- we reached every one of our 
ambitious goals set for the year." 
 
   Milestones to look for in 2021 
 
 
   -- Daridorexant new drug application (NDA) submitted to the US FDA on 
      January 8, 2021 
 
   -- Filing of the daridorexant market authorization application (MAA) with 
      the EMA 
 
   -- Filing of the clazosentan NDA with the Japanese PMDA 
 
   -- PDUFA for ponesimod in multiple sclerosis* 
 
   -- Results of the registration study with lucerastat for Fabry disease 
 
   -- Results of the safety & efficacy study with cenerimod for systemic lupus 
      erythematosus 
 
   -- Conclusion of recruitment of PRECISION with aprocitentan for 
      difficult-to-control hypertension 
 
   -- Initiation of Phase 3 study with selatogrel for suspected AMI 
 
   Jean-Paul commented on the outlook for 2021: 
 
   "2021 promises to be another exciting year for Idorsia. We begin with 
the excellent news that the team has finished compiling the vast amounts 
of data generated in the daridorexant development program and we have 
submitted the new drug application to the US FDA. Clearly, we have a 
laser focus on the filings and launch preparations for daridorexant in 
the US and EU, as well as clazosentan in Japan, but there is much more 
to come. This year will see the start of the large Phase 3 study with 
selatogrel for the emergency treatment of suspected heart attack and we 
will get more results from our late-stage studies with read-outs from 
the study of cenerimod for lupus, and the registration study with 
lucerastat for Fabry disease in the second half of the year." 
 
   Jean-Paul concluded: 
 
   "Our previous endeavors demonstrate that we know what it takes to 
successfully bring drugs from the lab bench to the patients' bedside and 
we have all the ingredients needed to succeed: A team that is second to 
none, a powerful drug discovery engine and rich pipeline, a global 
expert commercial organization, and strong liquidity. We have already 
delivered incredible results in our short history, but this is just the 
beginning of creating a very exciting company. So, be prepared for 
more!" 
 
   Notes to the editor 
 
   *About the Revenue Sharing Agreement for ponesimod 
 
   Idorsia and Actelion Pharmaceuticals Ltd, one of the Janssen 
Pharmaceutical Companies of Johnson & Johnson, have entered into a 
revenue-sharing agreement in respect to ponesimod. Under the terms of 
the revenue-sharing agreement, Idorsia is entitled to receive quarterly 
payments of 8% of the net sales of ponesimod products from Actelion 
Pharmaceuticals Ltd. 
 
   About the Phase 3 program with daridorexant 
 
   In April and July of 2020, Idorsia reported positive results in each of 
the two pivotal Phase 3 studies of daridorexant in patients with 
insomnia. More details and commentary can be found in the dedicated 
press releases ( 
https://www.idorsia.com/media/news-details?newsId=2284972 first study 
release), ( https://www.idorsia.com/media/news-details?newsId=2329316 
second study release) and the investor webcasts ( 
https://www.idorsia.com/investors/news-and-events/webcast-daridorexant 
first study webcast), ( 
https://www.idorsia.com/investors/news-and-events/webcast-daridorexant-302-results 
second study webcast) which are available for replay on Idorsia's 
corporate website: http://www.idorsia.com www.idorsia.com 
 
   About the Japanese registration program with clazosentan 
 
   In November of 2020, Idorsia reported positive results in each of the 
two Japanese registration studies of clazosentan in patients with 
cerebral vasospasm following aneurysmal subarachnoid hemorrhage. More 
details can be found in the dedicated 
https://www.idorsia.com/media/news-details?newsId=2410833 press release. 
 
   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 (0) 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 
 
 
   -- Press Release PDF 
      https://ml-eu.globenewswire.com/Resource/Download/b15cb75f-31d8-4871-a018-baf54d7abe23 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

January 11, 2021 01:00 ET (06:00 GMT)

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